A A Pharma Inc.Abbott Laboratories LimitedAbbott Diabetes CareManufacturer name not currently availableAbiogen PharmaManufacturer name not currently availableAlbert Pharma Inc - " DO NOT USE "AbbVie CorporationAccel Pharma Inc.Accord Healthcare Inc.Acon Laboratories IncorporatedAccelera Pharma Canada, Inc.Actelion Pharmaceutiques Canada Inc.Actavis Pharma CompanyAscensia Diabetes Care Canada Inc.Adria Laboratories of Canada Ltd.Manufacturer name not currently availableAdvanz Pharma Canada Inc.AEterna Zentaris Inc.Agila Specialties Pvt. Ltd.Agnes Pharmaceutical Products Inc.Agouron Pharmaceuticals Canada Inc.Actavis Group PTC ehfManufacturer name not currently availableAgila-Jamp Canada Inc.Akcea Therapeutics, Inc.Akorn Pharmaceuticals Canada Inc. - "DO NOT USE"Manufacturer name not currently availableAltana Pharma Inc.Albert Pharma Inc. - "DO NOT USE"Alcon Canada Inc.Alexion Pharmaceuticals Inc.Alexion Pharma GMBHAltius Healthcare Inc.ALK-Abello A/SAllergan Inc.Almirall LimitedAlnylam Netherlands B.V.AllerPharma Inc.Altimed Pharmaceutical CompanyAlveda Pharmaceuticals Inc.ALZA CanadaAmada (Nutritional Products)Ambicare Pharmaceuticals Inc.Allmedicus Co., Ltd.Amdipharm LimitedAmgen Canada Inc.Amphastar Pharmaceuticals Inc.Amicus Therapeutics UK Ltd., BuckinghamshireAmylyx Pharmaceuticals Inc.Analog Pharma Canada Inc.Manufacturer name not currently availableAngita Pharma Inc.Acerus Pharmaceuticals CorporationApoPharma Inc.APP Pharmaceuticals LLCAtnahs Pharma UK LimitedApotex Inc.ARA Pharmaceuticals Inc.Argeny Canada Inc.Aralez Pharmaceuticals Canada Inc.Actavis Specialty Pharmaceuticals Co.Astellas Pharma Canada Inc.Aspen Pharmacare Canada Inc.Ascend Laboratories Ltd.Aspen Pharma Trading LimitedAspri Pharma Canada Inc.Astra Pharma Inc.Astra Zeneca - "DO NOT USE"Aton Pharma Inc.Auro Pharma Inc.Auto Control MedicalAventis PharmaAventis Pasteur Limited (S8)Avir Pharma Inc.Advanced Vision Research, Inc. (S8)Axcan Pharma Inc.Axxess Pharma Inc.Ayerst Laboratories, Division of Ayerst, McKenna & HarrisonAstraZenecaAstraZeneca USABaxter Corporation - Clintec Nutrition Division (S8)Bayer Inc., Health Care DivisionBaker Cummins IncBayer Healthcare LLC Subsidiary of Bayer CorporationBarr Laboratories Inc.Bausch & Lomb Canada Inc. - "DO NOT USE"Baxter CorporationBayer Inc., Consumer Care DivisionManufacturer name not currently availableBaker Cummins Inc. - "DO NOT USE"Biosimilar Collaborations Ireland LimitedBioCryst Pharmaceutical IncManufacturer name not currently availableBD Consumer HealthcareManufacturer name not currently availableBeiGene Switzerland GmbHBerlex Canada Inc. - "DO NOT USE"Berlex Canada IncAxcan Pharma Inc.BGP Pharma ULCBausch Health Canada Inc.Biocodex SABiogen Idec Canada Inc.Biomed 2002 Inc.BioMarin International Ltd.Bionime CorporationBiovail Pharmaceuticals CanadaBiosyent Pharma Inc.Draxis Health Inc.Bausch & Lomb Inc.Biomarin International LimitedBiomed PharmaBristol-Myers Squibb Canada Inc. - "DO NOT USE"Bioniche Pharma (Canada) Ltd. (S8)BioNTech Manufacturing GmbHManufacturer name not currently availableBoehringer-Ingelheim (Canada) Ltd./LteeBoehringer - Mannheim CanadaBoots Pharmaceuticals - "DO NOT USE"Bristol Myers Squibb Canada IncB. Braun Medical Inc. (S8)Bard Pharmaceuticals (1990) Inc.Bristol-Myers Squibb Canada Inc. Nutritional Div. OttawaBicon SDN. BHD.Bausch & Lomb Canada IncBauch & Lomb Surgical Inc. (S8)Burroughs Wellcome Inc.Byk Canada Inc.Ajinomoto Cambrooke, Inc.C.B. Fleet Company Inc.Manufacturer name not currently availableCIBA VisionClement Clark International Ltd.CellChem Pharmaceuticals Inc.Church & Dwight Canada Corp., Inc.Concordia Laboratories Inc.Canderm Pharmacal Ltd./Ltee - "DO NOT USE"Canderm Pharmacal LtdCelltrion Healthcare Co. Ltd.Celltrion Inc.Celgene Inc.Centocor Ortho Biotech IncCephalon Inc.Manufacturer name not currently availableCiba-Geigy Self Medication ProductsCheplapharm Arzneimittel GmbHChiesi Canada Corp.Church and Dwight Canada Corp.Ciba Pharmaceuticals, Division of Ciba-Geigy Canada Ltd.Chilcott Laboratories-Division of Warner-Lambert Canada Inc.Cipher Pharmaceuticals Inc.Clinigen Healthcare Ltd.Clark Laboratory - "DO NOT USE"Clintec (Non-Formulary) - " DO NOT USE"Cosmair Canada Inc.Manufacturer name not currently availableCan-Med Pharma Inc.Manufacturer name not currently availableConnaught Novo Nordisk Canada Inc. - "DO NOT USE"Cobalt Pharmaceuticals CompanyColumbia LaboratoriesPasteur Merieux Connaught CanadaCovis Pharma GmbHCovis Pharma B.V.Clay-Park Labs Inc.Crystaal Corp.CSL Behring Canada, Inc.Custom Pharmaceuticals - "DO NOT USE"Cubist PharmaceuticalsChauvin Pharmaceuticals Limited (S8)Cycle Pharmaceuticals Ltd.Cytex Pharmaceutical Co.DAC PharmaceuticalsDavid Bull Laboratories - "DO NOT USE"David Bull Laboratories (Canada) Inc.DC LabsDdrops CompanyDeciphera Pharmaceuticals, LLCDermik Laboratories Canada Inc.Desbergers LimitedDexcom Inc.Dioptic Laboratories, Division of Akorn Pharmaceuticals CanaL. P. Dey (S8)Dupont Merck Pharma (Endo Canada Division) - "DO NOT USE"Dominion PharmacalDPT Laboratories - "DO NOT USE"Dupont Merck Pharma - "DO NOT USE"Dermtek Pharmaceuticals Ltd.Manufacturer Name currently not availableDr. Reddy's Laboratories Inc.Drug Trading Company Ltd. - "DO NOT USE"Duchesnay Inc.Du Pont PharmaManufacturer name not currently availableECL Pharma Group Ltd.Endo Canada Division Du Pont Merck PharmaEndoManufacturer name not currently availableEntra Health Systems.Eisai LimitedElan Pharmaceuticals, Inc.Manufacturer name not currently availableElan Pharma International Ltd.Elvium Life SciencesEMD Serono Canada Inc.Endoceutics Inc.Enzon Inc. (S8)Endo Operations Ltd.Endo Par Innovation Company, LLCErfa Canada Inc.Ethypharm Inc.Euro GenericsEugia Pharma Inc.Euro-Pharm International CanadaEndo Ventures Ltd.Evans Medical Ltd.Fabrigen Inc.Famy Care LtdFaulding Canada Inc.Ferring Inc.Manufacturer name not currently availableFisons Corporation LimitedFresenius Kabi Canada Ltd.Boots Pharmaceuticals Ltd.Formative Pharma Inc.Forus Therapeutics Inc.Fournier Pharma Inc.Merck Frosst Canada & Cie, Merck Frosst Canada & Co.Fujisawa Canada Inc.Galderma Canada IncGalderma - "DO NOT USE"Manufacturer name not currently availableGlaxoSmithKline Consumer Healthcare Inc.GlaxoSmithKline Consumer Healthcare ULCManufacturer name not currently availableGenDerm Canada Inc. - "DO NOT USE"Geigy Pharmaceuticals,Division of Ciba-Geigy Canada Ltd.Genmed, A Division of Pfizer Canada Inc.Genpharm Inc.Genentech Inc. - "DO NOT USE"Genzyme - "DO NOT USE"Gilead Sciences Canada, Inc.Glaxo Canada Inc.Glenwood Laboratories Canada Ltd. - "DO NOT USE"Glades, Division of Stiefel Canada Inc. - "DO NOT USE"Glenwood Laboratories Canada LtdGlenmark Pharmaceuticals Canada Inc.Glaxo Wellcome Inc.Generic Medical Partners Inc.Gentes and Bolduc PharmaciensG Pohl Boskamp GMBH & Co KG, hohenlockstedtGlenwood GmbH Pharmazeutische ErzeugnisseManufacturer name not currently availableGraceway PharmaceuticalsGrifols Therapeutics Inc.GlaxoSmithKline Inc., GlaxoSmithKline Consumer Health CareGlaxoSmithKline Shire BiochemGW Pharma LimitedGenzyme Canada Inc.Halewood Chemicals LimitedLes Lab Charton, Division of Herdt & Charton - "DO NOT USE"Healthcomm International Inc. (S8)Healthpoint CanadaManufacturer name not currently availableHEYL Chemisch-pharmazeutische Fabrik GmbH & Co. KGHikma Canada LimitedHill Dermaceuticals Inc.H.J. Sutton Industries Ltd.Hollister Stier Laboratories LLCHaleon Canada ULCHoffmann-La Roche LimitedHLS Therapeutics Inc.Manufacturer name not currently availableHoechst Marion Roussel Canada Inc.Hoechst Canada Inc.,Pharmaceutical Div.(Hoechst-Roussel CanaManufacturer name not currently availableHome Diagnostics IncHope Pharmaceuticals Ltd.Frank W. Horner Inc.Hospira Healthcare Corporation.Horizon Therapeutics Ireland DCHorizon Pharma Ireland Ltd.HRA Pharma Rare DiseasesHoechst-Roussel Canada Inc.Manufacturer name not currently availableICN Canada LimitedID Biomedical Corporation of Quebec.Ideal Life Inc.Ignite Pharma Inc.Immunotech Research Ltd.Immunex CorporationIncyte CorporationIndivior UK LimitedInterfalk Canada Inc. - "DO NOT USE"Manufacturer name not currently availableiNova PharmaceuticalsIntercept Pharmaceuticals Inc.Manufacturer name not currently availableInspiRx Inc.InterMune Canada, Inc.Iolab Canada Inc.Manufacturer name not currently availableIpsen Biopharmaceuticals Canada Inc.Insight Pharmaceuticals CorporationInsight Pharmaceuticals, LLCIpsen LimitedI-Sens, Inc.Ivax Laboratories IncorporatedJacobus Pharmaceutical Company Inc.Johnson & Johnson IncJamieson Laboratories Ltd.Janssen Inc.Manufacturer name not currently availableJazz Pharmaceuticals Canada Inc.Chiron Canada ULC (S8)JHP Pharmaceuticals LLCJanssen-Ortho Inc.Jouveinal Inc.Jamp Pharma CorporationJuno Pharmaceuticals Corp.Kaleo Inc.Kabi PharmaciaKey Pharmaceuticals,Div.of Schering Canada Inc.Manufacturer name not currently availableKnoll Pharma Inc. - "DO NOT USE"Knoll Pharma Inc.Kenral Inc.,Division of The Upjohn Company of CanadaKnight Therapeutics Inc.Kremers-Urban (Canada) - "DO NOT USE"Manufacturer name not currently availableKVR PharmaceuticalsKYE Pharmaceuticals Inc.Kyowa Kirin LimitedKyowa Kirin, Inc.Laboratoire Atlas Inc.Labopharm Inc.Laboratoires Fournier S.A.Laboratoires Trianon Inc.Leadiant Biosciences, Inc.Laboratoires TheaLeda Health Innovations Inc.Lee-Adams Lab.Lederle Division-of Cyanamid Canada Inc.Leo Pharma Inc.Lifescan Canada Ltd.Eli Lilly Canada Inc.Linepharma International LimitedLIOH Inc.The Liposome Company Inc. (S8)Linson Pharma Inc.Loxo Oncology, Inc.Luitpold Pharmaceuticals Inc.Lundbeck Inc.Lupin Pharma Canada LimitedLaboratoire X.OManufacturer name not currently availableMeda ABMallinckrodt Canada ULCPaul Maney Labs., Division of Canapharm Ind. Inc.Marcan Pharmaceuticals Inc.Mantra Pharma Inc.Mayne Pharma (Canada) Inc.Medicago Inc.McNeil Consumer Products Co.Manufacturer name not currently availableManufacturer name not currently availableMedfhar Inc.MDA Inc.Medunik CanadaManufacturer name not currently availableManufacturer name not currently availableMedexus Inc.Meta Pharmaceuticals Inc.Medicis Canada Ltd.Medisense Canada Inc.Medical Futures Inc.MediHub International Inc., AjaxMedican PharmaMerck Canada Inc.MeliaPharm Inc.Medical Mart Supplies - "DO NOT USE"Mendelikabs Inc.MedTech Products Inc.Merrell Dow Pharmaceuticals (Canada) Inc.Medican Technologies Inc.Merus Labs Inc.Meda Valeant Pharma Canada Inc.Merz Pharmaceutical GmbhMerck Frosst Canada Ltd.Merck Frosst/Schering Pharma GPMGI Pharma Inc.Mitsubishi Tanabe Pharma CorporationMint Pharmaceuticals Inc.Miles Canada Inc Pharmaceutical Division - "DO NOT USE"Miles Canada Inc.Diagnostic Division - "DO NOT USE"Miles Canada Inc., Pharmaceuticals DivisionMead Johnson & Company LLCMead Johnson NutritionalsManufacturer name not currently availableMead Johnson Canada3M Pharmaceuticals, Division 3M Canada Inc.MM Therapeutics Inc.Medical Mart Supplies LtdModerna Biopharma Canadian CorporationModerna Therapeutics Inc.Med-O-Gen Medical Inc.Mission Pharmacal CompanyMayne Pharma (Canada) Inc. (S8)Medexus Pharmaceuticals Inc.Merit Pharmaceuticals - "DO NOT USE"Marion Merrell Dow CanadaMerck Sharp & Dohme Canada, Division of Merck Frosst CanadaMylan Pharmaceuticals ULCMylan Specialty LPManufacturer name not currently availableNatco Pharma (Canada) Inc.Nadeau Laboratory Ltd.Nestle Canada Inc.Manufacturer name not currently availableNephro-Tech, Inc. (S8)Nestle Health ScienceNeuraxpharm Arzneimittel GmbHNext Generation Pharma Inc.Novartis Vaccines And Diagnostics Inc.Nova Biomedical Corporation.Novartis Nutrition CorporationNovo Nordisk Canada IncNovopharm Ltd.Novartis Pharma Canada Inc.Manufacturer name not currently availableNutravite Pharmaceuticals Inc.NPS Pharma Holding Limited.Nora PharmaNordic Laboratories Inc., Marion Merrell Dow (Canada) Inc.Nestle Enterprises S.A.NT Pharma Canada LtdNutricia North AmericaNovavax Inc.Nu-Pharm Inc.Nycomed Canada Inc.Organon Canada Inc.Manufacturer name not currently availableOdan Laboratories Ltd.Organon Teknika Canada IncOrganon Sanofi-Synthelabo CanadaOrtho McNeilOmega Laboratories Ltd.OptimaPharma, a Division of Taro Pharmaceuticals Inc.OPI S.A.Optimer Pharmaceuticals Canada Inc.Orchid HealthcareOrganon Canada Ltd./LteeOrimed PharmaOrphan Medical Inc. (S8)Manufacturer name not currently availableOryx Pharmaceuticals Inc.Organon Teknika Inc. - "DO NOT USE"Otsuka Pharmaceutical Co. Ltd.Ovation Pharmaceuticals Inc.Paladin Labs Inc.PAR PharmaceuticalPatriot, A Division of Janssen Inc.Pathogenesis Canada Ltd.Pharmalab (1982) Inc. (S8)Manufacturer name not currently availableParke-Davis,Division Warner-Lambert Canada Inc.Pro Doc Laboratories - "DO NOT USE"Pediapharm Licensing Inc.Pendopharm, Division of Pharmascience Inc.Perrigo InternationalPfizer Consumer HealthcarePierre Fabre Dermo-Cosmetique Canada Inc.Pfizer Canada Inc.Purdue PharmaPurdue Frederick Inc.Proctor & Gamble Inc.PanGeo Pharma (Canada) Inc.Proctor & Gamble Pharmaceuticals Canada, Inc.Pharmacia Canada Inc.Phebra CanadaPharmacosmos A/SManufacturer name not currently availablePharmel Inc.pharmaand GmbHPharmetics (2011) Inc.Pharmaco Canada Inc. - "DO NOT USE"Pharmapar Inc.Pharmaco Canada IncPharma Stulln Inc.Pharmacia & UpjohnPharmascience Inc.Pharmetics Inc. (S8)Pharmavite Lab. - "DO NOT USE"Manufacturer name not currently availablePharmaceutical Partners of CanadaPaladin Pharma Inc.Pro Doc LimiteePrempharm Inc.Proval Pharma Inc.Pharmaris Canada Inc.Pharmavite CorporationManufacturer name not currently availableQuality Home Products, a division of H.J. Sutton Ind. Ltd.Questcor Operations Ltd.Quest Vitamins, Division of Pangeo Health Brands Inc. (S8)Ratiopharm Inc. (DO NOT USE)Ranbaxy Pharmaceuticals Canada Inc.RB Pharmaceuticals Ltd.Roberts Pharmaceutical of Canada Inc.Reed & Carnrick,Division of Block Drug Company (Canada) Ltd.Roche Diabetes Care GmbHReddy-Cheminor Inc.Recordati Rare Diseases Inc.Rekah Pharmaceuticals Industry Ltd.Rhoxalpharma Inc.Rhodiapharm Inc.Rhythm Pharmaceuticals Inc.Laboratoire Riva Inc.Richmond Pharmaceuticals Inc.Manufacturer name not currently availableRichmond Pharmaceuticals Inc.Rivex Pharma Inc.Manufacturer name not currently availableManufacturer Name currently not availableRoche Diagnostics, a division of Hoffmann-La Roche LimitedRougier Pharma, Division of Ratiopharm Inc.Romark LaboratoriesRoberts Pharmaceutical - "DO NOT USE"Rhone-Poulenc Rorer Consumer Inc. - "DO NOT USE"Ross Laboratories-Abbott (Nutritional Products)Roussel Canada Inc.(Hoechst-Roussel Canada Inc.)C. A. Roy Limited - "DO NOT USE"Ratiopharm Inc.Rhone-Poulenc Rorer-Ethical DivisionRhone-Poulenc Rorer Consumer Inc.Respironics Respiratory Drug Delivery (UK) Ltd.Sabex Inc. - "DO NOT USE"Sanofi-Aventis Canada Inc.Savient Pharmaceuticals Inc.Sanofi Pasteur Limited.Sanofi Genzyme, a Division of Sanofi-Aventis Canada Inc.Sanis Health Inc.Salix Pharmaceuticals Inc.Samsung Bioepis Co. LtdSandoz Canada Inc. - "DO NOT USE"Sanofi Canada Inc.Sanofi - Synthelabo Canada Inc.Santen Inc.Sanofi Aventis PharmaSanofi Winthrop - "DO NOT USE"Shire BioChem Inc.STIEFFEL BCD PHARMAManufacturer name not currently availableSchein PharmaceuticalSchering Canada Inc.Manufacturer name not currently availableManufacturer name not currently availableSanofi Consumer Health Inc.Schering-Plough Canada Inc.Shoppers Drug MartStanley Pharmaceuticals Ltd.Sandoz Canada Inc.Searle Canada Inc.Seaford Pharmaceuticals IncSeattle Generics Inc.Sepracor Pharmaceuticals Inc.Seqirus PTY LTD.Manufacturer name not currently availableSepta Pharmaceuticals Inc.Servier Canada Inc.Seagen Inc.Shenzhen Techdow Pharmaceutical Co., Ltd.Shire Human Genetic Therapies Inc.Shire Pharma Canada ULCSHS International Ltd.Sherwood Inc.Shionogi Inc.SHS North AmericaSigma-Tau Pharmaceutical Inc.Sabex 2002 IncSivem Pharmaceuticals ULCSmithKline Beecham Consumer Healthcare.Seaford Pharmaceuticals Inc. (S8)Skymed CorporationManufacturer name not currently availableSolvay Kingswood Inc. - "DO NOT USE"Searchlight Pharma Inc.Smith Kline Beecham Pharma IncSumitomo Pharma Canada INC.Smith & Nephew Inc.Solvay Kingswood Inc. - "DO NOT USE"Sorres Pharma Inc.Shire Orphan Therapies Inc.Sun PharmaSun Pharma Global FZESolvay Pharma Inc.Shire Pharmaceuticals Ireland Limited.Squire Pharmaceuticals Inc.Manufacturer name not currently availableSerono Canada Inc.Stason Pharmaceuticals Inc., IrvineSterimax Inc.Sterling HealthStiefel Canada Inc.Stallergenes Canada Inc.Sterinova Inc.Strides Pharma Canada Inc.Manufacturer name not currently availableSun Pharmaceutical IncSunovion Pharmaceuticals Canada Inc.Supplements Aromatik Inc.Swedish Orphan BioVitrumSwiss Herbal Remedies Ltd.Syntex Inc.SynCare Pharmaceutical Inc.Taiho Pharma Canada Inc.Taidoc Technology CorporationTakeda Canada Inc.Tanta Pharmaceutical Co.TAP PharmaceuticalsTaro Pharmaceuticals Inc.Tanvex BioPharma USA, Inc.Teva Branded Pharmaceutical Products R&D Inc.Trans Canaderm Inc.Technilab Inc.Teligent Canada Inc.Teva Canada Innovation.Teligent OUTeligent Pharma Inc.Therasense Canada Inc.Teva Canada LimitedTeva Women's Health Inc.Theramed CorporationThrombogenics NVThermor Ltd.Tican Pharmaceuticals Ltd.Tillomed Laboratories Ltd.Tillotts Pharma AGTEVA Pharmaceutical Industries Ltd.Laboratory Trianon Inc. - "DO NOT USE"Trudell Medical International3M Pharmaceuticals/3M Canada Inc. - "DO NOT USE"Tolmar International Ltd.Takeda Pharmaceuticals America Inc.Tillotts Pharma GMBH:TaroPharma, a Division of Taro Pharmaceuticals Inc.Manufacturer name not currently availableTremblay Harrison Inc.Trillium Health Care Products Inc.Trophic Canada Ltd.TerSera Therapeutics LLCTriton Pharma Inc.UCB Canada Inc.Ucyclyd PharmaUpjohn Canada ULCUltragenyx Pharmaceuticals Inc.Unimed Canada Inc.Univar Ltd.The Upjohn Company of CanadaManufacturer name not currently availableManufacturer name not currently availableUnited Therapeutics Corporation (S8)Valeo Pharma Inc.Valeant Canada Ltd.Vanc Pharmaceuticals Inc.Vertex Pharmaceuticals (Canada) Inc.Verity Pharmaceuticals Inc.Vita Health Products Inc. (S8)Viatris CanadaVifor Fresenius Medical Care Renal Pharma Ltd.ViiV Healthcare ULCVita Health Products Inc.Vifor (International) Inc.Vitaflo USA, LLCVivus Inc.Viva PharmaceuticalsLundbeck Canada Inc.VPI Pharmaceuticals Inc.Virco Pharmaceutical (Canada) Inc.Waymar Pharmaceuticals Inc.Manufacturer name not currently availableWampoleWarner Chilcott Canada Co.Watson Laboratories Inc.Wyeth PharmaceuticalsManufacturer name not currently availableWomen's Capital CorporationWellSpring Pharmaceutical Canada Corp.Whitehall-Robins IncManufacturer name not currently availableWinthrop LaboratoriesWarner-Lambert - "DO NOT USE"Manufacturer name not currently availableWN Pharmaceuticals Ltd.Wockhardt UK Ltd. (S8)Whitehall-Robins Inc. - "DO NOT USE"Manufacturer name not currently availableWestwood Squibb PharmaceuticalsWestcan Pharmaceuticals - "DO NOT USE"Wyeth-Ayerst Canada Inc.Wyeth Ltd.Waymade PLCXediton Pharmaceuticals Inc.Xenex Laboratories Inc.Manufacturer cannot be identifiedBaxter AG (S8)Manufacturer for Gov't Pharmacy ItemsZydusZeneca Pharma Inc.Zila Pharmaceuticals Inc.Zogenix, Inc.ZR Pharma & GMBHZymcan Pharmaceuticals Inc.ANTIHISTAMINESBILASTINE00012.5mg/mLOral SolJamp Bilastine Oral SolutionJPC.16262026-03-31BlextenARZ2026-03-31000220mgTabBlextenARZ2024-12-30Sandoz BilastineSDZ1.12402024-12-30Auro-BilastineAUR1.12292025-01-31GLN-BilastineGLP1.12432024-12-30Jamp-BilastineJPC1.12402024-12-30Mar-BilastineMAR1.12402024-12-30M-BilastineMAT1.12402024-12-30Apo-Bilastine TabletsAPX1.12402024-12-30NRA-BilastineNRA1.12432024-12-30CETIRIZINE HYDROCHLORIDE000310mgTabReactineMCL2007-12-19Apo-CetirizineAPX.40832007-12-19Extra Strength Allergy ReliefPMS.39382009-11-13Mar-CetirizineMAR.40832014-10-29Jamp-CetirizineJPC.40832016-08-30Nat-CetirizineNAT.40832020-05-29Jamp CetirizineJPC.40832022-07-29000420mgTabReactineMCL2008-12-23PMS-CetirizinePMS.75352008-12-23Mar-CetirizineMAR.75352014-10-29Apo-CetirizineAPX.75352016-06-29Jamp-CetirizineJPC.75352017-10-30Mint-CetirizineMIN.75352020-02-28Nat-CetirizineNAT.75352020-05-29M-CetirizineMAT.75352021-11-30CetirizineSAI.75352021-07-30Jamp Cetirizine TabletsJPC.75352022-05-31NRA-CetirizineNRA.75352022-05-31Teva-CetirizineTEV.75352022-11-30NRA-Cetirizine TabletsNRA.75352023-05-31CetirizineSIV.75352023-09-28LORATADINE000510mgTabClaritinSCP2007-12-19Apo-LoratadineAPX.62672007-12-19.6267RUPATADINE000610mgTabRupallMPI2025-03-31PMS-RupatadinePMS.99932025-03-31Apo-RupatadineAPX.99932025-03-31Riva-RupatadineRIA.99932025-12-30ANTI-INFECTIVE AGENTSANTHELMINTICSMEBENDAZOLE0007100mgTabVermoxJAN10.49501996-10-0110.4950ANTIBIOTICS ANTIFUNGALSAMPHOTERICIN B0008Inj Pd-50mg PkFungizoneCHE104.05111996-10-01104.0511CASPOFUNGIN ACETATE000950mg/VialInj-Vial PkCancidasFRS2017-08-30Caspofungin for InjectionJUN222.00002017-08-30222.0000Caspofungin for InjectionFKC222.50002020-05-29222.5000FLUCONAZOLE001010mg/mLO/LDiflucan P.O.S.PFI1.36541999-04-151.3654For patients who are unable to swallow or tolerate solid oral dosage forms.LU Authorization Period: 1 year001150mgTab2.5808DiflucanPFI1996-10-01Teva-FluconazoleTEV1.29042.58082003-04-161.2904Apo-FluconazoleAPX1.29042.58081999-09-151.2904Mylan-FluconazoleMYL1.29042.58082003-04-161.2904PMS-FluconazolePMS1.29042.58082003-01-301.2904Act FluconazoleACV1.29042.58082008-01-151.2904FluconazoleSAI1.29042.58082022-03-311.2904FluconazoleSIV1.29042.58082023-12-291.29040012100mgTab2.2891DiflucanPFI1996-10-01Teva-FluconazoleTEV2.28912.28912003-04-162.2891Apo-FluconazoleAPX2.28912.28911999-09-152.2891Mylan-FluconazoleMYL2.28912.28912003-04-162.2891PMS-FluconazolePMS2.28912.28912003-01-302.2891Act FluconazoleACV2.28912.28912008-01-152.2891FluconazoleSAI2.28912.28912022-03-312.2891FluconazoleSIV2.28912.28912023-12-292.2891ITRACONAZOLE0013100mgCapSporanoxJAN6.67501996-10-013.9270Mint-ItraconazoleMIN3.92702017-07-313.9270001410mg/mLOral SolSporanoxJAN1998-12-31Jamp Itraconazole Oral SolutionJPC.41112020-04-30.4111Odan-ItraconazoleODN.41112020-08-28.4111For patients who are unable to swallow or tolerate solid oral dosage forms. LU Authorization Period: 1 yearKETOCONAZOLE0015200mgTab.9393NizoralJANA low pH is necessary for absorption. Antacids, anticholinergics/antispasmodics, H2-blockers, and omeprazole may decrease absorption. Ketoconazole is a potent inhibitor of hepatic oxidation of drugs and may cause significant elevation of blood levels of astemizole, cisapride, cyclosporine, terfenadine, theophylline and warfarin. Potentially fatal arrhythmias (torsade de pointes) can occur with the combination of ketoconazole and astemizole, cisapride or terfenadine. Insulin requirements may be reduced. Hepatotoxicity occurs in approximately 1 in 1500 patients treated with ketoconazole for onychomycosis; female gender, pre-existing disease, alcoholism and greater than 2 weeks of therapy are pre-disposing factors.1996-10-01Teva-KetoconazoleTEV.9393.9393A low pH is necessary for absorption. Antacids, anticholinergics/antispasmodics, H2-blockers, and omeprazole may decrease absorption. Ketoconazole is a potent inhibitor of hepatic oxidation of drugs and may cause significant elevation of blood levels of astemizole, cisapride, cyclosporine, terfenadine, theophylline and warfarin. Potentially fatal arrhythmias (torsade de pointes) can occur with the combination of ketoconazole and astemizole, cisapride or terfenadine. Insulin requirements may be reduced. Hepatotoxicity occurs in approximately 1 in 1500 patients treated with ketoconazole for onychomycosis; female gender, pre-existing disease, alcoholism and greater than 2 weeks of therapy are pre-disposing factors.2000-01-17.9393Apo-KetoconazoleAPX.9393.9393A low pH is necessary for absorption. Antacids, anticholinergics/antispasmodics, H2-blockers, and omeprazole may decrease absorption. Ketoconazole is a potent inhibitor of hepatic oxidation of drugs and may cause significant elevation of blood levels of astemizole, cisapride, cyclosporine, terfenadine, theophylline and warfarin. Potentially fatal arrhythmias (torsade de pointes) can occur with the combination of ketoconazole and astemizole, cisapride or terfenadine. Insulin requirements may be reduced. Hepatotoxicity occurs in approximately 1 in 1500 patients treated with ketoconazole for onychomycosis; female gender, pre-existing disease, alcoholism and greater than 2 weeks of therapy are pre-disposing factors.1999-09-15.9393MICAFUNGIN SODIUM001650mg/VialInj Pd-10mL Vial PkMycamineSDZ2023-09-28Micafungin Sodium for InjectionJUN93.10002023-09-2893.1000Micafungin Sodium for InjectionOMG93.10002025-12-3093.10000017100mg/VialInj Pd-10mL Vial PkMycamineSDZ2023-09-28Micafungin Sodium for InjectionJUN186.20002023-09-28186.2000Micafungin Sodium for InjectionOMG186.20002025-12-30186.2000NYSTATIN0018100000U/mLO/L.2072MycostatinBQU1996-10-01Ratio-NystatinRPH.0518.20721997-10-31.0518Jamp-Nystatin Oral Suspension USPJPC.0518.20722021-11-30.0518POSACONAZOLE0019100mgDR TabPosanolMEK53.76422021-01-2942.6030Sandoz PosaconazoleSDZ42.60302021-01-2942.6030GLN-PosaconazoleGLP42.60302023-11-3042.6030Taro-PosaconazoleTAR42.60302024-05-3142.6030Mint-PosaconazoleMIN42.60302024-08-3042.6030002040mg/mLO/LPosanolSCP10.18012023-03-318.2765Jamp PosaconazoleJPC8.27652023-03-318.2765TERBINAFINE HCL0021250mgTabLamisilNOV2007-12-19Apo-TerbinafineAPX.77142007-12-19.7714Teva-TerbinafineTEV.77142007-12-19.7714Co TerbinafineCOB.77142007-12-19.7714PMS-TerbinafinePMS.77142009-09-30.7714Auro-TerbinafineAUR.77142011-09-15.7714TerbinafineSAI.77142011-08-04.7714TerbinafineSIV.77142020-11-30.7714VORICONAZOLE002250mgTabVfendPFI13.56352005-09-276.7818Sandoz VoriconazoleSDZ6.78182014-05-296.7818Jamp VoriconazoleJPC6.78182022-11-306.78180023200mgTabVfendPFI54.23232005-09-2726.4807Sandoz VoriconazoleSDZ26.48072014-05-2926.4807Jamp VoriconazoleJPC26.48072022-11-3026.4807Outpatient continuation of treatment for documented invasive aspergillosis in patients who have demonstrated a clinical response to either oral or parenteral voriconazole. * The first prescription must be written by a physician based at the hospital where the patient was hospitalized. Note: Limited to 3 months of reimbursement.LU Authorization Period: 1 yearANTIBIOTICS CARBAPENEMSMEROPENEM00241g/VialPd for Inj SolMerremPFI2021-04-30Meropenem for InjectionSDZ47.99002021-10-2947.9900Meropenem for Injection, USPFKC47.99002025-08-2947.9900Taro-MeropenemSPC47.99002021-04-3047.9900Meropenem for InjectionSTE47.99002021-09-3047.9900Meropenem for InjectionJPC47.99002024-03-2847.99000025500mg/VialPd for Inj SolMerremPFI2021-04-30Meropenem for InjectionSDZ23.99502021-10-2923.9950Meropenem for Injection, USPFKC23.99502025-08-2923.9950Taro-MeropenemSPC23.99502021-04-3023.9950Meropenem for InjectionSTE23.99502021-09-3023.9950ANTIBIOTICS ERYTHROMYCINSErythromycin alone is not adequate for the treatment of H. influenzae infections. It lacks consistently reliable activity against this organism. Erythromycin is a potent inhibitor of hepatic oxidation of some drugs and may cause significant elevation of blood levels of astemizole, carbamazepine, cyclosporine, digoxin, dihydropyridines, terfenadine, theophylline and warfarin. Potentially fatal arrhythmias (torsade de pointes) can occur with the combination of erythromycin and astemizole or terfenadine.AZITHROMYCIN0026100mg/5mLO/L-15mL PkZithromaxPFI17.64151997-08-288.8208Sandoz AzithromycinSDZ8.82082010-04-238.8208Auro-AzithromycinAUR8.82082020-04-308.82080027200mg/5mLO/L-15mL PkZithromaxPFI24.98851997-08-2812.4943Sandoz AzithromycinSDZ12.49432010-04-2312.4943Auro-AzithromycinAUR12.49432020-04-3012.49430028200mg/5mLO/L-22.5mL PkZithromaxPFI37.48282009-03-0218.7425Sandoz AzithromycinSDZ18.74252010-04-2318.7425Auro-AzithromycinAUR18.74252020-04-3018.74250029200mg/5mLO/L-37.5mL PkZithromax 200mg/5mL oral solution is not commercially available in the 37.5mL pack size and it is only shown in this interchangeable category to facilitate the interchangeability designation with Auro-Azithromycin 200mg/5mL - 37.5mL pack.ZithromaxPFI2020-05-29Auro-AzithromycinAUR31.23752020-05-2931.23750030250mgTabZithromaxPFI5.43821999-04-15.9410Apo-AzithromycinAPX.94102006-01-24.9410PMS-AzithromycinPMS.94102006-03-01.9410Sandoz AzithromycinSDZ.94102006-01-24.9410Novo-AzithromycinNOP.94102006-01-24.9410Riva-AzithromycinRIA.94102021-08-31.9410AzithromycinSAI.94102011-08-04.9410Apo-Azithromycin ZAPX.94102014-01-30.9410AzithromycinSIV.94102020-04-30.9410Jamp-AzithromycinJPC.94102016-11-30.9410Mar-AzithromycinMAR.94102016-11-30.9410NRA-AzithromycinNRA.94102020-06-30.9410AG-AzithromycinANG.94102020-10-30.9410M-AzithromycinMAT.94102021-08-31.9410AzithromycinDAC.94102026-02-27.94100031600mgTabZithromaxPFI1998-12-31PMS-AzithromycinPMS10.66522011-10-2510.6652For the prevention of disseminated Mycobacterium avium complex (MAC) disease in persons with advanced HIV infections.LU Authorization Period: 1 yearCLARITHROMYCIN0032500mgER Tab2.5144Biaxin XLBGP2.56725.13442003-01-301.2572Act Clarithromycin XLACV1.25722.51442014-12-181.2572Apo-Clarithromycin XLAPX1.25722.51442014-10-291.25720033125mg/5mLPed Gran2.3880BiaxinBGP.35003.50001997-08-28.2388Taro-ClarithromycinTAR.23882.38802013-01-29.23880034250mg/5mLSusp4.6850BiaxinBGP.68666.86602003-01-30.4685Taro-ClarithromycinTAR.46854.68502013-01-29.46850035250mgTab.8244Biaxin BIDBGP1.96573.93141996-10-01.4122PMS-ClarithromycinPMS.4122.82442007-10-03.4122Teva-ClarithromycinTEV.4122.82442012-12-21.4122Sandoz ClarithromycinSDZ.4122.82442008-08-28.4122Apo-ClarithromycinAPX.4122.82442007-09-04.4122Ran-ClarithromycinRAN.4122.82442011-08-04.4122ClarithromycinSIV.4122.82442020-06-30.4122ClarithromycinSAI.4122.82442020-04-30.4122M-ClarithromycinMAT.4122.82442021-10-29.41220036500mgTabBiaxin BIDBGP2007-10-03PMS-ClarithromycinPMS2.20092007-10-03Teva-ClarithromycinTEV2.20092013-01-29Sandoz ClarithromycinSDZ2.20092008-08-28Apo-ClarithromycinAPX2.20092007-10-03Ran-ClarithromycinRAN2.20092011-08-04ClarithromycinSIV2.20092020-06-30ClarithromycinSAI2.20092021-05-31M-ClarithromycinMAT2.20092021-10-29ERYTHROMYCIN BASE0037250mgTab.7460ErythromidABB1996-10-01Erythro-BaseAAP.1865.74601996-10-01.1865ERYTHROMYCIN ESTOLATE003850mg/mLO/L1.4260IlosoneLIL1996-10-01Novo-Rythro EstolateNOP.07131.42601996-10-01.0713ERYTHROMYCIN ETHYLSUCCINATE003940mg/mLO/L1.0035EES-200ABB1996-10-01Novo-Rythro Ethyl SuccinateNOP.06691.00351996-10-01.0669004080mg/mLO/L1.5195EES-400ABB1996-10-01Novo-Rythro Ethyl SuccinateNOP.10131.51951996-10-01.1013ANTIBIOTICS PENICILLINSAMOXICILLIN0041250mgCap.2016NovamoxinTEV.0672.20161996-10-01.0672Apo-AmoxiAPX.0672.20161996-10-01.0672AmoxilWAY1996-10-01Auro-AmoxicillinAUR.0672.20162012-12-21.0672Jamp-AmoxicillinJPC.0672.20162019-03-28.0672Amoxicillin Capsules BPSAI.0672.20162023-01-31.0672PRZ-AmoxicillinPRZ.0672.20162024-03-28.06720042500mgCap.3924NovamoxinTEV.1308.39241996-10-01.1308Apo-AmoxiAPX.1308.39241996-10-01.1308AmoxilWAY1996-10-01Auro-AmoxicillinAUR.1308.39242012-12-21.1308AmoxicillinSIV.1308.39242020-12-18.1308Jamp-AmoxicillinJPC.1308.39242019-03-28.1308AG-AmoxicillinANG.1308.39242020-12-18.1308Amoxicillin Capsules BPSAI.1308.39242023-01-31.1308PRZ-AmoxicillinPRZ.1308.39242024-03-28.13080043125mgChew TabNovamoxin ChewableTEV.50992008-11-04Amoxil ChewableAYE2008-11-040044250mgChew TabNovamoxin ChewableTEV.82822008-11-04Amoxil ChewableAYE2008-11-04004525mg/mLO/L.3705Apo-AmoxiAPX.0247.37051996-10-01.0247AmoxilWAY1996-10-01Jamp-AmoxicillinJPC.0247.37052023-07-31.0247004650mg/mLO/L.8100NovamoxinTEV.0540.81001996-10-01.0540Apo-AmoxiAPX.0540.81001996-10-01.0540Novamoxin (Sugar Reduced)TEV.0540.81001996-10-01.0540AmoxilWAY1996-10-01AmoxicillinSAI.0540.81002020-08-28.0540Amoxicillin (Sugar Reduced)SAI.0540.81002020-10-30.0540AmoxicillinSIV.0540.81002020-08-28.0540Auro-AmoxicillinAUR.0540.81002023-11-30.0540Sandoz AmoxicillinSDZ.0540.81002024-06-28.0540Jamp-AmoxicillinJPC.0540.81002023-08-31.0540004750mg/mLPd for Oral SuspMoxilen Forte 250mg/5mLJUN.08102023-01-20.0810AMOXICILLIN & CLAVULANIC ACIDAmoxicillin/clavulanic acid is not recommended as first line treatment for acute otitis media and sinusitis. Antibiotic resistance (H. influenzae, M. catarrhalis) due to B-lactamase production has caused only a minority of treatment failures with amoxicillin. Amoxicillin/clavulanic acid is first line treatment for infected bites of cat, dog or human.004825mg & 6.25mg/mLO/L1.8615ClavulinGSK.12411.86151996-10-01.1241004950mg & 12.5mg/mLO/L1.8240ClavulinGSK.27024.05301996-10-01.1216Jamp Amoxi Clav SuspensionJPC.12161.82402024-09-27.1216M-Amoxi ClavMAT.12161.82402024-03-28.12160050200mg & 28.5mg/5mLSuspClavulin (BID)GSK.19372000-01-17.1007Jamp Amoxi Clav SuspensionJPC.10072024-09-27.10070051400mg & 57mg/5mLSuspClavulin (BID)GSK.37792000-01-17.1591M-Amoxi ClavMAT.15912022-12-21.1591Jamp Amoxi Clav SuspensionJPC.15912024-09-27.15910052250mg & 125mgTab.7401ClavulinGSK1996-10-01Apo-Amoxi ClavAPX.2467.74012001-10-11.2467Auro-AmoxiclavAUR.2467.74012022-04-29.2467Jamp Amoxi ClavJPC.2467.74012022-02-28.24670053500mg & 125mgTab1.1334ClavulinGSK1.88755.66251996-10-01.3778Apo-Amoxi ClavAPX.37781.13342001-10-11.3778Auro-AmoxiclavAUR.37781.13342022-04-29.3778Sandoz Amoxi-Clav TabletsSDZ.37781.13342019-04-30.3778Jamp Amoxi ClavJPC.37781.13342022-02-28.3778Amoxicillin/ClavSAI.37781.13342024-04-30.37780054875mg & 125mgTabClavulin (BID)GSK2.75152000-01-17.5551Apo-Amoxi ClavAPX.55512003-09-04.5551Auro-AmoxiclavAUR.55512022-04-29.5551Sandoz Amoxi-Clav TabletsSDZ.55512019-04-30.5551Jamp Amoxi ClavJPC.55512022-02-28.5551Amoxicillin/ClavSAI.55512024-04-30.5551AMPICILLINUse with caution in urinary tract infections as even E. coli is resistant in approximately 20% of cases.0055250mgCap1.6892PenbritinAYE1996-10-01Novo-AmpicillinNOP.42231.68921996-10-01.42230056500mgCap3.2024PenbritinAYE1996-10-01Novo-AmpicillinNOP.80063.20241996-10-01.8006CLOXACILLIN0057250mgCap.8564OrbeninAYE1996-10-01Teva-CloxacillinTEV.2141.85641996-10-01.2141Jamp CloxacillinJPC.2141.85642022-12-21.21410058500mgCap1.6180OrbeninAYE1996-10-01Teva-CloxacillinTEV.40451.61801996-10-01.4045Jamp CloxacillinJPC.40451.61802022-12-21.4045005925mg/mLO/L2.4240Teva-CloxacillinTEV.06062.42401996-10-01.0606OrbeninWAY1996-10-01PENICILLIN V (POTASSIUM)006025mg/mLO/L1.0700Nadopen-VNDA1996-10-01Apo-Pen V-KAPX.05351.07001996-10-01.05350061300mgTab.7492PVF-K 500FRS1996-10-01PEN V-KAAP.1873.74921996-10-01.1873PIPERACILLIN SODIUM & TAZOBACTAM SODIUM00622g & 250mgInj Pd-2.25g Vial PkTazocinPFI2008-12-03Piperacillin & Tazobactam for InjectionAPX10.13002008-12-0310.1300Piperacillin & Tazobactam for InjectionSTE10.13002016-06-2910.1300Piperacillin and Tazobactam for InjTEL10.13002018-11-2910.1300Piperacillin & Tazobactam For InjectionAUR10.13002021-08-3110.130000633g & 375mgInj Pd-3.375g Vial PkTazocinWYE2008-12-03Piperacillin & Tazobactam for InjectionAPX15.20002008-12-0315.2000Piperacillin & Tazobactam for InjectionSTE15.20002016-06-2915.2000Piperacillin/Tazobactam powder for Inj.TEV15.20002012-07-2715.2000Piperacillin & Tazobactam for InjectionMYL15.20002012-12-2115.2000Piperacillin and Tazobactam for InjTEL15.20002018-11-2915.2000Piperacillin & Tazobactam For InjectionAUR15.20002021-08-3115.200000644g & 500mgInj Pd-4.5g Vial PkTazocinWYE2008-12-03Piperacillin & Tazobactam for InjectionAPX20.27002008-12-0320.2700Piperacillin & Tazobactam for InjectionSTE20.27002016-06-2920.2700Piperacillin/Tazobactam powder for Inj.TEV20.27002012-07-2720.2700Piperacillin and Tazobactam for InjTEL20.27002018-11-2920.2700Piperacillin & Tazobactam For InjectionAUR20.27002021-08-3120.2700ANTIBIOTICS TETRACYCLINESDOXYCYCLINE006540mgMR CapApprilonGAC2021-07-30Apo-Doxycycline MRAPX3.08502021-07-30DOXYCYCLINE HYCLATE006620mgCapPMS-DoxycyclinePMS2024-06-28Jamp DoxycyclineJPC1.35382024-06-280067100mgTabVibra-TabsPFI1996-10-01Apo-Doxy-TabsAPX.45602009-05-20.4560Teva-DoxycyclineTEV.45602010-12-14.4560Doxycycline TabletsSAI.45602011-09-15.4560PRZ-DoxycyclinePRZ.45602023-12-29.4560M-DoxycyclineMAT.45602024-07-31.4560NRA-DoxycyclineNRA.45602026-03-31.4560MINOCYCLINE HCL006850mgCapMinocyclineAAP.56162008-01-15.5616MinocinSTI2008-01-150069100mgCapMinocyclineAAP1.08362008-01-151.0836MinocinSTI2008-01-15TETRACYCLINETetracycline use during tooth development (last half of pregnancy and up to age 8) may cause permanent tooth discoloration or enamel hypoplasia. These reactions are more common during long-term use. Tetracyclines should not be used in these groups unless other antibiotics are unlikely to be effective or are contraindicated.0070250mgCap.2680TetracynPFI1996-10-01TetracyclineAAP.0670.26801996-10-01.0670TIGECYCLINE007150mg/VialPd for Inj-5mLVial Pk (Preservative-Free)TygacilPFI83.47402014-11-2783.4740ANTIBIOTICS OTHER ANTIBIOTICSCEFADROXIL0072500mgCap1.1790DuricefBQU1996-10-01Teva-CefadroxilTEV.58951.17902000-01-17.5895Apo-CefadroxilAPX.58951.17902000-04-17.5895Jamp CefadroxilJPC.58951.17902024-10-31.5895CEFAZOLIN SODIUM0073500mg/VialInj Pd-Vial PkCefazolin for InjectionTEV2022-01-31Cefazolin for Injection USPSDZ4.00002023-10-314.0000Cefazolin for InjectionSTE4.00002022-01-314.000000741g/VialInj Pd-Vial PkCefazolin for InjectionTEV2010-06-14Cefazolin for InjectionORC6.00002010-06-146.0000Cefazolin for Injection USPSDZ6.00002023-10-316.0000Cefazolin for InjectionSTE6.00002022-01-316.0000Cefazolin for Injection USPSTE6.00002023-09-286.0000007510g/VialInj Pd-Vial PkCefazolin for InjectionTEV2010-06-14Cefazolin for InjectionORC56.00002010-06-1456.0000Cefazolin for Injection USPSDZ56.00002023-10-3156.0000Cefazolin for InjectionSTE56.00002022-01-3156.0000Cefazolin for Injection USPSTE56.00002023-09-2856.0000007610g/VialInj Pd-Vial Pk (Preservative-Free)AncefSMJ2025-08-29Cefazolin for Injection, USPFKC56.00002025-08-2956.0000CEFIXIME007720mg/mLOral SuspSupraxODN.38991996-10-01.3899Auro-CefiximeAUR.38992019-11-29.38990078400mgTab2.7172SupraxODN2.71722.71721996-10-012.7172Auro-CefiximeAUR2.71722.71722014-12-182.7172CEFOXITIN SODIUM00791g/VialInj Pd-Vial PkMefoxinMSD2008-06-27Cefoxitin for Injection USPTEV10.60002012-04-2410.6000Cefoxitin for InjectionORC10.60002008-06-2710.600000802g/VialInj Pd-Vial PkMefoxinMSD2008-06-27Cefoxitin for Injection USPTEV21.25002012-04-2421.2500Cefoxitin for InjectionORC21.25002008-06-2721.2500CEFPROZIL0081125mg/5mLOral Susp-100mL PkRan-CefprozilRAN9.70002010-06-149.7000CefzilBQU2010-06-14Auro-CefprozilAUR9.70002024-04-309.70000082250mg/5mLOral Susp-100mL PkCefzilBQU2010-06-14Ran-CefprozilRAN19.38002010-06-1419.3800Auro-CefprozilAUR19.38002024-04-3019.38000083125mg/5mLOral Susp-75mL PkCefzilBQU1996-12-19Ran-CefprozilRAN7.27502010-06-147.2750Auro-CefprozilAUR7.27502012-11-277.27500084250mg/5mLOral Susp-75mL PkCefzilBQU1996-12-19Ran-CefprozilRAN14.53502007-09-0414.5350Auro-CefprozilAUR14.53502012-11-2714.53500085250mgTabCefzilBQU1996-12-19Ran-CefprozilRAN1.73742007-06-061.73740086500mgTabCefzilBQU1996-12-19Ran-CefprozilRAN2.00382007-06-062.0038Auro-CefprozilAUR2.00382012-04-242.0038CEFTRIAXONE DISODIUM00870.25g/VialInj Pd-Vial PkRocephinHLR1996-10-01Ceftriaxone Sodium For Injection BPSTE5.64302016-03-305.643000881g/VialInj Pd-Vial PkRocephinHLR1996-10-01Ceftriaxone Sodium for InjectionTEV12.49502008-03-2512.4950Ceftriaxone for InjectionFKC12.49502025-03-3112.4950CeftriaxoneSDZ12.49502007-05-0412.4950Ceftriaxone for Injection USPORC12.49502008-01-1512.4950Ceftriaxone Sodium For Injection BPSTE12.49502016-03-3012.495000892g/VialInj Pd-Vial PkRocephinHLR1996-10-01Ceftriaxone for InjectionFKC24.13952025-03-3124.1395CeftriaxoneSDZ24.13952007-05-0424.1395Ceftriaxone Sodium For Injection BPSTE24.13952016-03-3024.1395009010g/VialInj Pd-Vial PkRocephinHLR2008-08-28Ceftriaxone Sodium For Injection BPSDZ214.20002022-04-29214.2000Ceftriaxone Sodium For Injection BPSTE214.20002016-03-30214.2000CEFUROXIME AXETIL0091125mg/5mLSuspCeftinSDZ.17911998-10-21.17910092250mgTab.8388CeftinGSK1998-10-21Apo-CefuroximeAPX.4194.83882002-04-04.4194Auro-CefuroximeAUR.4194.83882012-05-29.4194Jamp CefuroximeJPC.4194.83882024-11-29.41940093500mgTab1.6616CeftinGSK1998-10-21Apo-CefuroximeAPX.83081.66162002-04-04.8308Auro-CefuroximeAUR.83081.66162012-05-29.8308Jamp CefuroximeJPC.83081.66162024-11-29.8308CEPHALEXIN MONOHYDRATE0094250mgCap1.4812CeporexGLA2006-06-15Teva-CephalexinTEV.37031.48121996-10-01.37030095500mgCap2.9008CeporexGLA2006-06-15Teva-CephalexinTEV.72522.90081996-10-01.7252009625mg/mLPd for Oral Susp3.0700KeflexPHE1996-10-01Teva-Cephalexin 125TEV.15353.07001996-10-01.1535Lupin-CephalexinLUP.15353.07002024-04-30.1535Auro-CephalexinAUR.15353.07002024-02-29.1535Jamp Cephalexin SuspensionJPC.15353.07002024-02-29.1535009750mg/mLPd for Oral Susp5.1460KeflexPHE1996-10-01Teva-Cephalexin 250TEV.25735.14601996-10-01.2573Lupin-CephalexinLUP.25735.14602024-04-30.2573Auro-CephalexinAUR.25735.14602024-03-28.2573Jamp Cephalexin SuspensionJPC.25735.14602024-02-29.25730098250mgTab.3464KeflexPHE1996-10-01Teva-CephalexinTEV.0866.34641996-10-01.0866Apo-CephalexAPX.0866.34641996-10-01.0866Auro-CephalexinAUR.0866.34642018-10-31.0866Lupin-CephalexinLUP.0866.34642025-12-30.0866Jamp CephalexinJPC.0866.34642023-02-28.0866CephalexinSAI.0866.34642022-10-31.08660099500mgTab.6924KeflexPHE1996-10-01Teva-CephalexinTEV.1731.69241996-10-01.1731Apo-CephalexAPX.1731.69241996-10-01.1731Auro-CephalexinAUR.1731.69242018-10-31.1731Lupin-CephalexinLUP.1731.69242025-12-30.1731Jamp CephalexinJPC.1731.69242023-02-28.1731CephalexinSIV.1731.69242020-12-18.1731CephalexinSAI.1731.69242022-10-31.1731CLINDAMYCIN HCL0100150mgCap1.7736Dalacin CPFI1996-10-01Teva-ClindamycinTEV.22171.77362000-11-30.2217Apo-ClindamycinAPX.22171.77362002-07-29.2217ClindamycinSAI.22171.77362022-04-29.2217Auro-ClindamycinAUR.22171.77362015-05-28.2217Med-ClindamycinGMP.22171.77362022-04-29.2217Riva-ClindamycinRIA.22171.77362021-09-30.2217M-ClindamycinMAT.22171.77362021-09-30.2217Jamp-ClindamycinJPC.22171.77362019-10-31.2217NRA-ClindamycinNRA.22171.77362020-10-30.22170101300mgCapDalacin CPFI1996-12-19Teva-ClindamycinTEV.44342000-11-30.4434Apo-ClindamycinAPX.44342002-07-29.4434ClindamycinSAI.44342022-04-29.4434Auro-ClindamycinAUR.44342015-05-28.4434Med-ClindamycinGMP.44342022-04-29.4434Riva-ClindamycinRIA.44342021-08-31.4434M-ClindamycinMAT.44342021-09-30.4434Jamp-ClindamycinJPC.44342019-10-31.4434NRA-ClindamycinNRA.44342020-10-30.4434CLINDAMYCIN PALMITATE010215mg/mLPd for Oral SuspDalacin C Flavoured GranulesPFI.31521996-10-01.3152CLINDAMYCIN PHOSPHATE0103300mg/2mLInj Sol-2mL PkDalacin CPFI8.8938Clindamycin is well absorbed by the oral route, therefore stepdown therapy from IV to oral is possible.1996-10-018.8938Clindamycin Phosphate Injection USPSDZClindamycin is well absorbed by the oral route, therefore stepdown therapy from IV to oral is possible. 2001-03-07DALBAVANCIN HYDROCHLORIDE0104500mg/VialPd for Sol (Preservative-Free)XydalbaEVL1005.61002024-05-311005.6100For the treatment of adults with methicillin resistant Staphylococcus aureus (MRSA) infection meeting all the following criteria; 1. Patient is 18 years of age or older; AND 2. Diagnosed with an acute bacterial skin and skin structure infection (ABSSSI) (e.g. cellulitis/erysipelas, major cutaneous abscess, wound infection) that is known (i.e. confirmed by culture and sensitivity test) or suspected to be caused by MRSA; AND 3. Treatment with standard orally administered antibiotics is inappropriate or inadequate; AND 4. Patient is deemed to be at high risk of nonadherence to a standard antibiotic treatment for MRSA ABSSSI or treatment with dalbavancin rather than a standard antibiotic treatment for MRSA ABSSSI will avoid the need for hospitalization OR will limit the need for prolonged hospitalization; AND 5. Patient's ABSSSI is not caused by non-MRSA or methicillin-sensitive Staphylococcus aureus (MSSA); AND 6. Patient does not have ABSSSI associated with any of the following types of infections: - Known or suspected osteomyelitis or septic arthritis - Infections complicated by the presence of prosthetic materials that would not be removed such as permanent cardiac pacemaker battery packs, or those involving joint replacement prosthesis - Self-limited infections such as isolated folliculitis and isolated furuncles or other infections that have a high cure rate after surgical incision alone - Patients who have had more than 2 surgical interventions or are expected to need more than 2 surgical interventions (defined as surgery that cannot be performed at the bedside) for the ABSSSI - Skin and skin structure infection with arterial insufficiency, such as deep diabetic foot ulcers, decubitus ulcers, and ischemic ulcers - Necrotizing fasciitis, gas gangrene - Burns greater than 20% of total body surface Approved dose: Up to 1500mg intravenously (IV), administered either as a single dose OR A two dose regimen of 1000mg IV followed one week later by 500mg IV. Duration: One treatment course using a single dose or a two dose regimen. Retreatment within 30 days from the initial dose may be considered on a case-by-case basis through the Exceptional Access Program (EAP). Please submit the culture and sensitivity report and other relevant clinical details regarding the patient's infection presentation including the dose, duration, and approximate date of treatment of all anti-infectives used to manage the infection.LU Authorization Period: 7 daysDAPTOMYCIN0105500mg/VialPd for Inj Sol-Vial PkCubicinSUO2020-11-30Daptomycin for InjectionDRR162.35002020-11-30162.3500Daptomycin for InjectionSDZ162.35002020-11-30162.3500Daptomycin for InjectionJUN162.35002024-02-29162.3500RIFAXIMIN0106550mgTabZaxineSAL8.30302016-06-298.3030For reducing the risk of overt hepatic encephalopathy (HE) recurrence (i.e., 2 or more episodes) in patients who are unable to achieve adequate control of HE recurrence with maximal tolerated dose of lactulose alone. Rifaximin should be used in combination with a maximal tolerated dose of lactulose. For patients not maintained on lactulose, the nature of the patient's intolerance to lactulose should be documented.LU Authorization Period: IndefiniteTOBRAMYCIN010728mgInh Pd-CapTOBI PodhalerBGP14.69112016-06-2914.6911For the management of cystic fibrosis patients with chronic pulmonary Pseudomonas aeruginosa (P. aeruginosa) infections. Tobramycin is administered in alternating periods of 28 days. After 28 days of therapy, patients should stop therapy for the next 28 days, and then resume therapy for the next 28 day on / 28 day off cycle.LU Authorization Period: Indefinite0108300mg/5mLInh Sol-5mL PkFor the management of cystic fibrosis patients with chronic pulmonary Pseudomonas aeruginosa (P. aeruginosa) infections. Tobramycin is administered in alternating periods of 28 days. After 28 days of therapy, patients should stop therapy for the next 28 days, and then resume therapy for the next 28 day on / 28 day off cycle.TOBIBGP64.58322006-10-2341.0985Teva-TobramycinTEV41.09852016-03-3041.0985TOBRAMYCIN SULFATEThe prescriber should be aware that tobramycin injection products may be preservative-free or preservative-containing. If applicable, the prescriber should choose the most appropriate formulation (preservative-free or preservative containing) for use in the specific clinical situation in which the product was prescribed.010980mg/2mLInj Sol-2mL PkNebcinLIL1996-10-01TobramycinSDZ3.15002002-04-043.1500Tobramycin Injection USPSTE3.15002023-04-283.1500Tobramycin Injection USPJPC3.15002024-06-283.1500VANCOMYCIN HCL0110125mgCapVancocinSLP5.18002016-12-225.1800Jamp-VancomycinJPC5.18002016-12-225.1800For the treatment of initial episodes of Clostridium difficile infection; mild cases, if no response or intolerance to an adequate trial of oral metronidazole*: *As defined by the Association of Medical Microbiology and Infectious Disease Canada treatment practice guidelines for Clostridium difficile infection, 2018. Notes: - Metronidazole 500mg orally three times daily for 10-14 days can be used in patients with mild diarrhea. - Discontinue antibiotics for other indications if possible. - Higher doses of vancomycin have not been shown to be beneficial. - There is no evidence to support combination therapy with metronidazole or fidaxomicin. Maximum funded dose: Vancomycin 125mg four times daily, up to 14 days Maximum funded quantity: 56 capsulesLU Authorization Period: 14 daysFor the treatment of initial episodes of Clostridium difficile infection; moderate or severe, uncomplicated cases*: *As defined by the Association of Medical Microbiology and Infectious Disease Canada treatment practice guidelines for Clostridium difficile infection, 2018. Notes: - Metronidazole 500mg orally three times daily for 10-14 days can be used in patients with mild diarrhea. - For mild to moderate cases, treatment should only be continued beyond 7 days if diarrhea persists, up to a maximum of 14 days. - Severe, uncomplicated cases should be treated for 10-14 days. There is no evidence to support treatment durations beyond 14 days. - Higher doses of vancomycin have not been shown to be beneficial. - There is no evidence to support combination therapy with metronidazole or fidaxomicin. Maximum funded dose: Vancomycin 125mg four times daily, up to 14 days Maximum funded quantity: 56 capsulesLU Authorization Period: 14 daysFor the treatment of recurrent Clostridium difficile infection (CDI), first recurrence, mild to moderate* or severe, uncomplicated* cases: *As defined by the Association of Medical Microbiology and Infectious Disease Canada treatment practice guidelines for Clostridium difficile infection, 2018. Notes: - Recurrent CDI is defined as the reoccurrence of CDI within 8 weeks following the onset of a previous episode which resolved with treatment. - Treatment should only be continued for 14 days. - Higher doses or longer treatment duration with vancomycin have not been shown to be beneficial. - There is no evidence to support combination therapy with metronidazole or fidaxomicin. Maximum funded dose: Vancomycin 125mg four times daily, up to 14 days Maximum funded quantity: 56 capsulesLU Authorization Period: 14 daysFor the treatment of recurrent Clostridium difficile infection (CDI), second or subsequent recurrences, mild to moderate* or severe, uncomplicated* cases: *As defined by the Association of Medical Microbiology and Infectious Disease Canada treatment practice guidelines for Clostridium difficile infection, 2018. Notes: - Recurrent CDI is defined as the reoccurrence of CDI within 8 weeks following the onset of a previous episode which resolved with treatment. - There is no evidence to support combination therapy with metronidazole or fidaxomicin. Funded dose: Vancomycin 125mg four times daily for 10-14 days, followed by vancomycin taper. Maximum funded quantity: 114 capsulesLU Authorization Period: 13 Weeks0111250mgCapVancocinSLP10.36002016-12-2210.3600Jamp-VancomycinJPC10.36002016-12-2210.3600ANTITUBERCULAR AGENTSETHAMBUTOL HCL0112100mgTabMyambutolLED1996-10-01EtibiVAL.28401996-10-01.28400113400mgTabEtibiVAL.85221996-10-01.8522MyambutolWAY1997-02-04RIFABUTIN0114150mgCapMycobutinPFI6.21611996-10-016.2161For the prevention of Mycobacterium Avium Intracellular (MAI) in:Patients with a CD4+ cell count less than 200/mm3 with an AIDS-defining diagnosis;LU Authorization Period: 1 yearPatients with a CD4+ cell count less than 100/mm3 without an AIDS-defining diagnosis.LU Authorization Period: 1 year0115150mgCapRifabutin Capsules, USPSTE23.0000For the prevention of Mycobacterium Avium Intracellular (MAI) in: Patients with a CD4+ cell count less than 200/mm3 with an AIDS-defining diagnosis; Patients with a CD4+ cell count less than 100/mm3 without an AIDS-defining diagnosis.2026-01-3023.0000RIFAMPINExcept when used for prophylaxis in contacts of H. influenzae or N. meningitidis, rifampin should not be used as monotherapy, as bacterial resistance will develop quickly.0116150mgCapRofactVAL.91811996-10-01.91810117300mgCapRofactVAL1.44521996-10-011.4452ANTIVIRALSABACAVIR & LAMIVUDINE & ZIDOVUDINE0118300mg & 150mg & 300mgTabTrizivirVIH19.04262003-01-3013.6425Apo-Abacavir-Lamivudine-ZidovudineAPX13.64252016-01-2813.6425ABACAVIR SULFATE011920mg/mLO/LZiagenVIH.61422000-01-17.61420120300mgTabZiagenVIH8.67252000-01-173.4828Apo-AbacavirAPX3.48282016-05-313.4828Mint-AbacavirMIN3.48282019-05-313.4828ABACAVIR SULFATE & LAMIVUDINE0121600mg & 300mgTabKivexaVIH28.31002006-06-155.9875Apo-Abacavir-LamivudineAPX5.98752016-05-315.9875Teva-Abacavir-LamivudineTEV5.98752016-05-315.9875Mylan-Abacavir-LamivudineMYL5.98752016-05-315.9875Auro-Abacavir/LamivudineAUR5.98752016-12-225.9875PMS-Abacavir-LamivudinePMS5.98752016-12-225.9875Jamp Abacavir/LamivudineJPC5.98752022-03-315.9875ACYCLOVIR0122200mg/5mLOral SuspZoviraxGLW.31421996-10-01.31420123200mgTabZoviraxGSK1996-10-01Apo-AcyclovirAPX.35111998-12-31.3511Mylan-AcyclovirMYL.35112001-06-07.3511Teva-AcyclovirTEV.35112008-01-15.3511Mint-AcyclovirMIN.35112022-10-31.35110124400mgTabZoviraxGSK1996-10-01Apo-AcyclovirAPX.88901998-12-31.8890Mylan-AcyclovirMYL.88902001-06-07.8890Teva-AcyclovirTEV.88902008-01-15.8890Mint-AcyclovirMIN.88902022-10-31.88900125800mgTabZoviraxGSK5.06921996-10-011.2673Apo-AcyclovirAPX1.26731998-12-311.2673Mylan-AcyclovirMYL1.26732001-03-071.2673Teva-AcyclovirTEV1.26732007-01-021.2673Mint-AcyclovirMIN1.26732022-10-311.2673ADEFOVIR DIPIVOXIL012610mgTabHepseraGIL2014-04-30AA-AdefovirAAP20.91302014-04-30ATAZANAVIR SULFATE0127150mgCapReyatazBQU11.69502004-11-042.8386Teva-AtazanavirTEV2.83862017-06-292.8386Mylan-AtazanavirMYL2.83862017-06-292.8386Jamp AtazanavirJPC2.83862023-03-312.83860128200mgCapReyatazBQU11.76332004-11-042.8552Teva-AtazanavirTEV2.85522017-06-292.8552Mylan-AtazanavirMYL2.85522017-06-292.8552Jamp AtazanavirJPC2.85522023-03-312.85520129300mgCapReyatazBQU2017-06-29Teva-AtazanavirTEV19.06812017-06-29Mylan-AtazanavirMYL19.06812017-06-29Jamp AtazanavirJPC19.06812023-04-28BICTEGRAVIR SODIUM/EMTRICITABINE/TENOFOVIR ALAFENAMIDE HEMIFUMARATE013050mg & 200mg & 25mgTabBiktarvyGIL40.16402019-07-3140.1640CABOTEGRAVIR0131200mg/mLInj Sol-ER Susp 3mL Vial Kit PkApretudeVIH1710.00002025-03-311710.0000013230mgTabVocabriaVIH30.82702021-11-3030.8270013330mgTabApretudeVIH30.07502025-03-3130.0750CABOTEGRAVIR & RILPIVIRINE0134200mg/mL & 300mg/mLInj Sol-2mL KitCabenuvaVIH1316.47002021-11-301316.47000135200mg/mL & 300mg/mLInj Sol-3mL KitCabenuvaVIH2568.71002021-11-302568.7100COBICISTAT & ELVITEGRAVIR & EMTRICITABINE & TENOFOVIR DISOPROXIL FUMARATE0136150mg & 150mg & 200mg & 300mgTabStribildGIL48.01772013-07-3048.0177DARUNAVIR0137600mgTabPrezistaJAN2010-03-02Auro-DarunavirAUR4.29702020-05-294.2970Apo-DarunavirAPX4.29702020-03-314.2970DarunavirJPC4.29702022-05-314.29700138800mgTabPrezistaJAN2013-07-30Auro-DarunavirAUR5.82952020-05-295.8295Apo-DarunavirAPX5.82952020-03-315.8295DarunavirJPC5.82952022-05-315.8295DARUNAVIR & COBICISTAT0139800mg & 150mgTabPrezcobixJAN25.18702016-06-2925.1870DELAVIRDINE MESYLATE0140100mgTabRescriptorPFI.76091999-04-15.7609DOLUTEGRAVIR014150mgTabTivicayVIH23.53672015-04-3023.5367DOLUTEGRAVIR & ABACAVIR & LAMIVUDINE014250mg & 600mg & 300mgTabTriumeqVIH52.14472015-05-2852.1447DOLUTEGRAVIR & RILPIVIRINE014350mg & 25mgTabJulucaVIH40.93432019-04-3040.9343DOLUTEGRAVIR SODIUM/LAMIVUDINE014450mg & 300mgTabDovatoVIH35.73672020-01-3135.7367DORAVIRINE0145100mgTabPifeltroMEK16.65002019-10-3116.6500DORAVIRINE/LAMIVUDINE/TENOFOVIR DISOPROXIL FUMARATE0146100mg & 300mg & 300mgTabDelstrigoMEK28.79002019-10-3128.7900EFAVIRENZ0147600mgTabSustivaBQU2003-09-04Mylan-EfavirenzMYL3.80302013-09-273.8030Teva-EfavirenzTEV3.80302013-09-273.8030Auro-EfavirenzAUR3.80302014-05-293.8030Jamp-EfavirenzJPC3.80302019-08-303.8030EFAVIRENZ/TENOFOVIR DISOPROXIL FUMARATE/EMTRICITABINE0148600mg/300mg/200mgTabAtriplaBQU45.32002008-08-2811.3300Teva-Efavirenz/Emtricitabine/TenofovirTEV11.33002017-09-2811.3300Mylan-Efavirenz/Emtricitabine/TenofovirMYL11.33002017-09-2811.3300Apo-Efavirenz-Emtricitabine-TenofovirAPX11.33002018-10-3111.3300Auro-Efavirenz-Emtricitabine-TenofovirAUR11.33002020-05-2911.3300PMS-Efavirenz-Emtricitabine-TenofovirPMS11.33002020-02-2811.3300Jamp Efavirenz/Emtricitabine/TenofovirJPC11.33002023-01-3111.3300ELVITEGRAVIR & COBICISTAT & EMTRICITABINE & TENOFOVIR ALAFENAMIDE0149150mg & 150mg & 200mg & 10mgTabGenvoyaGIL46.22732017-04-2746.2273EMTRICITABINE & RILPIVIRINE HCL & TENOFOVIR ALAFENAMIDE HEMIFUMARATE0150200mg & 25mg & 25mgTabOdefseyGIL43.38372018-08-3043.3837EMTRICITABINE & RILPIVIRINE HCL & TENOFOVIR DISOPROXIL0151200mg & 25mg & 300mgTabCompleraGIL44.86432012-09-2844.8643EMTRICITABINE & TENOFOVIR DISOPROXIL FUMARATE0152200mg & 300mgTabTruvadaGIL29.21402007-09-047.3035Teva-Emtricitabine/TenofovirTEV7.30352017-09-287.3035Mylan-Emtricitabine/Tenofovir DisoproxilMYL7.30352017-09-287.3035Apo-Emtricitabine-TenofovirAPX7.30352017-08-307.3035PMS-Emtricitabine/TenofovirPMS7.30352019-11-297.3035Jamp-Emtricitabine/Tenofovir DisoproxilJPC7.30352019-10-317.3035Auro-Emtricitabine-TenofovirAUR7.30352023-04-287.3035AG-Emtricitabine & Tenofovir DisoproxilANG7.30352021-01-297.3035Mint-Emtricitabine/TenofovirMIN7.30352022-10-317.3035ENTECAVIR01530.5mgTabBaracludeBQU22.66002013-01-294.4000Apo-EntecavirAPX5.50002013-01-294.4000PMS-EntecavirPMS5.50002014-10-294.4000Auro-EntecavirAUR5.50002016-03-304.4000Jamp-EntecavirJPC5.50002018-08-304.4000Accel-EntecavirACC4.40002022-01-314.4000Mint-EntecavirMIN5.50002020-03-314.4000EntecavirSAI5.50002022-12-214.4000Confirmed chronic Hepatitis B infection in persons with - HBV DNA greater than or equal to 1000 IU/mL AND - ALT levels greater than ULN OR - Evidence of fibrosis or - Documented evidence of cirrhosisLU Authorization Period: 1 yearFor patients with chronic Hepatitis B infection who have a contraindication, intolerance or inadequate response to one or more of the following: lamivudine, tenofovir, adefovir or telbivudine.LU Authorization Period: 1 yearPatients with chronic Hepatitis B infection currently receiving treatment with entecavir and requires treatment continuation.LU Authorization Period: 1 yearPatients with chronic Hepatitis B infection who are scheduled to undergo chemotherapy or significant immunosuppressive treatment.LU Authorization Period: 1 yearETRAVIRINE0154100mgTabIntelenceJAN6.57102009-01-306.57100155200mgTabIntelenceJAN12.61952012-05-2912.6195FAMCICLOVIR0156125mgTabFamvirAPU2007-09-04Apo-FamciclovirAPX2.02402007-09-042.02400157250mgTabFamvirAPU2007-09-04Apo-FamciclovirAPX2.72002007-09-042.72000158500mgTabFamvirAPU7.74381996-10-014.2591Apo-FamciclovirAPX4.25912007-04-024.2591Herpes zoster in patients 50 years of age or older, up to 72 hours* after appearance of lesions. Dose: 500mg 3 times/day for 7 days.*The patient must begin treatment within the time frame specified for the product to be reimbursed. There is no benefit from the therapy begun after this time frame.Network will limit supply to 7 days and 21 tablets.LU Authorization Period: 1 yearFOSAMPRENAVIR CALCIUM015950mg/mLOral SuspTelzirVIH.65352009-01-30.65350160700mgTabTelzirVIH9.43892006-01-129.4389GANCICLOVIR SODIUM0161500mg/VialPd Inj-10mL PkCytoveneCHE52.22822007-01-0252.2282GLECAPREVIR & PIBRENTASVIR0162100mg & 40mgTabMaviretABV238.09522019-02-28238.0952For treatment-naive or treatment-experienced (1) adult patients with chronic hepatitis C (CHC) infection who meet all the following criteria: (i) Treatment is prescribed by a hepatologist, gastroenterologist, infectious disease specialist or other prescriber experienced in treating chronic hepatitis C. (ii) Laboratory confirmed hepatitis C genotype 1, 2, 3, 4, 5, or 6; (iii) Established chronicity of HCV infection either by two laboratory confirmed quantitative HCV RNA values taken at least 6 months apart; OR One recent laboratory confirmed quantitative HCV RNA within the past 6 months and clinical features establishing a duration of HCV infection longer than 6 months (e.g. presence of fibrosis, presence of non-liver manifestations of HCV, prolonged ALT elevation greater than 6 months without another cause, HCV antibody positivity greater than 6 months), or risk factors for HCV acquisition greater than 6 months (e.g. injection drug use). Exclusion criteria: - Patients with genotype 1 who have relapsed but are treatment experienced on both an NS3/4A protease inhibitor and an NS5A inhibitor - For use in combination with other hepatitis C antiviral agents - Patients with decompensated cirrhosis or severe hepatic impairment (Child-Pugh C) Retreatment is not funded. Retreatment for re-infection in patients who have received an adequate prior course of Maviret will be considered on a case-by-case basis through the Exceptional Access Program. Treatment regimens for Maviret: I. Treatment-naive, non-cirrhotic genotype 1, 2, 3, 4, 5, or 6. Approved duration: 8 weeks II. Treatment-naive genotype 1, 2, 3, 4, 5, or 6 with compensated cirrhosis. Approved duration: 8 weeks III. Treatment-experienced, non-cirrhotic genotype 1, 2, 4, 5, or 6 who have failed peginterferon/ribavirin and/or sofosbuvir ONLY. Approved duration: 8 weeks Notes: (1) Treatment-experienced definitions vary by the genotype being treated. Health care professionals are advised to refer to the Maviret product monograph and prescribing guidelines for appropriate use of the drug product, including use in special populations. (2) NS3/4A Pls include simeprevir, boceprevir, and telepravir. (3) NS5A inhibitors include daclatasvir and ledipasvir.LU Authorization Period: 8 WeeksFor treatment-naive or treatment-experienced (1) adult patients with chronic hepatitis C (CHC) infection who meet all the following criteria: (i) Treatment is prescribed by a hepatologist, gastroenterologist, infectious disease specialist or other prescriber experienced in treating chronic hepatitis C; (ii) Laboratory confirmed hepatitis C genotype 1, 2, 4, 5, or 6; (iii) Established chronicity of HCV infection either by two laboratory confirmed quantitative HCV RNA values taken at least 6 months apart; OR One recent laboratory confirmed quantitative HCV RNA within the past 6 months and clinical features establishing a duration of HCV infection longer than 6 months (e.g. presence of fibrosis, presence of non-liver manifestations of HCV, prolonged ALT elevation greater than 6 months without another cause, HCV antibody positivity greater than 6 months), or risk factors for HCV acquisition greater than 6 months (e.g. injection drug use). Exclusion criteria: - Patients with genotype 1 who have relapsed but are treatment experienced on both an NS3/4A protease inhibitor and an NS5A inhibitor - For use in combination with other hepatitis C antiviral agents - Patients with decompensated cirrhosis or severe hepatic impairment (Child-Pugh C) Retreatment is not funded. Retreatment for re-infection in patients who have received an adequate prior course of Maviret will be considered on a case-by-case basis through the Exceptional Access Program. Treatment regimens for Maviret: I. Treatment-experienced, genotype 1, 2, 4, 5, or 6 with compensated cirrhosis who have failed peginterferon/ribavirin and/or sofosbuvir ONLY. Approved duration: 12 weeks II. Treatment-experienced genotype 1 non-cirrhotic or compensated cirrhosis who have failed an NS3/4A protease inhibitor (2) but are NS5A inhibitor naive. Approved duration: 12 weeks Notes: (1) Treatment-experienced definitions vary by the genotype being treated. Health care professionals are advised to refer to the Maviret product monograph and prescribing guidelines for appropriate use of the drug product, including use in special populations. (2) NS3/4A PIs include simeprevir, boceprevir, and telepravir. (3) NS5A inhibitors include daclatasvir and ledipasvir.LU Authorization Period: 12 Weeks.For treatment-naive or treatment-experienced (1) adult patients with chronic hepatitis C (CHC) infection who meet all the following criteria: (i) Treatment is prescribed by a hepatologist, gastroenterologist, infectious disease specialist or other prescriber experienced in treating chronic hepatitis C; (ii) Laboratory confirmed hepatitis C genotype 1 or 3; (iii) Established chronicity of HCV infection either by two laboratory confirmed quantitative HCV RNA values taken at least 6 months apart; OR One recent laboratory confirmed quantitative HCV RNA within the past 6 months and clinical features establishing a duration of HCV infection longer than 6 months (e.g. presence of fibrosis, presence of non-liver manifestations of HCV, prolonged ALT elevation greater than 6 months without another cause, HCV antibody positivity greater than 6 months), or risk factors for HCV acquisition greater than 6 months (e.g. injection drug use). Exclusion criteria: - Patients with genotype 1 who have relapsed but are treatment experienced on both an NS3/4A protease inhibitor and an NS5A inhibitor - For use in combination with other hepatitis C antiviral agents - Patients with decompensated cirrhosis or severe hepatic impairment (Child-Pugh C) Retreatment is not funded. Retreatment for re-infection in patients who have received an adequate prior course of Maviret will be considered on a case-by-case basis through the Exceptional Access Program. Treatment regimens for Maviret: I. Treatment-experienced genotype 1 non-cirrhotic or compensated cirrhosis who have failed an NS5A inhibitor (3) but is NS3/4A protease inhibitor naive. Approved duration: 16 weeks II. Treatment-experienced genotype 3 non-cirrhotic or compensated cirrhosis who have failed peginterferon/ribavirin and/or sofosbuvir ONLY. Approved duration: 16 weeks Notes: (1) Treatment-experienced definitions vary by the genotype being treated. Health care professionals are advised to refer to the Maviret product monograph and prescribing guidelines for appropriate use of the drug product, including use in special populations. (2) NS3/4A PIs include simeprevir, boceprevir, and telepravir. (3) NS5A inhibitors include daclatasvir and ledipasvir.LU Authorization Period: 16 Weeks.LAMIVUDINE016310mg/mLO/LReimbursement will not be provided for the treatment of hepatitis.3TCVIH.42671996-10-01.42670164100mgTabHeptovirGSK2012-11-27Apo-Lamivudine HBVAPX2.61542012-11-272.6154Jamp Lamivudine HBVJPC2.61542021-09-302.6154Confirmed chronic Hepatitis B infection in persons with - HBV DNA greater than or equal to 1000 IU/mL AND - ALT levels greater than ULN OR - Evidence of fibrosis or - Documented evidence of cirrhosisLU Authorization Period: 1 yearPatients with chronic Hepatitis B infection currently receiving treatment with lamivudine and requires treatment continuation.LU Authorization Period: 1 yearPatients with chronic Hepatitis B infection who are scheduled to undergo chemotherapy or significant immunosuppressive treatment.LU Authorization Period: 1 year0165150mgTabReimbursement will not be provided for the treatment of hepatitis.3TCVIH6.60821996-10-012.7323Apo-LamivudineAPX2.73232012-07-272.7323Jamp LamivudineJPC2.73232021-04-302.73230166300mgTabReimbursement will not be provided for the treatment of hepatitis.3TCVIH13.26732004-07-205.4857Apo-LamivudineAPX5.48572012-07-275.4857Jamp LamivudineJPC5.48572021-04-305.4857LAMIVUDINE & ZIDOVUDINE0167150mg & 300mgTabCombivirVIH13.22621999-09-152.6103Apo-Lamivudine-ZidovudineAPX2.61032012-07-272.6103Auro-Lamivudine/ZidovudineAUR2.61032014-05-292.6103Jamp Lamivudine / ZidovudineJPC2.61032022-04-292.6103LEDIPASVIR & SOFOSBUVIR016890mg & 400mgTabHarvoniGIL797.61902017-02-28797.6190For treatment-naive or treatment-experienced (1) adult patients with chronic hepatitis C (CHC) infection who meet all the following criteria: (i) Treatment is prescribed by a hepatologist, gastroenterologist, infectious disease specialist or other prescriber experienced in treating chronic hepatitis C; AND (ii) Laboratory confirmed hepatitis C genotype 1; AND (iii) Established chronicity of HCV infection either by two laboratory confirmed quantitative HCV RNA values taken at least 6 months apart; OR One recent laboratory confirmed quantitative HCV RNA within the past 6 months and clinical features establishing a duration of HCV infection longer than 6 months (e.g. presence of fibrosis, presence of non-liver manifestations of HCV, prolonged ALT elevation greater than 6 months without another cause, HCV antibody positivity greater than 6 months), or risk factors for HCV acquisition greater than 6 months (e.g. injection drug use). Treatment regimens: - Treatment-naive, non-cirrhotic, recent quantitative hepatitis C viral load less than 6 M IU/mL Approved duration: 8 weeks Retreatment is not funded. Retreatment for failure or re-infection in patients who have received an adequate prior course of direct-acting antiviral will be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 8 WeeksFor treatment-naive or treatment-experienced (1) adult patients with chronic hepatitis C (CHC) infection who meet all the following criteria: (i) Treatment is prescribed by a hepatologist, gastroenterologist, infectious disease specialist or other prescriber experienced in treating chronic hepatitis C; AND (ii) Laboratory confirmed hepatitis C genotype 1; AND (iii) Established chronicity of HCV infection either by two laboratory confirmed quantitative HCV RNA values taken at least 6 months apart; OR One recent laboratory confirmed quantitative HCV RNA within the past 6 months and clinical features establishing a duration of HCV infection longer than 6 months (e.g. presence of fibrosis, presence of non-liver manifestations of HCV, prolonged ALT elevation greater than 6 months without another cause, HCV antibody positivity greater than 6 months), or risk factors for HCV acquisition greater than 6 months (e.g. injection drug use). Treatment regimens: I. Treatment-naive, without cirrhosis, viral load greater than or equal to 6 M IU/mL; or treatment-naive with cirrhosis; or treatment-experienced without cirrhosis Approved duration: 12 weeks II. Treatment-naive or treatment-experienced with decompensated cirrhosis (2) Approved regimen: 12 weeks in combination with ribavirin (Ibavyr) III. Treatment-naive or treatment-experienced liver transplant recipients without cirrhosis or with compensated cirrhosis (2) Approved regimen: 12 weeks in combination with ribavirin (Ibavyr) Retreatment is not funded. Retreatment for failure or re-infection in patients who have received an adequate prior course of direct-acting antiviral will be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 12 Weeks.For treatment-naive or treatment-experienced (1) adult patients with chronic hepatitis C (CHC) infection who meet all the following criteria: (i) Treatment is prescribed by a hepatologist, gastroenterologist, infectious disease specialist or other prescriber experienced in treating chronic hepatitis C; AND (ii) Laboratory confirmed hepatitis C genotype 1; AND (iii) Established chronicity of HCV infection either by two laboratory confirmed quantitative HCV RNA values taken at least 6 months apart; OR One recent laboratory confirmed quantitative HCV RNA within the past 6 months and clinical features establishing a duration of HCV infection longer than 6 months (e.g. presence of fibrosis, presence of non-liver manifestations of HCV, prolonged ALT elevation greater than 6 months without another cause, HCV antibody positivity greater than 6 months), or risk factors for HCV acquisition greater than 6 months (e.g. injection drug use). Treatment regimen: - Treatment-experienced, cirrhotic: Approved duration: 24 weeks Retreatment is not funded. Retreatment for failure or re-infection in patients who have received an adequate prior course of direct-acting antiviral will be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 24 Weeks.1. Treatment-experienced are those who failed prior therapy with an interferon-based regimen, including regimens containing an HCV protease inhibitor. 2. Compensated cirrhosis (Child-Turcotte-Pugh A [i.e. Scores 5 to 6]) and decompensated cirrhosis (Child-Turcotte-Pugh B or C [i.e. Score 7 or above]) may be considered. 3. Health care professionals are advised to refer to the product monograph and prescribing guidelines for appropriate use of the drug product, including use in special populations.LOPINAVIR & RITONAVIR016980mg/mL & 20mg/mLO/LKaletraABV2.46352001-10-112.46350170100mg & 25mgTabKaletraABV3.04892009-04-013.04890171200mg & 50mgTabKaletraABV6.09792007-09-046.0979MARAVIROC0172150mgTabCelsentriVIH21.62082014-04-3021.62080173300mgTabCelsentriVIH21.62082014-04-3021.6208NELFINAVIR MESYLATE0174250mgTabViraceptPFI2.18141999-04-152.18140175625mgTabViraceptPFI5.46422005-05-255.4642NEVIRAPINE0176400mgER TabViramune XRBOE2012-07-27Apo-Nevirapine XRAPX1.85192016-01-281.85190177200mgTabViramuneBOE1999-04-15Auro-NevirapineAUR1.23462011-05-191.2346Teva-NevirapineTEV1.23462011-05-191.2346Mylan-NevirapineMYL1.23462012-08-271.2346Jamp NevirapineJPC1.23462013-07-301.2346NIRMATRELVIR & RITONAVIR0178150mg & 100mgTab-20 PkPaxlovidPFI580.00002024-05-17580.00000179150mg & 100mgTab-30 PkPaxlovidPFI1288.88002024-05-171288.8800For the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in patients 65 years of age or older with: - a positive result from direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing (either using rapid antigen test or PCR), and - symptoms present for 5 days or fewer. Paxlovid (DIN: 02527804) is intended for patients with renal impairment or on dialysis. If Paxlovid (DIN: 02524031) is being dispensed for such patients, it requires dose adjustment. Treatment decisions should be individualized based on the prescriber's assessment of patient risk because not all medical or social vulnerabilities carry the same risk. Prescribers should consult Ontario Health Recommendations for Antiviral Therapy for Adults with Mild to Moderate COVID-19 (April 2024). Pharmacists and prescribers should be informed of and stay current with a drug product's official indications in accordance with Health Canada's approved product monograph. Some aspects of the above criteria may differ from the official indications as described in the product monograph for Paxlovid. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of drug products. Note: The funded treatment is one dose pack* for a treatment duration of 5 days. * Dose pack for DIN: 02524031 is package of 30 tablets divided in 5 daily-dose blister cards containing 4 nirmatrelvir tablets (150mg each) and 2 ritonavir tablets (100mg each). * Dose pack for DIN: 02527804 is a package of 20 tablets divided in 5 daily-dose blister cards containing 2 nirmatrelvir tablets (150mg each) and 2 ritonavir tablets (100mg each).LU Authorization Period: 5 days to align with funded treatment duration.For the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in immunocompromised* patients 18 years of age or older regardless of vaccine status or prior COVID-19 infections with: - a positive result from direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing (either using rapid antigen test or PCR), and - symptoms present for 5 days or fewer. * Prescribers should consult Ontario Health Recommendations for Antiviral Therapy for Adults with Mild to Moderate COVID-19 (April 2024). Examples of immunocompromised include: - Advanced untreated human immunodeficiency virus (HIV) or treated HIV with a CD4 count equal or less than 200 per mm3 or CD4 fraction equal or less than 15% - Bone marrow or stem cell transplant - Solid organ transplant - Have active hematological malignancy or recently received treatment for hematological malignancy - E.g., have received treatment with any anti-CD20 agents or B-cell depleting agents in the last 2 years - Chimeric antigen receptor (CAR) T-cell therapy in the last 6 months - Treatment for cancer (including solid tumors), limited to: systemic therapy in the last 6 months (e.g., chemotherapy, molecular therapy, immunotherapy, targeted therapies, monoclonal antibodies, excluding those receiving adjunctive hormonal therapy only) or radiation therapy in the last 3 months - Prednisone use equal to or greater than 20mg/day (or corticosteriod equivalent) for 14 days or more, or other moderately or severely immunosuppressive therapies (e.g., alkylating agents) - Primary immunodeficiencies. For example: - Hypogammaglobulinemia - Combined immune deficiencies affecting T-cells - Immune dysregulation (e.g., familial hemophagocytic lymphohistiocytosis) - Type 1 interferon defects caused by a genetic primary immunodeficiency disorder or secondary to anti-interferon autoantibodies - Diagnosed by an immunologist and requires ongoing immunoglobulin replacement therapy (IVIg or SCIg) - Primary immunodeficiency with a confirmed genetic cause (e.g., DiGeorge syndrome, Wiskott-Aldrich syndrome) Paxlovid (DIN: 02527804) is intended for patients with renal impairment or on dialysis. If Paxlovid (DIN: 02524031) is being dispensed for such patients, it requires dose adjustment. Treatment decisions should be individualized based on the prescriber's assessment of patient risk because not all medical or social vulnerabilities carry the same risk. Pharmacists and prescribers should be informed of and stay current with a drug product's official indications in accordance with Health Canada's approved product monograph. Some aspects of the above criteria may differ from the official indications as described in the product monograph for Paxlovid. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of drug products. Note: The funded treatment is one dose pack** for a treatment duration of 5 days. In exceptional circumstances, the funded treatment is two dose packs** for a treatment duration of 10 days based on prescriber clinical judgement in consultation with an infectious disease specialist. Pharmacy operators must obtain and retain appropriate documentation to support claims for such extended therapy. For guidance, prescribers may consult Ontario Health - Frequently Asked Questions on Antiviral Therapy for Adults with Mild to Moderate COVID-19 (April 2024).** Dose pack for DIN: 02524031 is package of 30 tablets divided in 5 daily-dose blister cards containing 4 nirmatrelvir tablets (150mg each) and 2 ritonavir tablets (100mg each). ** Dose pack for DIN: 02527804 is a package of 20 tablets divided in 5 daily-dose blister cards containing 2 nirmatrelvir tablets (150mg each) and 2 ritonavir tablets (100mg each).LU Authorization Period: 5 days or 10 days to align with funded treatment duration.For the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in patients 18 to 64 years of age with at least 1 risk factor* associated with more severe COVID-19 outcomes with: - a positive result from direct severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral testing (either using rapid antigen test or PCR), and - symptoms present for 5 days or fewer. The risk of progression to severe COVID-19 depends on the quantity of underlying medical conditions and how controlled the medical conditions are. * When assessing risk factors, prescribers may want to consult Ontario Health Recommendations for Antiviral Therapy for Adults with Mild to Moderate COVID-19 (April 2024). Examples of risk factors include: Vaccination Status: - Have never received a COVID-19 vaccine Medical Conditions: - Active tuberculosis (treated or untreated) - Cerebrovascular disease - Chronic kidney disease, especially CKD stage 4 or 5 and dialysis - Chronic lung diseases, limited to: asthma, bronchiectasis, chronic obstructive pulmonary disease, interstitial lung disease, pulmonary embolism, pulmonary hypertension - Chronic liver diseases, limited to: cirrhosis, non-alcoholic fatty liver disease, alcoholic liver disease, autoimmune hepatitis - Cystic fibrosis - Diabetes mellitus, type 1 or type 2 - Disabilities and developmental delay, including Down syndrome - Heart conditions (e.g., heart failure, coronary artery disease, cardiomyopathies) - Mental health conditions, limited to: mood disorders (including depression), schizophrenia spectrum disorders - Neurologic conditions that cause an inability to control respiratory secretions or communicate disease progression (e.g., cognitive disorders such as Alzheimer-type dementia) - Obesity (body mass index above 30kg per m2) - Pregnancy or recent pregnancy (42 days post-partum/end of pregnancy) Note for consideration: Certain medical or social vulnerabilities may confer an increased risk of disease progression because affected individuals may experience challenges in recognizing, communicating or acting on progressive COVID-19 symptoms. People who are at a high risk of poor outcomes from COVID-19 based on social determinants of health should be considered priority populations for access to antivirals. Individuals at high risk include Indigenous people, Black people, other members of racialized communities; people experiencing intellectual, developmental, or cognitive disabilities; people who use substances regularly (e.g., alcohol); people who live with mental health conditions; and people who are underhoused. Paxlovid (DIN: 02527804) is intended for patients with renal impairment or on dialysis. If Paxlovid (DIN: 02524031) is being dispensed for such patients, it requires dose adjustment. Treatment decisions should be individualized based on the prescriber's assessment of patient risk because not all medical or social vulnerabilities carry the same risk. Pharmacists and prescribers should be informed of and stay current with a drug product's official indications in accordance with Health Canada's approved product monograph. Some aspects of the above criteria may differ from the official indications as described in the product monograph for Paxlovid. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of drug products. Note: The funded treatment is one dose pack** for a treatment duration of 5 days.** Dose pack for DIN: 02524031 is package of 30 tablets divided in 5 daily-dose blister cards containing 4 nirmatrelvir tablets (150mg each) and 2 ritonavir tablets (100mg each). ** Dose pack for DIN: 02527804 is a package of 20 tablets divided in 5 daily-dose blister cards containing 2 nirmatrelvir tablets (150mg each) and 2 ritonavir tablets (100mg each).LU Authorization Period: 5 days to align with funded treatment duration.OSELTAMIVIR PHOSPHATE018030mgCapTamifluHLR2.11502011-03-15.5243Nat-OseltamivirNAT.52432018-05-31.5243Jamp OseltamivirJPC.52432020-11-30.5243Mint-OseltamivirMIN.52432020-08-28.5243Sandoz OseltamivirSDZ.52432021-01-29.5243018145mgCapTamifluHLR3.25402011-03-151.6135Nat-OseltamivirNAT1.61352018-05-311.6135Sandoz OseltamivirSDZ1.61352021-01-291.6135018275mgCapTamifluHLR4.19402003-04-161.0393Nat-OseltamivirNAT1.03932016-11-301.0393Jamp OseltamivirJPC1.03932020-11-301.0393Mint-OseltamivirMIN1.03932020-07-311.0393Sandoz OseltamivirSDZ1.03932021-01-291.0393For the prophylaxis (max: 75mg daily) of institutionalized individuals during confirmed* outbreaks of Influenza A or Influenza B.Network will limit supply to 6 weeks.*The outbreak must be confirmed by Public Health.LU Authorization Period: 1 yearFor the treatment (max: 75mg bid) of institutionalized individuals during confirmed* outbreaks due to: Influenza B or, Influenza A (as an alternative to amantadine) or, Influenza A where new cases have developed despite amantadine prophylaxis.Network will limit supply to 5 days.*The outbreak must be confirmed by Public Health.LU Authorization Period: 1 yearFor treatment of individuals who are at high risk* of complications from influenza infection and have either: 1. Laboratory-confirmed influenza A or influenza B infection; OR 2. Illness consistent with influenza A or influenza B infection *High risk of complications from influenza infection is defined by the presence of one or more of the following medical conditions, age-related factors, or other characteristics: - Asthma and other chronic pulmonary diseases, including bronchopulmonary dysplasia, cystic fibrosis, chronic bronchitis, and emphysema - Cardiovascular disease (excluding isolated hypertension), including congenital and acquired heart disease, such as heart failure and symptomatic coronary artery disease - Renal disease - Chronic liver disease - Diabetes mellitus and other metabolic diseases - Anemia and hemoglobinopathies, such as sickle cell disease - Cancer, immunosuppression, or immunodeficiency due to disease (e.g., HIV infection, especially if CD4 is less than 200 per microlitre) or management of underlying conditions (e.g., solid organ transplant or hematopoietic stem cell transplant recipients, those receiving immunosuppressive therapies for autoimmune conditions or other disorders) - Neurological disease and neurodevelopmental disorders that compromise handling of respiratory secretions (cognitive dysfunction; spinal cord injury; neuromuscular, neurovascular, neurodegenerative, and seizure disorders; cerebral palsy; metabolic disorders) - Children aged younger than 5 years - Individuals aged 65 years or older - Individuals of any age who are residents of nursing homes or other chronic care facilities - Pregnancy and up to 4 weeks postpartum regardless of how the pregnancy ended - Obesity with a body mass index (BMI) greater than or equal to 40 or a BMI greater than 3 z-scores above the mean for age and gender - Children and adolescents aged younger than 18 years undergoing treatment for long periods with acetylsalicylic acid - Indigenous peoples Maximum dosage: 75mg twice daily for 5 days Treatment should be initiated as soon as possible (ideally no more than 48 hours) after onset of symptoms to achieve optimal benefits.LU Authorization Period: 6 MonthsPrescribers and dispensers should be informed of the drug product's official indications as set out in Health Canada's approved product monograph. Aspects of the above funding criteria may differ from the official indications in the product monograph. Where there is a difference between the product monograph and the above reimbursement criteria, the criteria govern for the purpose of the drug product's funding under the Ontario Drug Benefit Program. The reimbursement criteria are intended for information purposes only and do not provide any medical diagnosis, symptom assessment, health counselling, or medical opinion for Ontario Drug Benefit Program recipients. This information also does not constitute medical advice for prescribers or dispensers.01836mg/mLO/LTamifluHLR2020-08-28Nat-OseltamivirNAT.28112020-08-28RALTEGRAVIR POTASSIUM0184400mgTabIsentressMFC14.03012010-04-2314.03010185600mgTabIsentress HDMEK14.03012019-07-3114.0301REMDESIVIR0186100mg/vialPd for Sol-100mg Vial PkVekluryGIL660.53002025-05-30660.5300For the treatment of coronavirus disease 2019 (COVID-19) in non-hospitalized individuals who: - have a diagnosis of COVID-19 based on a positive Rapid Antigen Test or PCR test; AND - are at high-risk for progression to severe COVID-19 due to: - being moderately or severely immunocompromised (see below), or - being 65 years of age or older, or - having one or more risk factors (see below); AND - will not be using remdesivir in combination with any other antiviral medication for COVID-19 (e.g. Paxlovid). Remdesivir is an alternative option for patients who cannot receive nirmatrelvir-ritonavir (Paxlovid) due to contraindications, intolerance, potential drug-drug interactions, and/or greater than 5 days since symptom onset. Remdesivir should be initiated as soon as possible after a diagnosis of COVID-19 based on a positive Rapid Antigen Test or PCR test, and within 7 days of symptom onset. The funded treatment duration is up to 3 days, unless the prescriber has prescribed treatment for up to 5 days in consultation with an infectious disease specialist and this is documented by the pharmacy, in which case the funded treatment duration is up to 5 days. Pharmacists and prescribers should be informed of and stay current with a drug product's official indications in accordance with Health Canada's approved product monograph. Some aspects of the above criteria may differ from the official indications as described in the product monograph for remdesivir. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of drug products.Examples of moderately or severely immunocompromised individuals include those with: - Advanced untreated human immunodeficiency virus (HIV) or treated HIV with a CD4 count equal or less than 200 per mm3 or CD4 fraction equal or less than 15% - Bone marrow or stem cell transplant - Solid organ transplant - Active hematological malignancy or recently received treatment for hematological malignancy E.g., have received treatment with any anti-CD20 agents or B-cell depleting agents in the last 2 years - Chimeric antigen receptor (CAR) T-cell therapy in the last 6 months - Treatment for cancer (including solid tumors), limited to: systemic therapy in the last 6 months (e.g., chemotherapy, molecular therapy, immunotherapy, targeted therapies, monoclonal antibodies, excluding those receiving adjunctive hormonal therapy only) or radiation therapy in the last 3 months - Prednisone use equal to or greater than 20mg/day (or corticosteroid equivalent) for 14 days or more, or other moderately or severely immunosuppressive therapies (e.g., alkylating agents) - Primary immunodeficiencies. For example: - Hypogammaglobulinemia - Combined immune deficiencies affecting T-cells - Immune dysregulation (e.g., familial hemophagocytic lymphohistiocytosis) - Type 1 interferon defects caused by a genetic primary immunodeficiency disorder or secondary to anti-interferon autoantibodies - Diagnosed by an immunologist and requires ongoing immunoglobulin replacement therapy (IVIg or SCIg) - Primary immunodeficiency with a confirmed genetic cause (e.g., DiGeorge syndrome, Wiskott-Aldrich syndrome)The risk of progression to severe COVID-19 depends on the quantity of underlying chronic comorbidities and how controlled the conditions are. When assessing risk factors, prescribers may want to consult the most recent Ontario Health COVID-19 clinical guidance. Examples of risk factors include: - Has never received a COVID-19 vaccine - Active tuberculosis (treated or untreated) - Cerebrovascular disease - Chronic kidney disease (CKD), especially CKD stage 4 or 5 and dialysis - Chronic lung diseases (asthma, bronchiectasis, chronic obstructive pulmonary disease, interstitial lung disease, pulmonary embolism, pulmonary hypertension) - Chronic liver diseases (cirrhosis, non-alcoholic fatty liver disease, alcoholic liver disease, autoimmune hepatitis) - Cystic fibrosis - Diabetes mellitus type 1 or type 2 - Disabilities and developmental delay, including Down syndrome - Heart conditions, e.g., heart failure, coronary artery disease, cardiomyopathies - Mental health conditions, e.g., mood disorders (including depression), schizophrenia spectrum disorders - Neurologic conditions that cause an inability to control respiratory secretions or communicate disease progression (e.g., cognitive disorders such as Alzheimer-type dementia) - Obesity (body mass index above 30kg per metre squared) - Pregnancy or recent pregnancy (42 days post-partum/end of pregnancy) LU Authorization Period: Length of funded treatment duration (see above)RILPIVIRINE HYDROCHLORIDE018725mgTabEdurantJAN17.75002012-07-2717.7500RITONAVIR0188100mgTabNorvirABB1.56602012-02-291.1745Auro-RitonavirAUR1.17452022-10-311.1745SOFOSBUVIR0189400mgTabSovaldiGIL654.76192017-02-28654.7619In combination with ribavirin (Ibavyr) for treatment-naive or treatment-experienced (1) adult patients with chronic hepatitis C (CHC) infection who meet all the following criteria: (i) Treatment is prescribed by a hepatologist, gastroenterologist, infectious disease specialist or other prescriber experienced in treating chronic hepatitis C; AND (ii) Laboratory confirmed hepatitis C genotype 2; AND (iii) Established chronicity of HCV infection either by two laboratory confirmed quantitative HCV RNA values taken at least 6 months apart; OR One recent laboratory confirmed quantitative HCV RNA within the past 6 months and clinical features establishing a duration of HCV infection longer than 6 months (e.g. presence of fibrosis, presence of non-liver manifestations of HCV, prolonged ALT elevation greater than 6 months without another cause, HCV antibody positivity greater than 6 months), or risk factors for HCV acquisition greater than 6 months (e.g. injection drug use). For patients who meet the eligibility criteria for sofosbuvir (Sovaldi), clinicians are encouraged to choose sofosbuvir/velpatasvir (Epclusa) as the preferred therapeutic option over sofosbuvir with ribavirin regimens for treatment of genotype 2 or 3 patients only. This recommendation is based on evidence that Epclusa offers advantages in some patient populations, including potentially higher SVR rates and a shorter course of therapy for genotype 3 infections. Treatment regimens for sofosbuvir (Sovaldi) for genotype 2: - Treatment-naive or treatment-experienced genotype 2 Approved regimen: 12 weeks in combination with ribavirin (Ibavyr) Retreatment is not funded. Retreatment for failure or re-infection in patients who have received an adequate prior course of direct-acting antiviral will be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 12 Weeks.In combination with ribavirin (Ibavyr) for treatment-naive or treatment-experienced (1) adult patients with chronic hepatitis C (CHC) infection who meet all the following criteria: (i) Treatment is prescribed by a hepatologist, gastroenterologist, infectious disease specialist or other prescriber experienced in treating chronic hepatitis C; AND (ii) Laboratory confirmed hepatitis C genotype 3; AND (iii) Established chronicity of HCV infection either by two laboratory confirmed quantitative HCV RNA values taken at least 6 months apart; OR One recent laboratory confirmed quantitative HCV RNA within the past 6 months and clinical features establishing a duration of HCV infection longer than 6 months (e.g. presence of fibrosis, presence of non-liver manifestations of HCV, prolonged ALT elevation greater than 6 months without another cause, HCV antibody positivity greater than 6 months), or risk factors for HCV acquisition greater than 6 months (e.g. injection drug use). For patients who meet the eligibility criteria for sofosbuvir (Sovaldi), clinicians are encouraged to choose sofosbuvir/velpatasvir (Epclusa) as the preferred therapeutic option over sofosbuvir with ribavirin regimens for treatment of genotype 2 or 3 patients only. This recommendation is based on evidence that Epclusa offers advantages in some patient populations, including potentially higher SVR rates and a shorter course of therapy for genotype 3 infections. Treatment regimens for sofosbuvir (Sovaldi) for genotype 3: - Treatment-naive or treatment-experienced without cirrhosis, or with compensated cirrhosis (2), or with decompensated cirrhosis (2), or post-liver transplant Approved regimen: 24 weeks in combination with ribavirin (Ibavyr). Retreatment is not funded. Retreatment for failure or re-infection in patients who have received an adequate prior course of direct-acting antiviral will be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 24 Weeks.1. Treatment-experienced are those who failed prior therapy with an interferon-based regimen, including regimens containing an HCV protease inhibitor. 2. Compensated cirrhosis (Child-Turcotte-Pugh A [i.e. Score 5 to 6]) and decompensated cirrhosis (Child-Turcotte-Pugh B or C [i.e. Score 7 or above]) may be considered. 3. Combination therapy with Zepatier (elbasvir/grazoprevir) will not be considered for funding. 4. Health care professionals are advised to refer to the product monograph and prescribing guidelines for appropriate use of the drug product, including use in special populations.SOFOSBUVIR & VELPATASVIR0190400mg & 100mgTabEpclusaGIL714.28572017-02-28714.2857For treatment-naive or treatment-experienced (1) adult patients with chronic hepatitis C (CHC) infection who meet all the following criteria: (i) Treatment is prescribed by a hepatologist, gastroenterologist, infectious disease specialist or other prescriber experienced in treating chronic hepatitis C; AND (ii) Laboratory confirmed hepatitis C genotype 1, 2, 3, 4, 5, 6 or mixed genotypes; AND (iii) Established chronicity of HCV infection either by two laboratory confirmed quantitative HCV RNA values taken at least 6 months apart; OR One recent laboratory confirmed quantitative HCV RNA within the past 6 months and clinical features establishing a duration of HCV infection longer than 6 months (e.g. presence of fibrosis, presence of non-liver manifestations of HCV, prolonged ALT elevation greater than 6 months without another cause, HCV antibody positivity greater than 6 months), or risk factors for HCV acquisition greater than 6 months (e.g. injection drug use). Treatment regimens for Epclusa (sofosbuvir-velpatasvir): I. Treatment-naive or treatment-experienced (1) non-cirrhotic or compensated cirrhosis (2) Approved duration: 12 weeks II. Treatment-naive or treatment-experienced patients with decompensated cirrhosis (2) Approved regimen: 12 weeks in combination with ribavirin (Ibavyr) Retreatment is not funded. Retreatment for failure or re-infection in patients who have received an adequate prior course of direct-acting antiviral will be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 12 Weeks.1. Treatment-experienced are those who failed prior therapy with an interferon-based regimen, including regimens containing an HCV protease inhibitor. 2. Compensated cirrhosis (Child-Turcotte-Pugh A [i.e. Scores 5 to 6]) and decompensated cirrhosis (Child-Turcotte-Pugh B or C [i.e. Score 7 or above]) may be considered. 3. Health care professionals are advised to refer to the product monograph and prescribing guidelines for appropriate use of the drug product, including use in special populations.SOFOSBUVIR & VELPATASVIR & VOXILAPREVIR0191400mg & 100mg & 100mgTabVoseviGIL714.28572018-02-28714.2857For treatment-experienced (1) adult patients with chronic hepatitis C (CHC) infection who meet all the following criteria: (i) Treatment is prescribed by a hepatologist, gastroenterologist, infectious disease specialist or other prescriber experienced in treating chronic hepatitis C; AND (ii) Laboratory confirmed hepatitis C genotype 1, 2, 3, 4, 5, 6 or mixed genotypes; AND (iii) Established chronicity of HCV infection either by two laboratory confirmed quantitative HCV RNA values taken at least 6 months apart; OR One recent laboratory confirmed quantitative HCV RNA within the past 6 months and clinical features establishing a duration of HCV infection longer than 6 months (e.g. presence of fibrosis, presence of non-liver manifestations of HCV, prolonged ALT elevation greater than 6 months without another cause, HCV antibody positivity greater than 6 months), or risk factors for HCV acquisition greater than 6 months (e.g. injection drug use). Treatment regimen for Vosevi (sofosbuvir-velpatasvir-voxilaprevir): Treatment-experienced, non-cirrhotic or compensated cirrhosis (2) Approved duration: 12 weeks Retreatment is not funded. Retreatment for failure or re-infection in patients who have received an adequate prior course of Vosevi will be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 12 Weeks.1. Treatment-experienced are those who failed prior therapy with a HCV regimen containing: i. NS5A inhibitor* for genotype 1, 2, 3, 4, 5, or 6; OR ii. Sofosbuvir (Sovaldi) without an NS5A inhibitor for genotype 1, 2, 3, or 4 *NS5A inhibitors include: daclatasvir (Daklinza), elbasvir (as part of Zepatier), ledipasvir (as part of Harvoni), ombitasvir (as part of Holkira Pak), velpatasvir (as part of Epclusa), pibrentasvir (as part of Maviret) 2. Compensated cirrhosis (Child-Turcotte-Pugh A [i.e. Scores 5 to 6]) may be considered. 3. Health care professionals are advised to refer to the product monograph and prescribing guidelines for appropriate use of the drug product, including use in special populations.TENOFOVIR ALAFENAMIDE019225mgTabVemlidyGIL19.55372026-01-3019.5537Confirmed chronic Hepatitis B infection in persons with - HBV DNA greater than or equal to 1000 IU/mL AND - ALT levels greater than ULN OR - Evidence of fibrosis OR - Documented evidence of cirrhosisLU Authorization Period: 1 yearFor patients with chronic Hepatitis B infection who have a contraindication, intolerance or inadequate response to one or more of the following: lamivudine, entecavir, adefovir or telbivudine.LU Authorization Period: 1 yearPatient is pregnant (2nd trimester or later) with HBV DNA greater than 1,000,000 IU/mL.LU Authorization Period: 1 yearPatients with chronic Hepatitis B infection currently receiving treatment with tenofovir and requires treatment continuation.LU Authorization Period: 1 yearPatients with chronic Hepatitis B infection who are scheduled to undergo chemotherapy or significant immunosuppressive treatment.LU Authorization Period: 1 yearTENOFOVIR DISOPROXIL0193300mgTabVireadGIL19.55372007-01-024.8884Teva-TenofovirTEV4.88842017-09-284.8884Apo-TenofovirAPX4.88842017-09-284.8884Mylan-Tenofovir DisoproxilMYL4.88842017-09-284.8884PMS-TenofovirPMS4.88842018-06-294.8884Auro-TenofovirAUR4.88842017-09-284.8884Nat-TenofovirNAT4.88842018-07-314.8884Jamp-TenofovirJPC4.88842019-02-284.8884TenofovirSAI4.88842021-10-294.8884Mint-TenofovirMIN4.88842021-11-304.8884TenofovirSIV4.88842022-07-294.8884Confirmed chronic Hepatitis B infection in persons with - HBV DNA greater than or equal to 1000 IU/mL AND - ALT levels greater than ULN OR - Evidence of fibrosis OR - Documented evidence of cirrhosisLU Authorization Period: 1 yearFor patients with chronic Hepatitis B infection who have a contraindication, intolerance or inadequate response to one or more of the following: lamivudine, entecavir, adefovir or telbivudine.LU Authorization Period: 1 yearPatient is pregnant (2nd trimester or later) with HBV DNA greater than 1,000,000 IU/mL.LU Authorization Period: 1 yearPatients with chronic Hepatitis B infection currently receiving treatment with tenofovir and requires treatment continuation.LU Authorization Period: 1 yearPatients with chronic Hepatitis B infection who are scheduled to undergo chemotherapy or significant immunosuppressive treatment.LU Authorization Period: 1 yearFor HIV/AIDS.LU Authorization Period: 1 yearVALACYCLOVIR0194500mgTabValtrexGSK4.56471996-12-19.6198Apo-ValacyclovirAPX.61982008-08-28.6198PMS-ValacyclovirPMS.61982008-08-28.6198Riva-ValacyclovirRIA.61982025-08-29.6198Co ValacyclovirCOB.61982010-10-28.6198Sandoz ValacyclovirSDZ.61982015-09-30.6198Mylan-ValacyclovirMYL.61982010-07-20.6198Teva-ValacyclovirTEV.61982012-11-27.6198Auro-ValacyclovirAUR.61982013-07-30.6198Jamp ValacyclovirJPC.61982021-07-30.6198Jamp-ValacyclovirJPC.61982015-12-22.6198ValacyclovirSIV.61982020-08-28.6198ValacyclovirSAI.61982016-11-30.619801951000mgTabValtrexGSK2010-07-20Mylan-ValacyclovirMYL5.85372010-07-20Apo-ValacyclovirAPX5.85372010-10-28PMS-ValacyclovirPMS5.85372012-05-29Auro-ValacyclovirAUR5.85372020-12-18ValacyclovirSAI5.85372021-12-17ValacyclovirSIV5.85372026-01-30Jamp ValacyclovirJPC5.85372026-02-27VALGANCICLOVIR019650mg/mLPd for Oral Sol-100mL PkValcyteCHE321.84542020-02-28150.9900Auro-ValganciclovirAUR150.99002023-12-29150.9900For those unable to swallow or tolerate solid oral dosage form AND For the treatment of Cytomegalovirus (CMV) retinitis in patients with HIV/AIDS.LU Authorization Period: 1 yearFor those unable to swallow or tolerate solid oral dosage form AND For the prevention of Cytomegalovirus (CMV) in solid organ transplant patients (not lung or heart-lung).LU Authorization Period: Up to 6 monthsFor those unable to swallow or tolerate solid oral dosage form AND For the prevention of Cytomegalovirus (CMV) in lung or heart-lung transplant patients.LU Authorization Period: Up to 12 months0197450mgTabValcyteCHE28.96832003-04-165.8553Teva-ValganciclovirTEV5.85532015-01-285.8553Auro-ValganciclovirAUR5.85532015-11-265.8553Mint-ValganciclovirMIN5.85532020-07-315.8553For the treatment of CMV retinitis in patients with HIV/AIDS.LU Authorization Period: 1 yearFor the prevention of Cytomegalovirus (CMV) in solid organ transplant patients (not lung or heart-lung).LU Authorization Period: Up to 6 monthsFor the prevention of Cytomegalovirus (CMV) in lung or heart-lung transplant patients.LU Authorization Period: Up to 12 monthsZANAMIVIR01985mgPd Inh-5 Rotadisks PkRelenzaGSK49.23002010-03-0249.2300For the treatment or prophylaxis of institutionalized individuals during confirmed outbreaks due to influenza A or Influenza B when the predominant circulating strain is resistant to oseltamivir or for the prophylaxis of influenza A, where new cases have developed despite amantadine prophylaxis. The outbreak must be confirmed by Public Health.For treatment: 2 inhalations of 5mg (10mg) bid for 5 days,LU Authorization Period: 1 yearFor prophylaxis: 2 inhalations of 5mg (10mg) once daily for 10 days.LU Authorization Period: 1 yearZIDOVUDINE0199100mgCapRetrovirVIH2009-06-23Apo-ZidovudineAPX2.23662009-06-23PLASMODICIDES (ANTIMALARIALS)ATOVAQUONE & PROGUANIL HCL0200250mg & 100mgTabMalaroneGSK6.35582012-04-244.1308Teva-Atovaquone ProguanilTEV4.13082012-04-244.1308Mylan-Atovaquone/ProguanilMYL4.13082014-01-304.1308Atovaquone ProguanilSAI4.13082020-07-314.1308Atovaquone and Proguanil HydrochlorideGLP4.13082018-02-284.1308HYDROXYCHLOROQUINE SULFATE0201200mgTabPlaquenilSAV.65161996-10-01.1576Apo-HydroxyquineAPX.15762003-09-04.1576Mint-HydroxychloroquineMIN.15762016-04-29.1576Jamp-HydroxychloroquineJPC.15762020-04-07.1576NRA-HydroxychloroquineNRA.15762021-12-17.1576HydroxychloroquineSAI.15762022-07-29.1576MEFLOQUINE HCL0202250mgTabLariamHLR2007-06-06MefloquineAAP3.69502007-06-063.6950SULFONAMIDESSULFASALAZINE0203500mgEnt TabPMS-Sulfasalazine-E.C.PMS.38631996-10-01.3863Salazopyrin EN-TABS 500 MGPFI.55121996-10-01.38630204500mgTabPMS-SulfasalazinePMS.18071996-10-01.1807SalazopyrinPFI.36141996-10-01.1807Jamp SulfasalazineJPC.18072026-02-27.1807SULFONESDAPSONE0205100mgTab1.1952DapsoneJAC1.40611.40611996-10-011.1952Mar-DapsoneMAR1.19521.19522019-05-311.1952ANTIPROTOZOALSATOVAQUONE0206750mg/5mLO/LMepronGSK3.76611997-04-102.3785GLN-AtovaquoneGLP2.37852022-10-312.3785TRICHOMONACIDESMETRONIDAZOLE0207500mgCap.8217PMS-MetronidazolePMS.2739.82171996-10-01.2739FlagylSAC1996-10-01Apo-MetronidazoleAPX.2739.82172004-07-20.2739Auro-MetronidazoleAUR.2739.82172018-07-31.2739MetronidazoleJPC.2739.82172022-06-30.2739M-MetronidazoleMAT.2739.82172022-04-29.2739MetronidazoleSAI.2739.82172024-03-28.27390208250mgTab.1716Apo-Metronidazole TabletsAPX.0572.17161996-10-01.0572FlagylRPP2001-02-28Mint-MetronidazoleMIN.0572.17162024-10-31.0572URINARY ANTI-INFECTIVESFOSFOMYCIN TROMETHAMINE0209Sachet-3g PkThe recommended dosage for women over 18 years with acute uncomplicated urinary tract infections (acute cystitis) is one sachet containing the equivalent of 3 grams of fosfomycin. A single dose of fosfomycin should be used to treat an episode of acute cystitis.MonurolPAL22.10002015-07-2914.0250Jamp-FosfomycinJPC14.02502018-11-2914.0250NITROFURANTOINNitrofurantoin macrocrystals may be better tolerated. Avoid use of nitrofurantoin during the last 6 weeks of pregnancy. Use with caution in patients with renal impairment.021050mgCap1.1708MacrodantinPGP1996-10-01Teva-NitrofurantoinTEV.29271.17081998-12-31.2927Jamp NitrofurantoinJPC.29271.17082025-05-30.29270211100mgCap2.1996MacrodantinPGP1996-10-01Teva-NitrofurantoinTEV.54992.19961998-12-31.5499Jamp NitrofurantoinJPC.54992.19962025-05-30.5499021250mgTab.6812NifuranMAN2006-06-15NitrofurantoinAAP.1703.68121996-10-01.17030213100mgTab.9088NifuranMAN2006-06-15NitrofurantoinAAP.2272.90881996-10-01.2272NITROFURANTOIN MONO/MICRO CRYSTALS0214100mgCapMacroBIDWAR1996-12-19PMS-Nitrofurantoin BIDPMS.30672018-07-31.3067Auro-Nitrofurantoin BIDAUR.30672024-07-31.3067Jamp Nitrofurantoin BIDJPC.30672025-04-30.3067MISCELLANEOUS ANTI-INFECTIVESCEFEPIME02151gInj Pd-Vial PkMaxipimeBQU2009-05-20Cefepime for InjectionAPX12.93602009-05-20Apo-CefepimeAPX30.20002018-08-3002162gInj Pd-Vial PkMaxipimeBQU2009-05-20Cefepime for InjectionAPX30.19632009-05-20Apo-CefepimeAPX30.20002018-08-30CIPROFLOXACINCiprofloxacin is not intended for the treatment of asymptomatic bacteriuria in the absence of risk factors. Avoid use in pregnancy and children < 18 years of age. Ciprofloxacin inhibits theophylline clearance and also affects phenytoin kinetics. Theophylline doses should be decreased and blood levels of phenytoin or theophylline monitored when either of these drugs is used concomitantly with ciprofloxacin.021710g/100mLOral Susp5.7560CiproBAY.57565.75602001-03-07.5756For patients who are unable to swallow or tolerate solid oral dosage forms.LU Authorization Period: 1 year0218250mgTab.8908CiproBAY1996-10-01Teva-CiprofloxacinTEV.4454.89082004-07-20.4454Apo-CiprofloxAPX.4454.89082004-07-20.4454Ratio-CiprofloxacinRPH.4454.89082004-07-20.4454Act CiprofloxacinTEV.4454.89082004-07-20.4454PMS-CiprofloxacinPMS.4454.89082004-07-20.4454Sandoz CiprofloxacinSDZ.4454.89082004-07-20.4454Ran-CiprofloxRAN.4454.89082008-03-25.4454CiprofloxacinSAI.4454.89082011-08-04.4454Septa-CiprofloxacinSET.4454.89082012-06-26.4454Mar-CiprofloxacinMAR.4454.89082012-05-29.4454Jamp-CiprofloxacinJPC.4454.89082012-09-28.4454Auro-CiprofloxacinAUR.4454.89082012-08-27.4454CiprofloxacinSIV.4454.89082020-06-30.4454Mint-CiprofloxMIN.4454.89082014-07-30.44540219500mgTab1.0050CiproBAY1996-10-01Apo-CiprofloxAPX.50251.00502004-07-20.5025Ratio-CiprofloxacinRPH.50251.00502004-07-20.5025Act CiprofloxacinTEV.50251.00502004-07-20.5025PMS-CiprofloxacinPMS.50251.00502004-07-20.5025Sandoz CiprofloxacinSDZ.50251.00502004-07-20.5025Ran-CiprofloxRAN.50251.00502008-03-25.5025CiprofloxacinSAI.50251.00502011-08-04.5025Septa-CiprofloxacinSET.50251.00502012-06-26.5025Mar-CiprofloxacinMAR.50251.00502012-05-29.5025Jamp-CiprofloxacinJPC.50251.00502012-09-28.5025Auro-CiprofloxacinAUR.50251.00502012-08-27.5025CiprofloxacinSIV.50251.00502020-06-30.5025Mint-CiprofloxMIN.50251.00502014-07-30.5025NRA-CiprofloxacinNRA.50251.00502021-02-26.50250220750mgTab1.8402CiproBAY1996-10-01Apo-CiprofloxAPX.92011.84022004-07-20.9201Ratio-CiprofloxacinRPH.92011.84022004-07-20.9201Act CiprofloxacinTEV.92011.84022004-07-20.9201PMS-CiprofloxacinPMS.92011.84022004-07-20.9201Sandoz CiprofloxacinSDZ.92011.84022004-07-20.9201Ran-CiprofloxRAN.92011.84022008-03-25.9201Septa-CiprofloxacinSET.92011.84022012-06-26.9201Mar-CiprofloxacinMAR.92011.84022012-05-29.9201Jamp-CiprofloxacinJPC.92011.84022012-09-28.9201Auro-CiprofloxacinAUR.92011.84022012-08-27.9201Mint-CiprofloxMIN.92011.84022014-07-30.9201CIPROFLOXACIN HCL & CIPROFLOXACIN BASE0221500mgER TabCipro XLBAY2005-02-22PMS-Ciprofloxacin XLPMS2.31102014-03-272.3110For patients with uncomplicated urinary tract infections (acute cystitis) who have failure, intolerance or hypersensitivity to all formulary antibiotic alternatives that are listed as General Benefits.LU Authorization Period: 1 yearERTAPENEM02221g/VialInj Pd-Vial PkInvanzMFC2021-03-29Ertapenem for InjectionJUN52.26502023-04-2852.2650Ertapenem for InjectionAUR52.26502021-11-3052.2650Ertapenem for InjectionFKC52.26502025-08-2952.2650Ertapenem for InjectionDRR52.26502021-03-2952.2650LEVOFLOXACIN0223250mgTabLevaquinJAN1999-09-15Novo-LevofloxacinNOP1.20382005-01-251.2038Apo-LevofloxacinAPX1.20382009-09-301.2038Sandoz LevofloxacinSDZ1.20382009-09-301.2038Act LevofloxacinTEV1.20382009-09-301.2038Riva-LevofloxacinRIA1.20382020-06-301.2038Mint-LevofloxacinMIN1.20382021-10-291.2038Jamp LevofloxacinJPC1.20382024-09-271.20380224500mgTabLevaquinJAN1999-09-15Novo-LevofloxacinNOP1.37182005-01-251.3718Apo-LevofloxacinAPX1.37182009-09-301.3718Sandoz LevofloxacinSDZ1.37182009-09-301.3718Act LevofloxacinTEV1.37182009-09-301.3718Riva-LevofloxacinRIA1.37182020-06-301.3718Mint-LevofloxacinMIN1.37182021-10-291.3718Jamp LevofloxacinJPC1.37182024-09-271.37180225750mgTabLevaquinJAN2009-09-30Novo-LevofloxacinNOP6.54842009-09-30Sandoz LevofloxacinSDZ6.54842009-11-13Act LevofloxacinTEV6.54842009-09-30Apo-LevofloxacinAPX6.54842009-09-30Riva-LevofloxacinRIA6.54842020-08-28Mint-LevofloxacinMIN6.54842021-11-30Jamp LevofloxacinJPC6.54842024-07-31LINEZOLID02262mg/mLInj-300mL PkZyvoxamPFI2014-10-29Linezolid InjectionJPC88.74002020-05-2988.74000227600mgTabZyvoxamPFI2003-01-30Sandoz LinezolidSDZ19.30412014-10-2919.3041Apo-LinezolidAPX19.30412014-10-2919.3041Jamp LinezolidJPC19.30412023-01-3119.3041For the treatment of patients with:Methicillin-resistant Staphylococcus species (MRSA, MRSE) infections* in patients who are intolerant or have failed vancomycin therapy, or have contraindications to venous access.LU Authorization Period: 1 yearVancomycin resistant Enterococcus species (VRE) infections* in patients switching from IV linezolid.LU Authorization Period: 1 yearStep-down therapy for the treatment of methicillin-resistant Staphylococcus species or vancomycin resistant Enterococcus species (VRE) infections* after parenteral therapy or hospital/ emergency department discharge.* Infections must be documented and culture proven. Not approved for colonization (e.g. nares, urine, etc). Maximum 28 days supply.LU Authorization Period: 1 yearMOXIFLOXACIN HYDROCHLORIDE0228400mgTabAveloxBAY2001-06-07Teva-MoxifloxacinTEV1.52302016-01-281.5230Sandoz MoxifloxacinSDZ1.52302018-01-311.5230Apo-MoxifloxacinAPX1.52302016-03-301.5230Auro-MoxifloxacinAUR1.52302016-01-281.5230Jamp-MoxifloxacinJPC1.52302015-12-221.5230Mar-MoxifloxacinMAR1.52302016-01-281.5230Jamp-Moxifloxacin TabletsJPC1.52302016-03-301.5230Med-MoxifloxacinGMP1.52302017-02-281.5230M-MoxifloxacinMAT1.52302019-03-281.5230AG-MoxifloxacinANG1.52302020-11-301.5230MoxifloxacinSAI1.52302022-06-301.5230NORFLOXACIN0229400mgTab3.7172NoroxinMSD1996-10-01NorfloxacinAAP1.85863.71721999-04-151.8586SULFAMETHOXAZOLE & TRIMETHOPRIMAvoid using sulfamethoxazole/trimethoprim during the last 6 weeks of pregnancy.023040mg & 8mg/mLO/L1.0260SeptraBWE1996-10-01Bactrim Sugar FreeHLR1996-10-01Teva-TrimelTEV.10261.02601996-10-01.10260231400mg & 80mgTab.8736SeptraBWE1996-10-01BactrimHLR1996-10-01SulfatrimAAP.2184.87361996-10-01.21840232800mg & 160mgTab.4148Septra DSBWE1996-10-01Bactrim-DSHLR1996-10-01Sulfatrim-DSAAP.2074.41481996-10-01.2074TRIMETHOPRIM0233100mgTab.5234ProloprimBWE1996-10-01TrimethoprimAAP.2617.52342001-06-07.26170234200mgTab.5378ProloprimBWE1996-10-01TrimethoprimAAP.5378.53782001-06-07.5378ANTINEOPLASTIC AGENTSABIRATERONE ACETATE0235250mgTabZytigaJAN35.52302021-03-297.6563Reddy-AbirateroneDRR7.65632021-03-297.6563Sandoz AbirateroneSDZ7.65632021-03-297.6563Apo-Abiraterone Film Coated TabletsAPX7.65632021-03-297.6563PMS-AbirateronePMS7.65632021-03-297.6563Nat-AbirateroneNAT7.65632021-03-297.6563Jamp AbirateroneJPC7.65632021-03-297.6563Mar-AbirateroneMAR7.65632021-03-297.6563PRZ-AbirateronePRZ7.65632025-12-307.65630236500mgTabZytigaJAN71.04602021-03-2915.3125Apo-Abiraterone Film Coated TabletsAPX15.31252021-03-2915.3125PMS-AbirateronePMS15.31252021-03-2915.3125Mar-AbirateroneMAR15.31252021-03-2915.3125Sandoz AbirateroneSDZ15.31252022-03-3115.3125AbirateroneJPC15.31252022-10-3115.3125Jamp AbirateroneJPC15.31252023-06-3015.3125Reddy-AbirateroneDRR15.31252023-06-3015.3125PRZ-AbirateronePRZ15.31252025-12-3015.3125AFATINIB023720mgTabGiotrifBOE80.83342024-12-3038.7392Sandoz AFAtinibSDZ38.73922024-12-3038.7392Mar-AfatinibMAR38.73922025-03-3138.7392023830mgTabGiotrifBOE80.83342024-12-3038.7392Sandoz AFAtinibSDZ38.73922024-12-3038.7392Mar-AfatinibMAR38.73922025-03-3138.7392023940mgTabGiotrifBOE80.83342024-12-3038.7392Sandoz AFAtinibSDZ38.73922024-12-3038.7392Mar-AfatinibMAR38.73922025-03-3138.7392ALTRETAMINE024050mgCapHexalenLIL3.36001996-10-013.3600ANASTROZOLE02411mgTabArimidexAZC6.35571996-12-19.9522PMS-AnastrozolePMS.95222012-12-21.9522Ran-AnastrozoleRAN.95222012-12-21.9522Sandoz AnastrozoleSDZ.95222012-09-28.9522Jamp-AnastrozoleJPC.95222013-01-29.9522AnastrozoleACH.95222012-12-21.9522Taro-AnastrozoleTAR.95222013-01-29.9522Apo-AnastrozoleAPX.95222012-12-21.9522Med-AnastrozoleGMP.95222012-12-21.9522Mar-AnastrozoleMAR.95222013-01-29.9522Riva-AnastrozoleRIA.95222021-08-31.9522Mint-AnastrozoleMIN.95222013-01-29.9522Co AnastrozoleCOB.95222012-12-21.9522Nat-AnastrozoleNAT.95222015-04-30.9522AnastrozoleSAI.95222020-06-30.9522CCP-AnastrozoleCCP.95222017-12-21.9522AnastrozoleSIV.95222023-08-31.9522BICALUTAMIDE024250mgTabCasodexAZC1996-12-19Teva-BicalutamideTEV1.26902006-04-041.2690Co BicalutamideCOB1.26902006-04-041.2690PMS-BicalutamidePMS1.26902006-04-041.2690Apo-BicalutamideAPX1.26902008-01-151.2690Bicalutamide TabletsACH1.26902010-07-201.2690Jamp-BicalutamideJPC1.26902011-03-151.2690Ran-BicalutamideRAN1.26902011-12-151.2690BicalutamideSAI1.26902022-06-301.2690BOSUTINIB0243100mgTabBosulifPFI38.97872025-10-3121.4383Reddy-BosutinibDRR21.43832025-10-3121.43830244500mgTabBosulifPFI152.24032025-10-3183.7322Reddy-BosutinibDRR83.73222025-10-3183.7322BUSERELIN ACETATE02456.3mgImplant KitSuprefact Depot 2 MonthsCHE929.23481997-04-10929.234802469.45mgImplant KitSuprefact Depot 3 MonthsCHE1376.99382000-11-301376.993802471mg/mLInj Sol-5.5mL PkSuprefactCHE78.58731999-01-0878.587302481mg/mLNas Sp-10mL PkSuprefactCHE85.53001999-01-0885.5300BUSULFAN02492mgTabMyleranASN2.37881996-10-012.3788CAPECITABINE0250150mgTabXelodaHLR1.94782001-06-07.4575Teva-CapecitabineTEV.45752013-10-31.4575Sandoz CapecitabineSDZ.45752014-12-18.4575Ach-CapecitabineACH.45752015-02-26.4575Taro-CapecitabineTAR.45752017-10-30.4575CapecitabineSAI.45752021-12-17.4575CapecitabineJPC.45752022-07-29.45750251500mgTabXelodaHLR6.49332001-06-071.5250Teva-CapecitabineTEV1.52502013-10-311.5250Sandoz CapecitabineSDZ1.52502014-12-181.5250Ach-CapecitabineACH1.52502015-02-261.5250Taro-CapecitabineTAR1.52502017-10-301.5250Mint-CapecitabineMIN1.52502021-12-171.5250CapecitabineSAI1.52502021-12-171.5250CapecitabineJPC1.52502022-07-291.5250CHLORAMBUCIL02522mgTabLeukeranASN2.23641996-10-012.2364CYCLOPHOSPHAMIDE025325mgTabProcytoxBAX.35452005-05-25.3545025450mgTabCytoxanBQU1996-10-01ProcytoxBAX.47732005-05-25.4773CYPROTERONE ACETATE025550mgTabAndrocurAMD1.40851996-10-011.4000CyproteroneAAP1.40852004-07-201.4000Med-CyproteroneGMP1.40002013-11-281.4000DASATINIB025620mgTabSprycelBQU38.68502020-01-3132.8823Apo-DasatinibAPX32.88232020-01-3132.8823Teva-DasatinibTEV32.88232021-04-3032.8823Taro-DasatinibTAR32.88232021-03-2932.8823Reddy-DasatinibDRR32.88232021-06-3032.8823025750mgTabSprycelBQU77.85672020-01-3166.1783Apo-DasatinibAPX66.17822020-01-3166.1782Teva-DasatinibTEV66.17822021-04-3066.1782Taro-DasatinibTAR66.17832021-03-2966.1783Reddy-DasatinibDRR66.17822021-06-3066.1782025870mgTabSprycelBQU85.80422020-01-3172.9337Teva-DasatinibTEV72.93362021-04-3072.9336Apo-DasatinibAPX72.93362020-01-3172.9336Taro-DasatinibTAR72.93372021-03-2972.9337Reddy-DasatinibDRR72.93362021-06-3072.9336025980mgTabSprycelBQU2020-01-31Teva-DasatinibTEV117.32552021-04-30Apo-DasatinibAPX117.32552020-01-31Taro-DasatinibTAR117.32572021-03-29Reddy-DasatinibDRR117.32552021-06-300260100mgTabSprycelBQU155.60832020-01-31132.2671Apo-DasatinibAPX132.26712020-01-31132.2671Teva-DasatinibTEV132.26712021-04-30132.2671Taro-DasatinibTAR132.26702021-03-29132.2670Reddy-DasatinibDRR132.26702021-06-30132.26700261140mgTabSprycelBQU2021-03-29Taro-DasatinibTAR141.88062021-03-29Reddy-DasatinibDRR141.88062021-06-30DAUNORUBICIN0262Inj Pd-20mg PkCerubidineSLP91.00001996-10-0191.0000DEGARELIX ACETATE026380mgPd for Inj-Vial PkFirmagonFEI274.17602011-03-15274.17600264120mgPd for Inj-Vial PkFirmagonFEI370.94402011-03-15370.9440ENZALUTAMIDE026540mgCapXtandiASE29.19542026-03-3121.8966Jamp EnzalutamideJPC21.89662026-03-3121.8966ERLOTINIB026625mgTabTarcevaHLR2015-02-26Teva-ErlotinibTEV11.86662015-02-2611.8666Apo-ErlotinibAPX11.86672017-10-3011.8667Nat-ErlotinibNAT11.86672019-03-2811.86670267100mgTabTarcevaHLR2015-02-26Teva-ErlotinibTEV47.46662015-02-2647.4666PMS-ErlotinibPMS47.46672016-09-2947.4667Apo-ErlotinibAPX47.46672017-10-3047.4667Nat-ErlotinibNAT47.46672019-03-2847.46670268150mgTabTarcevaHLR2015-02-26Teva-ErlotinibTEV71.20002015-02-2671.2000PMS-ErlotinibPMS71.20002016-09-2971.2000Apo-ErlotinibAPX71.20002017-10-3071.2000Nat-ErlotinibNAT71.20002019-03-2871.2000ETOPOSIDE026950mgCapVepesidCHE48.75701996-10-0148.7570EVEROLIMUS02702.5mgTabAfinitorNOV202.65402020-02-28172.2559Teva-EverolimusTEV172.25592020-02-28172.2559Sandoz EverolimusSDZ172.25592020-12-18172.2559PMS-EverolimusPMS172.25592021-11-30172.2559Nat-EverolimusNAT172.25592023-05-31172.2559Reddy-EverolimusDRR172.25592024-09-27172.255902715mgTabAfinitorNOV202.65402020-02-28172.2559Teva-EverolimusTEV172.25592020-02-28172.2559Sandoz EverolimusSDZ172.25592020-12-18172.2559PMS-EverolimusPMS172.25592021-11-30172.2559Nat-EverolimusNAT172.25592023-05-31172.2559Reddy-EverolimusDRR172.25592024-09-27172.2559027210mgTabAfinitorNOV202.65402020-02-28172.2559Teva-EverolimusTEV172.25592020-02-28172.2559Sandoz EverolimusSDZ172.25592020-12-18172.2559PMS-EverolimusPMS172.25592021-11-30172.2559Nat-EverolimusNAT172.25592023-05-31172.2559Reddy-EverolimusDRR172.25592024-09-27172.2559EXEMESTANE027325mgTabAromasinPFI6.24632002-07-293.1232Act ExemestaneTEV3.12322012-10-303.1232Med-ExemestaneGMP3.12322014-01-303.1232FLUDARABINE PHOSPHATE027410mgTabFludaraGZM41.89402004-04-0641.8940For the first-line treatment of chronic lymphocytic leukemia (CLL) in combination with rituximab (with or without cyclophosphamide).LU Authorization Period: IndefiniteFor second line therapy of patients with chronic lymphocytic leukemia (CLL) who have failed or are intolerant to chlorambucil.LU Authorization Period: IndefiniteFLUOROURACIL & SALICYLIC ACID02750.5% w/w & 10% w/wTop SolActikerallCIP2.08782018-10-312.0878FLUTAMIDE0276250mgTabEuflexSCH1996-10-01FlutamideAAP1.82551999-04-151.8255FULVESTRANT027750mg/mLInj SolFaslodexAZC135.33202019-03-2840.8027Teva-Fulvestrant InjectionTEV40.80272019-03-2840.8027Fulvestrant InjectionSDZ40.80272019-04-3040.8027Fulvestrant InjectableJPC40.80272025-01-3140.8027Fulvestrant InjectionFOM40.80272025-03-3140.8027Fulvestrant InjectionSTE40.80272025-11-2840.8027GEFITINIB0278250mgTabIressaAZC74.10632017-10-3062.3050Apo-GefitinibAPX62.30502017-10-3062.3050Sandoz GefitinibSDZ62.30502019-08-3062.3050Nat-GefitinibNAT62.30502019-10-3162.3050Jamp-GefitinibJPC62.30502021-01-2962.3050GOSERELIN ACETATE02793.6mgDepot InjZoladexTRS422.67781996-10-01422.6778028010.8mgDepot InjZoladex LATRS1204.73221996-12-191204.7322HYDROXYUREA0281500mgCapHydreaBQU1.19621996-10-011.0203Mylan-HydroxyureaMYL1.02032002-07-291.0203Apo-HydroxyureaAPX1.02032004-04-061.0203IMATINIB MESYLATE0282100mgTabPharmacists and prescribers should be informed of a drug product's official indications as set out in Health Canada's approved product monograph.GleevecNOV29.74752007-01-025.2079Apo-ImatinibAPX5.20792013-05-315.2079Nat-ImatinibNAT5.20792014-06-265.2079Teva-ImatinibTEV5.20792013-05-315.2079PMS-ImatinibPMS5.20792015-07-295.2079Ach-ImatinibACH5.20792021-01-295.2079Mint-ImatinibMIN5.20792020-08-285.2079Jamp ImatinibJPC5.20792021-06-305.2079ImatinibSAI5.20792021-05-315.2079ImatinibSIV5.20792024-05-315.20790283400mgTabPharmacists and prescribers should be informed of a drug product's official indications as set out in Health Canada's approved product monograph.GleevecNOV118.99002007-01-0220.8314Apo-ImatinibAPX20.83142013-05-3120.8314Nat-ImatinibNAT20.83142014-06-2620.8314Teva-ImatinibTEV20.83142013-05-3120.8314PMS-ImatinibPMS20.83142015-07-2920.8314Ach-ImatinibACH20.83142021-01-2920.8314Mint-ImatinibMIN20.83142020-08-2820.8314Jamp ImatinibJPC20.83142021-06-3020.8314ImatinibSAI20.83142021-05-3120.8314ImatinibSIV20.83142024-05-3120.8314LETROZOLE02842.5mgTabFemaraNOV8.75431998-12-311.3780PMS-LetrozolePMS1.37802010-07-201.3780Med-LetrozoleGMP1.37802010-07-201.3780Letrozole Tablets USPACH1.37802010-07-201.3780Teva-LetrozoleTEV1.37802013-06-271.3780Sandoz LetrozoleSDZ1.37802010-06-141.3780LetrozoleCOB1.37802010-07-201.3780Apo-LetrozoleAPX1.37802011-05-191.3780Ran-LetrozoleRAN1.37802011-12-151.3780Jamp-LetrozoleJPC1.37802012-08-271.3780Mar-LetrozoleMAR1.37802012-01-191.3780Zinda-LetrozoleSTA1.37802014-01-031.3780Riva-LetrozoleRIA1.37802021-08-311.3780Nat-LetrozoleNAT1.37802015-04-301.3780CCP-LetrozoleCCP1.37802018-01-311.3780LetrozoleSAI1.37802021-05-311.3780Mint-LetrozoleMIN1.37802021-10-291.3780NRA-LetrozoleNRA1.37802022-06-301.3780LetrozoleSIV1.37802022-09-291.3780Jamp Letrozole TabletsJPC1.37802024-10-311.3780LEUPROLIDE ACETATE02853.75mgInj-KitLupron Depot PDSABB404.69521996-10-01404.695202867.5mgInj-KitLupron Depot PDSABB387.97001996-10-01387.9700028711.25mgInj-KitLupron Depot PDSABB1205.89562000-07-171205.8956028822.5mgInj-KitLupron Depot PDSABB1071.00001997-08-281071.0000028930mgInj-KitLupron Depot PDSABB1428.00002000-04-171428.000002903.75mg/VialPd for Inj - Vial PkZeulide DepotVET304.00002020-05-29304.0000029122.5mg/VialPd for Inj - Vial PkZeulide DepotVET873.00002020-05-29873.000002927.5mgPd Susp Inj-Pref Syr KitEligardTOL310.72002004-07-20310.7200029322.5mgPd Susp Inj-Pref Syr KitEligardTOL891.00002004-07-20891.0000029430mgPd Susp Inj-Pref Syr KitEligardTOL1285.20002005-05-251285.2000029545mgPd Susp Inj-Pref Syr KitEligardTOL1659.90002006-06-151659.9000LOMUSTINE (CCNU)029610mgCapGleostineSET211.24002025-11-28211.2400029740mgCapLomustineSET336.92002025-11-28336.9200029810mgCapCeeNUBQU7.89001996-10-017.8900029940mgCapCeeNUBQU13.60251996-10-0113.60250300100mgCapCeeNUBQU22.45501996-10-0122.4550MEGESTROL ACETATE030140mgTabMegaceBQU1996-10-01MegestrolAAP1.33401996-10-011.33400302160mgTabMegaceBQU1996-10-01MegestrolAAP5.81511996-10-015.8151MELPHALAN03032mgTabAlkeranASN2.53181996-10-012.5318MERCAPTOPURINE030450mgTabPurinetholNOP2.8610Decrease dose of mercaptopurine to 25-33% of initial dose if allopurinol used concomitantly. 1996-10-012.8610Mercaptopurine Tablets USPSTE2.8610Decrease dose of mercaptopurine to 25-33% of initial dose if allopurinol used concomitantly.2014-03-272.8610METHOTREXATE030520mg/2mLInj Sol-2mL PkMethotrexate SodiumMAY12.50002002-04-0412.5000030650mg/2mLInj Sol-2mL PkMethotrexateWAY1998-03-17MethotrexateMAY8.92002005-10-068.9200Methotrexate Injection BPACH8.92002021-02-268.9200030710mg/0.2mLInj Sol-Pref SyrMetoject SubcutaneousMDX16.30002020-02-2814.8200Methotrexate SubcutaneousACH14.82002025-12-3014.8200PMS-Methotrexate InjectionPMS14.82002024-05-3114.8200030812.5mg/0.25mLInj Sol-Pref SyrMetoject SubcutaneousMDX17.16002020-02-2815.6000Methotrexate SubcutaneousACH15.60002025-12-3015.6000PMS-Methotrexate InjectionPMS15.60002024-05-3115.6000030915mg/0.3mLInj Sol-Pref SyrMetoject SubcutaneousMDX16.38002019-04-3016.3800Methotrexate SubcutaneousACH16.38002020-11-3016.3800PMS-Methotrexate InjectionPMS16.38002024-05-3116.3800031017.5mg/0.35mLInj Sol-Pref SyrMetoject SubcutaneousMDX16.00002018-02-2816.0000Methotrexate SubcutaneousACH16.00002020-05-2916.0000PMS-Methotrexate InjectionPMS16.00002024-05-3116.0000031120mg/0.4mLInj Sol-Pref SyrMetoject SubcutaneousMDX17.50002018-02-2817.5000Methotrexate SubcutaneousACH17.50002020-05-2917.5000PMS-Methotrexate InjectionPMS17.50002024-05-3117.5000031222.5mg/0.45mLInj Sol-Pref SyrMetoject SubcutaneousMDX17.50002018-02-2817.5000Methotrexate SubcutaneousACH17.50002020-05-2917.5000PMS-Methotrexate InjectionPMS17.50002024-05-3117.5000031325mg/0.5mLInj Sol-Pref SyrMetoject SubcutaneousMDX19.50002018-02-2819.5000Methotrexate SubcutaneousACH19.50002020-05-2919.5000PMS-Methotrexate InjectionPMS19.50002024-05-3119.500003142.5mgTabPMS-MethotrexatePMS.25131997-02-04.2513Apo-MethotrexateAPX.25132001-10-11.2513Ach-MethotrexateACH.25132021-12-17.2513Auro-MethotrexateAUR.25132023-03-31.2513M-MethotrexateMAT.25132024-06-28.2513031510mgTabMethotrexate Tablets, USPPFI2025-08-29Jamp Methotrexate TabletsJPC2.37892025-08-29PMS-Methotrexate TabletsPMS2.37892026-01-30MITOTANE0316500mgTabLysodrenHRA9.79002021-11-309.7900NILOTINIB0317150mgCapTasignaNOV33.77622025-03-3116.5570Apo-NilotinibAPX16.55702025-03-3116.5570Reddy-NilotinibDRR16.55702025-07-3116.55700318200mgCapTasignaNOV47.01642025-03-3123.0473Apo-NilotinibAPX23.04732025-03-3123.0473Reddy-NilotinibDRR23.04732025-07-3123.0473PALBOCICLIB031975mgTabIbrancePFI253.91232024-11-29126.9562Taro-PalbociclibTAR126.95622024-11-29126.9562PMS-PalbociclibPMS126.95622024-11-29126.95620320100mgTabIbrancePFI253.91232024-11-29126.9562Taro-PalbociclibTAR126.95622024-11-29126.9562PMS-PalbociclibPMS126.95622024-11-29126.95620321125mgTabIbrancePFI253.91232024-11-29126.9562Taro-PalbociclibTAR126.95622024-11-29126.9562PMS-PalbociclibPMS126.95622024-11-29126.9562PAZOPANIB0322200mgTabVotrientGSK41.31472022-09-2930.9655PMS-PazopanibPMS30.96552022-09-2930.9655Eugia-PazopanibEUP30.96552025-08-2930.9655POMALIDOMIDE03231mgCapPomalystBQU500.00002023-04-28425.0000Reddy-PomalidomideDRR425.00002023-04-28425.0000Nat-PomalidomideNAT425.00002023-04-28425.0000Apo-PomalidomideAPX425.00002023-04-28425.0000Sandoz PomalidomideSDZ425.00002023-04-28425.0000Jamp PomalidomideJPC425.00002023-08-31425.000003242mgCapPomalystBQU500.00002023-04-28425.0000Reddy-PomalidomideDRR425.00002023-04-28425.0000Nat-PomalidomideNAT425.00002023-04-28425.0000Apo-PomalidomideAPX425.00002023-04-28425.0000Sandoz PomalidomideSDZ425.00002023-04-28425.0000Jamp PomalidomideJPC425.00002023-08-31425.000003253mgCapPomalystBQU500.00002023-04-28425.0000Reddy-PomalidomideDRR425.00002023-04-28425.0000Nat-PomalidomideNAT425.00002023-04-28425.0000Apo-PomalidomideAPX425.00002023-04-28425.0000Sandoz PomalidomideSDZ425.00002023-04-28425.0000Jamp PomalidomideJPC425.00002023-08-31425.000003264mgCapPomalystBQU500.00002023-04-28425.0000Reddy-PomalidomideDRR425.00002023-04-28425.0000Nat-PomalidomideNAT425.00002023-04-28425.0000Apo-PomalidomideAPX425.00002023-04-28425.0000Sandoz PomalidomideSDZ425.00002023-04-28425.0000Jamp PomalidomideJPC425.00002023-08-31425.0000PROCARBAZINE HCL032750mgCapMatulaneLBI176.7388Procarbazine inhibits monoamine oxidase. Avoid alcohol and foods with high tyramine content (e.g. aged cheese, red wine, yogurt, etc.)1996-10-01176.7388RITUXIMAB032810mg/mLInj Sol (Preservative-Free)RuxiencePFI29.70002020-07-3129.7000For the treatment of adults with severe active rheumatoid arthritis (RA) (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or anti-CCP positive, and radiographic evidence of rheumatoid arthritis) who meet ALL the following criteria. 1. Patient has experienced failure to respond, documented intolerance, or contraindication to optimal use of one of the following disease modifying, anti-rheumatic (DMARD) regimens: A) i) Methotrexate (20mg/week) for at least 3 months, AND ii) Leflunomide (20mg/day) for at least 3 months, in addition to iii) An adequate trial of at least one combination of DMARDs for 3 months; OR B) i) Methotrexate (20mg/week) for at least 3 months, AND ii) Leflunomide in combination with methotrexate for at least 3 months; OR C) i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.) 2. Patient has experienced failure to respond, documented intolerance, or contraindication to an adequate trial of at least ONE anti-TNF agent (e.g., adalimumab, etanercept, infliximab, golimumab, certolizumab pegol). 3. Patient is not using rituximab in a maintenance setting. 4. Patient is not using a treatment course of rituximab earlier than 6 months after the completion of a prior course of rituximab. 5. Rituximab is not used in combination with another biologic to treat the patient's RA. 6. Treatment must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. One course of treatment is 1000mg followed two weeks later by the second 1000mg dose.LU Authorization Period: 3 MonthsFor the re-treatment of patients with severe active rheumatoid arthritis (RA) (greater than or equal to 5 swollen joints, and rheumatoid factor positive and/or anti-CCP positive, and radiographic evidence of rheumatoid arthritis) who meet ALL the following criteria: 1. Patient has met the initiation criteria for rituximab in accordance with RFU 583; 2. Patient has experienced loss of effect after having responded to the prior treatment course of rituximab (Response is defined as a 20% reduction in the swollen joint count compared to the joint count prior to the first, pre-treatment course evaluated at 3 to 4 months following the administered course AND improvement in 2 swollen joints); AND 3. Patient is not using rituximab in a maintenance setting; AND 4. Patient is not using a treatment course of rituximab earlier than 6 months after the completion of a prior course of rituximab; AND 5. Rituximab is not used in combination with another biologic to treat the patient's RA. 6. Treatment must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. One course of re-treatment is 1000mg followed two weeks later by the second 1000mg dose.LU Authorization Period: 3 MonthsRituximab is used in combination with glucocorticoids for the induction of remission in patients with severely active Granulomatosis with Polyangiitis [(GPA), also known as Wegener's Granulomatosis (WG)] OR microscopic polyangiitis (MPA), for patients who meet all of the following criteria: 1. The patient must have severe active disease that is life- or organ-threatening as supported by laboratory and/or imaging reports. AND 2. There is a positive serum assay for either proteinase 3-ANCA (anti-neutrophil cytoplasmic autoantibodies) or myeloperoxidase-ANCA. AND 3. Cyclophosphamide cannot be used by the patient for one of the following reasons: a. The patient has failed a minimum of six IV pulses of cyclophosphamide; OR b. The patient has failed three months of oral cyclophosphamide therapy; OR c. The patient has a severe intolerance or an allergy to cyclophosphamide; OR d. Cyclophosphamide is contraindicated; OR e. The patient has received a cumulative lifetime dose of at least 25g of cyclophosphamide; OR f. The patient wishes to preserve ovarian/testicular function for fertility. 4. The request is from a prescriber experienced in the diagnosis and management of GPA, MPA, and vasculitis. Exclusion criteria: The patient should not have received a course of rituximab in the prior 6 months. The recommended dosing regimen for the initial treatment would be a once weekly infusion dosed at 375 milligrams per square metre x 4 weeks. Case-by-case considerations for patients not meeting the LU criteria may be considered through the Exceptional Access Program. LU Authorization Period: 1 month (1 treatment course)Rituximab (Ruxience) treatment will be used for patients with severely active Granulomatosis with Polyangiitis [(GPA), also known as Wegener's Granulomatosis (WG)] OR microscopic polyangiitis (MPA) who have achieved disease remission. Patient must meet all of the following criteria: 1. The patient must have severe active disease that is life- or organ-threatening as supported by laboratory and/or imaging reports. 2. There is a positive serum assay for either proteinase 3-ANCA (anti-neutrophil cytoplasmic autoantibodies) or myeloperoxidase-ANCA. A copy of the laboratory report must be provided. 3. Stabilization of the condition with induction doses of cyclophosphamide (injectable or oral doses are acceptable) and a glucocorticoid as combination over 4 to 6 months until disease remission prior to initiation of rituximab. 4. The request is from a prescriber experienced in the diagnosis and management of GPA, MPA, and vasculitis. Exclusion criteria: The patient should not have received a dose of rituximab in the prior 6 months. Doses of rituximab administered at intervals more frequently than every 6 months are not funded. The recommended dosing regimen: A fixed dose regimen of Rituximab of 500mg IV every 6 months. Case-by-case considerations for patients not meeting the LU criteria may be considered through the Exceptional Access Program.LU Authorization Period: 1 year032910mg/mLInj Sol (Preservative-Free)RiximyoSDZ29.70002020-07-3129.7000For the treatment of adults with severe active rheumatoid arthritis (RA) (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or anti-CCP postive, and radiographic evidence of rheumatoid arthritis) who meet ALL the following criteria. 1. Patient has experienced failure to respond, documented intolerance, or contraindication to optimal use of one of the following disease modifying, anti-rheumatic (DMARD) regimens: A) i) Methotrexate (20mg/week) for at least 3 months, AND ii) Leflunomide (20mg/day) for at least 3 months, in addition to iii) An adequate trial of at least one combination of DMARDs for 3 months; OR B) i) Methotrexate (20mg/week) for at least 3 months, AND ii) Leflunomide in combination with methotrexate for at least 3 months; OR C) i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine 400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.) 2. Patient has experienced failure to respond, documented intolerance, or contraindication to an adequate trial of at least ONE anti-TNF agent (e.g., adalimumab, etanercept, infliximab, golimumab, certolizumab pegol). 3. Patient is not using rituximab in a maintenance setting. 4. Patient is not using a treatment course of rituximab earlier than 6 months after the completion of a prior course of rituximab. 5. Rituximab is not used in combination with another biologic to treat the patient's RA. 6. Treatment must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. One course of treatment is 1000mg followed two weeks later by the second 1000mg dose. LU Authorization Period: 3 MonthsFor the re-treatment of patients with severe active rheumatoid arthritis (RA) (greater than or equal to 5 swollen joints, and rheumatoid factor positive and/or anti-CCP positive, and radiographic evidence of rheumatoid arthritis) who meet ALL the following criteria: 1. Patient has met the initiation criteria for rituximab in accordance with RFU 581; 2. Patient has experienced loss of effect after having responded to the prior treatment course of rituximab (Response is defined as a 20% reduction in the swollen joint count compared to the joint count prior to the first, pre-treatment course evaluated at 3 to 4 months following the administered course AND improvement in 2 swollen joints); AND 3. Patient is not using rituximab in a maintenance setting; AND 4. Patient is not using a treatment course of rituximab earlier than 6 months after the completion of a prior course of rituximab; AND 5. Rituximab is not used in combination with another biologic to treat the patient's RA. 6. Treatment must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. One course of re-treatment is 1000mg followed two weeks later by the second 1000mg dose.LU Authorization Period: 3 MonthsRituximab is used in combination with glucocorticoids for the induction of remission in patients with severely active Granulomatosis with Polyangiitis [(GPA), also known as Wegener's Granulomatosis (WG)] OR microscopic polyangiitis (MPA), for patients who meet all of the following criteria: 1. The patient must have severe active disease that is life- or organ-threatening as supported by laboratory and/or imaging reports. AND 2. There is a positive serum assay for either proteinase 3-ANCA (anti-neutrophil cytoplasmic autoantibodies) or myeloperoxidase-ANCA. AND 3. Cyclophosphamide cannot be used by the patient for one of the following reasons: a. The patient has failed a minimum of six IV pulses of cyclophosphamide; OR b. The patient has failed three months of oral cyclophosphamide therapy; OR c. The patient has a severe intolerance or an allergy to cyclophosphamide; OR d. Cyclophosphamide is contraindicated; OR e. The patient has received a cumulative lifetime dose of at least 25g of cyclophosphamide; OR f. The patient wishes to preserve ovarian/testicular function for fertility. 4. The request is from a prescriber experienced in the diagnosis and management of GPA, MPA, and vasculitis. Exclusion criteria: The patient should not have received a course of rituximab in the prior 6 months. The recommended dosing regimen for the initial treatment would be a once weekly infusion dosed at 375 milligrams per square metre x 4 weeks. Case-by-case considerations for patients not meeting the LU criteria may be considered through the Exceptional Access Program.LU Authorization Period: 1 month (1 treatment course)Rituximab (Riximyo) treatment will be used for patients with severely active Granulomatosis with Polyangiitis [(GPA), also known as Wegener's Granulomatosis (WG)] OR microscopic polyangiitis (MPA) who have achieved disease remission. Patient must meet all of the following criteria: 1. The patient must have severe active disease that is life- or organ-threatening as supported by laboratory and/or imaging reports. 2. There is a positive serum assay for either proteinase 3-ANCA (anti-neutrophil cytoplasmic autoantibodies) or myeloperoxidase-ANCA. A copy of the laboratory report must be provided. 3. Stabilization of the condition with induction doses of cyclophosphamide (injectable or oral doses are acceptable) and a glucocorticoid as combination over 4 to 6 months until disease remission prior to initiation of rituximab. 4. The request is from a prescriber experienced in the diagnosis and management of GPA, MPA, and vasculitis. Exclusion criteria: The patient should not have received a dose of rituximab in the prior 6 months. Doses of rituximab administered at intervals more frequently than every 6 months are not funded. The recommended dosing regimen: A fixed dose regimen of Rituximab of 500mg IV every 6 months. Case-by-case considerations for patients not meeting the LU criteria may be considered through the Exceptional Access Program.LU Authorization Period: 1 year0330100mg/10mLInj Sol-10mL Vial PkTruximaCEH297.00002020-03-31297.00000331500mg/50mLInj Sol-50mL Vial PkTruximaCEH1485.00002020-03-311485.0000For the treatment of adults with severe active rheumatoid arthritis (RA) (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or anti-CCP positive, and radiographic evidence of rheumatoid arthritis) who meet ALL the following criteria. 1. Patient has experienced failure to respond, documented intolerance, or contraindication to optimal use of one of the following disease modifying, anti-rheumatic (DMARD) regimens: A. i) Methotrexate (20mg/week) for at least 3 months, AND ii) Leflunomide (20mg/day) for at least 3 months, in addition to iii) An adequate trial of at least one combination of DMARDs for 3 months; OR B. i) Methotrexate (20mg/week) for at least 3 months, AND ii) Leflunomide in combination with methotrexate for at least 3 months; OR C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.) 2. Patient has experienced failure to respond, documented intolerance, or contraindication to an adequate trial of at least ONE anti-TNF agent (e.g., adalimumab, etanercept, infliximab, golimumab, certolizumab pegol). 3. Patient is not using rituximab in a maintenance setting. 4. Patient is not using a treatment course of rituximab earlier than 6 months after the completion of a prior course of rituximab. 5. Rituximab is not used in combination with another biologic to treat the patient's RA. 6. Treatment must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. One course of treatment is 1000mg followed two weeks later by the second 1000mg dose. LU Authorization Period: 3 MonthsFor the re-treatment of patients with severe active rheumatoid arthritis (RA) (greater than or equal to 5 swollen joints, and rheumatoid factor positive and/or anti-CCP positive, and radiographic evidence of rheumatoid arthritis) who meet ALL the following criteria: 1. Patient has met the initiation criteria for rituximab in accordance with RFU 575; 2. Patient has experienced loss of effect after having responded to the prior treatment course of rituximab (Response is defined as a 20% reduction in the swollen joint count compared to the joint count prior to the first, pre-treatment course evaluated at 3 to 4 months following the administered course AND improvement in 2 swollen joints); AND 3. Patient is not using rituximab in a maintenance setting; AND 4. Patient is not using a treatment course of rituximab earlier than 6 months after the completion of a prior course of rituximab; AND 5. Rituximab is not used in combination with another biologic to treat the patient's RA. 6. Treatment must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. One course of re-treatment is 1000mg followed two weeks later by the second 1000mg dose. LU Authorization Period: 3 MonthsRituximab is used in combination with glucocorticoids for the induction of remission in patients with severely active Granulomatosis with Polyangiitis [(GPA), also known as Wegener's Granulomatosis (WG)] OR microscopic polyangiitis (MPA), for patients who meet all of the following criteria: 1. The patient must have severe active disease that is life- or organ-threatening as supported by laboratory and/or imaging reports. AND 2. There is a positive serum assay for either proteinase 3-ANCA (anti-neutrophil cytoplasmic autoantibodies) or myeloperoxidase-ANCA. AND 3. Cyclophosphamide cannot be used by the Patient for ONE of the following reasons: a. The patient has failed a minimum of six IV pulses of cyclophosphamide; OR b. The patient has failed three months of oral cyclophosphamide therapy; OR c. The patient has a severe intolerance or an allergy to cyclophosphamide; OR d. Cyclophosphamide is contraindicated; OR e. The patient has received a cumulative lifetime dose of at least 25g of cyclophosphamide; OR f. The patient wishes to preserve ovarian/testicular function for fertility. 4. The request is from a prescriber experienced in the diagnosis and management of GPA, MPA, and vasculitis. Exclusion criteria: The patient should not have received a course of rituximab in the prior 6 months. The recommended dosing regimen for the initial treatment would be a once weekly infusion dosed at 375 milligrams per square metre x 4 weeks. Case-by-case considerations for patients not meeting the LU criteria may be considered through the Exceptional Access Program.LU Authorization Period: 1 month (1 treatment course)Rituximab (Truxima) treatment will be used for patients with severely active Granulomatosis with Polyangiitis [(GPA), also known as Wegener's Granulomatosis (WG)] OR microscopic polyangiitis (MPA) who have achieved disease remission. Patient must meet all of the following criteria: 1. The patient must have severe active disease that is life- or organ-threatening as supported by laboratory and/or imaging reports. 2. There is a positive serum assay for either proteinase 3-ANCA (anti-neutrophil cytoplasmic autoantibodies) or myeloperoxidase-ANCA. A copy of the laboratory report must be provided. 3. Stabilization of the condition with induction doses of cyclophosphamide (injectable or oral doses are acceptable) and a glucocorticoid as combination over 4 to 6 months until disease remission prior to initiation of rituximab. 4. The request is from a prescriber experienced in the diagnosis and management of GPA, MPA, and vasculitis. Exclusion criteria: The patient should not have received a dose of rituximab in the prior 6 months. Doses of rituximab administered at intervals more frequently than every 6 months are not funded. The recommended dosing regimen: A fixed dose regimen of Rituximab of 500mg IV every 6 months. Case-by-case considerations for patients not meeting the LU criteria may be considered through the Exceptional Access Program.LU Authorization Period: 1 yearTAMOXIFEN CITRATE033210mgTabApo-TamoxAPX.17501996-10-01.1750Teva-TamoxifenTEV.17501996-10-01.1750TamofenSAV1996-10-01NolvadexAZC1996-10-01033320mgTabApo-TamoxAPX.35001996-10-01.3500Teva-TamoxifenTEV.35001996-10-01.3500TamofenSAV1996-10-01Nolvadex DAZC1996-10-01TEMOZOLOMIDE03345mgCapTemodalMEK8.03402000-07-171.9500Teva-TemozolomideTEV1.95002016-01-281.9500Taro-TemozolomideTAR1.95002015-11-261.9500Jamp TemozolomideJPC1.95002022-09-291.9500033520mgCapTemodalMEK32.13602000-07-177.8000Teva-TemozolomideTEV7.80002013-05-317.8000Taro-TemozolomideTAR7.80002015-11-267.8000Jamp TemozolomideJPC7.80002022-09-297.80000336100mgCapTemodalMEK160.68622000-07-1739.0015Teva-TemozolomideTEV39.00152013-05-3139.0015Taro-TemozolomideTAR39.00152015-11-2639.0015Jamp TemozolomideJPC39.00152022-09-2939.00150337140mgCapTemodalMEK224.96232011-09-1554.6025Teva-TemozolomideTEV54.60252013-05-3154.6025Taro-TemozolomideTAR54.60252015-11-2654.6025Jamp TemozolomideJPC54.60252022-09-2954.60250338250mgCapTemodalMEK401.70412000-07-1797.5010Teva-TemozolomideTEV97.50102013-05-3197.5010Taro-TemozolomideTAR97.50102015-11-2697.5010Jamp TemozolomideJPC97.50102022-09-2997.5010THIOGUANINE033940mgTabLanvisASN6.74121996-10-016.7412TRIPTORELIN PAMOATE03403.75mg/VialInj Pd with Sterile Water-Vial PkTrelstar (1 Month)KNT346.31002007-01-02346.3100034111.25mg/VialInj Pd with Sterile Water-Vial PkTrelstar LA (3 Month)KNT1038.97002007-01-021038.970003423.75mg/VialInj Pd-Vial PkTrelstar (1 Month)KNT346.31002007-01-02346.3100034311.25mg/VialInj Pd-Vial PkTrelstar LA (3 Month)KNT1038.97002007-01-021038.9700034422.5mg/VialSR Inj Pd with Sterile Water-Vial PkTrelstarKNT1659.90002014-10-291659.9000VINCRISTINE SULFATE03451mg/mLInj SolOncovinLIL1996-10-01Vincristine SulfateNOP30.60001996-10-0130.6000AUTONOMIC AGENTSPARASYMPATHOMIMETIC (CHOLINERGIC) AGENTSBETHANECHOL CHLORIDE034610mgTabDuvoidPPI.51261996-10-01.5126034725mgTabDuvoidPPI.83001996-10-01.8300034850mgTabDuvoidPPI.99211996-10-01.9921CARBACHOL03492mgTabCarbacholGLA.37271996-10-01.3727DONEPEZIL HCL03505mgOrally Disintegrating TabAricept RDTPFI2014-02-27Sandoz Donepezil ODTSDZ3.61762014-05-29Co Donepezil ODTCOB3.61762014-02-27035110mgOrally Disintegrating TabAricept RDTPFI2014-02-27Sandoz Donepezil ODTSDZ3.61762014-05-29Co Donepezil ODTCOB3.61762014-02-2703525mgTabAriceptPFI5.18561999-06-01.4586PMS-DonepezilPMS.45862014-02-27.4586Sandoz DonepezilSDZ.45862014-03-27.4586Teva-DonepezilTEV.45862014-02-27.4586Apo-DonepezilAPX.45862014-02-27.4586Ran-DonepezilRAN.45862014-02-27.4586Co DonepezilCOB.45862014-02-27.4586Auro-DonepezilAUR.45862014-03-27.4586Mar-DonepezilMAR.45862014-02-27.4586Ach-DonepezilACH.45862014-05-29.4586Jamp-DonepezilJPC.45862014-02-27.4586Mint-DonepezilMIN.45862019-09-30.4586Bio-DonepezilBMP.45862016-04-29.4586Jamp-Donepezil TabletsJPC.45862014-12-18.4586DonepezilSIV.45862022-07-29.4586DonepezilSAI.45862018-05-31.4586Septa-DonepezilSET.45862014-12-18.4586AG-DonepezilANG.45862021-09-30.4586Nat-DonepezilNAT.45862015-10-29.4586M-DonepezilMAT.45862021-10-29.4586DonepezilRIA.45862021-08-31.4586NRA-DonepezilNRA.45862024-01-31.4586035310mgTabAriceptPFI5.18561999-06-01.4586PMS-DonepezilPMS.45862014-02-27.4586Sandoz DonepezilSDZ.45862014-03-27.4586Teva-DonepezilTEV.45862014-02-27.4586Apo-DonepezilAPX.45862014-02-27.4586Ran-DonepezilRAN.45862014-02-27.4586Co DonepezilCOB.45862014-02-27.4586Auro-DonepezilAUR.45862014-02-27.4586Mar-DonepezilMAR.45862014-02-27.4586Ach-DonepezilACH.45862014-05-29.4586Jamp-DonepezilJPC.45862014-02-27.4586Mint-DonepezilMIN.45862019-09-30.4586Bio-DonepezilBMP.45862016-04-29.4586Jamp-Donepezil TabletsJPC.45862014-12-18.4586DonepezilSIV.45862022-07-29.4586DonepezilSAI.45862018-05-31.4586Septa-DonepezilSET.45862014-12-18.4586AG-DonepezilANG.45862021-09-30.4586Nat-DonepezilNAT.45862015-10-29.4586M-DonepezilMAT.45862021-10-29.4586DonepezilRIA.45862021-08-31.4586NRA-DonepezilNRA.45862024-01-31.4586Initial Trial: For patients with mild to moderate Alzheimer's Disease (Mini-Mental State Exam [MMSE] 10-26). Patients will be reimbursed for a period of up to 3 months after which continued treatment must be reassessed. Network note: Maximum duration 3 months.LU Authorization Period: 1 yearContinuation: Further reimbursement will be made available to those patients whose disease has not progressed/deteriorated while on this drug. Patients must continue to have a MMSE score of 10-26.LU Authorization Period: 1 yearGALANTAMINE HYDROBROMIDE03548mgER CapReminyl ERJAN2006-01-12Pat-Galantamine ERPAR1.24652011-05-191.2465Mylan-Galantamine ERMYL1.24652011-03-151.2465Auro-Galantamine ERAUR1.24652014-09-251.2465Galantamine ERSAI1.24652020-06-301.2465035516mgER CapReminyl ERJAN2006-01-12Pat-Galantamine ERPAR1.24652011-05-191.2465Mylan-Galantamine ERMYL1.24652011-03-151.2465Auro-Galantamine ERAUR1.24652014-09-251.2465Galantamine ERSAI1.24652020-06-301.2465035624mgER CapReminyl ERJAN2006-01-12Pat-Galantamine ERPAR1.24652011-05-191.2465Mylan-Galantamine ERMYL1.24652011-03-151.2465Auro-Galantamine ERAUR1.24652014-09-251.2465Galantamine ERSAI1.24652020-06-301.2465Initial Trial: For patients with mild to moderate Alzheimer's Disease (Mini-Mental State Exam [MMSE] 10-26). Patients will be reimbursed for a period of up to 3 months after which continued treatment must be reassessed. Network note: Maximum duration 3 months.LU Authorization Period: 1 yearContinuation: Further reimbursement will be made available to those patients whose disease has not progressed/deteriorated while on this drug. Patients must continue to have a MMSE score of 10-26.LU Authorization Period: 1 yearPILOCARPINE HCL03575mgTabSalagenAMD2013-05-31M-PilocarpineMAT1.17082020-07-311.1708Jamp PilocarpineJPC1.17082021-05-311.1708PYRIDOSTIGMINE BROMIDE0358180mgLA TabMestinonVAL1.45251996-10-011.4525035960mgTabMestinonVAL.65121996-10-01.2673Riva-PyridostigmineRIA.26732020-10-30.2673Jamp Pyridostigmine BromideJPC.26732023-04-28.2673RIVASTIGMINE03601.5mgCapExelonKNT3.37112001-03-07.6514Sandoz RivastigmineSDZ.65142009-11-19.6514Apo-RivastigmineAPX.65152010-03-02.6514Med-RivastigmineGMP.65142014-01-30.6514Mint-RivastigmineMIN.65152013-09-27.6514Jamp RivastigmineJPC.65142020-01-31.6514Jamp Rivastigmine CapsulesJPC.65142025-08-29.651403613mgCapExelonKNT3.37112001-03-07.6514Sandoz RivastigmineSDZ.65142009-11-19.6514Apo-RivastigmineAPX.65152010-03-02.6514Med-RivastigmineGMP.65142014-01-30.6514Mint-RivastigmineMIN.65152013-09-27.6514Jamp RivastigmineJPC.65142020-01-31.6514Jamp Rivastigmine CapsulesJPC.65142025-08-29.651403624.5mgCapExelonKNT3.37112001-03-07.6514Sandoz RivastigmineSDZ.65142009-11-19.6514Apo-RivastigmineAPX.65152010-03-02.6514Med-RivastigmineGMP.65142014-01-30.6514Mint-RivastigmineMIN.65152013-09-27.6514Jamp RivastigmineJPC.65142020-01-31.6514Jamp Rivastigmine CapsulesJPC.65142025-08-29.651403636mgCapExelonKNT3.37112001-03-07.6514Sandoz RivastigmineSDZ.65142009-11-19.6514Apo-RivastigmineAPX.65152010-03-02.6514Med-RivastigmineGMP.65142014-01-30.6514Mint-RivastigmineMIN.65152013-09-27.6514Jamp RivastigmineJPC.65142020-01-31.6514Jamp Rivastigmine CapsulesJPC.65142025-08-29.6514Initial Trial: For patients with mild to moderate Alzheimer's Disease (Mini-Mental State Exam [MMSE] 10-26). Patients will be reimbursed for a period of up to 3 months after which continued treatment must be reassessed. Network note: Maximum duration 3 months.LU Authorization Period: 1 yearContinuation: Further reimbursement will be made available to those patients whose disease has not progressed/deteriorated while on this drug. Patients must continue to have a MMSE score of 10-26.LU Authorization Period: 1 year03649mg/5 Sq CmTrans PatchExelon Patch 5KNT2017-01-31Mylan-Rivastigmine Patch 5MYL3.97732017-01-31Sandoz Rivastigmine Patch 5SDZ3.97732017-01-31036518mg/10 Sq CmTrans PatchExelon Patch 10KNT2017-01-31Mylan-Rivastigmine Patch 10MYL3.97732017-01-31Sandoz Rivastigmine Patch 10SDZ3.97732017-01-31PARASYMPATHOLYTIC (CHOLINERGIC BLOCKING) AGENTSACLIDINIUM BROMIDE0366400mcg/actuationPd Inh-60 Dose PkTudorza GenuairCOP57.04672014-08-2857.0467BENZTROPINE MESYLATE03671mgTabPDP-BenztropinePEN.05632018-08-30.0563ETHOPROPAZINE HCL036850mgTabParsitanSLP.31531996-10-01.3153FLAVOXATE HCL0369200mgTabUrispasPAL1996-10-01Apo-FlavoxateAPX2002-07-29GLYCOPYRRONIUM BROMIDE037050mcgInh Pd-CapSeebri BreezhalerNOV1.8302The dose of Seebri Breezhaler should not exceed 50mcg per day.2013-08-291.8302HYOSCINE BUTYLBROMIDE037110mgTabBuscopanSCO.36552020-07-31.2711Accel-HyoscineACC.27112021-11-30.2711For the management of patients receiving palliative care*.LU Authorization Period: 1 year*The patient must have a progressive life-limiting illness and require this medication for palliative purposes.IPRATROPIUM BROMIDE0372250mcg/mLInh Sol-20mL PkAtroventBOE1996-10-01AA-IpraventAAP6.31402000-11-306.3140Novo-IpramideNOP6.31401999-04-156.3140PMS-IpratropiumPMS6.31401999-04-156.3140For the vast majority of patients, a metered dose inhaler is the preferred therapy. Nebulizer therapy will be reimbursed for patients who are unable to use a metered dose inhaler, including an inhaler with a spacer attachment, or a turbuhaler.Patients who have a tracheostomy;LU Authorization Period: IndefinitePatients with cystic fibrosis in whom nebulizer therapy is indicated;LU Authorization Period: IndefinitePatients with severe mental or physical disabilities;LU Authorization Period: IndefinitePatients who have previously used nebulizer therapy within the last 12 month period.LU Authorization Period: Indefinite0373125mcg/mLInh Sol-2mL UDV PkAtrovent UDVBOE1996-10-01PMS-IpratropiumPMS1.15051999-04-151.15050374250mcg/mLInh Sol-2mL UDV PkAtrovent UDVBOE1996-10-01Ratio-Ipratropium UDVRPH1.31801996-12-191.3180Teva-Ipratropium SterinebsTEV1.31801999-09-151.3180PMS-IpratropiumPMS1.31801999-04-151.3180For the vast majority of patients, a metered dose inhaler is the preferred therapy. Nebulizer therapy will be reimbursed for patients who are unable to use a metered dose inhaler, including an inhaler with a spacer attachment, or a turbuhaler.Individuals must have a known hypersensitivity to the preservative in the bulk solution, and have a tracheostomy;LU Authorization Period: IndefiniteIndividuals must have a known hypersensitivity to the preservative in the bulk solution, and be patients with cystic fibrosis in whom nebulizer therapy is indicated;.LU Authorization Period: IndefiniteIndividuals must have a known hypersensitivity to the preservative in the bulk solution, and have severe mental or physical disabilities;LU Authorization Period: IndefinitePatients who have previously used nebulizer therapy within the last 12 month period.LU Authorization Period: Indefinite037520mcg/Metered DoseInh-200 Dose PkAtrovent HFABOE21.36002004-11-0411.2530Jamp Ipratropium HFAJPC11.25302024-09-2711.2530IPRATROPIUM BROMIDE/SALBUTAMOL0376500mcg/2.5mg/2.5mLInh Sol-2.5mL Amp PkCombivent UDVBOE1998-12-31Teva-Combo SterinebsTEV.80662006-01-24.8066Ipratropium Bromide and Salbutamol SulphMDI.80662019-12-20.8066For the vast majority of patients, a metered dose inhaler is the preferred therapy. Nebulizer therapy will be reimbursed for patients who are unable to use a metered dose inhaler, including an inhaler with a spacer attachment, or a turbuhaler.Patients who have a tracheostomy;LU Authorization Period: IndefinitePatients with cystic fibrosis in whom nebulizer therapy is indicated;LU Authorization Period: IndefinitePatients with severe mental or physical disabilities;LU Authorization Period: IndefinitePatients who have previously used nebulizer therapy within the last 12 month period.LU Authorization Period: IndefiniteOXYBUTYNIN CHLORIDE03771mg/mLO/LDitropanJNO1996-10-01PMS-OxybutyninPMS.12491998-12-31.124903785mgTabDitropanPGP1996-10-01Apo-OxybutyninAPX.09861996-10-01.0986Novo-OxybutyninNOP.09861998-12-31.0986PMS-OxybutyninPMS.09862000-07-17.0986OxybutyninSAI.09862011-10-25.0986PROCYCLIDINE HCL03792.5mgTabPdp-ProcyclidinePEN.05771996-10-01.0577SCOPOLAMINE HYDROBROMIDE03800.4mg/mLInj Sol (Preservative Free)Scopolamine Hydrobromide InjectionHOS2011-05-19Scopolamine Hydrobromide InjectionOMG6.51002011-05-196.510003810.6mg/mLInj Sol (Preservative Free)Scopolamine Hydrobromide InjectionHOS2011-05-19Scopolamine Hydrobromide InjectionOMG7.04002011-05-197.0400For the management of patients receiving palliative care*.LU Authorization Period: 1 year*The patient must have a progressive life-limiting illness and require this medication for palliative purposes.TRIHEXYPHENIDYL HCL03822mgTabArtaneLED1996-10-01TrihexyphenidylAAP.03761996-10-01.037603835mgTabArtaneLED1996-10-01TrihexyphenidylAAP.06811996-10-01.0681TRIMEBUTINE MALEATE0384100mgTabModulonBFI2008-01-15Apo-TrimebutineAPX.32652008-01-15.3265Mint-TrimebutineMIN.32652024-03-28.32650385200mgTabModulonBFI2008-01-15Apo-TrimebutineAPX.76772008-01-15.7677Mint-TrimebutineMIN.76772024-03-28.7677PARASYMPATHOLYTIC (CHOLINERGIC BLOCKING) AGENTS ANTIMUSCARINICS/ANTISPASMODICSGLYCOPYRROLATE03860.2mg/mLInj SolSandoz GlycopyrrolateSDZ2.78252017-07-312.7825RobinulWYA2015-03-31Glycopyrrolate InjectionOMG2.78252015-03-312.7825Glycopyrrolate Injection USPSTE2.78252022-08-312.782503870.4mg/2mLInj Sol (Preservative Free)Glycopyrrolate Injection USPSTE2.78252022-08-312.7825Glycopyrrolate Injection USPJPC2.78252024-08-302.7825RobinulWYA2022-08-3103884mg/20mLInj Sol (With Preservative)Glycopyrrolate Injection USPSTE2.78252022-08-312.7825Glycopyrrolate Injection USPJPC2.78252024-03-282.7825RobinulWYA2022-08-31For the management of patients receiving palliative care*.LU Authorization Period: 1 year*The patient must have a progressive life-limiting illness and require this medication for palliative purposes.HYOSCINE BUTYLBROMIDE038920mg/mLInj SolBuscopanSCO4.88802017-06-294.8880For the management of patients receiving palliative care*.LU Authorization Period: 1 year*The patient must have a progressive life-limiting illness and require this medication for palliative purposes.TIOTROPIUM BROMIDE MONOHYDRATE039018mcgInh CapSpirivaBOE.9143Each tiotropium 18mcg capsule contains 18mcg of tiotropium, equivalent to 22.5mcg of tiotropium bromide monohydrate.2003-09-04.9143Lupin-TiotropiumLUP.9143Each tiotropium 18mcg capsule contains 18mcg of tiotropium, equivalent to 22.5mcg of tiotropium bromide monohydrate.2024-03-28.9143Apo-TiotropiumAPX.91432025-02-28.914303912.5mcg/ActuationInh Sol-60 Actuation PkSpiriva RespimatBOE57.2340Each actuation of Spiriva Respimat contains 2.5mcg of tiotropium, supplied as tiotropium bromide monohydrate.2016-03-3057.2340TIOTROPIUM BROMIDE MONOHYDRATE & OLODATEROL HYDROCHLORIDE03922.5mcg & 2.5mcg/ActuationInh Sol-60 Actuation PkInspiolto RespimatBOE67.1580Each actuation of Inspiotto Respimat contains 2.5mcg of tiotropium, supplied as tiotropium bromide monohydrate, and 2.5mcg of olodaterol, supplied as olodaterol hydrochloride.2016-03-3067.1580For the long-term treatment of patients with moderate to severe chronic obstructive pulmonary disease (COPD-see notes below) who have had an inadequate response to a long-acting bronchodilator (i.e., long-acting beta-2 agonist (LABA), or long-acting muscarinic antagonist (LAMA)).LU Authorization Period: IndefiniteCOPD disease severity is based on spirometry, symptoms and disability (see classification tables below). Classification COPD Stages - Symptoms and disability: Mild: Shortness of breath from COPD when hurrying on the level or walking up a slight hill. Moderate: Shortness of breath from COPD causing the patient to stop after walking approximately 100m (or after a few minutes) on the level Severe: Shortness of breath from COPD resulting in the patient being too breathless to leave the house, breathless when dressing or undressing (MRC 5), or the presence of chronic respiratory failure or clinical signs of right heart failure Classification by impairment of lung function: COPD stage and spirometry (post bronchodilator) FEV1 predicted: Mild: Greater than or equal to 80 percent Moderate: 50 to 79 percent Severe: 30 to 49 percent Very severe: Less than 30 percent UMECLIDINIUM039362.5mcgBlister Pd Inh-30 Dose PkIncruse ElliptaGSK50.00002016-02-2550.0000SYMPATHOMIMETIC (ADRENERGIC) AGENTSACLIDINIUM BROMIDE & FORMOTEROL FUMARATE DIHYDRATE0394400mcg & 12mcgMetered Dose Pd Inh-60 Dose PkDuaklir GenuairCOP65.16862016-02-2565.1686For the long-term treatment of patients with moderate to severe chronic obstructive pulmonary disease (COPD-see notes below) who have had an inadequate response to a long-acting bronchodilator (i.e., long-acting beta-2 agonist (LABA), or long-acting muscarinic antagonist (LAMA)).LU Authorization Period: IndefiniteCOPD disease severity is based on spirometry, symptoms and disability (see classification tables below). Classification COPD Stages - Symptoms and disability: Mild: Shortness of breath from COPD when hurrying on the level or walking up a slight hill. Moderate: Shortness of breath from COPD causing the patient to stop after walking approximately 100m (or after a few minutes) on the level Severe: Shortness of breath from COPD resulting in the patient being too breathless to leave the house, breathless when dressing or undressing (MRC 5), or the presence of chronic respiratory failure or clinical signs of right heart failure Classification by impairment of lung function: COPD stage and spirometry (post bronchodilator) FEV1 predicted: Mild: Greater than or equal to 80 percent Moderate: 50 to 79 percent Severe: 30 to 49 percent Very severe: Less than 30 percent BUDESONIDE & FORMOTEROL FUMARATE DIHYDRATE0395100mcg/6mcgPd Inh-120 Dose PkSymbicort 100 TurbuhalerAZC79.85002003-01-3079.85000396200mcg/6mcgPd Inh-120 Dose PkSymbicort 200 TurbuhalerAZC103.75002003-01-30103.7500For the treatment of asthma in patients who are using optimum anti-inflammatory treatment and are still experiencing breakthrough symptoms.LU Authorization Period: IndefiniteBUDESONIDE&GLYCOPYRRONIUM (GLYCOPYRRONIUM BROMIDE)&FORMOTEROL FUMARATE DIHYDRATE0397160mcg & 7.2mcg & 5mcg/ActMetered Dose Inh-120 Dose PkBreztri AerosphereAZC127.00002022-10-31127.0000For the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema and to reduce exacerbations of COPD in patients with a history of exacerbations in patients who require a combination of an inhaled corticosteroid (ICS), long-acting muscarinic antagonist (LAMA), and a long-acting beta2-adrenergic agonist (LABA).LU Authorization Period: IndefiniteEPINEPHRINE HCL039830mg/30mLInj Sol-30mL PkAdrenalinSLP22.23001996-10-0122.2300FLUTICASONE FUROATE & UMECLIDINIUM BROMIDE & VILANTEROL TRIFENATATE0399100mcg & 62.5mcg & 25mcgPd Inh-30 Dose PkTrelegy ElliptaGSK137.6700Prescribers should be informed and stay current with a drug's official indications in accordance with Health Canada's approved product monograph.2019-09-30137.6700For the long-term, once daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema and to reduce exacerbations of COPD in patients with a history of exacerbations in patients who require a combination of an inhaled corticosteroid (ICS), long-acting muscarinic antagonist (LAMA), and a long-acting beta2-adrenergic agonist (LABA).LU Authorization Period: IndefiniteFLUTICASONE FUROATE & VILANTEROL0400100mcg & 25mcgBlister Pd Inh-30 Dose PkBreo ElliptaGSK110.50002015-03-31110.5000For the treatment of asthma in patients who are using optimum anti-inflammatory treatment and are still experiencing breakthrough symptoms.LU Authorization Period: IndefiniteFor the long-term treatment of patients with moderate to severe chronic obstructive pulmonary disease (COPD-see notes below) who have a history of exacerbations and have had an inadequate response to a long-acting bronchodilator (i.e., long-acting beta-2 agonist (LABA), or long-acting muscarinic antagonist (LAMA)). LU Authorization Period: IndefiniteCOPD disease severity is based on spirometry, symptoms and disability (see classification below). Classification COPD Stages - Symptoms and disability: Mild: Shortness of breath from COPD when hurrying on the level or walking up a slight hill Moderate: Shortness of breath from COPD causing the patient to stop after walking approximately 100m (or after a few minutes) on the level Severe: Shortness of breath from COPD resulting in the patient being too breathless to leave the house, breathless when dressing or undressing (MRC 5), or the presence of chronic respiratory failure or clinical signs of right heart failure Classification by impairment of lung function: COPD stage and spirometry (post bronchodilator) FEV1 predicted: Mild: Greater than or equal to 80 percent Moderate: 50 to 79 percent Severe: 30 to 49 percent Very severe: Less than 30 percent0401200mcg & 25mcgBlister Pd Inh-30 Dose PkBreo ElliptaGSK171.89002016-08-30171.8900For the treatment of asthma in patients who are using optimum anti-inflammatory treatment and are still experiencing breakthrough symptoms.LU Authorization Period: IndefiniteFORMOTEROL FUMARATE040212mcg/CapInh Pd-Device PkForadilNOV55.77001998-12-3155.7700For the treatment of asthma in patients who are using optimum anti-inflammatory treatment and are still experiencing breakthrough symptoms.This drug is not for relief of acute symptoms.LU Authorization Period: IndefiniteFORMOTEROL FUMARATE DIHYDRATE04036mcg/Metered DosePd Inh-60 Dose PkOxeze TurbuhalerAZC39.07002001-03-0739.0700040412mcg/Metered DosePd Inh-60 Dose PkOxeze TurbuhalerAZC51.99001999-04-1551.9900For the treatment of asthma in patients who are using optimum anti-inflammatory treatment and are still experiencing breakthrough symptoms.This drug is not for relief of acute symptoms.LU Authorization Period: IndefiniteINDACATEROL040575mcgInh Pd-CapOnbrez BreezhalerNOV1.55002013-04-301.5500For patients with moderate to severe COPD with persistent respiratory symptoms despite an adequate trial of, or an intolerance to, a regularly scheduled short-acting bronchodilator AND a long-acting anticholinergic. Note: The dose of Onbrez Breezhaler should not exceed 75mcg per day.LU Authorization Period: IndefiniteINDACATEROL & GLYCOPYRRONIUM0406110mcg & 50mcgInh Pd-CapUltibro BreezhalerNOV2.58302015-05-282.5830For the long-term treatment of patients with moderate to severe chronic obstructive pulmonary disease (COPD-see notes below) who have had an inadequate response to a long-acting bronchodilator (i.e., long-acting beta-2 agonist (LABA), or long-acting muscarinic antagonist (LAMA)).LU Authorization Period: IndefiniteCOPD disease severity is based on spirometry, symptoms and disability (see classification tables below). Classification COPD Stages - Symptoms and disability: Mild: Shortness of breath from COPD when hurrying on the level or walking up a slight hill. Moderate: Shortness of breath from COPD causing the patient to stop after walking approximately 100m (or after a few minutes) on the level Severe: Shortness of breath from COPD resulting in the patient being too breathless to leave the house, breathless when dressing or undressing (MRC 5), or the presence of chronic respiratory failure or clinical signs of right heart failure Classification by impairment of lung function: COPD stage and spirometry (post bronchodilator) FEV1 predicted: Mild: Greater than or equal to 80 percent Moderate: 50 to 79 percent Severe: 30 to 49 percent Very severe: Less than 30 percent MOMETASONE FUROATE & FORMOTEROL FUMARATE DIHYDRATE0407100mcg & 5mcgMetered Dose Inh-120 Dose PkZenhaleOCI129.89002012-02-29129.89000408200mcg & 5mcgMetered Dose Inh-120 Dose PkZenhaleOCI157.39002012-02-29157.3900For the treatment of asthma in patients who are using optimum anti-inflammatory treatment and are still experiencing breakthrough symptoms.LU Authorization Period: IndefiniteORCIPRENALINE SULFATE04092mg/mLO/LAlupentBOE1996-10-01OrciprenalineAAP.05742001-03-07.0574SALBUTAMOL04101mg/mLInh Sol- 2.5mL PkTeva-Salbutamol Sterinebs P.F.TEV.36171996-10-01.3617PMS-SalbutamolPMS.36171997-04-10.3617Ventolin Nebules P.F.GSK1998-10-21For the vast majority of patients, a metered dose inhaler is the preferred therapy. Nebulizer therapy will be reimbursed for patients who are unable to use a metered dose inhaler, including an inhaler with a spacer attachment, or a turbuhaler.Individuals must have a known hypersensitivity to the preservative in the bulk solution, and have a tracheostomy;LU Authorization Period: IndefiniteIndividuals must have a known hypersensitivity to the preservative in the bulk solution, and be patients with cystic fibrosis in whom nebulizer therapy is indicated;.LU Authorization Period: IndefiniteIndividuals must have a known hypersensitivity to the preservative in the bulk solution, and have severe mental or physical disabilities;LU Authorization Period: IndefinitePatients who have previously used nebulizer therapy within the last 12 month period.LU Authorization Period: Indefinite04112mg/mLInh Sol- 2.5mL PkTeva-Salbutamol Sterinebs P.F.TEV.68711997-04-10.6750PMS-SalbutamolPMS.67501997-04-10.6750Ventolin Nebules P.F.GSK2006-06-15For the vast majority of patients, a metered dose inhaler is the preferred therapy. Nebulizer therapy will be reimbursed for patients who are unable to use a metered dose inhaler, including an inhaler with a spacer attachment, or a turbuhaler.Individuals must have a known hypersensitivity to the preservative in the bulk solution, and have a tracheostomy;LU Authorization Period: IndefiniteIndividuals must have a known hypersensitivity to the preservative in the bulk solution, and be patients with cystic fibrosis in whom nebulizer therapy is indicated;.LU Authorization Period: IndefiniteIndividuals must have a known hypersensitivity to the preservative in the bulk solution, and have severe mental or physical disabilities;LU Authorization Period: IndefinitePatients who have previously used nebulizer therapy within the last 12 month period.LU Authorization Period: Indefinite04125mg/mLInh Sol-10mL PkVentolinGSK3.11101998-04-033.1110For the vast majority of patients, a metered dose inhaler is the preferred therapy. Nebulizer therapy will be reimbursed for patients who are unable to use a metered dose inhaler, including an inhaler with a spacer attachment, or a turbuhaler.Patients who have a tracheostomy;LU Authorization Period: IndefinitePatients with cystic fibrosis in whom nebulizer therapy is indicated;LU Authorization Period: IndefinitePatients with severe mental or physical disabilities;LU Authorization Period: IndefinitePatients who have previously used nebulizer therapy within the last 12 month period.LU Authorization Period: Indefinite0413100mcg/Metered DoseInh-200 dose PkApo-SalventAPX1996-10-01Ratio-Salbutamol InhalerRPH1996-10-01Novo-SalmolNOP1996-10-01VentolinGLW1997-07-12Airomir HFAGRA6.25931998-12-315.0000Ventolin HFAGSK6.00002009-11-135.0000Apo-Salbutamol HFAAPX5.00002003-01-015.0000Novo-Salbutamol HFANOP5.00002011-05-195.0000Salbutamol HFASAI5.00002020-04-075.000004142mgTabVentolinGLA1996-10-01Apo-SalventAPX.12741996-10-01.127404154mgTabVentolinGLA1996-10-01Apo-SalventAPX.21341996-10-01.2134SALMETEROL XINAFOATE041650mcgPd Inh-60 Dose PkSereVent DiskusGSK79.56001998-12-3179.5600For the treatment of asthma in patients who are using optimum anti-inflammatory treatment and are still experiencing breakthrough symptoms.This drug is not for relief of acute symptoms.LU Authorization Period: IndefiniteFor patients with moderate to severe COPD with persistent respiratory symptoms despite an adequate trial of, or an intolerance to, a regularly scheduled short-acting bronchodilator AND a long-acting anticholinergic.LU Authorization Period: IndefiniteSALMETEROL XINAFOATE & FLUTICASONE PROPIONATE041725/125mcg/Metered DoseInh-120 Dose PkAdvair 125GSK135.87002003-01-30135.8700041825/250mcg/Metered DoseInh-120 Dose PkAdvair 250GSK192.88002003-01-30192.8800041950/100mcgInh-60 Dose PkAdvair DiskusGSK113.49002001-10-1142.4050PMS-FluticasonePropionateSalmeterol DPIPMS42.40502020-04-3042.4050Wixela InhubMYL42.40502020-04-3042.4050042050/250mcgInh-60 Dose PkAdvair DiskusGSK135.87002000-07-1750.7600PMS-FluticasonePropionateSalmeterol DPIPMS50.76002020-04-3050.7600Wixela InhubMYL50.76002020-03-3150.7600042150/500mcgInh-60 Dose PkAdvair DiskusGSK192.88002000-07-1772.0600PMS-FluticasonePropionateSalmeterol DPIPMS72.06002020-04-3072.0600Wixela InhubMYL72.06002020-03-3172.0600For the treatment of asthma in patients who are using optimum anti-inflammatory treatment and are still experiencing breakthrough symptoms.LU Authorization Period: IndefiniteTERBUTALINE SULFATE04220.5mg/DoseInh-100 Dose PkBricanyl TurbuhalerAZC8.49001996-10-018.490004230.5mg/DoseInh-120 Dose PkBricanyl TurbuhalerAZC11.54002021-10-2911.5400UMECLIDINIUM & VILANTEROL042462.5mcg & 25mcgBlister Pd Inh-30 Dose PkAnoro ElliptaGSK88.51002015-06-2988.5100For the long-term treatment of patients with moderate to severe chronic obstructive pulmonary disease (COPD-see notes below) who have had an inadequate response to a long-acting bronchodilator (i.e., long-acting beta-2 agonist (LABA), or long-acting muscarinic antagonist (LAMA)).LU Authorization Period: IndefiniteCOPD disease severity is based on spirometry, symptoms and disability (see classification tables below). Classification COPD Stages - Symptoms and disability: Mild: Shortness of breath from COPD when hurrying on the level or walking up a slight hill. Moderate: Shortness of breath from COPD causing the patient to stop after walking approximately 100m (or after a few minutes) on the level Severe: Shortness of breath from COPD resulting in the patient being too breathless to leave the house, breathless when dressing or undressing (MRC 5), or the presence of chronic respiratory failure or clinical signs of right heart failure Classification by impairment of lung function: COPD stage and spirometry (post bronchodilator) FEV1 predicted: Mild: Greater than or equal to 80 percent Moderate: 50 to 79 percent Severe: 30 to 49 percent Very severe: Less than 30 percent SKELETAL MUSCLE RELAXANTSMuscle relaxants, other than baclofen and dantrolene sodium, are not indicated for spasticity due to cerebral palsy, multiple sclerosis, spinal cord injury, etc.BACLOFEN04252mg/mLInj Sol (Preservative-Free)Lioresal IntrathecalNOV2015-08-26Baclofen IntrathecalSTE35.45002015-08-2635.4500Baclofen InjectionTEL35.45002019-02-2835.4500Baclofen IntrathecalAVP35.45002021-09-3035.4500Baclofen Injection USPJPC35.45002025-07-3135.450004260.05mg/mLInj Sol-1mL Pk (Preservative-Free)Lioresal IntrathecalNOV2015-08-26Baclofen InjectionSTE11.25002015-08-2611.2500Baclofen InjectionTEL11.25002019-02-2811.250004270.5mg/mLInj Sol-20mL Pk (Preservative-Free)Lioresal IntrathecalNOV2015-08-26Baclofen IntrathecalSTE177.25002015-08-26177.2500Baclofen InjectionTEL177.25002019-02-28177.2500Baclofen IntrathecalAVP177.25002021-09-30177.2500042810mgTabLioresalNOV.87951996-10-01.1595PMS-BaclofenPMS.15951996-10-01.1595Mylan-BaclofenMYL.15951996-10-01.1595Apo-BaclofenAPX.15951996-10-01.1595Ratio-BaclofenRPH.15951999-04-15.1595BaclofenSAI.15952011-09-15.1595Jamp BaclofenJPC.15952026-01-30.1595BaclofenSIV.15952024-10-31.1595042920mgTabLioresal DSNOV1.71221996-10-01.3104PMS-BaclofenPMS.31041996-10-01.3104Mylan-BaclofenMYL.31041996-10-01.3104Apo-BaclofenAPX.31041996-10-01.3104Ratio-BaclofenRPH.31041999-04-15.3104BaclofenSAI.31042011-09-15.3104Jamp BaclofenJPC.31042026-01-30.3104BaclofenSIV.31042024-10-31.3104CYCLOBENZAPRINE HCL043010mgTabFlexerilFRS1996-10-01Teva-Cyclobenzaprine HCLTEV1996-10-01Apo-CyclobenzaprineAPX1996-10-01PMS-CyclobenzaprinePMS1996-12-19Ratio-CyclobenzaprineRPH1999-09-15Riva-CyclobenzaprineRIA2025-04-30CyclobenzaprineSAI2011-08-04Auro-CyclobenzaprineAUR2011-12-15Jamp-CyclobenzaprineJPC2012-11-27CyclobenzaprineSIV2020-08-28AG-CyclobenzaprineANG2020-12-18FlexerilORI2020-06-30DANTROLENE SODIUM043125mgCapDantrium CapsulesEDO.75581996-10-01.7558ORPHENADRINE CITRATE043260mg/2mLInj Sol-2mL PkNorflexMMH1996-10-01OrphenadrineCYI1998-12-31TIZANIDINE HCL04334mgTabZanaflexELA2007-06-06Apo-TizanidineAPX.87582007-06-06.8758Mint-TizanidineMIN.87582023-12-29.8758BLOOD FORMATION AND COAGULATIONANTIANEMIA DRUGS(IRON) FERRIC CARBOXYMALTOSE043450mg/mLInj SolFerinjectVIR22.50002025-12-3022.5000For the treatment of patients with iron deficiency anemia (IDA) who meets ALL the following criteria: - Patient has documented diagnosis of IDA confirmed by laboratory testing results (e.g. hemoglobin, ferritin); AND - Patient has experienced a failure to respond, documented intolerance, or contraindication to an adequate trial (i.e. at least 4 weeks) of at least one oral iron therapy; AND - Patient does not have hemochromatosis or other iron storage disorders; AND - The iron formulation is administered in a setting where appropriate monitoring and management of hypersensitivity reactions can be provided to the patient.LU Authorization Period: 1 yearFor the treatment of iron deficiency in patients with heart failure where ALL the following criteria apply: 1. Patient is 18 years of age or older; AND 2. Patient has heart failure with New York Heart Association (NYHA) class II or III; AND 3. Patient has a left ventricular ejection fraction (LVEF) less than or equal to 40% determined by echocardiography; AND 4. Patient has a ferritin level less than or equal to 300mcg/L with a transferrin saturation (TSAT) less than 15%; AND 5. The iron formulation is prescribed by a cardiologist or prescriber with expertise in the management of chronic heart failure.LU Authorization Period: 6 MonthsFERRIC DERISOMALTOSE0435100mg elemental iron/mLInj Sol (Preservative-Free)MonoferricPHC45.00002021-02-2645.0000For the treatment of patients with Iron Deficiency Anemia (IDA) who meet ALL the following criteria: - Patient has documented diagnosis of IDA confirmed by laboratory testing results (e.g. hemoglobin, ferritin); AND - Patient's IDA has experienced a failure to respond, documented intolerance, or contraindication to an adequate trial (i.e. at least 4 weeks) of at least one oral iron therapy; AND - Patient does not have hemochromatosis or other iron storage disorders; AND - Monoferric is administered in a setting where appropriate monitoring and management of hypersensitivity reactions can be provided to the Patient. LU Authorization Period: 1 yearFERROUS FUMARATE0436300mgCapPalaferGSK1996-10-01Jamp-FerJPC.10572016-01-28.1057043760mg/mLO/LPalaferGSK.10921996-10-01.1092FERROUS GLUCONATE0438300mgTabFerrous GluconateJPC1996-10-01Ferrous Gluconate 300mgAAP.04241996-10-01.0424FERROUS SULFATE043975mg/mLO/LFer-In-SolMJS.24361997-01-03.2436IRON SUCROSE044020mg/mLInj Sol-5mL Pk (Preservative-Free)VenoferLUI2021-03-29PMS-Iron SucrosePMS27.50002021-03-2927.5000COAGULANTS AND ANTI-COAGULANTSAPIXABAN04412.5mgTabEliquisBQU1.63362013-08-29.4084Teva-ApixabanTEV.40842024-01-31.4084Auro-ApixabanAUR.40842023-01-31.4084Apo-ApixabanAPX.40842022-08-31.4084Ach-ApixabanACH.40842022-11-30.4084Sandoz Apixaban SDZSDZ.40842022-11-30.4084Mar-ApixabanMAR.40842022-11-30.4084Nat-ApixabanNAT.40842022-11-30.4084Mint-ApixabanMIN.40842023-07-31.4084Taro-ApixabanTAR.40842022-11-30.4084Riva-ApixabanRIA.40842024-10-31.4084NRA-ApixabanNRA.40842022-11-30.4084Jamp ApixabanJPC.40842022-11-30.4084M-ApixabanMAT.40842022-11-30.4084ApixabanSIV.40842022-12-21.4084NRA-Apixaban TabletsNRA.40842024-08-30.4084ApixabanSAI.40842024-12-30.408404425mgTabEliquisBQU1.63362013-08-29.4084Teva-ApixabanTEV.40842024-01-31.4084Auro-ApixabanAUR.40842023-01-31.4084Apo-ApixabanAPX.40842022-08-31.4084Ach-ApixabanACH.40842022-11-30.4084Sandoz Apixaban SDZSDZ.40842022-11-30.4084Mar-ApixabanMAR.40842022-11-30.4084Nat-ApixabanNAT.40842022-11-30.4084Mint-ApixabanMIN.40842023-01-31.4084Taro-ApixabanTAR.40842022-11-30.4084Riva-ApixabanRIA.40842024-10-31.4084NRA-ApixabanNRA.40842022-11-30.4084Jamp ApixabanJPC.40842022-11-30.4084M-ApixabanMAT.40842022-11-30.4084ApixabanSIV.40842022-12-21.4084NRA-Apixaban TabletsNRA.40842024-08-30.4084ApixabanSAI.40842024-12-30.4084DABIGATRAN ETEXILATE044375mgCapPradaxaBOE2019-10-31Apo-DabigatranAPX1.64432019-10-310444110mgCapPradaxaBOE1.80602012-04-241.2540Apo-DabigatranAPX1.25402019-05-311.25400445150mgCapPradaxaBOE1.80602012-04-241.2540Apo-DabigatranAPX1.25402019-05-311.2540DALTEPARIN SODIUM04463500IU/0.28mLInj Pref SyrFragminPFI8.31102016-03-308.311004477500IU/0.3mLInj Pref SyrFragminPFI17.81202012-02-2917.812004482500IU/0.2mLInj Pref SyrFragminPFI5.93701996-10-015.937004495000IU/0.2mLInj Pref SyrFragminPFI11.87401997-04-1011.8740045010000IU/0.4mLInj Pref SyrFragminPFI23.75002011-03-1523.7500045112500IU/0.5mLInj Pref SyrFragminPFI29.68802011-03-1529.6880045215000IU/0.6mLInj Pref SyrFragminPFI35.61602011-03-1535.6160045318000IU/0.72mLInj Pref SyrFragminPFI42.74002011-03-1542.7400045416500IU/0.66mLInj Pref Syr-0.66mL PkFragminPFI39.17802021-02-2639.1780045525000IU/mLMultidose 3.8mL PkFragminPFI178.10001998-12-31178.1000For acute treatment of deep venous thrombosis (DVT), for a maximum of three weeks;LU Authorization Period: 1 yearFor DVT in pregnant or lactating females;LU Authorization Period: 1 yearFor DVT in patients whom treatment with warfarin is not tolerated, or contraindicated;LU Authorization Period: 1 yearFor DVT in patients who have failed treatment with warfarin.LU Authorization Period: 1 yearENOXAPARIN045620mg/0.2mLInj Sol-0.2mL Pref Syr (Preservative-Free)NorombyJUN3.52802021-06-303.5280045730mg/0.3mLInj Sol-0.3mL Pref Syr (Preservative-Free)RedescaSHE4.96202021-04-304.9620045830mg/0.3mLInj Sol-0.3mL Pref Syr (Preservative-Free)InclunoxSDZ4.96202021-05-314.9620045930mg/0.3mLInj Sol-0.3mL Pref Syr (Preservative-Free)NorombyJUN4.91242021-06-304.9124046030mg/0.3mLInj Sol-0.3mL Pref Syr (Preservative-Free)ElonoxFKC4.91242023-02-284.9124046130mg/0.3mLInj Sol-0.3mL Pref Syr (Preservative-Free)AxberiBAX4.91242025-04-304.9124046240mg/0.4mLInj Sol-0.4mL Pref Syr (Preservative-Free)RedescaSHE6.61602021-04-306.6160046340mg/0.4mLInj Sol-0.4mL Pref Syr (Preservative-Free)InclunoxSDZ6.61602021-05-316.6160046440mg/0.4mLInj Sol-0.4mL Pref Syr (Preservative-Free)NorombyJUN6.54982021-06-306.5498046540mg/0.4mLInj Sol-0.4mL Pref Syr (Preservative-Free)ElonoxFKC6.54982023-02-286.5498046640mg/0.4mLInj Sol-0.4mL Pref Syr (Preservative-Free)AxberiBAX6.54982025-04-306.5498046760mg/0.6mLInj Sol-0.6mL Pref Syr (Preservative-Free)RedescaSHE9.92402021-04-309.9240046860mg/0.6mLInj Sol-0.6mL Pref Syr (Preservative-Free)InclunoxSDZ9.92402021-05-319.9240046960mg/0.6mLInj Sol-0.6mL Pref Syr (Preservative-Free)NorombyJUN9.82482021-06-309.8248047060mg/0.6mLInj Sol-0.6mL Pref Syr (Preservative-Free)ElonoxFKC9.82482023-02-289.8248047160mg/0.6mLInj Sol-0.6mL Pref Syr (Preservative-Free)AxberiBAX9.82482025-04-309.8248047280mg/0.8mLInj Sol-0.8mL Pref Syr (Preservative-Free)RedescaSHE13.23202021-04-3013.2320047380mg/0.8mLInj Sol-0.8mL Pref Syr (Preservative-Free)InclunoxSDZ13.23202021-05-3113.2320047480mg/0.8mLInj Sol-0.8mL Pref Syr (Preservative-Free)NorombyJUN13.09972021-06-3013.0997047580mg/0.8mLInj Sol-0.8mL Pref Syr (Preservative-Free)ElonoxFKC13.09972023-02-2813.0997047680mg/0.8mLInj Sol-0.8mL Pref Syr (Preservative-Free)AxberiBAX13.09972025-04-3013.09970477120mg/0.8mLInj Sol-0.8mL Pref Syr (Preservative-Free)Redesca HPSHE19.84802021-04-3019.84800478120mg/0.8mLInj Sol-0.8mL Pref Syr (Preservative-Free)Inclunox HPSDZ19.84802021-05-3119.84800479120mg/0.8mLInj Sol-0.8mL Pref Syr (Preservative-Free)Noromby HPJUN19.64952021-06-3019.64950480120mg/0.8mLInj Sol-0.8mL Pref Syr (Preservative-Free)Elonox HPFKC19.64952023-02-2819.64950481120mg/0.8mLInj Sol-0.8mL Pref Syr (Preservative-Free)Axberi HPBAX19.64952025-04-3019.64950482100mg/mLInj Sol-1mL Pref Syr (Preservative-Free)RedescaSHE16.54002021-04-3016.54000483100mg/mLInj Sol-1mL Pref Syr (Preservative-Free)InclunoxSDZ16.54002021-05-3116.54000484100mg/mLInj Sol-1mL Pref Syr (Preservative-Free)NorombyJUN16.37462021-06-3016.37460485100mg/mLInj Sol-1mL Pref Syr (Preservative-Free)ElonoxFKC16.37462023-02-2816.37460486100mg/mLInj Sol-1mL Pref Syr (Preservative-Free)AxberiBAX16.37462025-04-3016.37460487150mg/mLInj Sol-1mL Pref Syr (Preservative-Free)Redesca HPSHE24.81002021-04-3024.81000488150mg/mLInj Sol-1mL Pref Syr (Preservative-Free)Inclunox HPSDZ24.81002021-05-3124.81000489150mg/mLInj Sol-1mL Pref Syr (Preservative-Free)Noromby HPJUN24.56192021-06-3024.56190490150mg/mLInj Sol-1mL Pref Syr (Preservative-Free)Elonox HPFKC24.56192023-02-2824.56190491150mg/mLInj Sol-1mL Pref Syr (Preservative-Free)Axberi HPBAX24.56192025-04-3024.56190492300mg/3mLInj Sol-3mL Vial Pk (With Preservative)RedescaSHE49.62002021-04-3049.6200EPTIFIBATIDE04930.75mg/mL100mL Vial PkIntegrilinMEK2013-09-27Eptifibatide InjectionTEV94.56002013-09-27Eptifibatide InjectionJUN124.33002026-03-3104942mg/mL10mL Vial PkIntegrilinMEK2013-09-27Eptifibatide InjectionTEV32.30002013-09-27Eptifibatide InjectionJUN42.46002026-03-31FONDAPARINUX SODIUM04952.5mg/0.5mLInj Sol-Pref Syr 0.5mL Pk (Preservative Free)ArixtraASN13.46422004-04-0611.1944Fondaparinux Sodium InjectionDRR11.19442014-07-3011.1944For the post-operative prophylaxis of venous thromboembolic events in patients undergoing orthopedic surgery of the lower limbs such as hip fracture, hip replacement or knee surgery.Limited to 9 days of reimbursement.LU Authorization Period: 1 year04967.5mg/0.6mLInj Sol-Pref Syr 0.6mL Pk (Preservative Free)ArixtraASN2014-07-30Fondaparinux Sodium InjectionDRR18.13562014-07-3018.1356NADROPARIN CALCIUM04979500IU/mLPref Syr-0.3mL PkFraxiparineASN5.41501999-04-155.415004989500IU/mLPref Syr-0.4mL PkFraxiparineASN6.84001999-04-156.840004999500IU/mLPref Syr-0.6mL PkFraxiparineASN9.05801999-04-159.0580050019000IU/mLPref Syr-0.6mL PkFraxiparine ForteASN18.11702000-01-1718.1170050119000IU/mLPref Syr-0.8mL PkFraxiparine ForteASN18.11702000-01-1718.117005029500IU/mLPref Syr-1.0mL PkFraxiparineASN9.05801999-04-159.0580050319000IU/mLPref Syr-1.0mL PkFraxiparine ForteASN18.11702000-01-1718.1170For acute treatment of deep venous thrombosis (DVT), for a maximum of three weeks;LU Authorization Period: 1 yearFor DVT in pregnant or lactating females;LU Authorization Period: 1 yearFor DVT in patients whom treatment with warfarin is not tolerated, or contraindicated;LU Authorization Period: 1 yearFor DVT in patients who have failed treatment with warfarin.LU Authorization Period: 1 yearRIVAROXABAN05042.5mgTabXareltoBAH1.42002019-12-20.3550Reddy-RivaroxabanDRR.35502023-12-29.3550Taro-RivaroxabanTAR.35502023-12-29.3550PMS-RivaroxabanPMS.35502023-12-29.3550Sandoz RivaroxabanSDZ.35502023-12-29.3550RivaroxabanSIV.35502024-01-31.3550Apo-RivaroxabanAPX.35502023-12-29.3550Teva-RivaroxabanTEV.35502025-03-31.3550RivaroxabanSAI.35502025-03-31.3550M-RivaroxabanMAT.35502025-02-28.3550Jamp RivaroxabanJPC.35502025-08-29.3550050510mgTabXareltoBAH2.87002009-06-23.7175Apo-RivaroxabanAPX.71752023-12-29.7175Reddy-RivaroxabanDRR.71752023-12-29.7175Sandoz RivaroxabanSDZ.71752023-12-29.7175Taro-RivaroxabanTAR.71752023-12-29.7175Teva-RivaroxabanTEV.71752023-12-29.7175PMS-RivaroxabanPMS.71752023-12-29.7175Jamp RivaroxabanJPC.71752024-04-30.7175RivaroxabanSIV.71752024-01-31.7175RivaroxabanSAI.71752025-03-31.7175M-RivaroxabanMAT.71752025-02-28.7175050615mgTabXareltoBAH2.87002012-07-27.7175Apo-RivaroxabanAPX.71752023-12-29.7175Reddy-RivaroxabanDRR.71752023-12-29.7175Sandoz RivaroxabanSDZ.71752023-12-29.7175Taro-RivaroxabanTAR.71752023-12-29.7175Teva-RivaroxabanTEV.71752023-12-29.7175PMS-RivaroxabanPMS.71752023-12-29.7175Jamp RivaroxabanJPC.71752024-04-30.7175RivaroxabanSIV.71752024-01-31.7175RivaroxabanSAI.71752025-03-31.7175M-RivaroxabanMAT.71752025-02-28.7175050720mgTabXareltoBAH2.87002012-07-27.7175Apo-RivaroxabanAPX.71752023-12-29.7175Reddy-RivaroxabanDRR.71752023-12-29.7175Sandoz RivaroxabanSDZ.71752023-12-29.7175Taro-RivaroxabanTAR.71752023-12-29.7175Teva-RivaroxabanTEV.71752023-12-29.7175PMS-RivaroxabanPMS.71752023-12-29.7175Jamp RivaroxabanJPC.71752024-04-30.7175RivaroxabanSIV.71752024-01-31.7175RivaroxabanSAI.71752025-03-31.7175M-RivaroxabanMAT.71752025-02-28.7175TICAGRELOR050860mgTabBrilintaAZC2022-05-31Apo-TicagrelorAPX1.28442022-12-21Taro-TicagrelorTAR1.28442022-05-31M-TicagrelorMAT1.28442022-12-21Jamp TicagrelorJPC1.28442024-02-29050990mgTabBrilintaAZC1.81872013-04-30.3960Apo-TicagrelorAPX.39602023-01-31.3960Taro-TicagrelorTAR.39602022-05-31.3960M-TicagrelorMAT.39602022-12-21.3960Jamp TicagrelorJPC.39602024-05-31.3960In combination with low-dose ASA for patients with: - Non-ST elevation acute coronary syndrome (ACS)* (unstable angina or myocardial infarction [MI]); OR - ST-segment elevation myocardial infarction (STEMI); OR - Stent thrombosis while taking clopidogrel plus low-dose ASA. Treatment must be initiated in hospital. Notes: A) *ACS without ST elevation is defined as 2 of 3 of the following criteria: 1. ST-segment changes on electrocardiogram (ECG) indicating ischemia 2. Positive biomarker indicating myocardial necrosis 3. One of the following: - Greater than or equal to 60 years of age - Previous MI or coronary artery bypass graft (CABG) - Coronary artery disease (CAD) with greater than or equal to 50% stenosis in greater than or equal to 2 vessels - Previous ischemic stroke, transient ischemic attack (TIA; hospital-based diagnosis), carotid stenosis (greater than or equal to 50%), or cerebral revascularization - Diabetes mellitus - Peripheral artery disease - Chronic renal dysfunction B) Co-administration of ticagrelor with high maintenance dose ASA (greater than 150mg daily) is not recommended. C) Definite stent thrombosis, according to the Academic Research Consortium, is a total occlusion originating in or within 5 mm of the stent, or is a visible thrombus within the stent, or is within 5 mm of the stent in the presence of an acute ischemic clinical syndrome within 48 hours. Definite stent thrombosis must be confirmed by angiography or by pathologic confirmation of acute thrombosis. D) Ticagrelor is contraindicated in patients with active pathological bleeding, in those with a history of intracranial hemorrhage and moderate to severe hepatic impairment. LU Authorization Period: 1 yearTINZAPARIN SODIUM05102500IU/0.25mLInj Pref SyrInnohepLEO7.30422010-07-207.304205118000IU/0.4mLInj Pref SyrInnohepLEO22.72082015-08-2622.7208051212000IU/0.6mLInj Pref SyrInnohepLEO35.78662015-08-2635.7866051316000IU/0.8mLInj Pref SyrInnohepLEO47.71582015-08-2647.715805143500IU/0.35mLInj Pref SyrInnohepLEO10.21572011-08-0410.215705154500IU/0.45mLInj Pref SyrInnohepLEO13.13742011-08-0413.1374051610000IU/0.5mLInj Pref SyrInnohepLEO29.79391998-12-3129.7939051714000IU/0.7mLInj Pref SyrInnohepLEO41.74972011-08-0441.7497051818000IU/0.9mLInj Pref SyrInnohepLEO53.67272011-08-0453.6727051910000IU/mLInj-2mL PkInnohepLEO55.14691997-04-1055.1469052020000IU/mLInj-2mL PkInnohepLEO117.62451998-12-31117.6245For acute treatment of deep venous thrombosis (DVT), for a maximum of three weeks;LU Authorization Period: 1 yearFor DVT in pregnant or lactating females;LU Authorization Period: 1 yearFor DVT in patients whom treatment with warfarin is not tolerated, or contraindicated;LU Authorization Period: 1 yearFor DVT in patients who have failed treatment with warfarin.LU Authorization Period: 1 yearFor the acute treatment of pulmonary embolism, maximum of three weeks.LU Authorization Period: 1 yearWARFARINThe use of International Normalized Ratio (INR) instead of Prothrombin Time results to control warfarin dosing is strongly recommended. Prothrombin Time results can vary three-fold depending on the reagent used; INR corrects for this and substantially improves safety and efficacy of warfarin therapy.05211mgTabCoumadinBQU1996-10-01Taro-WarfarinTAR.07962001-06-07.0796Apo-WarfarinAPX.07962001-06-07.079605222mgTabCoumadinBQU1996-10-01Taro-WarfarinTAR.08412001-06-07.0841Apo-WarfarinAPX.08412001-06-07.084105232.5mgTabCoumadinBQU1996-10-01Taro-WarfarinTAR.06742001-06-07.0674Apo-WarfarinAPX.06742001-06-07.067405243mgTabCoumadinBQU2001-06-07Taro-WarfarinTAR.10432002-04-04.1043Apo-WarfarinAPX.10432003-01-30.104305254mgTabCoumadinBQU1996-10-01Taro-WarfarinTAR.10432001-06-07.1043Apo-WarfarinAPX.10432001-06-07.104305265mgTabCoumadinBQU1996-10-01Taro-WarfarinTAR.06752001-06-07.0675Apo-WarfarinAPX.06752001-06-07.067505276mgTabCoumadinBQU2008-06-27Taro-WarfarinTAR.51602008-12-03052810mgTabCoumadinBQU1996-10-01Taro-WarfarinTAR.12112001-06-07.1211Apo-WarfarinAPX.12112001-06-07.1211COAGULANTS AND ANTI-COAGULANTS DIRECT FACTOR XA INHIBITORSEDOXABAN052915mgTabLixianaSEV2.93932019-04-301.4697Sandoz EdoxabanSDZ1.46972025-06-301.4697Teva-EdoxabanTEV1.46972025-06-301.4697053030mgTabLixianaSEV2.93932019-04-30.7348Sandoz EdoxabanSDZ.73482025-06-30.7348Teva-EdoxabanTEV.73482025-06-30.7348Jamp EdoxabanJPC.73482025-06-30.7348053160mgTabLixianaSEV2.93932019-04-30.7348Sandoz EdoxabanSDZ.73482025-06-30.7348Teva-EdoxabanTEV.73482025-06-30.7348Jamp EdoxabanJPC.73482025-06-30.7348COAGULANTS AND ANTI-COAGULANTS HEMOSTATICSTRANEXAMIC ACID0532500mgTabCyklokapronPFI2013-04-30Tranexamic Acid TabletsSTE.80712013-04-30.8071Gd-Tranexamic AcidGEM.80712015-07-29.8071Mar-Tranexamic AcidMAR.80712020-08-28.8071Tranexamic AcidJPC.80712022-01-31.8071HEMATOPOIETIC AGENTSDARBEPOETIN ALFA0533150mcg/0.3mLPref Syr-0.3mL PkAranespAMG402.00002014-12-18402.00000534200mcg/0.4mLPref Syr-0.4mL PkAranespAMG701.02002014-08-28701.02000535300mcg/0.6mLPref Syr-0.6mL PkAranespAMG1082.95002014-01-301082.95000536500mcg/1.0mLPref Syr-1.0mL PkAranespAMG1804.94002014-04-301804.9400ESAs (Eprex or Aranesp) for patients with: -Cancer diagnosis and receiving chemotherapy; AND -Presence of anemia caused by chemotherapy with a hemoglobin count less than 100g/L; AND -Patient has been informed of the risks and benefits of ESA therapy AND Anemia cannot be managed by use of blood transfusions due to at least one of the following: -Religious beliefs do not allow the patient to receive transfusions. -Previous severe (potentially life-threatening) reaction to a transfusion or difficulty cross-matching. -Myeloid cancers that cannot be managed with blood transfusions -Patient lives far away from treatment centre and/or transfusions cannot be coordinated with chemotherapy -Patients receiving neoadjuvant chemotherapy with anemia and at risk of high blood losses due to surgery Please refer to the product monograph for starting dose, dose adjustment and discontinuation recommendations. NOTE: Health Canada has issued the following statements regarding ESA therapy for the treatment of anemia due to chemotherapy in patients with non-myeloid malignancies: In patients with a long life expectancy, the decision to administer ESAs should be based on a benefit-risk assessment with the participation of the individual patient. This should take into account the specific clinical context such as (but not limited to) the type of tumor and its stage, the degree of anemia, life expectancy, the environment in which the patient is being treated and known risks of transfusions and ESAs. If appropriate, red blood cell transfusion should be the preferred treatment for the management of anemia in patients with a long life expectancy and who are receiving myelosuppressive chemotherapy. ESAs are not indicated for use in patients receiving hormonal agents, therapeutic biologic products, or radiotherapy unless receiving concomitant myelosuppressive chemotherapy. Health Canada has also issued the following Serious Warnings and Precautions for cancer patients regarding ESAs: ESAs increased the risks for death and serious cardiovascular and thromboembolic events in some controlled clinical trials. ESAs shortened overall survival and/or increased the risk of tumour progression or recurrence in some clinical studies in patients with breast, head and neck, lymphoid, cervical and non-small cell lung cancers when dosed to target a hemoglobin of greater than or equal to 120g/L. To minimize the above risks, use the lowest dose needed to avoid red blood cell (RBC) transfusions. Use ESAs only for treatment of anemia due to concomitant myelosuppressive chemotherapy. If appropriate, red blood cell transfusion should be the preferred treatment for the management of anemia in patients with a long life expectancy and who are receiving myelosuppressive chemotherapy. Discontinue ESAs following completion of a chemotherapy course. LU Authorization Period: 1 yearELTROMBOPAG OLAMINE053725mgTabRevoladeGSK65.00002023-07-3155.2500Apo-EltrombopagAPX55.25002023-07-3155.2500053850mgTabRevoladeGSK130.00002023-07-31110.5000Apo-EltrombopagAPX110.50002023-07-31110.5000EPOETIN ALFA053910,000IU/mLPref Syr - 1mL PkEprexJAN142.50002007-01-02142.5000054040,000IU/mLPref Syr - 1mL PkEprexJAN486.79002007-01-02486.7900054120,000IU/0.5mLPref Syr-0.5mL PkEprexJAN325.09002009-03-02325.0900ESAs (Eprex or Aranesp) for patients with: -Cancer diagnosis and receiving chemotherapy; AND -Presence of anemia caused by chemotherapy with a hemoglobin count less than 100g/L; AND -Patient has been informed of the risks and benefits of ESA therapy AND Anemia cannot be managed by use of blood transfusions due to at least one of the following: -Religious beliefs do not allow the patient to receive transfusions. -Previous severe (potentially life-threatening) reaction to a transfusion or difficulty cross-matching. -Myeloid cancers that cannot be managed with blood transfusions -Patient lives far away from treatment centre and/or transfusions cannot be coordinated with chemotherapy -Patients receiving neoadjuvant chemotherapy with anemia and at risk of high blood losses due to surgery Please refer to the product monograph for starting dose, dose adjustment and discontinuation recommendations. NOTE: Health Canada has issued the following statements regarding ESA therapy for the treatment of anemia due to chemotherapy in patients with non-myeloid malignancies: In patients with a long life expectancy, the decision to administer ESAs should be based on a benefit-risk assessment with the participation of the individual patient. This should take into account the specific clinical context such as (but not limited to) the type of tumor and its stage, the degree of anemia, life expectancy, the environment in which the patient is being treated and known risks of transfusions and ESAs. If appropriate, red blood cell transfusion should be the preferred treatment for the management of anemia in patients with a long life expectancy and who are receiving myelosuppressive chemotherapy. ESAs are not indicated for use in patients receiving hormonal agents, therapeutic biologic products, or radiotherapy unless receiving concomitant myelosuppressive chemotherapy. Health Canada has also issued the following Serious Warnings and Precautions for cancer patients regarding ESAs: ESAs increased the risks for death and serious cardiovascular and thromboembolic events in some controlled clinical trials. ESAs shortened overall survival and/or increased the risk of tumour progression or recurrence in some clinical studies in patients with breast, head and neck, lymphoid, cervical and non-small cell lung cancers when dosed to target a hemoglobin of greater than or equal to 120g/L. To minimize the above risks, use the lowest dose needed to avoid red blood cell (RBC) transfusions. Use ESAs only for treatment of anemia due to concomitant myelosuppressive chemotherapy. If appropriate, red blood cell transfusion should be the preferred treatment for the management of anemia in patients with a long life expectancy and who are receiving myelosuppressive chemotherapy. Discontinue ESAs following completion of a chemotherapy course. LU Authorization Period: 1 yearFILGRASTIM0542300mcg/0.5mLInj Sol-0.5mL Pref SyrNivestymPFI138.53762020-07-31138.53760543300mcg/0.5mLInj Sol-0.5mL Pref Syr (Preservative-Free)NypoziTAV138.53762024-01-31138.53760544300mcg/0.5mLInj Sol-0.5mL Pref Syr (Preservative-Free)FilraJPC105.67982025-07-31105.67980545480mcg/0.8mLInj Sol-0.8mL Pref SyrNivestymPFI221.66402020-07-31221.66400546480mcg/0.8mLInj Sol-0.8mL Pref Syr (Preservative-Free)NypoziTAV221.66402024-01-31221.66400547480mcg/0.8mLInj Sol-0.8mL Pref Syr (Preservative-Free)FilraJPC169.08722025-07-31169.08720548480mcg/1.6mLInj Sol-1.6mL Vial PkNivestymPFI221.66402020-07-31221.66400549300mcg/mLInj Sol-1mL Vial PkNivestymPFI138.53762020-07-31138.53760550300mcg/0.5mLPref Syr-0.5mL PkGrastofilAPX105.67982016-12-22105.67980551480mcg/0.8mLPref Syr-0.8mL PkGrastofilAPX169.08722016-12-22169.0872PEGFILGRASTIM05526mg/0.6mLInj Sol-0.6mL Pref Autoinj (Preservative-Free)LapelgaAPX1375.00002023-09-281375.000005536mg/0.6mLInj Sol-0.6mL Pref Syr (Preservative-Free)ZiextenzoSDZ492.00002020-08-28492.000005546mg/0.6mLInj Sol-0.6mL Pref Syr (Preservative-Free)NiopegNRA492.00002025-07-31492.000005556mg/0.6mLInj Sol-0.6mL Pref Syr (Preservative-Free)PexegraJPC492.00002025-07-31492.000005566mg/0.6mLInj Sol-0.6mL Pref Syr Pk (Preservative-Free)NyvepriaPFI1375.00002021-08-311375.0000055710mg/mLInj Sol-Pref SyrFulphilaBCL492.00002020-05-29492.0000055810mg/mLInj Sol-Pref Syr - 0.6mL Pk (Preservative Free)LapelgaAPX492.00002019-08-30492.0000HEMORRHEOLOGIC AGENTSPENTOXIFYLLINE0559400mgSR TabTrentalSAV1999-01-07Apo-Pentoxifylline SRAPX.72381997-08-28.7238Jamp Pentoxifylline SRJPC.72382024-11-29.7238For the treatment of patients with critical limb ischemia (with arterial ulcers, gangrene and/or rest pain) and documented arterial vascular disease.Limited Use form must specify if arterial ulcers, gangrene and/or rest pain are present.LU Authorization Period: IndefiniteFor the treatment of patients with venous ulcers lasting, or expected to last, more than 8 weeks. Treatment should be discontinued after 3 months if there is no indication of objective benefit. The duration of therapy with pentoxifylline should not exceed 12 months.Pentoxifylline should be used in combination with compression therapy.LU Authorization Period: 1 yearCARDIOVASCULAR DRUGSCARDIAC DRUGSACEBUTOLOL HCL0560100mgTab.3742SectralSAV1996-10-01Apo-AcebutololAPX.1871.37421996-10-01.1871Teva-AcebutololTEV.1871.37421998-12-31.18710561200mgTab.5616SectralSAV1996-10-01Apo-AcebutololAPX.2808.56161996-10-01.2808Teva-AcebutololTEV.2808.56161998-12-31.28080562400mgTab1.0696SectralSAV1996-10-01Apo-AcebutololAPX.53481.06961996-10-01.5348Teva-AcebutololTEV.53481.06961997-08-28.5348AMIODARONE HCL0563200mgTabCordaronePFIThe manufacturer recommends that treatment with amiodarone be initiated in hospital and continued in a monitored environment under the care of a cardiologist, or internist with equivalent experience in such care. 1996-10-01Teva-AmiodaroneTEV.3706The manufacturer recommends that treatment with amiodarone be initiated in hospital and continued in a monitored environment under the care of a cardiologist, or internist with equivalent experience in such care.1999-09-15.3706PMS-AmiodaronePMS.3706The manufacturer recommends that treatment with amiodarone be initiated in hospital and continued in a monitored environment under the care of a cardiologist, or internist with equivalent experience in such care.2001-06-07.3706Sandoz AmiodaroneSDZ.3706The manufacturer recommends that treatment with amiodarone be initiated in hospital and continued in a monitored environment under the care of a cardiologist, or internist with equivalent experience in such care.2002-07-29.3706Apo-AmiodaroneAPX.3706The manufacturer recommends that treatment with amiodarone be initiated in hospital and continued in a monitored environment under the care of a cardiologist, or internist with equivalent experience in such care.2004-04-06.3706Riva-AmiodaroneRIA.37062021-08-31.3706AmiodaroneSAI.3706The manufacturer recommends that treatment with amiodarone be initiated in hospital and continued in a monitored environment under the care of a cardiologist, or internist with equivalent experience in such care.2011-10-25.3706AmiodaroneSIV.3706The manufacturer recommends that treatment with amiodarone be initiated in hospital and continued in a monitored environment under the care of a cardiologist, or internist with equivalent experience in such care.2020-06-30.3706Jamp AmiodaroneJPC.37062023-05-31.3706AMLODIPINE05641mg/mLOral SolPDP-AmlodipinePEN1.16672023-04-281.1667For patients unable to swallow or tolerate oral solid dosage forms of amlodipine.LU Authorization Period: 1 yearFor pediatric patients (less than 18 years of age) where the appropriate dose cannot be achieved using a listed solid oral dosage form of amlodipine.LU Authorization Period: 1 year05652.5mgTabNorvascUJC2024-12-30PMS-AmlodipinePMS.33282025-02-28Sandoz AmlodipineSDZ.33282024-12-30Jamp-AmlodipineJPC.33282025-06-30Mar-AmlodipineMAR.33282025-03-31AmlodipineSIV.33282025-02-28Ach-AmlodipineACH.33282025-09-29M-AmlodipineMAT.33282025-04-30AmlodipineSAI.33282025-03-31PRZ-AmlodipinePRZ.33282026-01-3005665mgTab.1343NorvascUJC1.77701.77701996-10-01.1343Teva-AmlodipineTEV.1343.13432009-09-30.1343Ratio-AmlodipineRPH.1343.13432009-09-30.1343Mylan-AmlodipineMYL.1343.13432009-09-30.1343Apo-AmlodipineAPX.1343.13432009-09-30.1343Gd-AmlodipineGEM.1343.13432009-09-30.1343PMS-AmlodipinePMS.1343.13432009-09-30.1343Sandoz AmlodipineSDZ.1343.13432009-09-30.1343Act AmlodipineTEV.1343.13432009-09-30.1343Ran-AmlodipineRAN.1343.13432009-09-30.1343AmlodipineSAI.1343.13432011-08-04.1343Jamp-AmlodipineJPC.1343.13432012-02-29.1343Septa-AmlodipineSET.1343.13432011-03-15.1343Mint-AmlodipineMIN.1343.13432011-08-04.1343Mar-Amlodipine TabletsMAR.1343.13432012-01-19.1343AmlodipineSIV.1343.13432020-06-30.1343Auro-AmlodipineAUR.1343.13432013-04-30.1343Ach-AmlodipineACH.1343.13432019-01-31.1343AmlodipineJPC.1343.13432015-01-28.1343M-AmlodipineMAT.1343.13432021-09-30.1343NRA-AmlodipineNRA.1343.13432020-08-28.1343PRZ-AmlodipinePRZ.1343.13432022-12-21.1343056710mgTab.1993NorvascUJC2.59362.59361996-10-01.1993Teva-AmlodipineTEV.1993.19932009-09-30.1993Ratio-AmlodipineRPH.1993.19932009-09-30.1993Mylan-AmlodipineMYL.1993.19932009-09-30.1993Apo-AmlodipineAPX.1993.19932009-09-30.1993Gd-AmlodipineGEM.1993.19932009-09-30.1993PMS-AmlodipinePMS.1993.19932009-09-30.1993Sandoz AmlodipineSDZ.1993.19932009-09-30.1993Act AmlodipineTEV.1993.19932009-09-30.1993Ran-AmlodipineRAN.1993.19932009-09-30.1993AmlodipineSAI.1993.19932011-08-04.1993Jamp-AmlodipineJPC.1993.19932012-02-29.1993Septa-AmlodipineSET.1993.19932011-03-15.1993Mint-AmlodipineMIN.1993.19932011-08-04.1993Mar-Amlodipine TabletsMAR.1993.19932012-01-19.1993AmlodipineSIV.1993.19932020-06-30.1993Auro-AmlodipineAUR.1993.19932013-04-30.1993Ach-AmlodipineACH.1993.19932019-01-31.1993AmlodipineJPC.1993.19932015-01-28.1993M-AmlodipineMAT.1993.19932021-09-30.1993NRA-AmlodipineNRA.1993.19932020-08-28.1993PRZ-AmlodipinePRZ.1993.19932022-12-21.1993ATENOLOL056850mgTab.0938Apo-AtenolAPX.0938.09381996-10-01.0938Teva-AtenololTEV.0938.09381996-10-01.0938TenorminAZC.6150.61501996-10-01.0938Ratio-AtenololTEV.0938.09381996-10-01.0938PMS-AtenololPMS.0938.09381999-04-15.0938AtenololSIV.0938.09382010-06-14.0938Ran-AtenololRAN.0938.09382006-03-01.0938Jamp-AtenololJPC.0938.09382012-01-19.0938Mint-AtenolMIN.0938.09382012-01-19.0938Septa-AtenololSET.0938.09382012-03-26.0938AG-AtenololANG.0938.09382020-12-18.0938Mar-AtenololMAR.0938.09382012-01-19.0938AtenololSAI.0938.09382018-04-01.09380569100mgTab.1543Apo-AtenolAPX.1543.15431996-10-01.1543Teva-AtenololTEV.1543.15431996-10-01.1543TenorminAZC1.01171.01171996-10-01.1543Ratio-AtenololTEV.1543.15431996-10-01.1543PMS-AtenololPMS.1543.15431999-04-15.1543AtenololSIV.1543.15432010-06-14.1543Ran-AtenololRAN.1543.15432006-03-01.1543Jamp-AtenololJPC.1543.15432012-01-19.1543Mint-AtenolMIN.1543.15432012-01-19.1543Septa-AtenololSET.1543.15432012-03-26.1543AG-AtenololANG.1543.15432020-12-18.1543Mar-AtenololMAR.1543.15432012-01-19.1543AtenololSAI.1543.15432018-04-01.1543BISOPROLOL FUMARATE05701.25mgTabSandoz Bisoprolol TabletsSDZ.01522024-10-31.015205712.5mgTabSandoz Bisoprolol TabletsSDZ.03032024-10-31.030305725mgTabMonocorBIO2001-06-07Apo-BisoprololAPX.06062004-11-16.0606Teva-BisoprololTEV.06062005-08-19.0606BisoprololSAI.06062020-11-30.0606Mint-BisoprololMIN.06062019-03-28.0606Sandoz Bisoprolol TabletsSDZ.06062020-06-30.0606Bisoprolol TabletsSIV.06062020-12-18.0606Jamp BisoprololJPC.06062022-05-31.0606PRZ-BisoprololPRZ.06062026-02-27.0606057310mgTabMonocorCRY2001-06-07Apo-BisoprololAPX.08852004-11-16.0885Teva-BisoprololTEV.08852005-08-19.0885BisoprololSAI.08852020-11-30.0885Mint-BisoprololMIN.08852019-03-28.0885Sandoz Bisoprolol TabletsSDZ.08852020-06-30.0885Bisoprolol TabletsSIV.08852020-12-18.0885Jamp BisoprololJPC.08852022-05-31.0885PRZ-BisoprololPRZ.08852026-02-27.0885CARVEDILOL05743.125mgTab.4120CoregGSK1997-04-10PMS-CarvedilolPMS.2060.41202004-04-06.2060Apo-CarvedilolAPX.2060.41202004-04-06.2060CarvedilolSIV.2060.41202010-03-02.2060Ratio-CarvedilolRPH.2060.41202004-07-20.2060Ran-CarvedilolRAN.2060.41202005-12-06.2060CarvedilolSAI.2060.41202011-10-25.2060Jamp-CarvedilolJPC.2060.41202012-08-27.2060Auro-CarvedilolAUR.2060.41202014-04-30.206005756.25mgTab.4120CoregGSK1997-04-10PMS-CarvedilolPMS.2060.41202004-04-06.2060Apo-CarvedilolAPX.2060.41202004-04-06.2060CarvedilolSIV.2060.41202010-03-02.2060Ratio-CarvedilolRPH.2060.41202004-07-20.2060Ran-CarvedilolRAN.2060.41202005-12-06.2060CarvedilolSAI.2060.41202011-10-25.2060Jamp-CarvedilolJPC.2060.41202012-08-27.2060Auro-CarvedilolAUR.2060.41202014-04-30.2060057612.5mgTab.4120CoregGSK1997-04-10PMS-CarvedilolPMS.2060.41202004-04-06.2060Apo-CarvedilolAPX.2060.41202004-04-06.2060CarvedilolSIV.2060.41202010-03-02.2060Ratio-CarvedilolRPH.2060.41202004-07-20.2060Ran-CarvedilolRAN.2060.41202005-12-06.2060CarvedilolSAI.2060.41202011-10-25.2060Jamp-CarvedilolJPC.2060.41202012-08-27.2060Auro-CarvedilolAUR.2060.41202014-04-30.2060057725mgTab.4120CoregGSK1997-04-10PMS-CarvedilolPMS.2060.41202004-04-06.2060Apo-CarvedilolAPX.2060.41202004-04-06.2060CarvedilolSIV.2060.41202010-03-02.2060Ratio-CarvedilolRPH.2060.41202004-07-20.2060Ran-CarvedilolRAN.2060.41202005-12-06.2060CarvedilolSAI.2060.41202011-10-25.2060Jamp-CarvedilolJPC.2060.41202012-08-27.2060Auro-CarvedilolAUR.2060.41202014-04-30.2060For patients with:a) NYHA Class II or III Congestive Heart Failure (CHF); and b) Currently being treated with an angiotensin converting enzyme (ACE) inhibitor, diuretics with or without digoxin, or previously treated, and failed these agents; and c) An ejection fraction less than or equal to 35%; and d) At least one episode of symptomatic CHF within a 12 month period while receiving optimal management.LU Authorization Period: IndefiniteDIGOXINDigoxin toxicity is common and serious: digoxin levels should be monitored in the elderly, after adding drugs that affect urea clearance including diuretics, particularly spironolactone; verapamil and quinidine also interact significantly with digoxin. Dose should be reduced in renal impairment and in elderly patients. Chronic therapy should be re-evaluated.05780.05mg/mLO/LPMS-DigoxinPMS.36922002-04-04.369205790.0625mgTabPMS-DigoxinPMS.10892010-06-14.1089Jamp DigoxinJPC.10892022-09-29.1089Auro-DigoxinAUR.10892025-11-28.108905800.125mgTabPMS-DigoxinPMS.10302010-06-14.1030Jamp DigoxinJPC.10302022-09-29.1030Auro-DigoxinAUR.10302025-11-28.1030DILTIAZEM HCL0581120mgER TabTiazac XCBIO1.09112005-05-251.09110582180mgER TabTiazac XCBIO1.45022005-05-25.9195Teva-Diltiazem XCTEV.91952023-01-31.91950583240mgER TabTiazac XCBIO1.92592005-05-251.2212Teva-Diltiazem XCTEV1.22122023-01-311.22120584300mgER TabTiazac XCBIO1.92012005-05-251.2175Teva-Diltiazem XCTEV1.21752023-01-311.21750585360mgER TabTiazac XCBIO1.92582005-05-251.2211Teva-Diltiazem XCTEV1.22112023-01-311.22110586120mgLA Cap.3634Cardizem CDVAL1.62441.62441996-10-01.3634Apo-Diltiaz CDAPX.3634.36341997-08-28.3634Teva-Diltazem CDTEV.3634.36342001-06-07.3634Sandoz Diltiazem CDSDZ.3634.36342001-10-11.3634Co Diltiazem CDCOB.3634.36342012-01-19.3634Diltiazem CDSAI.3634.36342022-07-29.3634Diltiazem CDSIV.3634.36342020-07-31.3634Mar-Diltiazem CDMAR.3634.36342020-05-29.3634Jamp Diltiazem CDJPC.3634.36342023-01-31.3634M-Diltiazem CDMAT.3634.36342024-10-31.36340587180mgLA Cap.4824Cardizem CDVAL2.15652.15651996-10-01.4824Apo-Diltiaz CDAPX.4824.48241997-08-28.4824Teva-Diltazem CDTEV.4824.48242001-06-07.4824Sandoz Diltiazem CDSDZ.4824.48242001-10-11.4824Co Diltiazem CDCOB.4824.48242012-01-19.4824Diltiazem CDSAI.4824.48242022-07-29.4824Diltiazem CDSIV.4824.48242020-07-31.4824Mar-Diltiazem CDMAR.4824.48242020-05-29.4824Jamp Diltiazem CDJPC.4824.48242023-01-31.4824M-Diltiazem CDMAT.4824.48242024-10-31.48240588240mgLA Cap.6399Cardizem CDVAL2.86042.86041996-10-01.6399Apo-Diltiaz CDAPX.6399.63991997-08-28.6399Teva-Diltazem CDTEV.6399.63992001-06-07.6399Sandoz Diltiazem CDSDZ.6399.63992001-10-11.6399Co Diltiazem CDCOB.6399.63992012-01-19.6399Diltiazem CDSAI.6399.63992022-07-29.6399Diltiazem CDSIV.6399.63992020-07-31.6399Mar-Diltiazem CDMAR.6399.63992020-05-29.6399Jamp Diltiazem CDJPC.6399.63992023-01-31.6399M-Diltiazem CDMAT.6399.63992024-10-31.63990589300mgLA Cap.7999Cardizem CDVAL3.57553.57551996-10-01.7999Apo-Diltiaz CDAPX.7999.79991997-04-10.7999Teva-Diltazem CDTEV.7999.79992001-06-07.7999Sandoz Diltiazem CDSDZ.7999.79992001-10-11.7999Co Diltiazem CDCOB.7999.79992012-01-19.7999Diltiazem CDSAI.7999.79992022-07-29.7999Diltiazem CDSIV.7999.79992020-07-31.7999Mar-Diltiazem CDMAR.7999.79992020-05-29.7999Jamp Diltiazem CDJPC.7999.79992023-01-31.7999M-Diltiazem CDMAT.7999.79992024-10-31.79990590120mgSR Cap.2133TiazacVAL1.22631.22631998-12-31.2133Sandoz Diltiazem TSDZ.2133.21332006-01-24.2133Teva-Diltiazem HCL ERTEV.2133.21332006-03-01.2133Teva-Diltiazem TTEV.2133.21332012-01-19.2133Mar-Diltiazem TMAR.2133.21332018-08-30.2133Jamp Diltiazem TJPC.2133.21332020-11-30.2133Diltiazem TSAI.2133.21332021-12-17.2133M-Diltiazem TMAT.2133.21332024-10-31.21330591180mgSR Cap.2889TiazacVAL1.63831.63831998-12-31.2889Sandoz Diltiazem TSDZ.2889.28892006-01-24.2889Teva-Diltiazem HCL ERTEV.2889.28892006-03-01.2889Teva-Diltiazem TTEV.2889.28892012-01-19.2889Mar-Diltiazem TMAR.2889.28892018-08-30.2889Jamp Diltiazem TJPC.2889.28892020-11-30.2889Diltiazem TSAI.2889.28892021-12-17.2889M-Diltiazem TMAT.2889.28892024-10-31.28890592240mgSR Cap.3832TiazacVAL2.17302.17301998-12-31.3832Sandoz Diltiazem TSDZ.3832.38322006-01-24.3832Teva-Diltiazem HCL ERTEV.3832.38322006-03-01.3832Teva-Diltiazem TTEV.3832.38322012-01-19.3832Mar-Diltiazem TMAR.3832.38322018-08-30.3832Jamp Diltiazem TJPC.3832.38322020-11-30.3832Diltiazem TSAI.3832.38322021-12-17.3832M-Diltiazem TMAT.3832.38322024-10-31.38320593300mgSR Cap.4720TiazacVAL2.72162.72161998-12-31.4720Sandoz Diltiazem TSDZ.4720.47202006-01-24.4720Teva-Diltiazem HCL ERTEV.4720.47202006-03-01.4720Teva-Diltiazem TTEV.4720.47202012-01-19.4720Mar-Diltiazem TMAR.4720.47202018-08-30.4720Jamp Diltiazem TJPC.4720.47202020-11-30.4720Diltiazem TSAI.4720.47202021-12-17.4720M-Diltiazem TMAT.4720.47202024-10-31.47200594360mgSR Cap.5778TiazacVAL3.27663.27661998-12-31.5778Sandoz Diltiazem TSDZ.5778.57782006-01-24.5778Teva-Diltiazem HCL ERTEV.5778.57782006-03-01.5778Teva-Diltiazem TTEV.5778.57782012-01-19.5778Mar-Diltiazem TMAR.5778.57782018-08-30.5778Jamp Diltiazem TJPC.5778.57782020-11-30.5778Diltiazem TSAI.5778.57782021-12-17.5778M-Diltiazem TMAT.5778.57782024-10-31.5778059530mgTabAA-DiltiazAAP.21681996-10-01.2168CardizemBIO1996-10-01059660mgTabAA-DiltiazAAP.38021996-10-01.3802CardizemBIO1996-10-01DISOPYRAMIDE0597100mgCapNorpaceRBT1996-10-01RythmodanCHE.34582004-07-20.34580598100mgCapDisopyramide Phosphate USPDRR1.40002025-07-311.4000FLECAINIDE ACETATE059950mgTabTambocorGRA1996-10-01Apo-FlecainideAPX.13892006-07-19.1389Auro-FlecainideAUR.13892017-11-30.1389Mar-FlecainideMAR.13892021-03-29.1389Jamp FlecainideJPC.13892021-01-29.1389NRA-FlecainideNRA.13892023-07-31.1389FlecainideSAI.13892023-12-29.13890600100mgTabTambocorGRA1996-10-01Apo-FlecainideAPX.27792006-07-19.2779Auro-FlecainideAUR.27792017-11-30.2779Mar-FlecainideMAR.27792021-03-29.2779Jamp FlecainideJPC.27792021-01-29.2779NRA-FlecainideNRA.27792023-07-31.2779FlecainideSAI.27792023-12-29.2779IVABRADINE HCL06015mgTabLancoraSEV.91362018-10-31.913606027.5mgTabLancoraSEV1.67072018-10-311.6707For the treatment of stable chronic heart failure with reduced left ventricular ejection fraction (LVEF) (less than or equal to 35%) in adult patients with New York Heart Association (NYHA) classes II or III who are in sinus rhythm with a resting heart rate greater than or equal to 77 beats per minute (bpm), to reduce the incidence of cardiovascular mortality and hospitalizations for worsening heart failure, administered in combination with standard chronic heart failure therapies if the following are met: - Patients with NYHA class II to III symptoms despite at least four weeks of treatment with a stable dose of an angiotensin converting enzyme inhibitor (ACEI) or an angiotensin II receptor blocker (ARB) in combination with a beta blocker and, if tolerated, a mineralocorticoid receptor antagonist (MRA); AND - Patients with at least one hospitalization due to heart failure in the last year; AND - Resting heart rate must be documented as greater than or equal to 77 bpm on average using either an ECG on at least three separate visits or by continuous monitoring.LU Authorization Period: IndefiniteMETOPROLOL TARTRATE0603100mgLA TabLopresor SRNOV2001-10-11AA-Metoprolol SRAAP.20582007-11-10.20580604200mgLA TabLopresor SRNOV2001-10-11AA-Metoprolol SRAAP.25682007-11-10.2568060550mgTab.1248LopresorNOV1996-10-01BetalocAZC1996-10-01Apo-MetoprololAPX.0624.12481996-10-01.0624Teva-MetoprololTEV.0624.12481996-10-01.0624Apo-Metoprolol (Type L)APX.0624.12481996-10-01.0624Teva-Metoprolol (Uncoated)TEV.0624.12481996-10-01.0624PMS-Metoprolol-LPMS.0624.12481998-12-31.0624MetoprololSAI.0624.12482016-09-29.0624Sandoz Metoprolol (Type L)SDZ.0624.12482011-03-15.0624Jamp-Metoprolol-LJPC.0624.12482011-12-15.0624Metoprolol-LSIV.0624.12482022-06-30.0624AG-Metoprolol-LANG.0624.12482020-11-30.06240606100mgTab.2722LopresorNOV1996-10-01BetalocAZC1996-10-01Apo-MetoprololAPX.1361.27221996-10-01.1361Teva-MetoprololTEV.1361.27221996-10-01.1361Apo-Metoprolol (Type L)APX.1361.27221996-10-01.1361Teva-Metoprolol (Uncoated)TEV.1361.27221996-10-01.1361PMS-Metoprolol-LPMS.1361.27221998-12-31.1361MetoprololSAI.1361.27222016-09-29.1361Sandoz Metoprolol (Type L)SDZ.1361.27222011-03-15.1361Jamp-Metoprolol-LJPC.1361.27222011-12-15.1361Metoprolol-LSIV.1361.27222022-06-30.1361AG-Metoprolol-LANG.1361.27222020-11-30.1361MEXILETINE HCL0607100mgCapMexitilBOE1996-10-01Teva-MexiletineTEV.73461998-12-31.7346Mint-MexiletineMIN.73462024-05-31.73460608200mgCapMexitilBOE1996-10-01Teva-MexiletineTEV.98371998-12-31.9837Mint-MexiletineMIN.98372024-03-28.9837NADOLOL060940mgTab.2375CorgardBQU1996-10-01Apo-NadololAPX.2375.23751996-10-01.2375Mint-NadololMIN.2375.23752020-11-30.2375061080mgTab.6820CorgardBQU1996-10-01Apo-NadololAPX.3410.68201996-10-01.3410Mint-NadololMIN.3410.68202020-11-30.34100611160mgTab1.2046CorgardBQU1996-10-01Apo-NadololAPX1.20461.20461996-10-011.2046NIFEDIPINE06125mgCapNifedipineAAP.36791996-10-01.3679AdalatBAH1996-10-01061310mgCapNifedipineAAP.4877Rapid absorption of liquid nifedipine from pulvules can cause severe hypotension and aggravation of myocardial or cerebral ischemia.1996-10-01.4877AdalatBAHRapid absorption of liquid nifedipine from pulvules can cause severe hypotension and aggravation of myocardial or cerebral ischemia.1996-10-01PROPAFENONE HCL0614150mgTabRythmolABB1.52691996-10-01.6306Apo-PropafenoneAPX.63062001-10-11.6306Mylan-PropafenoneMYL.63062018-01-31.63060615300mgTabRythmolABB2.69151996-10-011.1116Apo-PropafenoneAPX1.11162001-10-111.1116Mylan-PropafenoneMYL1.11162018-01-311.1116PROPRANOLOL061660mgLA CapInderal-LAWAY2023-04-28Lupin-Propranolol LALUP.88132023-04-28061780mgLA CapInderal-LAWAY2023-04-28Lupin-Propranolol LALUP.99502023-04-280618120mgLA CapInderal-LAPFI2023-04-28Lupin-Propranolol LALUP1.53132023-04-280619160mgLA CapInderal-LAWAY2023-04-28Lupin-Propranolol LALUP1.81132023-04-28062010mgTabTeva-PropranololTEV.08131996-10-01.0813InderalWAY1996-10-01062120mgTabTeva-PropranololTEV.11191996-10-01.1119InderalWAY1996-10-01PRZ-PropranololPRZ.11192025-07-31.1119062240mgTab.2478Teva-PropranololTEV.1239.24781996-10-01.1239Inderal-40AYE1996-10-01PRZ-PropranololPRZ.1239.24782025-07-31.1239062380mgTab.4114Teva-PropranololTEV.2057.41141996-10-01.2057InderalWAY1997-02-04PRZ-PropranololPRZ.2057.41142025-07-31.2057SOTALOL HCL062480mgTabSotacorBQU2007-12-19Apo-SotalolAPX.29662007-12-19.2966PMS-SotalolPMS.29662007-12-19.2966Jamp-SotalolJPC.29662012-08-27.29660625160mgTabSotacorBQU1996-10-01Ratio-SotalolRPH.16231996-10-01.1623Apo-SotalolAPX.16231996-10-01.1623Novo-SotalolNOP.16231998-12-31.1623PMS-SotalolPMS.16231999-04-15.1623Co SotalolCOB.16232006-10-23.1623Jamp-SotalolJPC.16232012-08-27.1623TIMOLOL MALEATE06265mgTab.4154BlocadrenFRS1996-10-01TimololAAP.2077.41541996-10-01.2077062710mgTab.6478BlocadrenFRS1996-10-01TimololAAP.3239.64781996-10-01.3239062820mgTab1.2608BlocadrenFRS1996-10-01TimololAAP.63041.26081996-10-01.6304VERAPAMIL HCL062980mgTab.8205IsoptinABB1996-10-01AA-VerapAAP.2735.82051996-10-01.2735Mylan-VerapamilMYL.2735.82051999-04-15.27350630120mgTab1.2750IsoptinABB1996-10-01AA-VerapAAP.42501.27501996-10-01.4250Mylan-VerapamilMYL.42501.27501999-04-15.4250ANTILIPEMIC DRUGSAMLODIPINE BESYLATE & ATORVASTATIN CALCIUM06315mg & 10mgTabCaduetUJC2.8536Note: Patients should be stabilized on a statin or a calcium channel blocker before being initiated on Amlodipine Besylate & Atrovastatin Calcium.2006-10-231.1603Gd-Amlodipine/AtorvastatinUJC1.1603Note: Patients should be stabilized on a statin or a calcium channel blocker before being initiated on Amlodipine Besylate & Atrovastatin Calcium.2011-10-251.1603Apo-Amlodipine-AtorvastatinAPX1.1603Note: Patients should be stabilized on a statin or a calcium channel blocker before being initiated on Amlodipine Besylate & Atrovastatin Calcium.2013-11-281.160306325mg & 20mgTabCaduetUJC3.3651Note: Patients should be stabilized on a statin or a calcium channel blocker before being initiated on Amlodipine Besylate & Atrovastatin Calcium.2006-10-231.3683Gd-Amlodipine/AtorvastatinUJC1.3683Note: Patients should be stabilized on a statin or a calcium channel blocker before being initiated on Amlodipine Besylate & Atrovastatin Calcium.2011-10-251.3683Apo-Amlodipine-AtorvastatinAPX1.3683Note: Patients should be stabilized on a statin or a calcium channel blocker before being initiated on Amlodipine Besylate & Atrovastatin Calcium.2013-11-281.368306335mg & 40mgTabCaduetUJC3.5570Note: Patients should be stabilized on a statin or a calcium channel blocker before being initiated on Amlodipine Besylate & Atrovastatin Calcium.2006-10-23.7232Gd-Amlodipine/AtorvastatinUJC.7232Note: Patients should be stabilized on a statin or a calcium channel blocker before being initiated on Amlodipine Besylate & Atrovastatin Calcium.2011-10-25.7232Apo-Amlodipine-AtorvastatinAPX.7232Note: Patients should be stabilized on a statin or a calcium channel blocker before being initiated on Amlodipine Besylate & Atrovastatin Calcium.2013-11-28.723206345mg & 80mgTabCaduetUJC3.5570Note: Patients should be stabilized on a statin or a calcium channel blocker before being initiated on Amlodipine Besylate & Atrovastatin Calcium.2006-10-23.7232Gd-Amlodipine/AtorvastatinUJC.7232Note: Patients should be stabilized on a statin or a calcium channel blocker before being initiated on Amlodipine Besylate & Atrovastatin Calcium.2011-10-25.7232Apo-Amlodipine-AtorvastatinAPX.7232Note: Patients should be stabilized on a statin or a calcium channel blocker before being initiated on Amlodipine Besylate & Atrovastatin Calcium.2013-11-28.7232063510mg & 10mgTabCaduetUJC3.0128Note: Patients should be stabilized on a statin or a calcium channel blocker before being initiated on Amlodipine Besylate & Atrovastatin Calcium.2006-10-231.2250Gd-Amlodipine/AtorvastatinUJC1.2250Note: Patients should be stabilized on a statin or a calcium channel blocker before being initiated on Amlodipine Besylate & Atrovastatin Calcium.2011-10-251.2250Apo-Amlodipine-AtorvastatinAPX1.2250Note: Patients should be stabilized on a statin or a calcium channel blocker before being initiated on Amlodipine Besylate & Atrovastatin Calcium.2013-11-281.2250063610mg & 20mgTabCaduetUJC3.7560Note: Patients should be stabilized on a statin or a calcium channel blocker before being initiated on Amlodipine Besylate & Atrovastatin Calcium.2006-10-231.5272Gd-Amlodipine/AtorvastatinUJC1.5272Note: Patients should be stabilized on a statin or a calcium channel blocker before being initiated on Amlodipine Besylate & Atrovastatin Calcium.2011-10-251.5272Apo-Amlodipine-AtorvastatinAPX1.5272Note: Patients should be stabilized on a statin or a calcium channel blocker before being initiated on Amlodipine Besylate & Atrovastatin Calcium.2013-11-281.5272063710mg & 40mgTabCaduetUJC3.9351Note: Patients should be stabilized on a statin or a calcium channel blocker before being initiated on Amlodipine Besylate & Atrovastatin Calcium.2006-10-23.8000Gd-Amlodipine/AtorvastatinUJC.8000Note: Patients should be stabilized on a statin or a calcium channel blocker before being initiated on Amlodipine Besylate & Atrovastatin Calcium.2011-10-25.8000Apo-Amlodipine-AtorvastatinAPX.8000Note: Patients should be stabilized on a statin or a calcium channel blocker before being initiated on Amlodipine Besylate & Atrovastatin Calcium.2013-11-28.8000063810mg & 80mgTabCaduetUJC3.9351Note: Patients should be stabilized on a statin or a calcium channel blocker before being initiated on Amlodipine Besylate & Atrovastatin Calcium.2006-10-23.8000Gd-Amlodipine/AtorvastatinUJC.8000Note: Patients should be stabilized on a statin or a calcium channel blocker before being initiated on Amlodipine Besylate & Atrovastatin Calcium.2011-10-25.8000Apo-Amlodipine-AtorvastatinAPX.8000Note: Patients should be stabilized on a statin or a calcium channel blocker before being initiated on Amlodipine Besylate & Atrovastatin Calcium.2013-11-28.8000ATORVASTATIN CALCIUM063910mgTabLipitorUJC2.18641997-08-28.1743Apo-AtorvastatinAPX.17432010-06-18.1743Teva-AtorvastatinTEV.17432010-06-18.1743Taro-AtorvastatinSPC.17432010-06-18.1743Sandoz AtorvastatinSDZ.17432010-07-20.1743AtorvastatinSAI.17432011-12-15.1743Ratio-AtorvastatinRPH.17432010-06-18.1743Jamp-AtorvastatinJPC.17432012-12-21.1743Mylan-AtorvastatinMYL.17432014-07-30.1743Auro-AtorvastatinAUR.17432013-09-27.1743Atorvastatin-10SIV.17432020-06-30.1743Reddy-AtorvastatinDRR.17432015-10-29.1743Mar-AtorvastatinMAR.17432016-10-27.1743Ach-Atorvastatin CalciumACH.17432019-12-20.1743M-AtorvastatinMAT.17432021-09-30.1743AtorvastatinRIA.17432021-08-31.1743NRA-AtorvastatinNRA.17432020-09-30.1743PMS-AtorvastatinPMS.17432020-06-30.1743AG-AtorvastatinANG.17432020-11-30.1743Mint-AtorvastatinMIN.17432020-04-30.1743Jamp Atorvastatin CalciumJPC.17432022-02-28.1743PMSC-AtorvastatinPMS.17432022-05-31.1743PRZ-AtorvastatinPRZ.17432022-11-30.1743AtorvastatinTEV.17432026-03-31.1743064020mgTabLipitorUJC2.73291997-08-28.2179Apo-AtorvastatinAPX.21792010-06-18.2179Teva-AtorvastatinTEV.21792010-06-18.2179Taro-AtorvastatinSPC.21792010-06-18.2179Sandoz AtorvastatinSDZ.21792010-07-20.2179AtorvastatinSAI.21792011-12-15.2179Ratio-AtorvastatinRPH.21792010-06-18.2179Jamp-AtorvastatinJPC.21792012-12-21.2179Mylan-AtorvastatinMYL.21792014-07-30.2179Auro-AtorvastatinAUR.21792013-09-27.2179Atorvastatin-20SIV.21792020-06-30.2179Reddy-AtorvastatinDRR.21792015-10-29.2179Mar-AtorvastatinMAR.21792016-10-27.2179Ach-Atorvastatin CalciumACH.21792019-12-20.2179M-AtorvastatinMAT.21792021-09-30.2179AtorvastatinRIA.21792021-08-31.2179NRA-AtorvastatinNRA.21792020-09-30.2179PMS-AtorvastatinPMS.21792020-06-30.2179AG-AtorvastatinANG.21792020-11-30.2179Mint-AtorvastatinMIN.21792020-04-30.2179Jamp Atorvastatin CalciumJPC.21792022-02-28.2179PMSC-AtorvastatinPMS.21792022-05-31.2179PRZ-AtorvastatinPRZ.21792022-11-30.2179AtorvastatinTEV.21792026-03-31.2179064140mgTabLipitorUJC2.93791997-08-28.2342Apo-AtorvastatinAPX.23422010-06-18.2342Teva-AtorvastatinTEV.23422010-06-18.2342Taro-AtorvastatinSPC.23422010-06-18.2342Sandoz AtorvastatinSDZ.23422010-07-20.2342AtorvastatinSAI.23422011-12-15.2342Ratio-AtorvastatinRPH.23422010-06-18.2342Jamp-AtorvastatinJPC.23422012-12-21.2342Mylan-AtorvastatinMYL.23422014-07-30.2342Auro-AtorvastatinAUR.23422013-09-27.2342Atorvastatin-40SIV.23422020-06-30.2342Reddy-AtorvastatinDRR.23422015-10-29.2342Mar-AtorvastatinMAR.23422016-10-27.2342Ach-Atorvastatin CalciumACH.23422019-12-20.2342M-AtorvastatinMAT.23422021-09-30.2342AtorvastatinRIA.23422021-08-31.2342NRA-AtorvastatinNRA.23422020-09-30.2342PMS-AtorvastatinPMS.23422020-06-30.2342AG-AtorvastatinANG.23422020-11-30.2342Mint-AtorvastatinMIN.23422020-04-30.2342Jamp Atorvastatin CalciumJPC.23422022-02-28.2342PMSC-AtorvastatinPMS.23422022-05-31.2342PRZ-AtorvastatinPRZ.23422022-11-30.2342AtorvastatinTEV.23422026-03-31.2342064280mgTabLipitorUJC2.93792002-04-04.2342Apo-AtorvastatinAPX.23422010-06-18.2342Teva-AtorvastatinTEV.23422010-06-18.2342Taro-AtorvastatinSPC.23422010-06-18.2342Sandoz AtorvastatinSDZ.23422010-07-20.2342AtorvastatinSAI.23422011-12-15.2342Ratio-AtorvastatinRPH.23422010-06-18.2342Jamp-AtorvastatinJPC.23422012-12-21.2342Mylan-AtorvastatinMYL.23422014-07-30.2342Auro-AtorvastatinAUR.23422013-09-27.2342Atorvastatin-80SIV.23422020-06-30.2342Reddy-AtorvastatinDRR.23422015-10-29.2342Mar-AtorvastatinMAR.23422016-10-27.2342Ach-Atorvastatin CalciumACH.23422019-12-20.2342M-AtorvastatinMAT.23422021-09-30.2342AtorvastatinRIA.23422021-08-31.2342NRA-AtorvastatinNRA.23422020-09-30.2342AG-AtorvastatinANG.23422020-11-30.2342Mint-AtorvastatinMIN.23422024-02-29.2342Jamp Atorvastatin CalciumJPC.23422022-02-28.2342PMSC-AtorvastatinPMS.23422021-12-17.2342PRZ-AtorvastatinPRZ.23422022-11-30.2342BEZAFIBRATE0643400mgSR TabBezalipALL3.08971996-10-011.7460Jamp-Bezafibrate SRJPC1.74602016-08-301.7460CHOLESTYRAMINE RESIN0644Oral Pd-Pouch PkQuestran Light 4g PkBQU2004-07-20Olestyr 4g/9g PkPMS.92171997-04-10.9217Cholestyramine-Odan 4g/sachetODN.92172017-03-28.9217Jamp-Cholestyramine 4g/SachetJPC.92172019-09-30.9217CLOFIBRATE0645500mgCapAtromid-SAYE1996-10-01Novo-FibrateNOP1996-10-01COLESEVELAM HYDROCHLORIDE0646625mgTabColesevelam Hydrochloride is indicated for the reduction of cholesterol blood level in patients with hypercholesterolemia (Frederickson Type IIa) as an adjunct to diet and lifestyle changes, when the response to these measures has been inadequate, in patients: . who are not adequately controlled with an HMG-CoA reductase inhibitor (statin) alone, or . who are unable to tolerate a statin.LodalisVAL1.41842014-05-29.5931Apo-ColesevelamAPX.59312022-01-31.59310647625mgTabColesevelam Hydrochloride is indicated for the reduction of cholesterol blood level in patients with hypercholesterolemia (Frederickson Type IIa) as an adjunct to diet and lifestyle changes, when the response to these measures has been inadequate, in patients: . who are not adequately controlled with an HMG-CoA reductase inhibitor (statin) alone, or . who are unable to tolerate a statin.ColesevelamGLP.59312024-04-30.5931COLESTIPOL HCLCombining psyllium with Colestid therapy improves the efficacy, and decreases costs, of antilipemic treatment.0648Gran-5g PkColestid RegularPFI1.45951996-10-011.4595EVOLOCUMAB0649140mg/mLInj Sol-Pref Syr AutoinjRepathaAMG291.66502018-04-30291.6650For the treatment of Heterozygous Familial Hypercholesterolemia (HeFH) in patients 18 years of age or older who meet the following criteria: - Definite or probable diagnosis of HeFH using the Simon Broome or Dutch Lipid Network criteria or genetic testing; AND - Unable to reach Low Density Lipoprotein Cholesterol (LDL-C) target (i.e., LDL-C less than 2.0 mmol/L for secondary prevention) or at least a 50% reduction in LDL-C from untreated baseline despite: A. Confirmed adherence to high dose statin (e.g., atorvastatin 80mg or rosuvastatin 40mg) in combination with ezetimibe for at least a total of 3 months; OR B. Confirmed adherence to ezetimibe for at least a total of 3 months and inability to tolerate high dose statin defined as: (i). Inability to tolerate at least 2 statins with at least one started at the lowest starting dose; AND (ii). For each statin (two statins in total), dose reduction is attempted for intolerable symptom (myopathy) or biomarker abnormality (creatine kinase (CK) greater than 5 times the upper limit of normal) resolution rather than discontinuation of statin altogether; AND (iii). For each statin (two statins in total), intolerable symptoms (myopathy) or abnormal biomarker (creatine kinase (CK) greater than 5 times the upper limit of normal) changes are reversible upon statin discontinuation but reproducible by re-challenge of statins where clinically appropriate; AND (iv). One of the following: I) Other known determinants of intolerable symptoms or abnormal biomarkers have been ruled out; OR II) Patient developed confirmed and documented rhabdomyolysis; OR III) Patient is statin contraindicated i.e. active liver disease, unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal Treatment with Repatha should be discontinued if the patient does not meet all of the following: 1. Patient is adherent to therapy. 2. Patient has achieved a reduction in LDL-C of at least 40% from baseline (4-8 weeks after initiation of Repatha). 3. Patient continues to have a significant reduction in LDL-C (with continuation of Repatha) of at least 40% from baseline since initiation of PCSK9 inhibitor. LDL-C should be checked periodically with continued treatment with PCSK9 inhibitors (e.g., every 6 months). Patients prescribed Repatha 140mg every two weeks are limited to 26 prefilled syringes (PFS) per year.LU Authorization Period: 1 yearTo reduce elevated low-density lipoprotein cholesterol (LDL-C) in adult patients with atherosclerotic cardiovascular disease (ASCVD) when all of the following criteria apply: 1. Patient is aged 18 years or older; AND 2. Patient has experienced a recent acute coronary syndrome (ACS) event, defined as those who have been hospitalized for a heart attack or unstable angina in the past 52 weeks; AND 3. Patient is unable to meet cholesterol targets, defined as having an LDL-C level 1.8mmol/L or greater, OR a non-HDL-C level 2.6mmol/L or greater, OR an Apo-B level 0.7g/L or greater, despite taking maximally tolerated dose of statins*; AND *Maximally tolerated dose of statins includes one moderate-to-high intensity statin (i.e., at least atorvastatin 20mg daily or equivalent) for at least 4 weeks before treatment OR documented intolerance to at least 2 statins OR contraindication to statin therapy. 4. Patient has received an adequate trial (i.e., at least 4 weeks) of ezetimibe** if only modest reductions in cholesterol targets are required (i.e., those with an LDL-C level of 1.8mmol/L to less than or equal to 2.2mmol/L, OR a non-HDL-C level of 2.6mmol/L to less than or equal to 2.9mmol/L, OR an Apo-B level of 0.7g/L to less than or equal to 0.8g/L) despite taking a maximally tolerated statin dose; AND **For clarity, an adequate trial of ezetimibe is not required for patients with an LDL-C level greater than 2.2mmol/L, a non-HDL-C level greater than 2.9mmol/L, or an Apo-B level greater than 0.8g/L, despite taking a maximally tolerated statin dose. 5. Prescribed by a healthcare practitioner with expertise managing patients in the post-ACS setting; AND 6. Is not being used in combination with other proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors. Treatment with Repatha should be discontinued if the patient does not meet all of the following: 1. Patient is adherent to therapy. 2. Patient has achieved a reduction in cholesterol parameters (i.e., LDL-C, and/or non-HDL-C and/or Apo-B) from baseline deemed clinically appropriate by the treating prescriber. Approved dose: 140mg every 2 weeks. Patients prescribed Repatha 140mg every two weeks are limited to 26 prefilled syringes (PFS) per year.LU Authorization Period: IndefiniteEZETIMIBE065010mgTabEzetrolOCI2.25082004-04-06.1811Teva-EzetimibeTEV.18112014-11-27.1811Act EzetimibeACV.18112014-11-27.1811PMS-EzetimibePMS.18112014-11-27.1811Sandoz EzetimibeSDZ.18112014-11-27.1811Ran-EzetimibeRAN.18112014-11-27.1811Mar-EzetimibeMAR.18112014-11-27.1811Jamp-EzetimibeJPC.18112014-11-27.1811Mint-EzetimibeMIN.18112014-11-27.1811Ach-EzetimibeACH.18112014-11-27.1811Apo-EzetimibeAPX.18112014-11-27.1811EzetimibeSIV.18112020-11-30.1811EzetimibeSAI.18112020-05-29.1811GLN-EzetimibeGLP.18112020-12-18.1811M-EzetimibeMAT.18112021-10-29.1811Auro-EzetimibeAUR.18112018-07-31.1811AG-EzetimibeANG.18112020-10-30.1811NRA-EzetimibeNRA.18112020-06-30.1811NRA-Ezetimibe TabletsNRA.18112024-04-30.1811For use in combination with a HMG-CoA reductase inhibitor ('statin') in patients with hypercholesterolemia who have not reached target LDL levels despite the use of maximally tolerated doses.LU Authorization Period: IndefiniteFor use as monotherapy in the management of hypercholesterolemia in patients who are intolerant to HMG-CoA reductase inhibitors or where HMG-CoA reductase inhibitors are contraindicated.LU Authorization Period: IndefiniteFENOFIBRATE0651100mgCapLipidilJOU1996-10-01Apo-FenofibrateAPX.61051996-12-19.6105065267mgCapLipidil MicroFOU2008-01-15AA-Feno-MicroAAP.60252008-01-150653200mgCapLipidil MicroSPH1996-10-01AA-Feno-MicroAAP.92572000-01-17.92570654100mgTabLipidil SupraLAF2008-11-04AA-Feno-SuperAAP.98832008-12-03Sandoz Fenofibrate SSDZ.78742009-08-180655160mgTabLipidil SupraBGP1.48322001-06-071.0022AA-Feno-SuperAAP1.00222006-06-141.0022065648mgTabLipidil EZFOU.50962006-10-23.3560Sandoz Fenofibrate ESDZ.35602013-03-20.35600657145mgTabLipidil EZFOU1.30482006-10-23.5489Sandoz Fenofibrate ESDZ.54892012-10-30.5489Taro-Fenofibrate ESPC.54892021-01-29.5489FLUVASTATIN SODIUM065820mgCapLescolNOV1996-10-01Teva-FluvastatinTEV.68822013-02-28.6882065940mgCapLescolNOV1996-10-01Teva-FluvastatinTEV.96712013-02-28.9671066080mgER TabLescol XLNOV1.62252005-02-221.6225GEMFIBROZIL0661300mgCapLopidPFI1996-10-01Apo-GemfibrozilAPX.13401996-10-01.1340Teva-GemfibrozilTEV.13402001-06-07.13400662600mgTabLopidPFI2008-02-12Apo-GemfibrozilAPX.75202008-02-12Teva-GemfibrozilTEV1.39822008-02-12LOVASTATIN066320mgTabMevacorMFC1996-10-01LovastatinAAP1.19311997-08-281.1931066440mgTabMevacorMFC1996-10-01LovastatinAAP2.17931997-08-282.1793PRAVASTATIN SODIUM066510mgTabPravacholBQU1996-10-01Apo-PravastatinAPX.29162001-06-07.2916Ratio-PravastatinRPH.29162003-09-04.2916Teva-PravastatinTEV.29162003-09-04.2916PMS-PravastatinPMS.29162004-04-06.2916Co PravastatinCOB.29162004-04-06.2916Ran-PravastatinRAN.29162007-09-04.2916Mint-PravastatinMIN.29162010-04-23.2916Jamp-PravastatinJPC.29162010-04-23.2916PravastatinSAI.29162020-10-30.2916PravastatinSIV.29162020-12-18.2916Mar-PravastatinMAR.29162018-08-30.2916Ach-PravastatinACH.29162020-04-30.2916Auro-PravastatinAUR.29162018-07-31.2916Sandoz Pravastatin TabletsSDZ.29162018-08-30.2916AG-PravastatinANG.29162020-12-18.2916M-PravastatinMAT.29162021-10-29.2916NRA-PravastatinNRA.29162026-01-30.2916066620mgTabPravacholBQU1996-10-01Apo-PravastatinAPX.34402001-06-07.3440Ratio-PravastatinRPH.34402003-09-04.3440Teva-PravastatinTEV.34402003-09-04.3440PMS-PravastatinPMS.34402004-04-06.3440Co PravastatinCOB.34402004-04-06.3440Ran-PravastatinRAN.34402007-09-04.3440Mint-PravastatinMIN.34402010-04-23.3440Jamp-PravastatinJPC.34402010-04-23.3440PravastatinSAI.34402020-10-30.3440PravastatinSIV.34402020-12-18.3440Mar-PravastatinMAR.34402018-08-30.3440Ach-PravastatinACH.34402020-04-30.3440Auro-PravastatinAUR.34402018-07-31.3440Sandoz Pravastatin TabletsSDZ.34402018-08-30.3440AG-PravastatinANG.34402020-12-18.3440M-PravastatinMAT.34402021-10-29.3440NRA-PravastatinNRA.34402026-01-30.3440066740mgTabPravacholBQU1997-08-28Apo-PravastatinAPX.41432001-06-07.4143Ratio-PravastatinRPH.41432003-09-04.4143Teva-PravastatinTEV.41432003-09-04.4143PMS-PravastatinPMS.41432004-04-06.4143Co PravastatinCOB.41432004-04-06.4143Ran-PravastatinRAN.41432007-09-04.4143Mint-PravastatinMIN.41432010-04-23.4143Jamp-PravastatinJPC.41432010-04-23.4143PravastatinSAI.41432020-10-30.4143PravastatinSIV.41432020-12-18.4143Mar-PravastatinMAR.41432018-08-30.4143Ach-PravastatinACH.41432020-04-30.4143Auro-PravastatinAUR.41432018-07-31.4143Sandoz Pravastatin TabletsSDZ.41432018-08-30.4143AG-PravastatinANG.41432020-12-18.4143M-PravastatinMAT.41432021-10-29.4143NRA-PravastatinNRA.41432026-01-30.4143ROSUVASTATIN CALCIUM06685mgTabCrestorAZC1.51772007-01-02.1284Apo-RosuvastatinAPX.12842012-05-29.1284Sandoz RosuvastatinSDZ.12842012-05-29.1284Co RosuvastatinCOB.12842012-05-29.1284Teva-RosuvastatinTEV.12842012-05-29.1284PMS-RosuvastatinPMS.12842012-05-29.1284Taro-RosuvastatinSPC.12842012-05-29.1284Jamp-RosuvastatinJPC.12842012-12-21.1284Mint-RosuvastatinMIN.12842013-08-29.1284Med-RosuvastatinGMP.12842014-01-30.1284RosuvastatinSAI.12842016-05-31.1284RosuvastatinSIV.12842020-06-30.1284Mar-RosuvastatinMAR.12842014-04-01.1284Ach-RosuvastatinACH.12842019-07-31.1284Auro-RosuvastatinAUR.12842016-04-01.1284NRA-RosuvastatinNRA.12842020-09-30.1284M-RosuvastatinMAT.12842021-10-29.1284Jamp Rosuvastatin CalciumJPC.12842021-04-30.1284PRZ-RosuvastatinPRZ.12842022-01-31.1284NRA-Rosuvastatin TabletsNRA.12842024-01-31.1284066910mgTabCrestorAZC1.61172003-09-04.1354Apo-RosuvastatinAPX.13542012-05-29.1354Sandoz RosuvastatinSDZ.13542012-05-29.1354Co RosuvastatinCOB.13542012-05-29.1354Teva-RosuvastatinTEV.13542012-05-29.1354PMS-RosuvastatinPMS.13542012-05-29.1354Taro-RosuvastatinSPC.13542012-05-29.1354Jamp-RosuvastatinJPC.13542012-12-21.1354Mint-RosuvastatinMIN.13542013-08-29.1354Med-RosuvastatinGMP.13542014-01-30.1354RosuvastatinSAI.13542016-05-31.1354RosuvastatinSIV.13542020-06-30.1354Mar-RosuvastatinMAR.13542014-04-01.1354Ach-RosuvastatinACH.13542019-07-31.1354Auro-RosuvastatinAUR.13542016-04-01.1354NRA-RosuvastatinNRA.13542020-09-30.1354M-RosuvastatinMAT.13542021-10-29.1354Jamp Rosuvastatin CalciumJPC.13542021-04-30.1354PRZ-RosuvastatinPRZ.13542022-01-31.1354NRA-Rosuvastatin TabletsNRA.13542024-01-31.1354067020mgTabCrestorAZC2.00572003-09-04.1692Apo-RosuvastatinAPX.16922012-05-29.1692Sandoz RosuvastatinSDZ.16922012-05-29.1692Co RosuvastatinCOB.16922012-05-29.1692Teva-RosuvastatinTEV.16922012-05-29.1692PMS-RosuvastatinPMS.16922012-05-29.1692Taro-RosuvastatinSPC.16922012-05-29.1692Jamp-RosuvastatinJPC.16922012-12-21.1692Mint-RosuvastatinMIN.16922013-08-29.1692Med-RosuvastatinGMP.16922014-01-30.1692RosuvastatinSAI.16922016-05-31.1692RosuvastatinSIV.16922020-06-30.1692Mar-RosuvastatinMAR.16922014-04-01.1692Ach-RosuvastatinACH.16922019-07-31.1692Auro-RosuvastatinAUR.16922016-04-01.1692NRA-RosuvastatinNRA.16922020-09-30.1692M-RosuvastatinMAT.16922021-10-29.1692Jamp Rosuvastatin CalciumJPC.16922021-04-30.1692PRZ-RosuvastatinPRZ.16922022-01-31.1692NRA-Rosuvastatin TabletsNRA.16922024-01-31.1692067140mgTabCrestorAZC2.35432003-09-04.1990Apo-RosuvastatinAPX.19902012-05-29.1990Sandoz RosuvastatinSDZ.19902012-05-29.1990Co RosuvastatinCOB.19902012-05-29.1990Teva-RosuvastatinTEV.19902012-05-29.1990PMS-RosuvastatinPMS.19902012-05-29.1990Taro-RosuvastatinSPC.19902012-05-29.1990Jamp-RosuvastatinJPC.19902012-12-21.1990Mint-RosuvastatinMIN.19902013-08-29.1990Med-RosuvastatinGMP.19902014-01-30.1990RosuvastatinSAI.19902016-05-31.1990RosuvastatinSIV.19902020-06-30.1990Mar-RosuvastatinMAR.19902014-04-01.1990Ach-RosuvastatinACH.19902019-07-31.1990Auro-RosuvastatinAUR.19902016-04-01.1990NRA-RosuvastatinNRA.19902021-04-30.1990M-RosuvastatinMAT.19902021-10-29.1990Jamp Rosuvastatin CalciumJPC.19902021-04-30.1990PRZ-RosuvastatinPRZ.19902022-01-31.1990NRA-Rosuvastatin TabletsNRA.19902024-01-31.1990SIMVASTATIN06725mgTabZocorMFC1996-10-01Apo-SimvastatinAPX.10232003-04-16.1023Co SimvastatinCOB.10232004-04-06.1023Teva-SimvastatinTEV.10232004-07-20.1023SimvastatinSAI.10232011-08-04.1023Ran-SimvastatinRAN.10232009-11-13.1023Mint-SimvastatinMIN.10232011-12-15.1023Mar-SimvastatinMAR.10232012-01-19.1023Jamp-SimvastatinJPC.10232012-08-27.1023SimvastatinSIV.10232022-07-29.1023Auro-SimvastatinAUR.10232013-09-27.1023Pharma-SimvastatinPMS.10232018-07-31.1023AG-SimvastatinANG.10232020-11-30.1023PMSC-SimvastatinPMS.10232025-07-31.1023067310mgTabZocorOCI2.81901996-10-01.2023Apo-SimvastatinAPX.20232003-04-16.2023Co SimvastatinCOB.20232004-04-06.2023Teva-SimvastatinTEV.20232004-07-20.2023Taro-SimvastatinTAR2005-10-06SimvastatinSAI.20232011-08-04.2023Ran-SimvastatinRAN.20232009-11-13.2023Mint-SimvastatinMIN.20232011-12-15.2023Mar-SimvastatinMAR.20232012-01-19.2023Jamp-SimvastatinJPC.20232012-08-27.2023SimvastatinSIV.20232022-07-29.2023Auro-SimvastatinAUR.20232013-09-27.2023Pharma-SimvastatinPMS.20232018-04-30.2023AG-SimvastatinANG.20232020-11-30.2023PMSC-SimvastatinPMS.20232025-07-31.2023067420mgTabZocorOCI3.48411996-10-01.2501Apo-SimvastatinAPX.25012003-04-16.2501Co SimvastatinCOB.25012004-04-06.2501Teva-SimvastatinTEV.25012004-07-20.2501Taro-SimvastatinTAR2005-10-06SimvastatinSAI.25012011-08-04.2501Ran-SimvastatinRAN.25012009-11-13.2501Mint-SimvastatinMIN.25012011-12-15.2501Mar-SimvastatinMAR.25012012-01-19.2501Jamp-SimvastatinJPC.25012012-08-27.2501SimvastatinSIV.25012022-07-29.2501Auro-SimvastatinAUR.25012013-09-27.2501Pharma-SimvastatinPMS.25012018-05-31.2501AG-SimvastatinANG.25012020-11-30.2501PMSC-SimvastatinPMS.25012025-07-31.2501067540mgTabZocorOCI3.48411996-12-19.2501Apo-SimvastatinAPX.25012003-04-16.2501Co SimvastatinCOB.25012004-04-06.2501Teva-SimvastatinTEV.25012004-07-20.2501Taro-SimvastatinTAR2005-10-06SimvastatinSAI.25012011-08-04.2501Ran-SimvastatinRAN.25012009-11-13.2501Mint-SimvastatinMIN.25012011-12-15.2501Mar-SimvastatinMAR.25012012-01-19.2501Jamp-SimvastatinJPC.25012012-08-27.2501SimvastatinSIV.25012022-07-29.2501Auro-SimvastatinAUR.25012013-09-27.2501Pharma-SimvastatinPMS.25012018-05-31.2501AG-SimvastatinANG.25012020-11-30.2501PMSC-SimvastatinPMS.25012025-07-31.2501067680mgTabZocorMFC2000-04-17Apo-SimvastatinAPX.25012003-04-16.2501Co SimvastatinCOB.25012004-04-06.2501Teva-SimvastatinTEV.25012004-07-20.2501SimvastatinSAI.25012011-08-04.2501Ran-SimvastatinRAN.25012009-11-13.2501Mint-SimvastatinMIN.25012011-12-15.2501Mar-SimvastatinMAR.25012012-01-19.2501Jamp-SimvastatinJPC.25012012-08-27.2501SimvastatinSIV.25012022-07-29.2501Auro-SimvastatinAUR.25012013-09-27.2501Pharma-SimvastatinPMS.25012018-07-31.2501AG-SimvastatinANG.25012020-11-30.2501PMSC-SimvastatinPMS.25012025-07-31.2501ANTILIPEMIC DRUGS PCSK9 INHIBITORSALIROCUMAB067775mg/mLInj Sol-Pref PenPraluentSAC267.83002019-03-28267.83000678150mg/mLInj Sol-Pref PenPraluentSAC267.83002019-03-28267.83000679300mg/2mLInj Sol-Pref Pen 2mL Pk (Preservative-Free)PraluentSAC535.66002024-11-29535.6600For the treatment of Heterozygous Familial Hypercholesterolemia (HeFH) in patients 18 years of age or older who meet the following criteria: 1. Definite or probable diagnosis of HeFH using the Simon Broome or Dutch Lipid Network criteria or genetic testing; AND 2. Unable to reach Low Density Lipoprotein Cholesterol (LDL-C) target (i.e., LDL-C less than 2.0 mmol/L for secondary prevention) or at least a 50% reduction in LDL-C from untreated baseline for primary prevention despite: A) Confirmed adherence to ezetimibe for at least a total of 3 months in combination with high dose statin (e.g., atorvastatin 80mg or rosuvastatin 40mg); OR B) Confirmed adherence to ezetimibe for at least a total of 3 months and inability to tolerate high dose statin defined as: (i) Inability to tolerate at least 2 statins with at least one started at the lowest starting dose; (ii) For each statin (two statins in total), dose reduction is attempted for intolerable symptom (myopathy) or biomarker abnormality (creatine kinase (CK) greater than 5 times the upper limit of normal) resolution rather than discontinuation of statin altogether; (iii) For each statin (two statins in total), intolerable symptoms (myopathy) or abnormal biomarker (creatine kinase (CK) greater than 5 times the upper limit of normal) changes are reversible upon statin discontinuation but reproducible by re-challenge of statins where clinically appropriate; and (iv) One of the following: (I.) Other known determinants of intolerable symptoms or abnormal biomarkers have been ruled out; (II.) Patient developed confirmed and documented rhabdomyolysis; (III.) Patient is statin contraindicated i.e. active liver disease, unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal. Treatment with alirocumab should be discontinued if the patient does not meet all of the following: 1. Patient is adherent to therapy. 2. Patient has achieved a reduction in LDL-C of at least 40% from baseline (4-8 weeks after initiation of alirocumab). 3. Patient continues to have a significant reduction in LDL-C (with continuation of alirocumab) of at least 40% from baseline since initiation of PCSK9 inhibitor. LDL-C should be checked periodically with continued treatment with PCSK9 inhibitors (e.g., every 6 months). Patients prescribed alirocumab 75mg every two weeks must use the 75mg/mL dosage strength and are limited to 26 pre-filled pens (PFP) per year. Patients prescribed alirocumab 150mg every two weeks must use the 150mg/mL dosage strength and are limited to 26 PFP per year. Patients prescribed alirocumab 300mg every four weeks may use either the 150mg/mL dosage strength (limited to 26 PFP per year) or the 300mg/2mL dosage strength (limited to 13 PFP per year).LU Authorization Period: 1 yearANTILIPEMIC DRUGS MISCELLANEOUS ANTILIPEMIC AGENTSINCLISIRAN0680284mg/1.5mLInj Sol-1.5mL Pref SyrLeqvioNOV2839.28002025-10-312839.2800For the treatment of Heterozygous Familial Hypercholesterolemia (HeFH) in patients 18 years of age or older who meet the following criteria: 1. Definite or probable diagnosis of HeFH using the Simon Broome or Dutch Lipid Network criteria or genetic testing; AND 2. Unable to reach Low Density Lipoprotein Cholesterol (LDL-C) target (i.e., LDL-C less than 2.0 mmol/L for secondary prevention) or at least a 50% reduction in LDL-C from untreated baseline for primary prevention despite: A) Confirmed adherence to ezetimibe for at least a total of 3 months in combination with high dose statin (e.g., atorvastatin 80mg or rosuvastatin 40mg); OR B) Confirmed adherence to ezetimibe for at least a total of 3 months and inability to tolerate high dose statin defined as: (i) Inability to tolerate at least 2 statins with at least one started at the lowest starting dose; AND (ii) For each statin (two statins in total), dose reduction is attempted for intolerable symptom (myopathy) or biomarker abnormality (creatine kinase (CK) greater than 5 times the upper limit of normal) resolution rather than discontinuation of statin altogether; AND (iii) For each statin (two statins in total), intolerable symptoms (myopathy) or abnormal biomarker (creatine kinase (CK) greater than 5 times the upper limit of normal) changes are reversible upon statin discontinuation but reproducible by re-challenge of statins where clinically appropriate; AND (iv) One of the following: (I.) Other known determinants of intolerable symptoms or abnormal biomarkers have been ruled out; (II.) Patient developed confirmed and documented rhabdomyolysis; (III.) Patient is statin contraindicated i.e. active liver disease, unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal. Inclisiran will not be funded when used in combination with proprotein convertase subtilisin/kexin type 9 (PCSK9) monoclonal antibodies. Treatment with inclisiran should be discontinued if the patient does not meet all of the following: 1. Patient is adherent to therapy. 2. Patient has achieved a reduction in LDL-C of at least 40% from baseline (4-8 weeks after initiation of inclisiran). 3. Patient continues to have a significant reduction in LDL-C (with continuation of inclisiran) of at least 40% from baseline since initiation of PCSK9 inhibitor. LDL-C should be checked periodically with continued treatment with PCSK9 inhibitors (e.g., every 6 months). Dosing: 284mg administered as a single subcutaneous injection: initially, again at 3 months, followed by every 6 monthsLU Authorization Period: 1 yearHYPOTENSIVE DRUGS (FOR DIURETICS SEE 40:28)ATENOLOL & CHLORTHALIDONE068150 & 25mgTabTenoretic 50/25AZC1996-10-01AA-AtenidoneAAP.53422004-09-14.53420682100 & 25mgTabTenoretic 100/25AZC1996-10-01AA-AtenidoneAAP.87552004-09-14.8755BENAZEPRIL06835mgTab.9485LotensinNOV1996-10-01BenazeprilAAP.9485.94852007-10-03.9485068410mgTab.9938LotensinNOV1996-10-01BenazeprilAAP.9938.99382007-10-03.9938068520mgTab1.2875LotensinNOV1996-10-01BenazeprilAAP1.28751.28752006-06-141.2875CANDESARTAN CILEXETIL06864mgTabAtacandCHE.97182006-04-19.1700Sandoz CandesartanSDZ.17002011-08-04.1700Apo-CandesartanAPX.17002011-08-04.1700Co CandesartanCOB.17002012-01-19.1700Candesartan Cilexetil TabletsACH.17002012-05-29.1700Ran-CandesartanRAN.17002013-04-30.1700Jamp-CandesartanJPC.17002012-09-28.1700CandesartanSAI.17002020-08-28.1700PMS-CandesartanPMS.17002012-10-30.1700Auro-CandesartanAUR.17002018-08-30.1700Mint-CandesartanMIN.17002023-06-30.1700NRA-CandesartanNRA.17002023-07-31.1700CandesartanSIV.17002023-05-31.1700Apo-Candesartan TabletsAPX.17002024-06-28.170006878mgTabAtacandCHE1.61621999-09-15.2281Sandoz CandesartanSDZ.22812011-08-04.2281Apo-CandesartanAPX.22812011-08-04.2281Teva-CandesartanTEV.22812012-05-29.2281Co CandesartanCOB.22812012-01-19.2281Candesartan Cilexetil TabletsACH.22812012-05-29.2281Ran-CandesartanRAN.22812013-04-30.2281Jamp-CandesartanJPC.22812012-09-28.2281CandesartanSIV.22812020-07-31.2281CandesartanSAI.22812020-08-28.2281PMS-CandesartanPMS.22812012-10-30.2281Auro-CandesartanAUR.22812018-08-30.2281Mint-CandesartanMIN.22812019-01-31.2281NRA-CandesartanNRA.22812023-01-31.2281Apo-Candesartan TabletsAPX.22812024-06-28.2281068816mgTabAtacandCHE1.61621999-09-15.2281Sandoz CandesartanSDZ.22812011-08-04.2281Apo-CandesartanAPX.22812011-08-04.2281Teva-CandesartanTEV.22812012-05-29.2281Co CandesartanCOB.22812012-01-19.2281Candesartan Cilexetil TabletsACH.22812012-05-29.2281Ran-CandesartanRAN.22812013-04-30.2281Jamp-CandesartanJPC.22812012-09-28.2281CandesartanSIV.22812020-07-31.2281CandesartanSAI.22812020-08-28.2281PMS-CandesartanPMS.22812012-10-30.2281Auro-CandesartanAUR.22812019-04-30.2281Mint-CandesartanMIN.22812019-01-31.2281NRA-CandesartanNRA.22812023-01-31.2281Apo-Candesartan TabletsAPX.22812024-06-28.2281068932mgTabAtacandCHE1.61622009-05-20.2281Teva-CandesartanTEV.22812012-05-29.2281Co CandesartanCOB.22812012-01-19.2281Candesartan Cilexetil TabletsACH.22812012-05-29.2281Ran-CandesartanRAN.22812013-04-30.2281Jamp-CandesartanJPC.22812012-09-28.2281PMS-CandesartanPMS.22812012-10-30.2281Apo-CandesartanAPX.22812013-02-28.2281Sandoz CandesartanSDZ.22812014-07-30.2281CandesartanSAI.22812020-08-28.2281Auro-CandesartanAUR.22812019-04-30.2281Mint-CandesartanMIN.22812024-03-28.2281NRA-CandesartanNRA.22812023-01-31.2281CandesartanSIV.22812023-05-31.2281Apo-Candesartan TabletsAPX.22812024-06-28.2281CANDESARTAN CILEXETIL & HYDROCHLOROTHIAZIDE069016mg & 12.5mgTabAtacand PlusCHE1.61622002-07-29.2156Sandoz Candesartan PlusSDZ.21562012-11-27.2156PMS-Candesartan-HCTZPMS.21562012-11-27.2156Candesartan/HCTZSAI.21562020-08-28.2156Candesartan HCTSIV.21562020-06-30.2156Teva-Candesartan/HCTZTEV.21562012-12-21.2156Auro-Candesartan HCTAUR.21562015-05-28.2156Jamp Candesartan-HCTJPC.21562019-07-31.2156NRA-Candesartan HCTZNRA.21562023-12-29.2156069132mg & 12.5mgTabAtacand PlusCHE1.61622010-07-20.2156Teva-Candesartan/HCTZTEV.21562013-06-27.2156Sandoz Candesartan PlusSDZ.21562014-07-30.2156Auro-Candesartan HCTAUR.21562015-05-28.2156Jamp Candesartan-HCTJPC.21562019-07-31.2156NRA-Candesartan HCTZNRA.21562023-12-29.2156Candesartan/HCTZSAI.21562024-04-30.2156069232mg & 25mgTabAtacand PlusCHE1.61622010-07-20.3008Sandoz Candesartan PlusSDZ.30082014-07-30.3008Auro-Candesartan HCTAUR.30082015-05-28.3008Jamp Candesartan-HCTJPC.30082019-07-31.3008NRA-Candesartan HCTZNRA.30082023-12-29.3008CAPTOPRIL06935mg/5mLOral SolNoyadaETH.60002025-10-31.6000069425mg/5mLOral SolNoyadaETH.65002025-10-31.6500For pediatric patients (less than 18 years of age) where the appropriate dose cannot be achieved using a listed solid oral dosage form of captopril.LU Authorization Period: 1 yearPharmacists and prescribers should be informed of and stay current with a drug product's official indications in accordance with Health Canada's approved product monograph. Some aspects of the above criteria may differ from the official indications as described in the product monograph for this drug product. The Executive Officer's funding of drug products is informed by advice from experts that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of drug products.For patients unable to swallow or tolerate solid oral dosage forms of captopril.LU Authorization Period: 1 year069512.5mgTab.6360CapotenBQU1996-10-01Apo-CaptoAPX.2120.63601996-10-01.2120Teva-CaptoprilTEV.2120.63601996-10-01.2120069625mgTab.9000CapotenBQU1996-10-01Apo-CaptoAPX.3000.90001996-10-01.3000Teva-CaptoprilTEV.3000.90001996-10-01.3000069750mgTab1.6770CapotenBQU1996-10-01Apo-CaptoAPX.55901.67701996-10-01.5590Teva-CaptoprilTEV.55901.67701996-10-01.55900698100mgTabCapotenBQU1996-10-01Apo-CaptoAPX1.03951996-10-011.0395Teva-CaptoprilTEV1.03951996-10-011.0395CILAZAPRIL06991mgTabInhibaceHLR1996-10-01Mylan-CilazaprilMYL.34262006-09-06.342607002.5mgTab.4295InhibaceHLR1996-10-01Mylan-CilazaprilMYL.4295.42952006-09-06.4295Apo-CilazaprilAPX.4295.42952007-03-09.429507015mgTab.4989InhibaceCHE1.16981.16981996-10-01.4989Mylan-CilazaprilMYL.4989.49892006-09-06.4989Apo-CilazaprilAPX.4989.49892007-03-09.4989CILAZAPRIL & HYDROCHLOROTHIAZIDE07025mg/12.5mgTabInhibace PlusCHE1.16942000-01-17.6306Apo-Cilazapril/HCTZAPX.63062007-01-02.6306CLONIDINE HCLSignificant rebound hypertension can occur after missing even one or two doses; this drug should be avoided in patients with cardiovascular fragility or suspected problems with compliance.07030.025mgTabDixaritBOE2007-06-06Teva-ClonidineTEV.27132008-05-16Sandoz ClonidineSDZ.27132022-02-28Mar-ClonidineMAR.27132022-05-31Jamp ClonidineJPC.27132023-01-31Mint-ClonidineMIN.27132023-07-31ClonidineSIV.27132024-03-2807040.1mgTab.2716CatapresBOE1996-10-01Teva-ClonidineTEV.0679.27161996-10-01.0679Mint-ClonidineMIN.0679.27162017-10-30.0679Sandoz ClonidineSDZ.0679.27162022-03-31.0679ClonidineSIV.0679.27162024-03-28.067907050.2mgTab.4848CatapresBOE1996-10-01Teva-ClonidineTEV.1212.48481996-10-01.1212Mint-ClonidineMIN.1212.48482017-10-30.1212Sandoz ClonidineSDZ.1212.48482022-03-31.1212ClonidineSIV.1212.48482024-03-28.1212DOXAZOSIN MESYLATE07061mgTab.1719Cardura-1AZC1996-10-01Apo-DoxazosinAPX.1719.17192000-01-17.1719Teva-DoxazosinTEV.1719.17192001-03-07.1719Jamp-DoxazosinJPC.1719.17192020-06-30.171907072mgTab.2062Cardura-2AZC1996-10-01Apo-DoxazosinAPX.2062.20622000-01-17.2062Teva-DoxazosinTEV.2062.20622001-03-07.2062Jamp-DoxazosinJPC.2062.20622020-06-30.206207084mgTab.2681Cardura-4AZC1996-10-01Apo-DoxazosinAPX.2681.26812000-01-17.2681Teva-DoxazosinTEV.2681.26812001-03-07.2681Jamp-DoxazosinJPC.2681.26812020-06-30.2681ENALAPRIL MALEATE07092.5mgTab.1863VasotecMFC** Each tablet is made with 2.5mg of enalapril maleate that is equivalent to 2mg of enalapril sodium, in the finished tablets. Discontinuation Letter from MFR.1996-10-01Apo-EnalaprilAPX.1863.18632007-12-19.1863Co EnalaprilCOB.1863.1863** Each tablet is made with 2.5mg of enalapril maleate that is equivalent to 2mg of enalapril sodium, in the finished tablets.2007-12-19.1863Sandoz EnalaprilSDZ.1863.1863** Each tablet is made with 2.5mg of enalapril maleate that is equivalent to 2mg of enalapril sodium, in the finished tablets.2007-12-19.1863Ratio-EnalaprilRPH.1863.1863** Each tablet is made with 2.5mg of enalapril maleate that is equivalent to 2mg of enalapril sodium, in the finished tablets.2007-12-19.1863Mylan-EnalaprilMYL.1863.1863** Each tablet is made with 2.5mg of enalapril maleate that is equivalent to 2mg of enalapril sodium, in the finished tablets.2007-12-19.1863Taro-EnalaprilTAR.1863.1863** Each tablet is made with 2.5mg of enalapril maleate that is equivalent to 2mg of enalapril sodium, in the finished tablets.2008-01-15.1863Novo-EnalaprilNOP.1863.1863** Each tablet is made with 2.5mg of enalapril maleate that is equivalent to 2mg of enalapril sodium, in the finished tablets.2008-05-16.1863Ran-EnalaprilRAN.1863.18632011-01-07.1863EnalaprilSAI.1863.18632022-02-28.1863EnalaprilSIV.1863.18632020-11-30.1863Mar-EnalaprilMAR.1863.18632019-06-28.1863Jamp-EnalaprilJPC.1863.18632019-04-30.186307105mgTab.2203VasotecOCI1.21821.2182** Each tablet is made with 5mg of enalapril maleate that is equivalent to 4mg of enalapril sodium, in the finished tablets.1996-10-01.2203Apo-EnalaprilAPX.2203.22032007-12-19.2203Teva-EnalaprilTEV.2203.2203** Each tablet is made with 5mg of enalapril maleate that is equivalent to 4mg of enalapril sodium, in the finished tablets.2008-05-16.2203Co EnalaprilCOB.2203.2203** Each tablet is made with 5mg of enalapril maleate that is equivalent to 4mg of enalapril sodium, in the finished tablets.2007-12-19.2203Sandoz EnalaprilSDZ.2203.2203** Each tablet is made with 5mg of enalapril maleate that is equivalent to 4mg of enalapril sodium, in the finished tablets.2007-12-19.2203Ratio-EnalaprilRPH.2203.2203** Each tablet is made with 5mg of enalapril maleate that is equivalent to 4mg of enalapril sodium, in the finished tablets.2007-12-19.2203Mylan-EnalaprilMYL.2203.2203** Each tablet is made with 5mg of enalapril maleate that is equivalent to 4mg of enalapril sodium, in the finished tablets.2007-12-19.2203Taro-EnalaprilTAR.2203.2203** Each tablet is made with 5mg of enalapril maleate that is equivalent to 4mg of enalapril sodium, in the finished tablets.2008-01-15.2203Ran-EnalaprilRAN.2203.22032011-01-07.2203EnalaprilSAI.2203.22032022-02-28.2203EnalaprilSIV.2203.22032020-11-30.2203Mar-EnalaprilMAR.2203.22032019-06-28.2203Jamp-EnalaprilJPC.2203.22032019-04-30.2203071110mgTab.2647VasotecOCI1.46381.4638** Each tablet is made with 10mg of enalapril maleate that is equivalent to 8mg of enalapril sodium, in the finished tablets.1996-10-01.2647Apo-EnalaprilAPX.2647.26472007-12-19.2647Teva-EnalaprilTEV.2647.2647** Each tablet is made with 10mg of enalapril maleate that is equivalent to 8mg of enalapril sodium, in the finished tablets.2008-05-16.2647Co EnalaprilCOB.2647.2647** Each tablet is made with 10mg of enalapril maleate that is equivalent to 8mg of enalapril sodium, in the finished tablets.2007-12-19.2647Sandoz EnalaprilSDZ.2647.2647** Each tablet is made with 10mg of enalapril maleate that is equivalent to 8mg of enalapril sodium, in the finished tablets.2007-12-19.2647Ratio-EnalaprilRPH.2647.2647** Each tablet is made with 10mg of enalapril maleate that is equivalent to 8mg of enalapril sodium, in the finished tablets.2007-12-19.2647Mylan-EnalaprilMYL.2647.2647** Each tablet is made with 10mg of enalapril maleate that is equivalent to 8mg of enalapril sodium, in the finished tablets.2007-12-19.2647Taro-EnalaprilTAR.2647.2647** Each tablet is made with 10mg of enalapril maleate that is equivalent to 8mg of enalapril sodium, in the finished tablets.2008-01-15.2647Ran-EnalaprilRAN.2647.26472011-01-07.2647EnalaprilSAI.2647.26472022-02-28.2647EnalaprilSIV.2647.26472020-11-30.2647Mar-EnalaprilMAR.2647.26472019-06-28.2647Jamp-EnalaprilJPC.2647.26472019-04-30.2647071220mgTab.3195VasotecOCI1.76651.7665** Each tablet is made with 20mg of enalapril maleate that is equivalent to 16mg of enalapril sodium, in the finished tablets.1996-10-01.3195Apo-EnalaprilAPX.3195.31952007-12-19.3195Teva-EnalaprilTEV.3195.3195** Each tablet is made with 20mg of enalapril maleate that is equivalent to 16mg of enalapril sodium, in the finished tablets.2008-05-16.3195Co EnalaprilCOB.3195.3195** Each tablet is made with 20mg of enalapril maleate that is equivalent to 16mg of enalapril sodium, in the finished tablets.2007-12-19.3195Sandoz EnalaprilSDZ.3195.3195** Each tablet is made with 20mg of enalapril maleate that is equivalent to 16mg of enalapril sodium, in the finished tablets.2007-12-19.3195Ratio-EnalaprilRPH.3195.3195** Each tablet is made with 20mg of enalapril maleate that is equivalent to 16mg of enalapril sodium, in the finished tablets.2007-12-19.3195Mylan-EnalaprilMYL.3195.3195** Each tablet is made with 20mg of enalapril maleate that is equivalent to 16mg of enalapril sodium, in the finished tablets.2007-12-19.3195Taro-EnalaprilTAR.3195.3195** Each tablet is made with 20mg of enalapril maleate that is equivalent to 16mg of enalapril sodium, in the finished tablets.2008-01-15.3195Ran-EnalaprilRAN.3195.31952011-01-07.3195EnalaprilSAI.3195.31952022-02-28.3195EnalaprilSIV.3195.31952020-11-30.3195Mar-EnalaprilMAR.3195.31952019-06-28.3195Jamp-EnalaprilJPC.3195.31952019-04-30.3195ENALAPRIL MALEATE & HYDROCHLOROTHIAZIDE07135mg & 12.5mgTabVasereticMFC2011-05-19Enalapril Maleate/HCTZAAP.87622011-05-19071410mg & 25mgTabVasereticOCI2011-05-19Enalapril Maleate/HCTZAAP1.22842011-05-19EPLERENONE071525mgTabInspraUJC3.35732015-05-281.3730Mint-EplerenoneMIN1.37302018-06-291.3730Jamp EplerenoneJPC1.37302024-08-301.3730071650mgTabInspraUJC3.35732015-05-281.3730Mint-EplerenoneMIN1.37302018-06-291.3730Jamp EplerenoneJPC1.37302024-08-301.3730For persons suffering from New York Heart Association (NYHA) class II chronic heart failure with left ventricular systolic dysfunction (with ejection fraction less than or equal to 35 percent), as a complement to standard therapy. Note: Patients must be on optimal therapy with an angiotensin-converting-enzyme (ACE) inhibitor, an angiotensin-receptor blocker (ARB), or both and a beta-blocker (unless contraindicated) at the recommended dose or maximal tolerated dose.LU Authorization Period: IndefiniteEPROSARTAN MESYLATE0717400mgTabTevetenSPH.77902002-07-29.77900718600mgTabTevetenSPH1.19102002-07-291.1910EPROSARTAN MESYLATE & HYDROCHLOROTHIAZIDE0719600mg & 12.5mgTabTeveten PlusSPH1.19102005-05-251.1910FELODIPINEGrapefruit juice or erythromycin triple the blood levels of felodipine and markedly increase both efficacy and adverse effects. Other dihydropyridines are affected to differing degrees by grapefruit juice.07202.5mgER TabPlendilGPE.60631996-10-01.4050Apo-FelodipineAPX.40502016-05-31.405007215mgER Tab.3565PlendilGPE.8020.80201996-10-01.3565Sandoz FelodipineSDZ.3565.35652007-01-02.3565Apo-FelodipineAPX.3565.35652016-05-31.3565072210mgER Tab.5350PlendilGPE1.20271.20271996-10-01.5350Sandoz FelodipineSDZ.5350.53502007-01-02.5350Apo-FelodipineAPX.5350.53502016-05-31.535007235mgSR Tab.5592RenedilSAV1999-01-07Sandoz FelodipineSDZ.5592.55922007-01-02.5592072410mgSR Tab.8390RenedilSAV1999-01-07Sandoz FelodipineSDZ.8390.83902007-01-02.8390FOSINOPRIL SODIUM072510mgTab.2178MonoprilBQU1996-10-01Teva-FosinoprilTEV.2178.21782004-04-06.2178Apo-FosinoprilAPX.2178.21782005-07-14.2178Ran-FosinoprilRAN.2178.21782010-03-02.2178Jamp-FosinoprilJPC.2178.21782010-04-23.2178FosinoprilSAI.2178.21782020-06-30.2178072620mgTab.2619MonoprilBQU1996-10-01Teva-FosinoprilTEV.2619.26192004-04-06.2619Apo-FosinoprilAPX.2619.26192005-07-14.2619Ran-FosinoprilRAN.2619.26192010-03-02.2619Jamp-FosinoprilJPC.2619.26192010-04-23.2619FosinoprilSAI.2619.26192020-06-30.2619HYDRALAZINE HCL072720mg/mLInj Sol-1mL Vial PkApresolineSTE11.65001996-10-018.7375Hydralazine Hydrochloride Injection, USPAUR8.73752023-09-288.7375072810mgTab.1420ApresolineNOV1996-10-01Apo-HydralazineAPX.0355.14201996-10-01.0355Jamp-HydralazineJPC.0355.14202017-11-30.0355Mint-HydralazineMIN.0355.14202018-05-31.0355HydralazineSAI.0355.14202024-04-30.0355072925mgTab.2436ApresolineSTE1996-10-01Apo-HydralazineAPX.0609.24361996-10-01.0609Jamp-HydralazineJPC.0609.24362017-11-30.0609Mint-HydralazineMIN.0609.24362018-05-31.0609HydralazineSAI.0609.24362024-04-30.0609073050mgTab.3824ApresolineNOV1996-10-01Apo-HydralazineAPX.0956.38241996-10-01.0956Jamp-HydralazineJPC.0956.38242017-11-30.0956Mint-HydralazineMIN.0956.38242018-05-31.0956HydralazineSAI.0956.38242024-04-30.0956IRBESARTAN073175mgTabAvaproSAV1.26711999-04-15.2281Teva-IrbesartanTEV.22812011-08-04.2281PMS-IrbesartanPMS.22812011-08-04.2281Sandoz IrbesartanSDZ.22812011-08-04.2281IrbesartanSAI.22812020-10-30.2281IrbesartanSIV.22812020-06-30.2281Apo-IrbesartanAPX.22812012-08-27.2281Auro-IrbesartanAUR.22812013-09-27.2281Ran-IrbesartanRAN.22812013-11-28.2281Jamp-IrbesartanJPC.22812014-03-27.2281Mint-IrbesartanMIN.22812015-05-28.2281M-IrbesartanMAT.22812022-11-30.2281Jamp IrbesartanJPC.22812025-04-30.22810732150mgTabAvaproSAV1.26711999-04-15.2281Teva-IrbesartanTEV.22812011-08-04.2281PMS-IrbesartanPMS.22812011-08-04.2281Co IrbesartanCOB.22812011-08-04.2281Sandoz IrbesartanSDZ.22812011-08-04.2281IrbesartanSAI.22812020-10-30.2281IrbesartanSIV.22812020-06-30.2281Apo-IrbesartanAPX.22812012-08-27.2281Auro-IrbesartanAUR.22812013-09-27.2281Ran-IrbesartanRAN.22812013-11-28.2281Jamp-IrbesartanJPC.22812014-03-27.2281Mint-IrbesartanMIN.22812015-05-28.2281M-IrbesartanMAT.22812022-11-30.2281Jamp IrbesartanJPC.22812025-03-31.22810733300mgTabAvaproSAV1.26711999-04-15.2281Teva-IrbesartanTEV.22812011-08-04.2281PMS-IrbesartanPMS.22812011-08-04.2281Co IrbesartanCOB.22812011-08-04.2281Sandoz IrbesartanSDZ.22812011-08-04.2281IrbesartanSAI.22812020-10-30.2281IrbesartanSIV.22812020-06-30.2281Apo-IrbesartanAPX.22812012-08-27.2281Auro-IrbesartanAUR.22812013-09-27.2281Ran-IrbesartanRAN.22812013-11-28.2281Jamp-IrbesartanJPC.22812014-03-27.2281Mint-IrbesartanMIN.22812015-05-28.2281M-IrbesartanMAT.22812022-11-30.2281Jamp IrbesartanJPC.22812025-03-31.2281IRBESARTAN & HYDROCHLOROTHIAZIDE0734150mg & 12.5mgTabAvalideSAV1.31662001-03-07.2281PMS-Irbesartan-HCTZPMS.22812011-08-04.2281Teva-Irbesartan HCTZTEV.22812011-08-04.2281Sandoz Irbesartan HCTSDZ.22812011-08-04.2281Co Irbesartan/HCTCOB.22812011-08-04.2281Ran-Irbesartan HCTZRAN.22812011-08-04.2281Irbesartan/HCTZSAI.22812020-10-30.2281Irbesartan HCTSIV.22812020-06-30.2281Apo-Irbesartan/HCTZAPX.22812013-03-20.2281Mint Irbesartan/HCTZMIN.22812012-11-27.2281Jamp-Irbesartan and HydrochlorothiazideJPC.22812014-03-27.2281Auro-Irbesartan HCTAUR.22812017-07-31.22810735300mg & 12.5mgTabAvalideSAV1.31662001-03-07.2281PMS-Irbesartan-HCTZPMS.22812011-08-04.2281Teva-Irbesartan HCTZTEV.22812011-08-04.2281Sandoz Irbesartan HCTSDZ.22812011-08-04.2281Co Irbesartan/HCTCOB.22812011-08-04.2281Ran-Irbesartan HCTZRAN.22812011-08-04.2281Irbesartan/HCTZSAI.22812021-10-29.2281Irbesartan HCTSIV.22812020-06-30.2281Apo-Irbesartan/HCTZAPX.22812013-03-20.2281Mint Irbesartan/HCTZMIN.22812012-11-27.2281Jamp-Irbesartan and HydrochlorothiazideJPC.22812014-03-27.2281Auro-Irbesartan HCTAUR.22812017-07-31.22810736300mg & 25mgTabAvalideSAV2007-03-09PMS-Irbesartan-HCTZPMS.21842011-08-04.2184Teva-Irbesartan HCTZTEV.21842011-08-04.2184Sandoz Irbesartan HCTSDZ.21842011-08-04.2184Co Irbesartan/HCTCOB.21842011-08-04.2184Ran-Irbesartan HCTZRAN.21842011-08-04.2184Irbesartan/HCTZSAI.21842020-10-30.2184Irbesartan HCTSIV.21842020-06-30.2184Apo-Irbesartan/HCTZAPX.21842013-03-20.2184Mint Irbesartan/HCTZMIN.21842012-11-27.2184Jamp-Irbesartan and HydrochlorothiazideJPC.21842014-03-27.2184Auro-Irbesartan HCTAUR.21842017-07-31.2184LABETALOL HCL0737100mgTabTrandatePPI.40441998-03-17.1983Apo-LabetalolAPX.19832001-10-11.1983Riva-LabetalolRIA.19832019-10-31.19830738200mgTabTrandatePPI.71481998-03-17.3504Apo-LabetalolAPX.35042001-10-11.3504Riva-LabetalolRIA.35042019-10-31.3504LISINOPRIL07395mgTab.1428PrinivilMFC1996-10-01Teva-Lisinopril (Type P)TEV.1428.14282007-12-19.1428Apo-LisinoprilAPX.1428.14281999-04-15.1428Sandoz LisinoprilSDZ.1428.14282007-12-19.1428074010mgTab.1716PrinivilMFC.9489.94891996-10-01.1716Teva-Lisinopril (Type P)TEV.1716.17162007-12-19.1716Apo-LisinoprilAPX.1716.17162001-06-07.1716Sandoz LisinoprilSDZ.1716.17162007-12-19.1716074120mgTab.2063PrinivilMFC1.14081.14081996-10-01.2063Teva-Lisinopril (Type P)TEV.2063.20632007-12-19.2063Apo-LisinoprilAPX.2063.20632001-06-07.2063Sandoz LisinoprilSDZ.2063.20632007-12-19.206307425mgTab.1347ZestrilAZC.5770.57701996-10-01.1347Apo-LisinoprilAPX.1347.13471997-08-28.1347Co LisinoprilCOB.1347.13472007-12-19.1347Teva-Lisinopril (Type Z)TEV.1347.13472007-12-19.1347Sandoz LisinoprilSDZ.1347.13472007-12-19.1347Ran-LisinoprilRAN.1347.13472007-12-19.1347Jamp-LisinoprilJPC.1347.13472012-01-19.1347LisinoprilSIV.1347.13472020-10-30.1347Auro-LisinoprilAUR.1347.13472013-04-30.1347Lisinopril (Type Z)SAI.1347.13472022-10-31.1347Lisinopril TabletsSIV.1347.13472026-01-30.1347074310mgTab.1619ZestrilAZC.6935.69351996-10-01.1619Apo-LisinoprilAPX.1619.16192001-06-07.1619Co LisinoprilCOB.1619.16192007-12-19.1619Teva-Lisinopril (Type Z)TEV.1619.16192007-12-19.1619Sandoz LisinoprilSDZ.1619.16192007-12-19.1619Ran-LisinoprilRAN.1619.16192007-12-19.1619Jamp-LisinoprilJPC.1619.16192012-01-19.1619LisinoprilSIV.1619.16192020-10-30.1619Auro-LisinoprilAUR.1619.16192013-04-30.1619Lisinopril (Type Z)SAI.1619.16192022-10-31.1619Lisinopril TabletsSIV.1619.16192026-01-30.1619074420mgTab.1945ZestrilAZC.8330.83301996-10-01.1945Apo-LisinoprilAPX.1945.19452001-06-07.1945Co LisinoprilCOB.1945.19452007-12-19.1945Teva-Lisinopril (Type Z)TEV.1945.19452007-12-19.1945Sandoz LisinoprilSDZ.1945.19452007-12-19.1945Ran-LisinoprilRAN.1945.19452007-12-19.1945Jamp-LisinoprilJPC.1945.19452012-01-19.1945LisinoprilSIV.1945.19452020-10-30.1945Auro-LisinoprilAUR.1945.19452013-04-30.1945Lisinopril (Type Z)SAI.1945.19452022-10-31.1945Lisinopril TabletsSIV.1945.19452026-01-30.1945LISINOPRIL & HYDROCHLOROTHIAZIDE074510mg & 12.5mgTabZestoreticAZC.92861996-10-01.2084Teva-Lisinopril/HCTZ (Type Z)TEV.20842008-01-15.2084Sandoz Lisinopril HCTSDZ.20842008-01-15.2084Lisinopril/HCTZ (Type Z)SAI.20842011-10-25.2084074610mg & 12.5mgTabPrinzideMFC1996-10-01Teva-Lisinopril/HCTZ (Type P)TEV.33342008-01-15.3334074720mg & 12.5mgTabPrinzideMFC1996-10-01Teva-Lisinopril/HCTZ (Type P)TEV.40062008-01-15.4006074820mg & 12.5mgTabZestoreticAZC1.11591996-10-01.2504Teva-Lisinopril/HCTZ (Type Z)TEV.25042008-01-15.2504Sandoz Lisinopril HCTSDZ.25042008-01-15.2504Lisinopril/HCTZ (Type Z)SAI.25042011-10-25.2504074920mg & 25mgTabZestoreticAZC2008-08-28Teva-Lisinopril/HCTZ (Type Z)TEV.70112008-08-28Sandoz Lisinopril HCTSDZ.70112008-12-23Lisinopril/HCTZ (Type Z)SAI.70112011-12-15075020mg/25mgTabPrinzideMFC2008-08-28Teva-Lisinopril/HCTZ (Type P)TEV.70112008-08-28LOSARTAN POTASSIUM075125mgTabCozaarOCI1.99241996-10-01.3147PMS-LosartanPMS.31472012-03-26.3147Sandoz LosartanSDZ.31472012-03-26.3147Co LosartanCOB.31482012-03-26.3147Apo-LosartanAPX.31482012-03-26.3147Teva-LosartanTEV.31482012-04-24.3147LosartanSIV.31472020-06-30.3147LosartanSAI.31472021-01-29.3147Jamp-LosartanJPC.31472013-05-31.3147Auro-LosartanAUR.31472013-05-31.3147Ran-LosartanRAN.31472013-09-27.3147Mint-LosartanMIN.31472014-05-29.3147Septa-LosartanSET.31472014-09-25.3147Bio-LosartanBMP.31472016-02-25.3147075250mgTabCozaarOCI1.99241996-10-01.3147PMS-LosartanPMS.31472012-03-26.3147Sandoz LosartanSDZ.31472012-03-26.3147Apo-LosartanAPX.31482012-03-26.3147Co LosartanCOB.31482012-03-26.3147Teva-LosartanTEV.31482012-03-26.3147LosartanSIV.31472020-06-30.3147LosartanSAI.31472021-01-29.3147Jamp-LosartanJPC.31472013-05-31.3147Auro-LosartanAUR.31472013-05-31.3147Ran-LosartanRAN.31472013-09-27.3147Mint-LosartanMIN.31472014-05-29.3147Septa-LosartanSET.31472014-09-25.3147Bio-LosartanBMP.31472016-02-25.31470753100mgTabCozaarOCI1.99241999-04-15.3147PMS-LosartanPMS.31472012-03-26.3147Sandoz LosartanSDZ.31472012-03-26.3147Apo-LosartanAPX.31482012-03-26.3147Co LosartanCOB.31482012-03-26.3147Teva-LosartanTEV.31482012-03-26.3147LosartanSIV.31472020-06-30.3147LosartanSAI.31472021-01-29.3147Jamp-LosartanJPC.31472013-05-31.3147Auro-LosartanAUR.31472013-05-31.3147Ran-LosartanRAN.31472013-09-27.3147Mint-LosartanMIN.31472014-05-29.3147Septa-LosartanSET.31472014-09-25.3147Bio-LosartanBMP.31472016-02-25.3147LOSARTAN POTASSIUM & HYDROCHLOROTHIAZIDE0754100mg & 12.5mgTabHyzaarOCI1.95082008-11-04.3082Sandoz Losartan HCTSDZ.30822012-03-26.3082Apo-Losartan/HCTZAPX.30822012-03-26.3082Teva-Losartan/HCTZTEV.30822012-03-26.3082Co Losartan/HCTCOB.30822012-08-27.3082Losartan HCTSIV.30822020-09-30.3082Mint-Losartan/HCTZMIN.30822012-09-28.3082PMS-Losartan-HCTZPMS.30822012-10-30.3082Auro-Losartan HCTAUR.30822014-06-26.3082Losartan/HCTZSAI.30822021-01-29.3082075550mg & 12.5mgTabHyzaarOCI1.99242000-11-30.3147Sandoz Losartan HCTSDZ.31472012-03-26.3147Teva-Losartan/HCTZTEV.31482012-03-26.3147Apo-Losartan/HCTZAPX.31482012-03-26.3147Co Losartan/HCTCOB.31472012-08-27.3147Losartan HCTSIV.31472020-09-30.3147Mint-Losartan/HCTZMIN.31472012-09-28.3147PMS-Losartan-HCTZPMS.31472012-10-30.3147Jamp-Losartan HCTZJPC.31472013-10-31.3147Auro-Losartan HCTAUR.31472014-07-30.3147Losartan/HCTZSAI.31472021-01-29.3147Septa-Losartan HCTZSET.31472014-12-18.31470756100mg & 25mgTabHyzaar DSOCI1.99242000-11-30.3147Sandoz Losartan HCT DSSDZ.31472012-03-26.3147Apo-Losartan/HCTZAPX.31482012-03-26.3147Teva-Losartan/HCTZTEV.31482012-03-26.3147Co Losartan/HCTCOB.31472012-08-27.3147Losartan HCTSIV.31472020-09-30.3147Mint-Losartan/HCTZ DSMIN.31472012-09-28.3147PMS-Losartan-HCTZPMS.31472012-10-30.3147Jamp-Losartan HCTZJPC.31472013-10-31.3147Auro-Losartan HCTAUR.31472014-06-26.3147Losartan/HCTZSAI.31472021-01-29.3147Septa-Losartan HCTZSET.31472014-12-18.3147METHYLDOPA0757125mgTab.4036AldometMSD1996-10-01MethyldopaAAP.1009.40361996-10-01.10090758250mgTab.6316AldometMSD2002-11-22MethyldopaAAP.1579.63161996-10-01.15790759500mgTab.5176AldometMSD1996-10-01MethyldopaAAP.2588.51761996-10-01.2588MINOXIDIL07602.5mgTabLonitenPFI.53871996-10-01.5387076110mgTabLonitenPFI1.18841996-10-011.1884NIFEDIPINE076230mgER Tab.6171Adalat XLBAY.6171.61711996-10-01.6171Mylan-Nifedipine Extended ReleaseMYL.6171.61712010-07-20.6171076360mgER Tab.9374Adalat XLBAY1996-10-01Mylan-Nifedipine Extended ReleaseMYL.9374.93742009-03-02.9374OLMESARTAN MEDOXOMIL076420mgTabOlmetecOCI1.39932010-04-23.3019Teva-OlmesartanTEV.30192017-06-29.3019Sandoz OlmesartanSDZ.30192017-06-29.3019Auro-OlmesartanAUR.30192017-06-29.3019Apo-OlmesartanAPX.30192017-06-29.3019Ach-OlmesartanACH.30192020-08-28.3019PMS-OlmesartanPMS.30192017-07-31.3019Jamp-OlmesartanJPC.30192017-06-29.3019GLN-OlmesartanGLP.30192020-12-18.3019OlmesartanSAI.30192020-10-30.3019NRA-OlmesartanNRA.30192020-12-18.3019076540mgTabOlmetecOCI1.39932010-04-23.3019Teva-OlmesartanTEV.30192017-06-29.3019Sandoz OlmesartanSDZ.30192017-06-29.3019Auro-OlmesartanAUR.30192017-06-29.3019Apo-OlmesartanAPX.30192017-06-29.3019Ach-OlmesartanACH.30192020-08-28.3019PMS-OlmesartanPMS.30192017-07-31.3019Jamp-OlmesartanJPC.30192017-06-29.3019GLN-OlmesartanGLP.30192020-12-18.3019OlmesartanSAI.30192020-10-30.3019NRA-OlmesartanNRA.30192020-12-18.3019OLMESARTAN MEDOXOMIL & HYDROCHLOROTHIAZIDE076620mg & 12.5mgTabOlmetec PlusOCI1.46932010-04-23.3019Act Olmesartan HCTTEV.30192017-06-29.3019Apo-Olmesartan/HCTZAPX.30192017-06-29.3019Ach-Olmesartan HCTZACH.30192019-08-30.3019GLN-Olmesartan HCTZGLP.30192021-04-30.3019Auro-Olmesartan HCTZAUR.30192019-11-29.3019NRA-Olmesartan HCTZNRA.30192021-10-29.3019Olmesartan/HCTZSAI.30192021-08-31.3019PRZ-Olmesartan/HCTZPRZ.30192022-11-30.3019076740mg & 12.5mgTabOlmetec PlusOCI1.46932010-04-23.3019Act Olmesartan HCTTEV.30192017-06-29.3019Apo-Olmesartan/HCTZAPX.30192017-06-29.3019Ach-Olmesartan HCTZACH.30192019-08-30.3019GLN-Olmesartan HCTZGLP.30192021-04-30.3019Auro-Olmesartan HCTZAUR.30192019-11-29.3019NRA-Olmesartan HCTZNRA.30192021-10-29.3019Olmesartan/HCTZSAI.30192021-08-31.3019PRZ-Olmesartan/HCTZPRZ.30192022-11-30.3019076840mg & 25mgTabOlmetec PlusOCI1.46932010-04-23.3019Act Olmesartan HCTTEV.30192017-06-29.3019Apo-Olmesartan/HCTZAPX.30192017-06-29.3019Ach-Olmesartan HCTZACH.30192019-08-30.3019GLN-Olmesartan HCTZGLP.30192021-04-30.3019Auro-Olmesartan HCTZAUR.30192019-11-29.3019NRA-Olmesartan HCTZNRA.30192021-10-29.3019Olmesartan/HCTZSAI.30192021-08-31.3019PRZ-Olmesartan/HCTZPRZ.30192022-11-30.3019PERINDOPRIL ARGININE & AMLODIPINE BESYLATE07693.5mg & 2.5mgTabViacoramSEV2019-07-31Apo-Perindopril/AmlodipineAPX.80752019-07-31PMS-Perindopril-AmlodipinePMS.80752024-04-3007707mg & 5mgTabViacoramSEV2019-07-31Apo-Perindopril/AmlodipineAPX.89252019-07-31PMS-Perindopril-AmlodipinePMS.89252024-04-30077114mg & 10mgTabViacoramSEV2019-07-31Apo-Perindopril/AmlodipineAPX.97752019-07-31PMS-Perindopril-AmlodipinePMS.97752024-04-30PERINDOPRIL ERBUMINE07722mgTabCoversylSEV.77901996-10-01.1632Apo-PerindoprilAPX.16322018-04-30.1632Auro-PerindoprilAUR.16322018-04-30.1632Teva-PerindoprilTEV.16322018-04-30.1632Sandoz Perindopril ErbumineSDZ.16322018-04-30.1632PMS-PerindoprilPMS.16322018-04-30.1632Mar-PerindoprilMAR.16322019-06-28.1632Mint-PerindoprilMIN.16322019-06-28.1632Jamp-PerindoprilJPC.16322019-09-30.1632Perindopril ErbumineSIV.16322020-07-31.1632Perindopril ErbumineSAI.16322020-07-31.1632AG-PerindoprilANG.16322020-10-30.1632M-Perindopril ErbumineMAT.16322021-09-30.1632NRA-PerindoprilNRA.16322020-07-31.1632Jamp Perindopril ErbumineJPC.16322023-01-31.163207734mgTabCoversylSEV.97531996-10-01.2042Apo-PerindoprilAPX.20422018-04-30.2042Auro-PerindoprilAUR.20422018-04-30.2042Teva-PerindoprilTEV.20422018-04-30.2042Sandoz Perindopril ErbumineSDZ.20422018-04-30.2042PMS-PerindoprilPMS.20422018-04-30.2042Mar-PerindoprilMAR.20422019-06-28.2042Mint-PerindoprilMIN.20422019-04-30.2042Jamp-PerindoprilJPC.20422019-04-30.2042Perindopril ErbumineSIV.20422020-07-31.2042Perindopril ErbumineSAI.20422020-07-31.2042AG-PerindoprilANG.20422020-10-30.2042M-Perindopril ErbumineMAT.20422021-09-30.2042NRA-PerindoprilNRA.20422020-07-31.2042Jamp Perindopril ErbumineJPC.20422023-01-31.204207748mgTabCoversylSEV1.36602004-07-20.2831Apo-PerindoprilAPX.28312008-03-25.2831Auro-PerindoprilAUR.28312018-04-30.2831Teva-PerindoprilTEV.28312018-04-30.2831Sandoz Perindopril ErbumineSDZ.28312018-04-30.2831PMS-PerindoprilPMS.28312018-04-30.2831Mar-PerindoprilMAR.28312019-06-28.2831Mint-PerindoprilMIN.28312019-04-30.2831Jamp-PerindoprilJPC.28312019-04-30.2831Perindopril ErbumineSIV.28312020-07-31.2831Perindopril ErbumineSAI.28312020-07-31.2831AG-PerindoprilANG.28312020-10-30.2831M-Perindopril ErbumineMAT.28312021-09-30.2831NRA-PerindoprilNRA.28312020-07-31.2831Jamp Perindopril ErbumineJPC.28312023-01-31.2831PERINDOPRIL ERBUMINE & INDAPAMIDE07752mg & 0.625mgTabCoversyl Plus LDSEV1.01602007-04-02.2113Sandoz Perindopril Erbumine/IndapamideLDSDZ.21132018-04-30.2113PMS-Perindopril-IndapamidePMS.21132023-10-31.2113Jamp Perindopril / IndapamideJPC.21132026-01-30.211307764mg & 1.25mgTabCoversyl PlusSEV1.20802007-04-02.2556Apo-Perindopril-IndapamideAPX.25562021-03-29.2556Teva-Perindopril/IndapamideTEV.25562018-04-30.2556Sandoz Perindopril Erbumine/IndapamideSDZ.25562018-04-30.2556Perindopril Erbumine/IndapamideSIV.25562022-03-31.2556Perindopril/IndapamideSAI.25562022-02-28.2556PMS-Perindopril-IndapamidePMS.25562023-10-31.2556Jamp Perindopril / IndapamideJPC.25562026-01-30.255607778mg & 2.5mgTabCoversyl Plus HDSEV1.36602010-04-23.2859Apo-Perindopril-IndapamideAPX.28592021-03-29.2859Teva-Perindopril/IndapamideTEV.28592018-04-30.2859Sandoz Perindopril Erbumine/IndapamideHDSDZ.28592018-04-30.2859Perindopril Erbumine/Indapamide HDSIV.28592022-03-31.2859Perindopril/IndapamideSAI.28592022-02-28.2859PMS-Perindopril-IndapamidePMS.28592023-10-31.2859Jamp Perindopril / IndapamideJPC.28592026-01-30.2859PINDOLOL07785mgTab.8136ViskenARZ.86721.73441996-10-01.4068Teva-PindololTEV.4068.81361996-10-01.4068077910mgTab1.3894ViskenARZ1.48072.96141996-10-01.6947Teva-PindololTEV.69471.38941996-10-01.6947078015mgTab1.9566ViskenNOV1996-10-01Teva-PindololTEV.97831.95661996-10-01.9783PINDOLOL & HYDROCHLOROTHIAZIDE078110mg & 25mgTabViskazideARZ1.36661996-10-011.3666078210mg & 50mgTabViskazideARZ1.36661996-10-011.3666PRAZOSIN HCL07831mgCapPrazosin Hydrochloride Capsules, USPSTE.27432023-09-28.274307842mgCapPrazosin Hydrochloride Capsules, USPSTE.37252023-09-28.372507855mgCapPrazosin Hydrochloride Capsules, USPSTE.51212023-09-28.512107861mgTab.5486MinipressPFI.2743.54861996-10-01.2743Apo-PrazoAPX.2743.54861996-10-01.2743Teva-PrazosinTEV.2743.54861996-10-01.274307872mgTab.7450MinipressPFI.3725.74501996-10-01.3725Apo-PrazoAPX.3725.74501996-10-01.3725Teva-PrazosinTEV.3725.74501996-10-01.372507885mgTab1.0242MinipressPFI.51211.02421996-10-01.5121Apo-PrazoAPX.51211.02421996-10-01.5121Teva-PrazosinTEV.51211.02421996-10-01.5121QUINAPRIL07895mgTab.4642AccuprilPFI1996-10-01Apo-QuinaprilAPX.4642.46422013-10-31.4642PMS-QuinaprilPMS.4642.46422019-11-29.4642079010mgTab.2321AccuprilPFI1996-10-01Apo-QuinaprilAPX.2321.23212013-10-31.2321PMS-QuinaprilPMS.2321.23212019-11-29.2321Jamp QuinaprilJPC.2321.23212024-01-31.2321079120mgTab.4642AccuprilPFI1996-10-01PMS-QuinaprilPMS.4642.46422019-11-29.4642Jamp QuinaprilJPC.4642.46422024-01-31.4642079240mgTab.4642AccuprilPFI1996-10-01PMS-QuinaprilPMS.4642.46422019-11-29.4642Jamp QuinaprilJPC.4642.46422024-01-31.4642QUINAPRIL & HYDROCHLOROTHIAZIDE079310mg & 12.5mgTabAccureticPFI2000-07-17Apo-Quinapril/HCTZAPX.23932013-10-31.2393Auro-Quinapril HCTZAUR.23932019-03-28.2393Jamp Quinapril / HCTZJPC.23932025-06-30.2393079420mg & 12.5mgTabAccureticPFI2000-07-17Apo-Quinapril/HCTZAPX.47862013-10-31.4786Auro-Quinapril HCTZAUR.47862019-03-28.4786079520mg & 25mgTabAccureticPFI2004-04-06Apo-Quinapril/HCTZAPX.23012013-10-31.2301Auro-Quinapril HCTZAUR.23012019-03-28.2301Jamp Quinapril / HCTZJPC.23012025-06-30.2301RAMIPRIL07961.25mgAltace CapSAV1.00271999-01-06.0708Apo-Ramipril CapAPX.07082007-03-09.0708PMS-Ramipril CapPMS.07082010-04-23.0708Co Ramipril CapCOB.07082007-11-10.0708Ramipril CapRIA2008-08-28Ramipril CapSIV.07082010-06-14.0708Ran-Ramipril CapRAN.07082008-11-04.0708Jamp-Ramipril CapJPC.07082010-04-23.0708Auro-Ramipril CapAUR.07082013-02-28.0708Mar-Ramipril CapMAR.07082014-05-29.0708Pharma-RamiprilPMS.07082018-09-27.0708PMSC-Ramipril CapPMS.07082025-12-30.070807972.5mgAltace CapSAV1.12811999-01-06.0817Teva-Ramipril CapTEV.08172007-06-06.0817Apo-Ramipril CapAPX.08172007-03-09.0817Ramipril CapRIA2008-08-28Ratio-Ramipril CapRPH.08172007-03-09.0817Ramipril CapSIV.08172010-06-14.0817Co Ramipril CapCOB.08172007-12-19.0817Ran-Ramipril CapRAN.08172008-11-04.0817Jamp-Ramipril CapJPC.08172010-04-23.0817Ramipril CapSAI.08172016-04-01.0817Auro-Ramipril CapAUR.08172013-02-28.0817Mar-Ramipril CapMAR.08172014-05-29.0817Mint-Ramipril CapMIN.08172014-06-26.0817Pharma-RamiprilPMS.08172018-09-27.0817AG-Ramipril CapANG.08172020-11-30.0817NRA-Ramipril CapNRA.08172020-09-30.0817PMSC-Ramipril CapPMS.08172025-12-30.081707985mgAltace CapSAV1.15751999-01-06.0817Teva-Ramipril CapTEV.08172007-06-06.0817Apo-Ramipril CapAPX.08172007-03-09.0817Ramipril CapRIA2008-08-28Ramipril CapSIV.08172010-06-14.0817Co Ramipril CapCOB.08172007-12-19.0817Ran-Ramipril CapRAN.08172008-11-04.0817Jamp-Ramipril CapJPC.08172010-04-23.0817Ramipril CapSAI.08172016-04-01.0817Auro-Ramipril CapAUR.08172013-02-28.0817Mar-Ramipril CapMAR.08172014-05-29.0817Mint-Ramipril CapMIN.08172014-06-26.0817Pharma-RamiprilPMS.08172018-09-27.0817AG-Ramipril CapANG.08172020-11-30.0817NRA-Ramipril CapNRA.08172020-09-30.0817PMSC-Ramipril CapPMS.08172025-12-30.0817079910mgAltace CapSAV1.48721999-01-06.1034Teva-Ramipril CapTEV.10342007-06-06.1034Apo-Ramipril CapAPX.10342007-03-09.1034Ramipril CapRIA2008-08-28Ramipril CapSIV.10342010-06-14.1034Co Ramipril CapCOB.10342007-11-10.1034Ran-Ramipril CapRAN.10342008-11-04.1034Jamp-Ramipril CapJPC.10342010-04-23.1034Ramipril CapSAI.10342016-04-01.1034Auro-Ramipril CapAUR.10342013-02-28.1034Mar-Ramipril CapMAR.10342014-05-29.1034Mint-Ramipril CapMIN.10342014-06-26.1034Pharma-RamiprilPMS.10342018-09-27.1034AG-Ramipril CapANG.10342020-11-30.1034NRA-Ramipril CapNRA.10342020-09-30.1034PMSC-Ramipril CapPMS.10342025-12-30.1034080015mgCapAltaceSAV2009-06-23Apo-RamiprilAPX.85502009-06-23Mar-RamiprilMAR.85502014-05-29Mint-RamiprilMIN.81322014-06-26Ran-RamiprilRAN.85502015-02-26Jamp-RamiprilJPC.85502016-09-29RAMIPRIL & HYDROCHLOROTHIAZIDE08012.5mg & 12.5mgTabAltace HCTSAV2007-06-06Ran-Ramipril HCTZRAN.22422018-05-31.224208025mg & 12.5mgTabAltace HCTSAV2007-06-06Ran-Ramipril HCTZRAN.30162018-12-21.301608035mg & 25mgTabAltace HCTSAV.49812007-06-06.2872Ran-Ramipril HCTZRAN.28722018-05-31.2872080410mg & 12.5mgTabAltace HCTSAV.68092007-06-06.2634PMS-Ramipril-HCTZPMS.26342011-03-15.2634Ran-Ramipril HCTZRAN.26342018-12-21.2634080510mg & 25mgTabAltace HCTSAV.65252007-06-06.2634PMS-Ramipril-HCTZPMS.26342011-03-15.2634Ran-Ramipril HCTZRAN.26342018-12-21.2634TELMISARTAN080640mgTabMicardisBOE1.44982000-04-17.2161Teva-TelmisartanTEV.21612012-03-26.2161Sandoz TelmisartanSDZ.21612012-02-29.2161Jamp TelmisartanJPC.21612021-02-26.2161TelmisartanSAI.21612020-09-30.2161TelmisartanSIV.21612021-05-31.2161Ach-TelmisartanACH.21612014-09-25.2161Apo-TelmisartanAPX.21612014-03-27.2161Auro-TelmisartanAUR.21612016-12-22.2161Mint-TelmisartanMIN.21612020-07-31.2161PMS-TelmisartanPMS.21612021-05-31.2161NRA-TelmisartanNRA.21612022-02-28.2161080780mgTabMicardisBOE1.44982000-04-17.2161Teva-TelmisartanTEV.21612012-03-26.2161Sandoz TelmisartanSDZ.21612012-02-29.2161Jamp TelmisartanJPC.21612021-02-26.2161TelmisartanSAI.21612020-09-30.2161TelmisartanSIV.21612021-05-31.2161Co TelmisartanCOB.21612012-12-21.2161Ach-TelmisartanACH.21612014-09-25.2161Apo-TelmisartanAPX.21612014-03-27.2161Auro-TelmisartanAUR.21612016-12-22.2161Mint-TelmisartanMIN.21612020-07-31.2161PMS-TelmisartanPMS.21612021-05-31.2161NRA-TelmisartanNRA.21612022-02-28.2161TELMISARTAN & AMLODIPINE BESYLATE080840mg & 10mgTabTwynstaBOE.84812012-02-29.4470Riva-Telmisartan / AmlodipineRIA.44702025-12-30.4470080940mg & 5mgTabTwynstaBOE.84812012-02-29.4470Riva-Telmisartan / AmlodipineRIA.44702025-12-30.4470081080mg & 10mgTabTwynstaBOE.84812012-02-29.3648Riva-Telmisartan / AmlodipineRIA.36482025-12-30.3648081180mg & 5mgTabTwynstaBOE.84812012-02-29.3648Riva-Telmisartan / AmlodipineRIA.36482025-12-30.3648TELMISARTAN & HYDROCHLOROTHIAZIDE081280mg & 12.5mgTabMicardis PlusBOE1.44982002-07-29.2098Teva-Telmisartan HCTZTEV.20982012-04-24.2098Jamp Telmisartan-HCTJPC.20982021-03-29.2098Telmisartan HCTZSIV.20982020-12-18.2098Co Telmisartan/HCTCOB.20982012-11-27.2098Sandoz Telmisartan HCTSDZ.20982012-11-27.2098Telmisartan/HCTZSAI.20982020-09-30.2098Telmisartan and Hydrochlorothiazide TabACH.20982014-09-25.2098Apo-Telmisartan/HCTZAPX.20982014-03-27.2098Auro-Telmisartan HCTZAUR.20982016-12-22.2098NRA-Telmisartan HCTZNRA.20982021-05-31.2098081380mg & 25mgTabMicardis PlusBOE1.44982009-11-13.2098Teva-Telmisartan HCTZTEV.20982012-04-24.2098Jamp Telmisartan-HCTJPC.20982021-03-29.2098Telmisartan HCTZSIV.20982020-12-18.2098Co Telmisartan/HCTCOB.20982012-11-27.2098Sandoz Telmisartan HCTSDZ.20982012-11-27.2098Telmisartan/HCTZSAI.20982020-09-30.2098Telmisartan and Hydrochlorothiazide TabACH.20982014-09-25.2098Apo-Telmisartan/HCTZAPX.20982014-03-27.2098Auro-Telmisartan HCTZAUR.20982016-12-22.2098NRA-Telmisartan HCTZNRA.20982021-05-31.2098TERAZOSIN HCL08141mgTab.3938HytrinABB1996-10-01Apo-TerazosinAPX.3938.39381998-12-31.3938PMS-TerazosinPMS.3938.39382001-10-11.393808152mgTab.5005HytrinABB1996-10-01Apo-TerazosinAPX.5005.50051998-12-31.5005PMS-TerazosinPMS.5005.50052001-10-11.500508165mgTab.6797HytrinABB1996-10-01Apo-TerazosinAPX.6797.67971998-12-31.6797PMS-TerazosinPMS.6797.67972001-10-11.6797081710mgTab.9950HytrinABB1996-10-01Apo-TerazosinAPX.9950.99501998-12-31.9950PMS-TerazosinPMS.9950.99502001-10-11.9950TRANDOLAPRIL08180.5mgCapMavikBGP2018-07-31Sandoz TrandolaprilSDZ.23722018-09-27PMS-TrandolaprilPMS.23722018-07-31Teva-TrandolaprilTEV.23722018-11-29Auro-TrandolaprilAUR.23722018-11-2908191mgCapMavikBGP.76361998-12-31.1762Sandoz TrandolaprilSDZ.17622018-09-27.1762PMS-TrandolaprilPMS.17622018-07-31.1762Teva-TrandolaprilTEV.17622018-11-29.1762Auro-TrandolaprilAUR.17622018-11-29.1762TrandolaprilSAI.17622023-01-31.1762TrandolaprilSIV.17622023-01-31.176208202mgCapMavikBGP.87751998-12-31.2025Sandoz TrandolaprilSDZ.20252018-09-27.2025PMS-TrandolaprilPMS.20252018-07-31.2025Teva-TrandolaprilTEV.20252018-11-29.2025Auro-TrandolaprilAUR.20252018-11-29.2025TrandolaprilSAI.20252023-01-31.2025TrandolaprilSIV.20252023-01-31.202508214mgCapMavikBGP1.08272004-07-20.2498Sandoz TrandolaprilSDZ.24982018-09-27.2498PMS-TrandolaprilPMS.24982018-07-31.2498Teva-TrandolaprilTEV.24982018-11-29.2498Auro-TrandolaprilAUR.24982018-11-29.2498TrandolaprilSAI.24982023-01-31.2498TrandolaprilSIV.24982023-01-31.2498VALSARTAN082240mgTabDiovanNOV2011-06-08Co ValsartanCOB.58232011-08-04Teva-ValsartanTEV.58232011-06-08Sandoz ValsartanSDZ.58232011-08-04Taro-ValsartanSPC.58232011-06-08ValsartanSAI.58232020-10-30Apo-ValsartanAPX.58232011-12-15ValsartanSIV.58232021-09-30Auro-ValsartanAUR.58232014-08-28M-ValsartanMAT.58232023-01-31082380mgTabDiovanNOV1.52752003-09-04.2159Co ValsartanCOB.21592011-08-04.2159Teva-ValsartanTEV.21592011-06-08.2159Sandoz ValsartanSDZ.21592011-06-08.2159Taro-ValsartanSPC.21592011-06-08.2159ValsartanSAI.21592020-09-30.2159Apo-ValsartanAPX.21592011-12-15.2159ValsartanSIV.21592021-09-30.2159Auro-ValsartanAUR.21592014-05-29.2159M-ValsartanMAT.21592022-10-31.21590824160mgTabDiovanNOV1.52252003-09-04.2159Co ValsartanCOB.21592011-08-04.2159Teva-ValsartanTEV.21592011-06-08.2159Sandoz ValsartanSDZ.21592011-06-08.2159Taro-ValsartanSPC.21592011-06-08.2159ValsartanSAI.21592020-09-30.2159Apo-ValsartanAPX.21592011-12-15.2159ValsartanSIV.21592021-09-30.2159Auro-ValsartanAUR.21592014-05-29.2159M-ValsartanMAT.21592022-10-31.21590825320mgTabDiovanNOV1.48282008-02-12.2098Co ValsartanCOB.20982011-08-04.2098Teva-ValsartanTEV.20982011-06-08.2098Sandoz ValsartanSDZ.20982011-06-08.2098ValsartanSAI.20982020-09-30.2098Apo-ValsartanAPX.20982011-12-15.2098ValsartanSIV.20982021-09-30.2098Auro-ValsartanAUR.20982014-05-29.2098VALSARTAN & HYDROCHLOROTHIAZIDE082680mg & 12.5mgTabDiovan-HCTNOV1.51392001-03-07.2213Sandoz Valsartan HCTSDZ.22132011-06-08.2213Teva-Valsartan/HCTZTEV.22132011-06-08.2213Valsartan HCTSAI.22132020-10-30.2213Apo-Valsartan/HCTZAPX.22132012-05-29.2213Valsartan HCTSIV.22132020-07-31.2213Auro-Valsartan HCTAUR.22132013-08-29.22130827160mg & 12.5mgTabDiovan-HCTNOV1.53102001-03-07.2240Sandoz Valsartan HCTSDZ.22402011-06-08.2240Teva-Valsartan/HCTZTEV.22402011-06-08.2240Valsartan HCTSAI.22402020-10-30.2240Apo-Valsartan/HCTZAPX.22402012-05-29.2240Valsartan HCTSIV.22402020-07-31.2240Auro-Valsartan HCTAUR.22402013-08-29.22400828160mg & 25mgTabDiovan-HCTNOV1.53102003-09-04.2238Sandoz Valsartan HCTSDZ.22382011-06-08.2238Teva-Valsartan/HCTZTEV.22382011-06-08.2238Valsartan HCTSAI.22382020-10-30.2238Apo-Valsartan/HCTZAPX.22382012-05-29.2238Valsartan HCTSIV.22382020-07-31.2238Auro-Valsartan HCTAUR.22382013-08-29.22380829320mg & 12.5mgTabDiovan-HCTNOV1.52752009-03-02.2235Sandoz Valsartan HCTSDZ.22352011-06-08.2235Teva-Valsartan/HCTZTEV.22352011-06-08.2235Valsartan HCTSAI.22352020-10-30.2235Apo-Valsartan/HCTZAPX.22352012-05-29.2235Valsartan HCTSIV.22352020-07-31.2235Auro-Valsartan HCTAUR.22352013-08-29.22350830320mg & 25mgTabDiovan-HCTNOV1.52502009-03-02.2231Sandoz Valsartan HCTSDZ.22312011-06-08.2231Teva-Valsartan/HCTZTEV.22312011-06-08.2231Valsartan HCTSAI.22312020-10-30.2231Apo-Valsartan/HCTZAPX.22312012-05-29.2231Auro-Valsartan HCTAUR.22312013-08-29.2231VERAPAMIL HCL0831120mgLA TabIsoptin SRBGP2007-09-04Mylan-Verapamil SRMYL.69002007-10-03Apo-Verap SRAPX.69002007-09-040832180mgLA Tab.5204Isoptin SRBGP2.09392.09391996-10-01.5204Apo-Verap SRAPX.5204.52042004-04-06.5204Mylan-Verapamil SRMYL.5204.52042016-11-30.52040833240mgLA Tab1.7143Isoptin SRBGP2.79242.79241996-10-011.7143Mylan-Verapamil SRMYL1.71431.71432016-10-271.7143HYPOTENSIVE DRUGS (FOR DIURETICS SEE 40:28) CENTRAL ALPHA-AGONISTSGUANFACINE08341mgER TabIntuniv XRTAK3.07502020-01-311.5375Jamp Guanfacine XRJPC1.53752022-03-311.5375Apo-Guanfacine XRAPX1.53752022-03-311.537508352mgER TabIntuniv XRTAK3.74132020-01-311.8707Jamp Guanfacine XRJPC1.87072022-03-311.8707Apo-Guanfacine XRAPX1.87072022-03-311.870708363mgER TabIntuniv XRTAK4.40752020-01-312.2038Jamp Guanfacine XRJPC2.20382022-03-312.2038Apo-Guanfacine XRAPX2.20382022-03-312.203808374mgER TabIntuniv XRTAK5.07382020-01-312.5369Jamp Guanfacine XRJPC2.53692022-03-312.5369Apo-Guanfacine XRAPX2.53692022-03-312.5369For the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 to 17 years who meet the following criteria: (i) As adjunctive therapy to psychostimulants; OR (ii) As monotherapy in patients who have significant intolerance to psychostimulants AND who have had an inadequate response to either atomoxetine or other non-stimulant alternative(s).LU Authorization Period: 1 yearVASODILATING DRUGSAMBRISENTAN08385mgTabVolibrisGSK133.92472019-01-31106.3288Apo-AmbrisentanAPX106.32882019-01-31106.3288Jamp AmbrisentanJPC106.32882022-09-29106.3288Sandoz Ambrisentan TabletsSDZ106.32882022-12-21106.3288083910mgTabVolibrisGSK133.92472019-01-31106.3288Apo-AmbrisentanAPX106.32882019-01-31106.3288Jamp AmbrisentanJPC106.32882022-09-29106.3288BETAHISTINE DIHYDROCHLORIDE08408mgTabSercSPH2011-05-19Teva-BetahistineTEV.22592011-05-19.2259Auro-BetahistineAUR.20702016-02-25.2070M-BetahistineMAT.22592022-05-31.2259Mint-BetahistineMIN.22592024-01-31.2259NRA-BetahistineNRA.22592024-08-30.2259084116mgTabSercBGP2007-09-04Teva-BetahistineTEV.35572007-09-04.3557PMS-BetahistinePMS.35572014-04-30.3557Co BetahistineCOB.35572012-01-19.3557Auro-BetahistineAUR.35572016-02-25.3557BetahistineSAI.35572020-06-30.3557M-BetahistineMAT.35572022-05-31.3557Mint-BetahistineMIN.35572024-01-31.3557NRA-BetahistineNRA.35572024-08-30.3557084224mgTabSercBGP2007-09-04Teva-BetahistineTEV.49832007-09-04PMS-BetahistinePMS.49832014-04-30Co BetahistineCOB.49832012-01-19Auro-BetahistineAUR.49832016-02-25BetahistineSAI.49832020-06-30M-BetahistineMAT.49832022-05-31Mint-BetahistineMIN.49832024-01-31NRA-BetahistineNRA.49832024-08-30BOSENTAN MONOHYDRATE084362.5mgTabTracleerJAN88.87252012-07-2732.0893PMS-BosentanPMS32.08932012-07-2732.0893Co BosentanCOB32.08932012-07-2732.0893Sandoz BosentanSDZ32.08932012-07-2732.0893Apo-BosentanAPX32.08932014-10-2932.0893Nat-BosentanNAT32.08932019-01-3132.0893Taro-BosentanTAR32.08932020-05-2932.08930844125mgTabTracleerJAN88.87252012-07-2732.0893PMS-BosentanPMS32.08932012-07-2732.0893Co BosentanCOB32.08932012-07-2732.0893Sandoz BosentanSDZ32.08932012-07-2732.0893Apo-BosentanAPX32.08932014-10-2932.0893Nat-BosentanNAT32.08932019-01-3132.0893Taro-BosentanTAR32.08932020-05-2932.0893DIPYRIDAMOLE084525mgTabPersantineBOE2009-03-02Apo-DipyridamoleAPX.26332009-03-02084650mgTabPersantineBOE2009-03-02Apo-DipyridamoleAPX.36852009-03-02.3685084775mgTabPersantineBOE2009-03-02Apo-DipyridamoleAPX.49632009-03-02DIPYRIDAMOLE & ACETYLSALICYLIC ACID0848200mg/25mgCapAggrenoxBOE2001-10-11Taro-Dipyridamole/ASATAR.66562019-01-31.6656For the secondary prevention of stroke.LU Authorization Period: IndefiniteISOSORBIDE DINITRATE08495mgSL TabISDNAAP.06331996-10-01.0633IsordilWAY1997-02-04085010mgTabISDNAAP.04851996-10-01.0485IsordilWAY1996-10-01085130mgTabISDNAAP.11351996-10-01.1135IsordilWAY1996-10-01ISOSORBIDE-5-MONONITRATE085260mgER TabImdurAZC2008-06-27Apo-ISMNAPX.49502008-06-27.4950PMS-ISMNPMS.49502008-08-28.4950NIMODIPINE085330mgTabNimotopLXO10.30062011-10-2510.3006As adjunctive therapy to improve the neurologic outcome following subarachnoid haemorrhage during the acute management period (within 4 days of haemorrhage).LU Authorization Period: 1 yearAs prophylaxis of ischemia if surgery is delayed.LU Authorization Period: 1 yearNITROGLYCERIN08540.4mg/Hr/20 Sq CmPatchTransderm-NitroNOV1.00101996-12-191.001008550.6mg/Hr/30 Sq CmPatchTransderm-NitroNOV1.02901997-04-101.029008560.4mg/Hr/14 Sq CmPatchTrinipatchPPI.89501999-04-15.895008570.6mg/Hr/21 Sq CmPatchTrinipatchPPI.89501999-04-15.895008580.3mgSL TabNitrostatUJC.18881996-10-01.188808590.6mgSL TabNitrostatUJC.18881996-10-01.188808600.4mg/Metered DoseSp-180 Dose PkNitrolingual PumpsprayJUN8.42002023-11-308.420008610.4mg/Metered DoseSp-75 Dose PkNitrolingual PumpspraySAC9.40002024-01-319.400008620.4mg/Metered DoseSpray-200 Dose PkNitrolingualAVE1996-10-01Mylan-Nitro Sublingual SprayMYL8.46002003-01-308.460008630.4mg/Metered DoseSpray-200 Dose PkNitrolingual Pump SpraySAV16.00001999-04-158.4200Rho-Nitro PumpspraySDZ8.42002014-06-268.420008640.2mg/HrTransdermal PatchNitro-Dur 0.2DRR2013-11-28Mylan-Nitro 0.2MYL.46872013-11-2808650.4mg/HrTransdermal PatchNitro-DurDRR.50401996-10-01.5040Mylan-Nitro 0.4MYL.50402013-11-28.504008660.6mg/HrTransdermal PatchNitro-DurDRR.50401996-10-01.5040Mylan-Nitro 0.6MYL.50402013-11-28.504008670.8mg/HrTransdermal PatchNitro-Dur 0.8DRR2013-11-28Mylan-Nitro 0.8MYL.95592013-11-28RIOCIGUAT08680.5mgTabAdempasBAH43.72002024-06-2824.0460Sandoz RiociguatSDZ24.04602024-06-2824.046008691.5mgTabAdempasBAH43.72002024-06-2824.0460Sandoz RiociguatSDZ24.04602024-06-2824.046008701mgTabAdempasBAH43.72002024-06-2824.0460Sandoz RiociguatSDZ24.04602024-06-2824.046008712.5mgTabAdempasBAH43.72002024-06-2824.0460Sandoz RiociguatSDZ24.04602024-06-2824.046008722mgTabAdempasBAH43.72002024-06-2824.0460Sandoz RiociguatSDZ24.04602024-06-2824.0460TADALAFIL08732.5mgTabCialisLIL2016-09-29PMS-TadalafilPMS3.64712016-09-293.6471Mylan-TadalafilMYL3.64712016-09-293.6471Apo-TadalafilAPX3.64702016-09-293.6470Act TadalafilACV3.64712016-09-293.6471Auro-TadalafilAUR3.64702016-09-293.6470Teva-TadalafilTEV3.86162016-10-273.8616Jamp-TadalafilJPC3.64712016-09-293.6471Ran-TadalafilRAN3.64712016-09-293.6471Mar-TadalafilMAR3.64712016-09-293.6471PRZ-TadalafilPRZ3.64702022-02-283.6470TadalafilSIV3.86162024-10-313.861608745mgTabCialisLIL2016-09-29PMS-TadalafilPMS3.64712016-09-293.6471Mylan-TadalafilMYL3.64712016-09-293.6471Apo-TadalafilAPX3.64702016-09-293.6470Act TadalafilACV3.64712016-09-293.6471Auro-TadalafilAUR3.64712016-09-293.6471Teva-TadalafilTEV3.86162016-10-273.8616Mint-TadalafilMIN3.64722016-09-293.6472Jamp-TadalafilJPC3.64712016-09-293.6471Ran-TadalafilRAN3.64712016-09-293.6471Mar-TadalafilMAR3.64712016-09-293.6471Priva-TadalafilNRA3.64712022-08-313.6471Riva-TadalafilRIA3.64712021-08-313.6471TadalafilSAI3.64712021-02-263.6471M-TadalafilMAT3.64702021-11-303.6470PRZ-TadalafilPRZ3.64712022-02-283.6471Ach-TadalafilACH3.64702023-05-313.6470NRA-TadalafilNRA3.64712022-12-213.6471TadalafilSIV3.86162024-10-313.8616087510mgTabCialisLIL2016-09-29PMS-TadalafilPMS11.92552016-09-2911.9255Mylan-TadalafilMYL11.92552016-09-2911.9255Apo-TadalafilAPX11.92502016-09-2911.9250Act TadalafilACV11.92552016-09-2911.9255Auro-TadalafilAUR11.92502016-09-2911.9250Teva-TadalafilTEV12.62702016-10-2712.6270Mint-TadalafilMIN11.92552023-08-3111.9255Jamp-TadalafilJPC11.92552016-09-2911.9255Ran-TadalafilRAN11.92552016-09-2911.9255Mar-TadalafilMAR11.92502016-09-2911.9250Priva-TadalafilNRA11.92502022-08-3111.9250TadalafilSAI11.92502021-02-2611.9250M-TadalafilMAT11.92502021-11-3011.9250PRZ-TadalafilPRZ11.92502022-02-2811.9250Ach-TadalafilACH11.92502023-05-3111.9250TadalafilSIV12.62702024-10-3112.6270087620mgTabAdcircaLIL15.35662015-12-2211.4725Apo-Tadalafil PAHAPX11.47252015-12-2211.4725087720mgTabCialisLIL2016-09-29PMS-TadalafilPMS12.35692016-09-2912.3569Mylan-TadalafilMYL12.35692016-09-2912.3569Apo-TadalafilAPX12.35752016-09-2912.3575Act TadalafilACV12.35692016-09-2912.3569Auro-TadalafilAUR12.35752016-09-2912.3575Teva-TadalafilTEV13.08382016-10-2713.0838Mint-TadalafilMIN12.35762016-09-2912.3576Jamp-TadalafilJPC12.35692016-09-2912.3569Ran-TadalafilRAN12.35692016-09-2912.3569Mar-TadalafilMAR12.35752016-09-2912.3575Priva-TadalafilNRA12.35752022-08-3112.3575Riva-TadalafilRIA12.35692021-08-3112.3569TadalafilSAI12.35692021-02-2612.3569AG-TadalafilANG12.35692021-09-3012.3569M-TadalafilMAT12.35752021-11-3012.3575PRZ-TadalafilPRZ12.35752022-02-2812.3575Ach-TadalafilACH12.35752023-05-3112.3575NRA-TadalafilNRA12.35752022-12-2112.3575TadalafilSIV13.08382024-10-3113.0838VARDENAFIL HCL087810mgOrally Disintergrating TabStaxynBAH2019-09-30Jamp-Vardenafil ODTJPC5.87782019-09-3008795mgTabLevitraBAY2018-12-21Mylan-VardenafilMYL9.32032018-12-21Apo-VardenafilAPX9.32032019-01-31Jamp-Vardenafil IRJPC9.32032018-12-21088010mgTabLevitraBAY2018-12-21Mylan-VardenafilMYL10.39762018-12-21Apo-VardenafilAPX10.39762019-01-31Jamp-Vardenafil IRJPC10.40192018-12-21VardenafilSAI10.39762021-12-17088120mgTabLevitraBAY2018-12-21Mylan-VardenafilMYL11.68112018-12-21Apo-VardenafilAPX11.68112019-01-31Jamp-Vardenafil IRJPC11.68112018-12-21VardenafilSAI11.68112021-12-17VERICIGUAT08822.5mgTabVerquvoBAH4.83002024-09-274.830008835mgTabVerquvoBAH4.83002024-09-274.8300088410mgTabVerquvoBAH4.83002024-09-274.8300For the treatment of symptomatic chronic heart failure (HF) as an adjunct to standard-of-care therapy in adult patients with reduced ejection fraction who are stabilized after a recent HF decompensation event, if all the following conditions are met: (a) Left ventricular ejection fraction (LVEF) less than 45%; (b) New York Heart Association (NYHA) class II to IV symptoms; (c) HF decompensation event requiring hospitalization within the previous 6 months and/or intravenous diuretic treatment for HF (without hospitalization) within the previous 3 months; (d) Vericiquat is used in combination with standard-of-care* HF therapy; and (e) Initiated under the supervision of a prescriber who is experienced in the management of HF. * Standard-of-care HF therapy includes one medication from each of the following categories, unless there is a contraindication or intolerance: (a) angiotensin receptor-neprilysin inhibitor (ARNI) or angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB); (b) beta blocker; (c) mineralocorticoid receptor antagonist (MRA); and (d) sodium-glucose cotransporter-2 (SGLT2) inhibitorLU Authorization Period: IndefiniteRENIN-ANGIOTENSIN ALDOSTERONE INHIBITORS ANGIOTENSIN II RECEPTOR ANTAGONISTSAZILSARTAN MEDOXOMIL088540mgTabEdarbiBHC2025-04-30Auro-Azilsartan MedoxomilAUR1.11772025-04-30088680mgTabEdarbiBHC2025-04-30Auro-Azilsartan MedoxomilAUR1.11772025-04-30SACUBITRIL & VALSARTAN088724.3mg & 25.7mgTabEntrestoNOV3.70602017-04-271.8530Sandoz Sacubitril-ValsartanSDZ1.85302026-03-311.8530PMS-Sacubitril-ValsartanPMS1.85302026-03-311.8530088848.6mg & 51.4mgTabEntrestoNOV3.70602017-04-271.8530Sandoz Sacubitril-ValsartanSDZ1.85302026-03-311.8530PMS-Sacubitril-ValsartanPMS1.85302026-03-311.8530088997.2mg & 102.8mgTabEntrestoNOV3.70602017-04-271.8530Sandoz Sacubitril-ValsartanSDZ1.85302026-03-311.8530PMS-Sacubitril-ValsartanPMS1.85302026-03-311.8530For the treatment of heart failure (HF) with reduced ejection fraction in patients with New York Heart Association (NYHA) class II or III HF to reduce the incidence of cardiovascular (CV) death and HF hospitalization, if all of the following clinical criteria are met: - Reduced left ventricular ejection fraction (LVEF) (Less than 40%); - Patient has NYHA class II to III symptoms despite at least four weeks of treatment with a stable dose of an angiotensin-converting enzyme inhibitor (ACEI) or an angiotensin II receptor antagonist (ARB); and - In combination with a beta blocker and other recommended therapies, including an aldosterone antagonist (if tolerable).LU Authorization Period: IndefiniteRENIN-ANGIOTENSIN ALDOSTERONE INHIBITORS ALDOSTERONE ANTAGONISFINERENONE089010mgTabKerendiaBAH3.25652024-03-283.2565089120mgTabKerendiaBAH3.25652024-03-283.2565For use as an adjunct to standard-of-care (SOC) therapy in adult patients diagnosed with BOTH chronic kidney disease (CKD) and type 2 diabetes (T2D) to reduce the risk of end-stage kidney disease and a sustained decrease in estimated glomerular filtration rate (eGFR), and cardiovascular death, nonfatal myocardial infarction, and hospitalization for heart failure in patients who meet the following criteria: 1. 18 years of age or older; AND 2. Diagnosed with CKD with an eGFR level greater than or equal to 25mL/min/1.73 square metres AND an albuminuria level greater than or equal to 30mg/g (or 3mg/mmol); AND 3. Patient is also diagnosed with T2D; AND 4. Finerenone is prescribed in addition to standard-of-care (SOC)* therapy for patients diagnosed with CKD with comorbid T2D; AND * SOC therapy is defined as maximally tolerated doses of angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) therapy in combination with a sodium-glucose cotransporter-2 (SGLT2) inhibitor unless SGLT2 inhibitors are contraindicated or not tolerated. 5. Patient does not have a diagnosis of chronic heart failure (CHF) with reduced ejection fraction and persistent symptoms meeting New York Heart Association Class II to IV; AND 6. Patient is not using finerenone in combination with another mineralocorticoid receptor antagonist (MRA); AND 7. Finerenone is prescribed in consultation with a nephrologist or other clinician with experience in the diagnosis and management of patients with CKD and T2D. Discontinuation Criteria: Patients meeting the initiation criteria and started on finerenone should be discontinued on treatment if the patient's eGFR is less than 15mL/min/1.73 square metres and/or if the urinary albumin-to-creatinine ratio (UACR) has increased from baseline level after starting treatment with finerenone. Approved Dosage: Up to 20mg once daily as per the product monographLU Authorization Period: 1 yearCENTRAL NERVOUS SYSTEM DRUGSANALGESICS NONSTEROIDAL ANTI-INFLAMMATORY AGENTSCELECOXIB0892100mgCapNSAIDs have a high rate of serious adverse effects in the elderly. When prescribing NSAIDs, the minimal effective dose for the shortest period of time should be used. In nonspecific pain and/or osteoarthritis, in the absence of joint inflammation (swelling), acetaminophen is a better first choice for analgesia. The most effective treatment to prevent NSAID-gastritis is misoprostol; although H-2 antagonists, such as ranitidine or cimetidine, are commonly used, they are not as effective. NSAIDs can significantly aggravate hypertension and congestive heart failure; ASA in doses below 1 gram per day is a better choice than other NSAID options if anti-inflammatory effects are required in patients with these conditions. Low dose ASA has additional benefits for anti-platelet indications that are not provided by other NSAIDs, and should be given in preference or in addition to other NSAIDs for patients with vascular indications.CelebrexUJC.84822000-04-17.1279Teva-CelecoxibTEV.12792015-01-28.1279PMS-CelecoxibPMS.12792015-01-28.1279Ran-CelecoxibRAN.12792015-01-28.1279Mint-CelecoxibMIN.12792015-01-28.1279Apo-CelecoxibAPX.12792015-01-28.1279Mar-CelecoxibMAR.12792015-01-28.1279Act CelecoxibACV.12792015-01-28.1279Jamp-CelecoxibJPC.12792015-01-28.1279Bio-CelecoxibBMP.12792016-02-25.1279CelecoxibSIV.12792020-06-30.1279CelecoxibSAI.12792021-03-29.1279AG-CelecoxibANG.12792020-11-30.1279Sdz CelecoxibSDZ.12792015-09-30.1279Auro-CelecoxibAUR.12792016-07-28.1279NRA-CelecoxibNRA.12792020-06-30.1279M-CelecoxibMAT.12792021-10-29.1279PMSC-CelecoxibPMS.12792022-01-31.12790893200mgCapNSAIDs have a high rate of serious adverse effects in the elderly. When prescribing NSAIDs, the minimal effective dose for the shortest period of time should be used. In nonspecific pain and/or osteoarthritis, in the absence of joint inflammation (swelling), acetaminophen is a better first choice for analgesia. The most effective treatment to prevent NSAID-gastritis is misoprostol; although H-2 antagonists, such as ranitidine or cimetidine, are commonly used, they are not as effective. NSAIDs can significantly aggravate hypertension and congestive heart failure; ASA in doses below 1 gram per day is a better choice than other NSAID options if anti-inflammatory effects are required in patients with these conditions. Low dose ASA has additional benefits for anti-platelet indications that are not provided by other NSAIDs, and should be given in preference or in addition to other NSAIDs for patients with vascular indications.CelebrexUJC1.69662000-04-17.2558Teva-CelecoxibTEV.25582015-01-28.2558PMS-CelecoxibPMS.25582015-01-28.2558Ran-CelecoxibRAN.25582015-01-28.2558Mint-CelecoxibMIN.25582015-01-28.2558Apo-CelecoxibAPX.25582015-01-28.2558Mar-CelecoxibMAR.25582015-01-28.2558Act CelecoxibACV.25582015-01-28.2558Jamp-CelecoxibJPC.25582015-01-28.2558Bio-CelecoxibBMP.25582016-02-25.2558CelecoxibSIV.25582020-06-30.2558CelecoxibSAI.25582021-03-29.2558AG-CelecoxibANG.25582020-11-30.2558Sdz CelecoxibSDZ.25582015-09-30.2558Auro-CelecoxibAUR.25582016-07-28.2558NRA-CelecoxibNRA.25582020-06-30.2558M-CelecoxibMAT.25582021-10-29.2558PMSC-CelecoxibPMS.25582022-06-30.2558OsteoarthritisFor patients who have failed an adequate trial of acetaminophen (e.g. acetaminophen 1g QID for several weeks) and have had:History of a documented, clinically significant ulcer or GI bleed; or Failure or intolerance to at least three listed NSAIDS.The maximum daily dose of celecoxib which will be reimbursed for the treatment of osteoarthritis is 200mg.LU Authorization Period: 1 yearRheumatoid arthritisFor patients who have had:History of a documented, clinically significant ulcer or GI bleed; or Failure or intolerance to at least three listed NSAIDS.The maximum daily dose of celecoxib which will be reimbursed for the treatment of rheumatoid arthritis is 400mg.LU Authorization Period: 1 yearDICLOFENAC POTASSIUM089450mgTabNSAIDs have a high rate of serious adverse effects in the elderly. When prescribing NSAIDs, the minimal effective dose for the shortest period of time should be used. In nonspecific pain and/or osteoarthritis, in the absence of joint inflammation (swelling), acetaminophen is a better first choice for analgesia. The most effective treatment to prevent NSAID-gastritis is misoprostol; although H-2 antagonists, such as ranitidine or cimetidine, are commonly used, they are not as effective. NSAIDs can significantly aggravate hypertension and congestive heart failure; ASA in doses below 1 gram per day is a better choice than other NSAID options if anti-inflammatory effects are required in patients with these conditions. Low dose ASA has additional benefits for anti-platelet indications that are not provided by other NSAIDs, and should be given in preference or in addition to other NSAIDs for patients with vascular indications.Voltaren RapideNOV2008-01-15Teva-Diclofenac-KTEV.39372008-01-15Apo-Diclo RapideAPX.39372008-01-15Sandoz Diclofenac RapideSDZ.45822008-01-15DICLOFENAC SODIUM089525mgEnt TabNSAIDs have a high rate of serious adverse effects in the elderly. When prescribing NSAIDs, the minimal effective dose for the shortest period of time should be used. In nonspecific pain and/or osteoarthritis, in the absence of joint inflammation (swelling), acetaminophen is a better first choice for analgesia. The most effective treatment to prevent NSAID-gastritis is misoprostol; although H-2 antagonists, such as ranitidine or cimetidine, are commonly used, they are not as effective. NSAIDs can significantly aggravate hypertension and congestive heart failure; ASA in doses below 1 gram per day is a better choice than other NSAID options if anti-inflammatory effects are required in patients with these conditions. Low dose ASA has additional benefits for anti-platelet indications that are not provided by other NSAIDs, and should be given in preference or in addition to other NSAIDs for patients with vascular indications.VoltarenGEI1996-10-01Apo-DicloAPX.15631996-10-01.1563PMS-DiclofenacPMS.15632008-10-01.1563089650mgEnt TabNSAIDs have a high rate of serious adverse effects in the elderly. When prescribing NSAIDs, the minimal effective dose for the shortest period of time should be used. In nonspecific pain and/or osteoarthritis, in the absence of joint inflammation (swelling), acetaminophen is a better first choice for analgesia. The most effective treatment to prevent NSAID-gastritis is misoprostol; although H-2 antagonists, such as ranitidine or cimetidine, are commonly used, they are not as effective. NSAIDs can significantly aggravate hypertension and congestive heart failure; ASA in doses below 1 gram per day is a better choice than other NSAID options if anti-inflammatory effects are required in patients with these conditions. Low dose ASA has additional benefits for anti-platelet indications that are not provided by other NSAIDs, and should be given in preference or in addition to other NSAIDs for patients with vascular indications.VoltarenNOV1.13841996-10-01.2064Teva-DiclofenacTEV.20641996-10-01.2064Apo-DicloAPX.20641996-10-01.2064Sandoz DiclofenacSDZ.20642012-01-19.2064PMS-DiclofenacPMS.20642008-10-01.2064089775mgLA TabNSAIDs have a high rate of serious adverse effects in the elderly. When prescribing NSAIDs, the minimal effective dose for the shortest period of time should be used. In nonspecific pain and/or osteoarthritis, in the absence of joint inflammation (swelling), acetaminophen is a better first choice for analgesia. The most effective treatment to prevent NSAID-gastritis is misoprostol; although H-2 antagonists, such as ranitidine or cimetidine, are commonly used, they are not as effective. NSAIDs can significantly aggravate hypertension and congestive heart failure; ASA in doses below 1 gram per day is a better choice than other NSAID options if anti-inflammatory effects are required in patients with these conditions. Low dose ASA has additional benefits for anti-platelet indications that are not provided by other NSAIDs, and should be given in preference or in addition to other NSAIDs for patients with vascular indications.Voltaren SRNOV1998-08-26Apo-Diclo SRAPX.76991998-12-31.76990898100mgLA TabNSAIDs have a high rate of serious adverse effects in the elderly. When prescribing NSAIDs, the minimal effective dose for the shortest period of time should be used. In nonspecific pain and/or osteoarthritis, in the absence of joint inflammation (swelling), acetaminophen is a better first choice for analgesia. The most effective treatment to prevent NSAID-gastritis is misoprostol; although H-2 antagonists, such as ranitidine or cimetidine, are commonly used, they are not as effective. NSAIDs can significantly aggravate hypertension and congestive heart failure; ASA in doses below 1 gram per day is a better choice than other NSAID options if anti-inflammatory effects are required in patients with these conditions. Low dose ASA has additional benefits for anti-platelet indications that are not provided by other NSAIDs, and should be given in preference or in addition to other NSAIDs for patients with vascular indications.Voltaren SRNOV1998-08-26Apo-Diclo SRAPX1.10531998-12-311.1053089950mgSupNSAIDs have a high rate of serious adverse effects in the elderly. When prescribing NSAIDs, the minimal effective dose for the shortest period of time should be used. In nonspecific pain and/or osteoarthritis, in the absence of joint inflammation (swelling), acetaminophen is a better first choice for analgesia. The most effective treatment to prevent NSAID-gastritis is misoprostol; although H-2 antagonists, such as ranitidine or cimetidine, are commonly used, they are not as effective. NSAIDs can significantly aggravate hypertension and congestive heart failure; ASA in doses below 1 gram per day is a better choice than other NSAID options if anti-inflammatory effects are required in patients with these conditions. Low dose ASA has additional benefits for anti-platelet indications that are not provided by other NSAIDs, and should be given in preference or in addition to other NSAIDs for patients with vascular indications.VoltarenNOV2.01301996-10-011.2818Sandoz DiclofenacSDZ1.28182009-03-021.28180900100mgSupNSAIDs have a high rate of serious adverse effects in the elderly. When prescribing NSAIDs, the minimal effective dose for the shortest period of time should be used. In nonspecific pain and/or osteoarthritis, in the absence of joint inflammation (swelling), acetaminophen is a better first choice for analgesia. The most effective treatment to prevent NSAID-gastritis is misoprostol; although H-2 antagonists, such as ranitidine or cimetidine, are commonly used, they are not as effective. NSAIDs can significantly aggravate hypertension and congestive heart failure; ASA in doses below 1 gram per day is a better choice than other NSAID options if anti-inflammatory effects are required in patients with these conditions. Low dose ASA has additional benefits for anti-platelet indications that are not provided by other NSAIDs, and should be given in preference or in addition to other NSAIDs for patients with vascular indications.VoltarenNOV1996-10-01Sandoz DiclofenacSDZ.58402009-03-02.584009011.5% W/WTop SolPennsaidPAL2014-10-29PMS-DiclofenacPMS.62272015-01-28Taro-DiclofenacTAR.62262014-10-29Diclofenac Topical SolutionSTE.62262018-06-29Jamp-DiclofenacJPC.62262018-06-29DICLOFENAC SODIUM & MISOPROSTOL090250mg & 200mcgTabNSAIDs have a high rate of serious adverse effects in the elderly. When prescribing NSAIDs, the minimal effective dose for the shortest period of time should be used. In nonspecific pain and/or osteoarthritis, in the absence of joint inflammation (swelling), acetaminophen is a better first choice for analgesia. The most effective treatment to prevent NSAID-gastritis is misoprostol; although H-2 antagonists, such as ranitidine or cimetidine, are commonly used, they are not as effective. NSAIDs can significantly aggravate hypertension and congestive heart failure; ASA in doses below 1 gram per day is a better choice than other NSAID options if anti-inflammatory effects are required in patients with these conditions. Low dose ASA has additional benefits for anti-platelet indications that are not provided by other NSAIDs, and should be given in preference or in addition to other NSAIDs for patients with vascular indications.Arthrotec 50PFI.76431996-10-01.3149Gd-Diclofenac/Misoprostol 50GEM.31492015-03-31.3149PMS-Diclofenac-MisoprostolPMS.31492021-01-29.3149090375mg & 200mcgTabNSAIDs have a high rate of serious adverse effects in the elderly. When prescribing NSAIDs, the minimal effective dose for the shortest period of time should be used. In nonspecific pain and/or osteoarthritis, in the absence of joint inflammation (swelling), acetaminophen is a better first choice for analgesia. The most effective treatment to prevent NSAID-gastritis is misoprostol; although H-2 antagonists, such as ranitidine or cimetidine, are commonly used, they are not as effective. NSAIDs can significantly aggravate hypertension and congestive heart failure; ASA in doses below 1 gram per day is a better choice than other NSAID options if anti-inflammatory effects are required in patients with these conditions. Low dose ASA has additional benefits for anti-platelet indications that are not provided by other NSAIDs, and should be given in preference or in addition to other NSAIDs for patients with vascular indications.Arthrotec 75PFI1.04021997-08-28.4286Gd-Diclofenac/Misoprostol 75GEM.42862015-03-31.4286PMS-Diclofenac-MisoprostolPMS.42862021-01-29.4286FLURBIPROFEN090450mgTabNSAIDs have a high rate of serious adverse effects in the elderly. When prescribing NSAIDs, the minimal effective dose for the shortest period of time should be used. In nonspecific pain and/or osteoarthritis, in the absence of joint inflammation (swelling), acetaminophen is a better first choice for analgesia. The most effective treatment to prevent NSAID-gastritis is misoprostol; although H-2 antagonists, such as ranitidine or cimetidine, are commonly used, they are not as effective. NSAIDs can significantly aggravate hypertension and congestive heart failure; ASA in doses below 1 gram per day is a better choice than other NSAID options if anti-inflammatory effects are required in patients with these conditions. Low dose ASA has additional benefits for anti-platelet indications that are not provided by other NSAIDs, and should be given in preference or in addition to other NSAIDs for patients with vascular indications.AnsaidPFI1996-10-01FlurbiprofenAAP.45301996-10-01.45300905100mgTabNSAIDs have a high rate of serious adverse effects in the elderly. When prescribing NSAIDs, the minimal effective dose for the shortest period of time should be used. In nonspecific pain and/or osteoarthritis, in the absence of joint inflammation (swelling), acetaminophen is a better first choice for analgesia. The most effective treatment to prevent NSAID-gastritis is misoprostol; although H-2 antagonists, such as ranitidine or cimetidine, are commonly used, they are not as effective. NSAIDs can significantly aggravate hypertension and congestive heart failure; ASA in doses below 1 gram per day is a better choice than other NSAID options if anti-inflammatory effects are required in patients with these conditions. Low dose ASA has additional benefits for anti-platelet indications that are not provided by other NSAIDs, and should be given in preference or in addition to other NSAIDs for patients with vascular indications.AnsaidPFI1996-10-01FlurbiprofenAAP.59301996-10-01.5930IBUPROFEN0906200mgTabNSAIDs have a high rate of serious adverse effects in the elderly. When prescribing NSAIDs, the minimal effective dose for the shortest period of time should be used. In nonspecific pain and/or osteoarthritis, in the absence of joint inflammation (swelling), acetaminophen is a better first choice for analgesia. The most effective treatment to prevent NSAID-gastritis is misoprostol; although H-2 antagonists, such as ranitidine or cimetidine, are commonly used, they are not as effective. NSAIDs can significantly aggravate hypertension and congestive heart failure; ASA in doses below 1 gram per day is a better choice than other NSAID options if anti-inflammatory effects are required in patients with these conditions. Low dose ASA has additional benefits for anti-platelet indications that are not provided by other NSAIDs, and should be given in preference or in addition to other NSAIDs for patients with vascular indications.MotrinUPJ2006-06-15Apo-IbuprofenAPX.03091996-10-01.0309IbuprofenJPC.03092023-02-28.03090907300mgTabNSAIDs have a high rate of serious adverse effects in the elderly. When prescribing NSAIDs, the minimal effective dose for the shortest period of time should be used. In nonspecific pain and/or osteoarthritis, in the absence of joint inflammation (swelling), acetaminophen is a better first choice for analgesia. The most effective treatment to prevent NSAID-gastritis is misoprostol; although H-2 antagonists, such as ranitidine or cimetidine, are commonly used, they are not as effective. NSAIDs can significantly aggravate hypertension and congestive heart failure; ASA in doses below 1 gram per day is a better choice than other NSAID options if anti-inflammatory effects are required in patients with these conditions. Low dose ASA has additional benefits for anti-platelet indications that are not provided by other NSAIDs, and should be given in preference or in addition to other NSAIDs for patients with vascular indications.MotrinUPJ1996-10-01Apo-IbuprofenAPX.13771996-10-01.13770908400mgTabNSAIDs have a high rate of serious adverse effects in the elderly. When prescribing NSAIDs, the minimal effective dose for the shortest period of time should be used. In nonspecific pain and/or osteoarthritis, in the absence of joint inflammation (swelling), acetaminophen is a better first choice for analgesia. The most effective treatment to prevent NSAID-gastritis is misoprostol; although H-2 antagonists, such as ranitidine or cimetidine, are commonly used, they are not as effective. NSAIDs can significantly aggravate hypertension and congestive heart failure; ASA in doses below 1 gram per day is a better choice than other NSAID options if anti-inflammatory effects are required in patients with these conditions. Low dose ASA has additional benefits for anti-platelet indications that are not provided by other NSAIDs, and should be given in preference or in addition to other NSAIDs for patients with vascular indications.MotrinUPJ.18711996-10-01.0468Apo-IbuprofenAPX.04681996-10-01.0468IbuprofenJPC.04682023-02-28.04680909600mgTabNSAIDs have a high rate of serious adverse effects in the elderly. When prescribing NSAIDs, the minimal effective dose for the shortest period of time should be used. In nonspecific pain and/or osteoarthritis, in the absence of joint inflammation (swelling), acetaminophen is a better first choice for analgesia. The most effective treatment to prevent NSAID-gastritis is misoprostol; although H-2 antagonists, such as ranitidine or cimetidine, are commonly used, they are not as effective. NSAIDs can significantly aggravate hypertension and congestive heart failure; ASA in doses below 1 gram per day is a better choice than other NSAID options if anti-inflammatory effects are required in patients with these conditions. Low dose ASA has additional benefits for anti-platelet indications that are not provided by other NSAIDs, and should be given in preference or in addition to other NSAIDs for patients with vascular indications.MotrinUPJ1996-10-01Apo-IbuprofenAPX.13131996-10-01.1313Novo-ProfenNOP.13131996-10-01.1313INDOMETHACIN091025mgCapNSAIDs have a high rate of serious adverse effects in the elderly. When prescribing NSAIDs, the minimal effective dose for the shortest period of time should be used. In nonspecific pain and/or osteoarthritis, in the absence of joint inflammation (swelling), acetaminophen is a better first choice for analgesia. The most effective treatment to prevent NSAID-gastritis is misoprostol; although H-2 antagonists, such as ranitidine or cimetidine, are commonly used, they are not as effective. NSAIDs can significantly aggravate hypertension and congestive heart failure; ASA in doses below 1 gram per day is a better choice than other NSAID options if anti-inflammatory effects are required in patients with these conditions. Low dose ASA has additional benefits for anti-platelet indications that are not provided by other NSAIDs, and should be given in preference or in addition to other NSAIDs for patients with vascular indications.IndocidMSD1996-10-01Teva-IndomethacinTEV.15191996-10-01.1519Mint-IndomethacinMIN.15192017-06-29.1519091150mgCapNSAIDs have a high rate of serious adverse effects in the elderly. When prescribing NSAIDs, the minimal effective dose for the shortest period of time should be used. In nonspecific pain and/or osteoarthritis, in the absence of joint inflammation (swelling), acetaminophen is a better first choice for analgesia. The most effective treatment to prevent NSAID-gastritis is misoprostol; although H-2 antagonists, such as ranitidine or cimetidine, are commonly used, they are not as effective. NSAIDs can significantly aggravate hypertension and congestive heart failure; ASA in doses below 1 gram per day is a better choice than other NSAID options if anti-inflammatory effects are required in patients with these conditions. Low dose ASA has additional benefits for anti-platelet indications that are not provided by other NSAIDs, and should be given in preference or in addition to other NSAIDs for patients with vascular indications.IndocidMSD1996-10-01Teva-IndomethacinTEV.24691996-10-01.2469Mint-IndomethacinMIN.24692017-06-29.2469091250mgSupNSAIDs have a high rate of serious adverse effects in the elderly. When prescribing NSAIDs, the minimal effective dose for the shortest period of time should be used. In nonspecific pain and/or osteoarthritis, in the absence of joint inflammation (swelling), acetaminophen is a better first choice for analgesia. The most effective treatment to prevent NSAID-gastritis is misoprostol; although H-2 antagonists, such as ranitidine or cimetidine, are commonly used, they are not as effective. NSAIDs can significantly aggravate hypertension and congestive heart failure; ASA in doses below 1 gram per day is a better choice than other NSAID options if anti-inflammatory effects are required in patients with these conditions. Low dose ASA has additional benefits for anti-platelet indications that are not provided by other NSAIDs, and should be given in preference or in addition to other NSAIDs for patients with vascular indications.IndocidMSD1996-10-01Odan-IndomethacinODN1.25001999-04-151.25000913100mgSupNSAIDs have a high rate of serious adverse effects in the elderly. When prescribing NSAIDs, the minimal effective dose for the shortest period of time should be used. In nonspecific pain and/or osteoarthritis, in the absence of joint inflammation (swelling), acetaminophen is a better first choice for analgesia. The most effective treatment to prevent NSAID-gastritis is misoprostol; although H-2 antagonists, such as ranitidine or cimetidine, are commonly used, they are not as effective. NSAIDs can significantly aggravate hypertension and congestive heart failure; ASA in doses below 1 gram per day is a better choice than other NSAID options if anti-inflammatory effects are required in patients with these conditions. Low dose ASA has additional benefits for anti-platelet indications that are not provided by other NSAIDs, and should be given in preference or in addition to other NSAIDs for patients with vascular indications.IndocidMSD1996-10-01Odan-IndomethacinODN1.65001999-04-151.6500KETOPROFEN091450mgCapNSAIDs have a high rate of serious adverse effects in the elderly. When prescribing NSAIDs, the minimal effective dose for the shortest period of time should be used. In nonspecific pain and/or osteoarthritis, in the absence of joint inflammation (swelling), acetaminophen is a better first choice for analgesia. The most effective treatment to prevent NSAID-gastritis is misoprostol; although H-2 antagonists, such as ranitidine or cimetidine, are commonly used, they are not as effective. NSAIDs can significantly aggravate hypertension and congestive heart failure; ASA in doses below 1 gram per day is a better choice than other NSAID options if anti-inflammatory effects are required in patients with these conditions. Low dose ASA has additional benefits for anti-platelet indications that are not provided by other NSAIDs, and should be given in preference or in addition to other NSAIDs for patients with vascular indications.KetoprofenAAP.34401996-10-01.3440OrudisRPP1996-10-01091550mgEnt TabNSAIDs have a high rate of serious adverse effects in the elderly. When prescribing NSAIDs, the minimal effective dose for the shortest period of time should be used. In nonspecific pain and/or osteoarthritis, in the absence of joint inflammation (swelling), acetaminophen is a better first choice for analgesia. The most effective treatment to prevent NSAID-gastritis is misoprostol; although H-2 antagonists, such as ranitidine or cimetidine, are commonly used, they are not as effective. NSAIDs can significantly aggravate hypertension and congestive heart failure; ASA in doses below 1 gram per day is a better choice than other NSAID options if anti-inflammatory effects are required in patients with these conditions. Low dose ASA has additional benefits for anti-platelet indications that are not provided by other NSAIDs, and should be given in preference or in addition to other NSAIDs for patients with vascular indications.Ketoprofen-EAAP.45031996-10-01.4503Orudis E-50RPP1996-10-010916100mgEnt TabNSAIDs have a high rate of serious adverse effects in the elderly. When prescribing NSAIDs, the minimal effective dose for the shortest period of time should be used. In nonspecific pain and/or osteoarthritis, in the absence of joint inflammation (swelling), acetaminophen is a better first choice for analgesia. The most effective treatment to prevent NSAID-gastritis is misoprostol; although H-2 antagonists, such as ranitidine or cimetidine, are commonly used, they are not as effective. NSAIDs can significantly aggravate hypertension and congestive heart failure; ASA in doses below 1 gram per day is a better choice than other NSAID options if anti-inflammatory effects are required in patients with these conditions. Low dose ASA has additional benefits for anti-platelet indications that are not provided by other NSAIDs, and should be given in preference or in addition to other NSAIDs for patients with vascular indications.Rhodis-ECSAV1996-10-01Ketoprofen-EAAP.91111996-10-01.9111Orudis E-100RPP1996-10-010917200mgLA TabNSAIDs have a high rate of serious adverse effects in the elderly. When prescribing NSAIDs, the minimal effective dose for the shortest period of time should be used. In nonspecific pain and/or osteoarthritis, in the absence of joint inflammation (swelling), acetaminophen is a better first choice for analgesia. The most effective treatment to prevent NSAID-gastritis is misoprostol; although H-2 antagonists, such as ranitidine or cimetidine, are commonly used, they are not as effective. NSAIDs can significantly aggravate hypertension and congestive heart failure; ASA in doses below 1 gram per day is a better choice than other NSAID options if anti-inflammatory effects are required in patients with these conditions. Low dose ASA has additional benefits for anti-platelet indications that are not provided by other NSAIDs, and should be given in preference or in addition to other NSAIDs for patients with vascular indications.Orudis SR-200RPP1996-10-01Ketoprofen SRAAP1.85451998-12-311.8545KETOROLAC TROMETHAMINE091810mgTabNSAIDs have a high rate of serious adverse effects in the elderly. When prescribing NSAIDs, the minimal effective dose for the shortest period of time should be used. In nonspecific pain and/or osteoarthritis, in the absence of joint inflammation (swelling), acetaminophen is a better first choice for analgesia. The most effective treatment to prevent NSAID-gastritis is misoprostol; although H-2 antagonists, such as ranitidine or cimetidine, are commonly used, they are not as effective. NSAIDs can significantly aggravate hypertension and congestive heart failure; ASA in doses below 1 gram per day is a better choice than other NSAID options if anti-inflammatory effects are required in patients with these conditions. Low dose ASA has additional benefits for anti-platelet indications that are not provided by other NSAIDs, and should be given in preference or in addition to other NSAIDs for patients with vascular indications.ToradolAAP2008-10-01Apo-KetorolacAPX.60282008-10-01Mint-KetorolacMIN.60282019-11-29Mar-KetorolacMAR.60282017-08-30Jamp KetorolacJPC.60282021-04-30MEFENAMIC ACID0919250mgCapNSAIDs have a high rate of serious adverse effects in the elderly. When prescribing NSAIDs, the minimal effective dose for the shortest period of time should be used. In nonspecific pain and/or osteoarthritis, in the absence of joint inflammation (swelling), acetaminophen is a better first choice for analgesia. The most effective treatment to prevent NSAID-gastritis is misoprostol; although H-2 antagonists, such as ranitidine or cimetidine, are commonly used, they are not as effective. NSAIDs can significantly aggravate hypertension and congestive heart failure; ASA in doses below 1 gram per day is a better choice than other NSAID options if anti-inflammatory effects are required in patients with these conditions. Low dose ASA has additional benefits for anti-platelet indications that are not provided by other NSAIDs, and should be given in preference or in addition to other NSAIDs for patients with vascular indications.PonstanAAP1996-10-01MefenamicAAP.49881997-04-10.4988MELOXICAM09207.5mgTabNSAIDs have a high rate of serious adverse effects in the elderly. When prescribing NSAIDs, the minimal effective dose for the shortest period of time should be used. In nonspecific pain and/or osteoarthritis, in the absence of joint inflammation (swelling), acetaminophen is a better first choice for analgesia. The most effective treatment to prevent NSAID-gastritis is misoprostol; although H-2 antagonists, such as ranitidine or cimetidine, are commonly used, they are not as effective. NSAIDs can significantly aggravate hypertension and congestive heart failure; ASA in doses below 1 gram per day is a better choice than other NSAID options if anti-inflammatory effects are required in patients with these conditions. Low dose ASA has additional benefits for anti-platelet indications that are not provided by other NSAIDs, and should be given in preference or in addition to other NSAIDs for patients with vascular indications.MobicoxBOE2001-03-07PMS-MeloxicamPMS.20032004-04-06.2003Apo-MeloxicamAPX.20032004-07-20.2003Co MeloxicamCOB.20032004-09-14.2003Teva-MeloxicamTEV.20032004-11-16.2003MeloxicamSAI.20032011-08-04.2003Auro-MeloxicamAUR.20032012-12-21.2003092115mgTabNSAIDs have a high rate of serious adverse effects in the elderly. When prescribing NSAIDs, the minimal effective dose for the shortest period of time should be used. In nonspecific pain and/or osteoarthritis, in the absence of joint inflammation (swelling), acetaminophen is a better first choice for analgesia. The most effective treatment to prevent NSAID-gastritis is misoprostol; although H-2 antagonists, such as ranitidine or cimetidine, are commonly used, they are not as effective. NSAIDs can significantly aggravate hypertension and congestive heart failure; ASA in doses below 1 gram per day is a better choice than other NSAID options if anti-inflammatory effects are required in patients with these conditions. Low dose ASA has additional benefits for anti-platelet indications that are not provided by other NSAIDs, and should be given in preference or in addition to other NSAIDs for patients with vascular indications.MobicoxBOE2024-08-30PMS-MeloxicamPMS.23112004-04-06.2311Apo-MeloxicamAPX.23112004-07-20.2311Co MeloxicamCOB.23112004-09-14.2311Teva-MeloxicamTEV.23112004-11-16.2311MeloxicamSAI.23112011-08-04.2311Auro-MeloxicamAUR.23112012-12-21.2311NABUMETONE0922500mgTabNSAIDs have a high rate of serious adverse effects in the elderly. When prescribing NSAIDs, the minimal effective dose for the shortest period of time should be used. In nonspecific pain and/or osteoarthritis, in the absence of joint inflammation (swelling), acetaminophen is a better first choice for analgesia. The most effective treatment to prevent NSAID-gastritis is misoprostol; although H-2 antagonists, such as ranitidine or cimetidine, are commonly used, they are not as effective. NSAIDs can significantly aggravate hypertension and congestive heart failure; ASA in doses below 1 gram per day is a better choice than other NSAID options if anti-inflammatory effects are required in patients with these conditions. Low dose ASA has additional benefits for anti-platelet indications that are not provided by other NSAIDs, and should be given in preference or in addition to other NSAIDs for patients with vascular indications.RelafenGSK2007-07-12NabumetoneAAP.73632007-09-04NAPROXEN0923250mgEnt TabNSAIDs have a high rate of serious adverse effects in the elderly. When prescribing NSAIDs, the minimal effective dose for the shortest period of time should be used. In nonspecific pain and/or osteoarthritis, in the absence of joint inflammation (swelling), acetaminophen is a better first choice for analgesia. The most effective treatment to prevent NSAID-gastritis is misoprostol; although H-2 antagonists, such as ranitidine or cimetidine, are commonly used, they are not as effective. NSAIDs can significantly aggravate hypertension and congestive heart failure; ASA in doses below 1 gram per day is a better choice than other NSAID options if anti-inflammatory effects are required in patients with these conditions. Low dose ASA has additional benefits for anti-platelet indications that are not provided by other NSAIDs, and should be given in preference or in addition to other NSAIDs for patients with vascular indications.Naprosyn EHLR2008-01-15Teva-Naproxen ECTEV.28352008-11-04Apo-Naproxen ECAPX.28352008-01-150924375mgEnt TabNSAIDs have a high rate of serious adverse effects in the elderly. When prescribing NSAIDs, the minimal effective dose for the shortest period of time should be used. In nonspecific pain and/or osteoarthritis, in the absence of joint inflammation (swelling), acetaminophen is a better first choice for analgesia. The most effective treatment to prevent NSAID-gastritis is misoprostol; although H-2 antagonists, such as ranitidine or cimetidine, are commonly used, they are not as effective. NSAIDs can significantly aggravate hypertension and congestive heart failure; ASA in doses below 1 gram per day is a better choice than other NSAID options if anti-inflammatory effects are required in patients with these conditions. Low dose ASA has additional benefits for anti-platelet indications that are not provided by other NSAIDs, and should be given in preference or in addition to other NSAIDs for patients with vascular indications.Naprosyn EHLR2008-01-15Teva-Naproxen ECTEV.36752008-11-04Apo-Naproxen ECAPX.36752008-01-150925500mgEnt TabNSAIDs have a high rate of serious adverse effects in the elderly. When prescribing NSAIDs, the minimal effective dose for the shortest period of time should be used. In nonspecific pain and/or osteoarthritis, in the absence of joint inflammation (swelling), acetaminophen is a better first choice for analgesia. The most effective treatment to prevent NSAID-gastritis is misoprostol; although H-2 antagonists, such as ranitidine or cimetidine, are commonly used, they are not as effective. NSAIDs can significantly aggravate hypertension and congestive heart failure; ASA in doses below 1 gram per day is a better choice than other NSAID options if anti-inflammatory effects are required in patients with these conditions. Low dose ASA has additional benefits for anti-platelet indications that are not provided by other NSAIDs, and should be given in preference or in addition to other NSAIDs for patients with vascular indications.Naprosyn EHLR2008-01-15Teva-Naproxen ECTEV.68942008-11-04Apo-Naproxen ECAPX.68942008-01-15092625mg/mLO/LNSAIDs have a high rate of serious adverse effects in the elderly. When prescribing NSAIDs, the minimal effective dose for the shortest period of time should be used. In nonspecific pain and/or osteoarthritis, in the absence of joint inflammation (swelling), acetaminophen is a better first choice for analgesia. The most effective treatment to prevent NSAID-gastritis is misoprostol; although H-2 antagonists, such as ranitidine or cimetidine, are commonly used, they are not as effective. NSAIDs can significantly aggravate hypertension and congestive heart failure; ASA in doses below 1 gram per day is a better choice than other NSAID options if anti-inflammatory effects are required in patients with these conditions. Low dose ASA has additional benefits for anti-platelet indications that are not provided by other NSAIDs, and should be given in preference or in addition to other NSAIDs for patients with vascular indications.Pediapharm Naproxen SuspensionMPI.09491996-10-01.09490927125mgTabNSAIDs have a high rate of serious adverse effects in the elderly. When prescribing NSAIDs, the minimal effective dose for the shortest period of time should be used. In nonspecific pain and/or osteoarthritis, in the absence of joint inflammation (swelling), acetaminophen is a better first choice for analgesia. The most effective treatment to prevent NSAID-gastritis is misoprostol; although H-2 antagonists, such as ranitidine or cimetidine, are commonly used, they are not as effective. NSAIDs can significantly aggravate hypertension and congestive heart failure; ASA in doses below 1 gram per day is a better choice than other NSAID options if anti-inflammatory effects are required in patients with these conditions. Low dose ASA has additional benefits for anti-platelet indications that are not provided by other NSAIDs, and should be given in preference or in addition to other NSAIDs for patients with vascular indications.NaprosynSYN2001-02-28Apo-NaproxenAPX.07811996-10-01.07810928250mgTabNSAIDs have a high rate of serious adverse effects in the elderly. When prescribing NSAIDs, the minimal effective dose for the shortest period of time should be used. In nonspecific pain and/or osteoarthritis, in the absence of joint inflammation (swelling), acetaminophen is a better first choice for analgesia. The most effective treatment to prevent NSAID-gastritis is misoprostol; although H-2 antagonists, such as ranitidine or cimetidine, are commonly used, they are not as effective. NSAIDs can significantly aggravate hypertension and congestive heart failure; ASA in doses below 1 gram per day is a better choice than other NSAID options if anti-inflammatory effects are required in patients with these conditions. Low dose ASA has additional benefits for anti-platelet indications that are not provided by other NSAIDs, and should be given in preference or in addition to other NSAIDs for patients with vascular indications.Apo-NaproxenAPX.10681996-10-01.1068Teva-NaproxenTEV.10681996-10-01.1068NaprosynHLR1996-10-010929375mgTabNSAIDs have a high rate of serious adverse effects in the elderly. When prescribing NSAIDs, the minimal effective dose for the shortest period of time should be used. In nonspecific pain and/or osteoarthritis, in the absence of joint inflammation (swelling), acetaminophen is a better first choice for analgesia. The most effective treatment to prevent NSAID-gastritis is misoprostol; although H-2 antagonists, such as ranitidine or cimetidine, are commonly used, they are not as effective. NSAIDs can significantly aggravate hypertension and congestive heart failure; ASA in doses below 1 gram per day is a better choice than other NSAID options if anti-inflammatory effects are required in patients with these conditions. Low dose ASA has additional benefits for anti-platelet indications that are not provided by other NSAIDs, and should be given in preference or in addition to other NSAIDs for patients with vascular indications.Apo-NaproxenAPX.14581996-10-01.1458Teva-NaproxenTEV.14581996-10-01.1458NaprosynHLR1996-10-010930500mgTabNSAIDs have a high rate of serious adverse effects in the elderly. When prescribing NSAIDs, the minimal effective dose for the shortest period of time should be used. In nonspecific pain and/or osteoarthritis, in the absence of joint inflammation (swelling), acetaminophen is a better first choice for analgesia. The most effective treatment to prevent NSAID-gastritis is misoprostol; although H-2 antagonists, such as ranitidine or cimetidine, are commonly used, they are not as effective. NSAIDs can significantly aggravate hypertension and congestive heart failure; ASA in doses below 1 gram per day is a better choice than other NSAID options if anti-inflammatory effects are required in patients with these conditions. Low dose ASA has additional benefits for anti-platelet indications that are not provided by other NSAIDs, and should be given in preference or in addition to other NSAIDs for patients with vascular indications.Teva-NaproxenTEV.45221996-10-01.4522Apo-NaproxenAPX.45221996-10-01.4522NaprosynHLR2000-04-17NAPROXEN & ESOMEPRAZOLE MAGNESIUM0931375mg & 20mgMR TabNSAIDs have a high rate of serious adverse effects in the elderly. When prescribing NSAIDs, the minimal effective dose for the shortest period of time should be used. In nonspecific pain and/or osteoarthritis, in the absence of joint inflammation (swelling), acetaminophen is a better first choice for analgesia. The most effective treatment to prevent NSAID-gastritis is misoprostol; although H-2 antagonists, such as ranitidine or cimetidine, are commonly used, they are not as effective. NSAIDs can significantly aggravate hypertension and congestive heart failure; ASA in doses below 1 gram per day is a better choice than other NSAID options if anti-inflammatory effects are required in patients with these conditions. Low dose ASA has additional benefits for anti-platelet indications that are not provided by other NSAIDs, and should be given in preference or in addition to other NSAIDs for patients with vascular indications.VimovoXED2017-04-27Mylan-Naproxen & Esomeprazole MRMYL.93082017-04-270932500mg & 20mgMR TabNSAIDs have a high rate of serious adverse effects in the elderly. When prescribing NSAIDs, the minimal effective dose for the shortest period of time should be used. In nonspecific pain and/or osteoarthritis, in the absence of joint inflammation (swelling), acetaminophen is a better first choice for analgesia. The most effective treatment to prevent NSAID-gastritis is misoprostol; although H-2 antagonists, such as ranitidine or cimetidine, are commonly used, they are not as effective. NSAIDs can significantly aggravate hypertension and congestive heart failure; ASA in doses below 1 gram per day is a better choice than other NSAID options if anti-inflammatory effects are required in patients with these conditions. Low dose ASA has additional benefits for anti-platelet indications that are not provided by other NSAIDs, and should be given in preference or in addition to other NSAIDs for patients with vascular indications.VimovoXED2017-04-27Mylan-Naproxen & Esomeprazole MRMYL.92742017-04-27NAPROXEN SODIUM0933275mgTabNSAIDs have a high rate of serious adverse effects in the elderly. When prescribing NSAIDs, the minimal effective dose for the shortest period of time should be used. In nonspecific pain and/or osteoarthritis, in the absence of joint inflammation (swelling), acetaminophen is a better first choice for analgesia. The most effective treatment to prevent NSAID-gastritis is misoprostol; although H-2 antagonists, such as ranitidine or cimetidine, are commonly used, they are not as effective. NSAIDs can significantly aggravate hypertension and congestive heart failure; ASA in doses below 1 gram per day is a better choice than other NSAID options if anti-inflammatory effects are required in patients with these conditions. Low dose ASA has additional benefits for anti-platelet indications that are not provided by other NSAIDs, and should be given in preference or in addition to other NSAIDs for patients with vascular indications.Teva-Naproxen SodiumTEV.34222022-08-31Apo-Napro-NaAPX.34222007-12-19AnaproxHLR2007-12-190934550mgTabNSAIDs have a high rate of serious adverse effects in the elderly. When prescribing NSAIDs, the minimal effective dose for the shortest period of time should be used. In nonspecific pain and/or osteoarthritis, in the absence of joint inflammation (swelling), acetaminophen is a better first choice for analgesia. The most effective treatment to prevent NSAID-gastritis is misoprostol; although H-2 antagonists, such as ranitidine or cimetidine, are commonly used, they are not as effective. NSAIDs can significantly aggravate hypertension and congestive heart failure; ASA in doses below 1 gram per day is a better choice than other NSAID options if anti-inflammatory effects are required in patients with these conditions. Low dose ASA has additional benefits for anti-platelet indications that are not provided by other NSAIDs, and should be given in preference or in addition to other NSAIDs for patients with vascular indications.Apo-Napro-Na DSAPX.66672007-12-19Teva-Naproxen Sodium DSTEV.66672022-08-31Anaprox DSHLR2007-12-19OXAPROZIN.0935600mgTabNSAIDs have a high rate of serious adverse effects in the elderly. When prescribing NSAIDs, the minimal effective dose for the shortest period of time should be used. In nonspecific pain and/or osteoarthritis, in the absence of joint inflammation (swelling), acetaminophen is a better first choice for analgesia. The most effective treatment to prevent NSAID-gastritis is misoprostol; although H-2 antagonists, such as ranitidine or cimetidine, are commonly used, they are not as effective. NSAIDs can significantly aggravate hypertension and congestive heart failure; ASA in doses below 1 gram per day is a better choice than other NSAID options if anti-inflammatory effects are required in patients with these conditions. Low dose ASA has additional benefits for anti-platelet indications that are not provided by other NSAIDs, and should be given in preference or in addition to other NSAIDs for patients with vascular indications.DayproHLR2007-07-12Apo-OxaprozinAPX.68922007-07-12PIROXICAM093610mgCapNSAIDs have a high rate of serious adverse effects in the elderly. When prescribing NSAIDs, the minimal effective dose for the shortest period of time should be used. In nonspecific pain and/or osteoarthritis, in the absence of joint inflammation (swelling), acetaminophen is a better first choice for analgesia. The most effective treatment to prevent NSAID-gastritis is misoprostol; although H-2 antagonists, such as ranitidine or cimetidine, are commonly used, they are not as effective. NSAIDs can significantly aggravate hypertension and congestive heart failure; ASA in doses below 1 gram per day is a better choice than other NSAID options if anti-inflammatory effects are required in patients with these conditions. Low dose ASA has additional benefits for anti-platelet indications that are not provided by other NSAIDs, and should be given in preference or in addition to other NSAIDs for patients with vascular indications.FeldenePFI1996-10-01Apo-PiroxicamAPX.44261996-10-01.4426Teva-PiroxicamTEV.44261996-10-01.4426093720mgCapNSAIDs have a high rate of serious adverse effects in the elderly. When prescribing NSAIDs, the minimal effective dose for the shortest period of time should be used. In nonspecific pain and/or osteoarthritis, in the absence of joint inflammation (swelling), acetaminophen is a better first choice for analgesia. The most effective treatment to prevent NSAID-gastritis is misoprostol; although H-2 antagonists, such as ranitidine or cimetidine, are commonly used, they are not as effective. NSAIDs can significantly aggravate hypertension and congestive heart failure; ASA in doses below 1 gram per day is a better choice than other NSAID options if anti-inflammatory effects are required in patients with these conditions. Low dose ASA has additional benefits for anti-platelet indications that are not provided by other NSAIDs, and should be given in preference or in addition to other NSAIDs for patients with vascular indications.FeldenePFI1996-10-01Apo-PiroxicamAPX.74221996-10-01.7422Teva-PiroxicamTEV.74221996-10-01.7422SULINDAC0938150mgTabNSAIDs have a high rate of serious adverse effects in the elderly. When prescribing NSAIDs, the minimal effective dose for the shortest period of time should be used. In nonspecific pain and/or osteoarthritis, in the absence of joint inflammation (swelling), acetaminophen is a better first choice for analgesia. The most effective treatment to prevent NSAID-gastritis is misoprostol; although H-2 antagonists, such as ranitidine or cimetidine, are commonly used, they are not as effective. NSAIDs can significantly aggravate hypertension and congestive heart failure; ASA in doses below 1 gram per day is a better choice than other NSAID options if anti-inflammatory effects are required in patients with these conditions. Low dose ASA has additional benefits for anti-platelet indications that are not provided by other NSAIDs, and should be given in preference or in addition to other NSAIDs for patients with vascular indications.ClinorilFRS1996-10-01Teva-SulindacTEV.44271996-10-01.44270939200mgTabNSAIDs have a high rate of serious adverse effects in the elderly. When prescribing NSAIDs, the minimal effective dose for the shortest period of time should be used. In nonspecific pain and/or osteoarthritis, in the absence of joint inflammation (swelling), acetaminophen is a better first choice for analgesia. The most effective treatment to prevent NSAID-gastritis is misoprostol; although H-2 antagonists, such as ranitidine or cimetidine, are commonly used, they are not as effective. NSAIDs can significantly aggravate hypertension and congestive heart failure; ASA in doses below 1 gram per day is a better choice than other NSAID options if anti-inflammatory effects are required in patients with these conditions. Low dose ASA has additional benefits for anti-platelet indications that are not provided by other NSAIDs, and should be given in preference or in addition to other NSAIDs for patients with vascular indications.ClinorilFRS1996-10-01Teva-SulindacTEV.52531996-10-01.5253TIAPROFENIC ACID0940200mgTabNSAIDs have a high rate of serious adverse effects in the elderly. When prescribing NSAIDs, the minimal effective dose for the shortest period of time should be used. In nonspecific pain and/or osteoarthritis, in the absence of joint inflammation (swelling), acetaminophen is a better first choice for analgesia. The most effective treatment to prevent NSAID-gastritis is misoprostol; although H-2 antagonists, such as ranitidine or cimetidine, are commonly used, they are not as effective. NSAIDs can significantly aggravate hypertension and congestive heart failure; ASA in doses below 1 gram per day is a better choice than other NSAID options if anti-inflammatory effects are required in patients with these conditions. Low dose ASA has additional benefits for anti-platelet indications that are not provided by other NSAIDs, and should be given in preference or in addition to other NSAIDs for patients with vascular indications.SurgamHRU1996-10-01Teva-TiaprofenicTEV.57281996-10-01.57280941300mgTabNSAIDs have a high rate of serious adverse effects in the elderly. When prescribing NSAIDs, the minimal effective dose for the shortest period of time should be used. In nonspecific pain and/or osteoarthritis, in the absence of joint inflammation (swelling), acetaminophen is a better first choice for analgesia. The most effective treatment to prevent NSAID-gastritis is misoprostol; although H-2 antagonists, such as ranitidine or cimetidine, are commonly used, they are not as effective. NSAIDs can significantly aggravate hypertension and congestive heart failure; ASA in doses below 1 gram per day is a better choice than other NSAID options if anti-inflammatory effects are required in patients with these conditions. Low dose ASA has additional benefits for anti-platelet indications that are not provided by other NSAIDs, and should be given in preference or in addition to other NSAIDs for patients with vascular indications.Teva-TiaprofenicTEV.80701996-10-01.8070SurgamSAV1999-01-07ANALGESICS OPIATE AGONISTSNarcotic analgesics can produce dependence and may be abused. Physical dependence, psychological dependence and tolerance may develop. Prescribers are cautioned about ordering these drugs for patients with a history of either emotional disturbances or drug abuse, including alcohol.ACETAMINOPHEN & CAFFEINE & CODEINE PHOSPHATE0942300mg & 15mg & 15mgTabTeva-Lenoltec No.2TEV.09331996-10-01.0933Tylenol with Codeine No. 2JAN1996-10-010943300mg & 15mg & 30mgTabTeva-Lenoltec No.3TEV.09801996-10-01.0980Tylenol with Codeine No. 3JAN1996-10-01ACETAMINOPHEN & CODEINE PHOSPHATE0944160mg & 8mg/5mLO/LPMS-Acetaminophen With CodeinePMS.13701998-12-31.1370Tylenol With Codeine ElixirJAN2007-01-020945300mg & 30mgTabTeva-Emtec-30TEV.13001996-10-01.1300Empracet-30BWE1996-10-010946300mg & 60mgTabTeva-Lenoltec No.4TEV.16851996-10-01.1685Tylenol with Codeine No. 4JAN1996-10-01ACETYLSALICYLIC ACID & BUTALBITAL & CAFFEINE0947330mg & 50mg & 40mgCapFiorinalNOV2008-12-23Teva-TecnalTEV1.61922008-12-23Apo-Butalbital-ASA-CaffeineAPX1.79392025-05-30ACETYLSALICYLIC ACID & BUTALBITAL & CAFFEINE & CODEINE PHOSPHATE0948330mg & 50mg & 40mg & 15mgCapFiorinal C1/4NOV2008-12-23Teva-Tecnal C1/4TEV1.73632008-12-23Apo-Butalbital-ASA-Caffeine-Codeine-C1/4APX1.73632025-03-310949330mg & 50mg & 40mg & 30mgCapFiorinal C1/2NOV2008-12-23Teva-Tecnal C1/2TEV2.12612008-12-23Apo-Butalbital-ASA-Caffeine-Codeine-C1/2APX2.12612025-03-31CODEINE PHOSPHATE095015mgTabTeva-CodeineTEV.05961996-10-01.0596CodeineROG1996-10-01095130mgTabTeva-CodeineTEV.09661996-10-01.0966CODEINE SULFATE TRIHYDRATE & MONOHYDRATE095250mgCR TabCodeine ContinPFP.51372002-04-04.51370953100mgCR TabCodeine ContinPFP1.02852002-04-041.02850954150mgCR TabCodeine ContinPFP1.54342002-04-041.54340955200mgCR TabCodeine ContinPFP2.05712002-04-042.0571For the treatment of chronic pain in patients who cannot tolerate, or have failed treatment with a listed long-acting opioid.LU Authorization Period: 1 yearFENTANYL TRANSDERMAL SYSTEM095612mcg/hrTrans PatchDuragesic 12JNO2008-12-23Teva-FentanylTEV3.32002008-12-233.3200Sandoz Fentanyl PatchSDZ3.32002010-03-023.3200For the treatment of chronic pain in patients who cannot tolerate, or have failed treatment with a long-acting opioid. Intolerance or failed treatment with a long-acting opioid will be subject to verification at the time of dispensing.LU Authorization Period: 1 year095712mcg/hrTrans PatchSandoz Fentanyl PatchSDZ3.32002024-09-273.3200Teva-FentanylTEV3.32002024-09-273.3200Duragesic 12JNO2024-09-27For the treatment of chronic pain in patients who have been stabilized on fentanyl and require the use of fentanyl 12mcg/hr patches for dose adjustment up or down to the lowest optimal opioid dose.LU Authorization Period: 1 year095825mcg/hrTrans PatchDuragesic 25JNO1996-10-01DuragesicJAN2010-04-23Teva-FentanylTEV8.56002007-01-028.5600Sandoz Fentanyl PatchSDZ8.56002010-03-028.5600095950mcg/hrTrans PatchDuragesic 50JNO1996-10-01DuragesicJAN2010-04-23Teva-FentanylTEV16.11002007-01-0216.1100Sandoz Fentanyl PatchSDZ16.11002010-03-0216.1100For the treatment of chronic pain in patients who cannot tolerate, or have failed treatment with a long-acting opioid. Intolerance or failed treatment with a long-acting opioid will be subject to verification at the time of dispensing.LU Authorization Period: 1 year096075mcg/hrTrans PatchDuragesic 75JNO1996-10-01DuragesicJAN2010-04-23Teva-FentanylTEV22.65002007-01-02Sandoz Fentanyl PatchSDZ22.65002010-03-020961100mcg/hrTrans PatchDuragesic 100JNO1996-10-01DuragesicJAN2010-04-23Teva-FentanylTEV28.19502007-01-02Sandoz Fentanyl PatchSDZ28.19502010-03-02HYDROMORPHONE HCL09624.5mgCR CapHydromorph ContinPFP.97492012-01-19.974909639mgCR CapHydromorph ContinPFP1.59282012-01-191.592809643mgCR CapHydromorph ContinPFP.80801998-12-31.808009656mgCR CapHydromorph ContinPFP1.20721998-12-311.2072096612mgCR CapHydromorph ContinPFP2.09901998-12-312.0990096718mgCR CapHydromorph ContinPFP3.02852002-04-043.0285096824mgCR CapHydromorph ContinPFP4.39251998-12-314.3925096930mgCR CapHydromorph ContinPFP5.26361999-09-155.263609702mg/mLInj Sol-1mL PkDilaudidPFP1996-10-01HydromorphoneSDZ1.78301996-12-191.7830097110mg/mLInj Sol-1mL PkDilaudid-HPPFP1996-10-01Hydromorphone HP-10SDZ4.34601998-12-314.346009721mg/mLOral SolDilaudidPFP1996-10-01PMS-HYDROmorphonePMS.09312006-01-24.093109731mgTabDilaudidPFP.10611996-10-01.0959PMS-HYDROmorphonePMS.09592001-10-11.0959Teva-HydromorphoneTEV.09592012-06-26.0959Apo-HydromorphoneAPX.09592012-06-26.095909742mgTabDilaudidPFP.15651996-10-01.1417PMS-HYDROmorphonePMS.14171997-04-10.1417Teva-HydromorphoneTEV.14172012-06-26.1417Apo-HydromorphoneAPX.14172012-06-26.141709754mgTabDilaudidPFP.24691996-10-01.2240PMS-HYDROmorphonePMS.22401999-04-15.2240Teva-HydromorphoneTEV.22402012-06-26.2240Apo-HydromorphoneAPX.22402012-06-26.224009768mgTabDilaudidPFP.38921996-10-01.3528PMS-HYDROmorphonePMS.35282001-10-11.3528Teva-HydromorphoneTEV.35282012-06-26.3528Apo-HydromorphoneAPX.35282012-06-26.3528METHADONE HCL097710mg/mLOral ConcentrateFor methadone maintenance treatment for addiction.Metadol-DPAL.16392017-01-31.1639097810mg/mLOral Concentrate (Cherry Flavour)For methadone maintenance treatment for addiction.MethadoseMAL.05252014-06-26.0525Odan-MethadoneODN.05252022-11-30.0525PMS-Methadone HCl Oral ConcentratePMS.05252025-08-29.0525097910mg/mLOral Concentrate (Unflavoured)For methadone maintenance treatment for addiction.MethadoseMAL.05252014-06-26.0525Jamp Methadone Oral ConcentrateJPC.05252022-08-31.0525Odan-MethadoneODN.05252022-08-31.0525PMS-Methadone HCl Oral ConcentratePMS.05252025-08-29.052509801mgTabMetadolPMS.13992024-04-30.1026Apo-MethadoneAPX.10262024-04-30.102609815mgTabMetadolPMS.46592024-04-30.3417Apo-MethadoneAPX.34172024-04-30.3417098210mgTabMetadolPMS.74542024-04-30.5466Apo-MethadoneAPX.54662024-04-30.5466098325mgTabMetadolPMS1.38502024-04-301.0157Apo-MethadoneAPX1.01572024-04-301.0157MORPHINE SULFATE098410mgER CapM-EslonETH.34161996-10-01.3416098515mgER CapM-EslonETH.39411996-12-19.3941098630mgER CapM-EslonETH.58751996-10-01.5875098760mgER CapM-EslonETH1.04571996-10-011.04570988100mgER CapM-EslonETH2.25541996-10-012.255409892mg/mLInj Sol AmpMorphine Sulfate Injection USPSDZ2.25102018-01-312.2510099010mg/mLInj Sol AmpMorphine SulfateSDZ2.38602018-01-312.3860099115mg/mLInj Sol AmpMorphine SulfateSDZ2.09401996-12-192.0940Morphine Sulfate Injection USPHOS1996-10-01099250mg/mLInj Sol-1mL PkMorphine HP-50SDZ6.81951996-10-016.8195099310mgSR CapKadianBGP.47502003-01-30.4750099420mgSR CapKadianBGP.92281997-08-28.9228099550mgSR CapKadianBGP1.74561997-08-281.74560996100mgSR CapKadianBGP3.04481997-08-283.0448099715mgSR TabMS ContinPFP1.00861996-10-01.4145Sandoz Morphine SRSDZ.41452002-07-29.4145Teva-Morphine SRTEV.41452009-04-01.4145099830mgSR TabMS ContinPFP1.52451996-10-01.6580Sandoz Morphine SRSDZ.65802002-07-29.6580Teva-Morphine SRTEV.65802009-06-23.6580099960mgSR TabMS ContinPFP2.68741996-10-011.2180Sandoz Morphine SRSDZ1.21802002-07-291.2180Teva-Morphine SRTEV1.21802008-04-091.21801000100mgSR TabMS ContinPFP4.09101996-10-011.5395Teva-Morphine SRTEV1.53952008-04-091.5395Sandoz Morphine SRSDZ1.53952019-02-281.53951001200mgSR TabMS ContinPFP7.62741996-10-014.5738Teva-Morphine SRTEV4.57372008-04-094.5737Sandoz Morphine SRSDZ4.57382019-02-284.5738100220mgTabMS-IRPFP.47021996-10-01.4702100330mgTabMS-IRPFP.60361996-10-01.603610045mgTabStatexPPI.07091996-10-01.0709PMS-Morphine SulfatePMS.07092025-02-28.0709100510mgTabStatexPPI.10961996-10-01.1096PMS-Morphine SulfatePMS.10962025-02-28.1096OXYCODONE HCL10065mgTabSupeudolSDZ.23332010-04-23.2333Oxy.IRPFP2009-01-30PMS-OxycodonePMS.23332009-01-30.2333100710mgTabSupeudolSDZ.34512010-04-23.3451Oxy.IRPFP2009-01-30PMS-OxycodonePMS.34512009-01-30.3451100820mgTabOxy.IRPFP2008-10-01SupeudolSDZ.60012008-10-01.6001PMS-OxycodonePMS.60012009-01-30.6001OXYCODONE HCL & ACETAMINOPHEN10095mg & 325mgTabTeva-OxycocetTEV.12851996-10-01.1285PercocetBQU2008-12-23EndocetBQU.12851996-10-01.1285Sandoz Oxycodone/AcetaminophenSDZ.12852008-10-01.1285Apo-Oxycodone/AcetAPX.12852009-09-30.1285OXYCODONE HCL & ACETYLSALICYLIC ACID10105mg & 325mgTabRatio-OxycodanRPH.45991996-10-01.4599PercodanBQU2008-12-23TRAMADOL HCL1011100mgER TabTriduralPAL2016-04-29Taro-Tramadol ERTAR.78532016-04-291012200mgER TabTriduralPAL2016-06-29Taro-Tramadol ERTAR.92442016-06-291013300mgER TabTriduralPAL2016-06-29Taro-Tramadol ERTAR1.28542016-06-29101450mgTabUltramJAN2014-08-28Apo-TramadolAPX.63862014-08-28Auro-TramadolAUR.63862019-06-28Mar-TramadolMAR.63862019-09-30Sandoz TramadolSDZ.63862021-02-26Jamp TramadolJPC.63862021-05-31Jamp Tramadol HClJPC.63862023-03-31TRAMADOL HCL & ACETAMINOPHEN101537.5mg & 325mgTabTramacetJAN2010-03-02Apo-Tramadol/AcetAPX.62642010-03-02Teva-Tramadol/AcetaminophenTEV.62642012-10-30Co Tramadol/AcetCOB.62642012-06-26Taro-Tramadol/AcetSPC.62642012-11-27Jamp-Acet-TramadolJPC.62642012-12-21Mar-Tramadol/AcetMAR.62642012-10-30Mint-Tramadol/AcetMIN.62642012-12-21PMS-Tramadol-AcetPMS.62642013-06-27Auro-Tramadol/AcetaminophenAUR.62642016-02-25NRA-Tramadol/ACETNRA.62642022-04-29ANALGESICS OPIATE PARTIAL AGONISTSBUPRENORPHINE1016100mg/0.5mLInj Sol- 0.5mL Pref SyrSublocadeIND550.00002020-04-30550.00001017300mg/1.5mLInj Sol- 1.5mL Pref SyrSublocadeIND550.00002020-04-30550.0000BUPRENORPHINE & NALOXONE10182mg & 0.5mgSL TabSuboxoneIND2.72612012-10-301.3350PMS-Buprenorphine-NaloxonePMS1.33502015-02-261.3350Act Buprenorphine/NaloxoneACV1.33502018-01-311.335010198mg & 2mgSL TabSuboxoneIND4.82932012-10-302.3650PMS-Buprenorphine-NaloxonePMS2.36502015-02-262.3650Act Buprenorphine/NaloxoneACV2.36502018-01-312.365010202mg & 0.5mgSoluble FilmSuboxoneIND2.67002024-05-312.670010214mg & 1mgSoluble FilmSuboxoneIND3.68892026-02-273.688910228mg & 2mgSoluble FilmSuboxoneIND4.73002024-05-314.7300102312mg & 3mgSoluble FilmSuboxoneIND7.09502024-05-317.0950BUPRENORPHINE HYDROCHLORIDE102480mgSubdermal Implant-Kit PkProbuphineKNT1495.00002020-04-301495.0000For the management of opioid use disorder in combination with counseling and psychosocial support in adult patients who meet the following criteria: - The patient is stabilized on a dose of no more than 8mg per day of sublingual buprenorphine for the preceding 90 days; AND - The patient is under the care of a health care provider with experience in the diagnosis and management of opioid use disorder and has been trained to implant and remove the buprenorphine subdermal implant. Recommended dose: Four 80mg implants inserted subdermally in the inner side of the upper arm for up to six months. The maximum quantity that can be claimed per patient is four (4) implant cycles (i.e. two (2) years of therapy). NOTE: The product monograph indicates that dosing beyond two (2) years cannot be recommended at this time. Probuphine subdermal implants are intended to be in place for six months of treatment. Probuphine implants are removed at the end of the six-month period. If continued treatment is desired, the implants should be replaced by new implants (implanted in the opposite arm) at the time of removal.LU Authorization Period: 2 yearsBUTORPHANOL TARTRATE102510mg/mLNas Sp-2.5mL PkStadol NSBQU2020-11-30Butorphanol Nasal SprayAAP64.02002020-11-3064.0200ANALGESICS MISCELLANEOUS ANALGESICS AND ANTIPYRETICSACETAMINOPHEN1026325mgAtasol TabHOR1996-10-01Novo-Gesic TabNOP.01141996-10-01.0114Apo-Acetaminophen TabAPX.01141996-10-01.0114Jamp Acetaminophen 325 CapletsJPC.01142023-07-31.0114Apo-Acetaminophen CapletsAPX.01142012-02-29.01141027500mgAtasol Forte TabHOR1996-10-01Novo-Gesic Forte TabNOP.01491996-10-01.0149Apo-Acetaminophen TabAPX.01491996-10-01.0149Jamp Acetaminophen 500 CapletsJPC.01492023-07-31.0149Apo-Acetaminophen CapletsAPX.01492012-02-29.0149102880mg/mLO/LAtasolHOR1996-10-01TempraMJS1999-01-01PediatrixRPH.14362001-10-11.14361029120mgSupAbenolPEN1996-10-01ACET 120PEN.53671998-03-17.53671030325mgSupAbenolPEN1996-10-01ACET 325PEN.66251998-03-17.66251031650mgSupAbenolPEN2007-01-02ACET 650PEN.76081998-03-17.7608OPIATE ANTAGONISTSNALTREXONE HCL103250mgTabReviaTEV2.80752015-11-262.8075Apo-NaltrexoneAPX2.80752015-11-262.8075Naltrexone Hydrochloride Tablets USPSTN2.80752017-08-302.8075ANTICONVULSANTSBRIVARACETAM103310mgTabBrivleraUCB4.32002018-12-212.3760Apo-BrivaracetamAPX2.37602024-11-292.3760103425mgTabBrivleraUCB4.32002018-12-212.3760Apo-BrivaracetamAPX2.37602024-11-292.3760103550mgTabBrivleraUCB4.32002018-12-212.1600Apo-BrivaracetamAPX2.16002024-11-292.1600Auro-BrivaracetamAUR2.16002024-11-292.1600103675mgTabBrivleraUCB4.32002018-12-212.3760Apo-BrivaracetamAPX2.37602024-11-292.37601037100mgTabBrivleraUCB4.32002018-12-212.1600Apo-BrivaracetamAPX2.16002024-11-292.1600Auro-BrivaracetamAUR2.16002024-11-292.1600- As adjunctive therapy in the treatment of patients with partial-onset seizures (POS) who have had an inadequate response or have significant intolerance to at least 2 other less costly anticonvulsant therapies (prior or current use); AND - Patients are not receiving concurrent therapy with levetiracetam; AND - Patients are under the care of a physician experienced in the treatment of epilepsy. Note: Less costly anticonvulsant therapies may include the following: Phenytoin, carbamazepine, gabapentin, lamotrigine, vigabatrin, topiramate, etc.LU Authorization Period: IndefiniteCARBAMAZEPINE1038100mgChew TabTegretolNOV1996-10-01Taro-CarbamazepineTAR.17022003-04-16.17021039200mgChew TabTegretolNOV1996-10-01Taro-CarbamazepineTAR.33022003-04-16.33021040200mgER TabCarbamazepine ER Tablets, USP 200mgSET4.70802024-06-284.70801041400mgER TabCarbamazepine ER Tablets, USP 400mgSET5.22162024-06-285.22161042200mgLA TabTegretol CRNOV.60411996-10-01.3845Sandoz Carbamazepine CRSDZ.38452006-07-19.38451043400mgLA TabTegretol CRNOV1.20831996-10-01.7689Sandoz Carbamazepine CRSDZ.76892006-07-19.7689For patients who have been tried on conventional carbamazepine with unsatisfactory results due to adverse effects or poor control of symptoms.LU Authorization Period: Indefinite1044100mg/5mLOral SuspTegretolNOV.11591996-12-19.0578Taro-CarbamazepineTAR.05782012-03-26.05781045200mgTabTegretolNOV1996-10-01Teva-CarbamazepineTEV.22171996-10-01.2217Mint-CarbamazepineMIN.22172024-06-28.2217CENOBAMATE104612.5mgTabXcopriEVL8.95802025-05-308.9580104725mgTabXcopriEVL8.95802025-05-308.9580104850mgTabXcopriEVL8.95802025-05-308.95801049100mgTabXcopriEVL8.95802025-05-308.95801050150mgTabXcopriEVL8.95802025-05-308.95801051200mgTabXcopriEVL8.95802025-05-308.9580105212.5mg & 25mgTab - (Starter Kit)XcopriEVL8.95802025-05-308.9580105350mg & 100mgTab - (Starter Kit)XcopriEVL8.95802025-05-308.95801054150mg & 200mgTab - (Starter Kit)XcopriEVL8.80002025-05-308.8000As adjunctive therapy in the treatment of patients with partial onset seizures (POS) who have had an inadequate response or have significant intolerance to at least 2 other less costly anticonvulsant therapies (prior or current use); AND Patients are under the care of a physician experienced in the treatment of epilepsy. Note: Less costly anticonvulsant therapies may include the following: Phenytoin, Carbamazepine, Gabapentin, Lamotrigine, Vigabatrin, Topiramate, etc.LU Authorization Period: IndefiniteCLOBAZAM105510mgTabFrisiumOVA1999-01-06Teva-ClobazamTEV.21971999-04-15.2197Apo-ClobazamAPX.21972003-01-30.2197As adjunctive therapy in the treatment of seizure disorders where control by other listed anticonvulsants has been unsatisfactory.Because a large number of patients will become refractory to the anticonvulsant effects of the drug over a period of time, the effectiveness of this drug must be re-evaluated after a period of six months.LU Authorization Period: IndefiniteCLONAZEPAM10560.5mgTabRivotrilHLR.29061996-10-01.0418PMS-ClonazepamPMS.04181996-10-01.0418Apo-ClonazepamAPX.04181996-10-01.0418PMS-Clonazepam-RPMS.04181996-10-01.0418Teva-ClonazepamTEV.04182000-04-17.041810572mgTabRivotrilHLR.50101996-10-01.0721PMS-ClonazepamPMS.07211996-10-01.0721Apo-ClonazepamAPX.07211996-10-01.0721Teva-ClonazepamTEV.07212000-04-17.0721DIVALPROEX SODIUM1058125mgEnt TabEpivalBGP.38281996-10-01.1539Apo-DivalproexAPX.15391999-09-15.1539Mylan-DivalproexMYL.15392017-06-29.15391059250mgEnt TabEpivalBGP.68831996-10-01.2767Apo-DivalproexAPX.27671999-09-15.2767Mylan-DivalproexMYL.27672017-06-29.27671060500mgEnt TabEpivalBGP1.37731996-10-01.5537Apo-DivalproexAPX.55371999-09-15.5537Mylan-DivalproexMYL.55372017-06-29.5537ESLICARBAZEPINE ACETATE1061200mgTabAptiomSUO9.87002015-11-264.9350Auro-EslicarbazepineAUR4.93502025-07-314.9350Apo-EslicarbazepineAPX4.93502025-06-304.93501062400mgTabAptiomSUO9.87002015-11-264.9350Auro-EslicarbazepineAUR4.93502025-07-314.9350Apo-EslicarbazepineAPX4.93502025-06-304.93501063600mgTabAptiomSUO9.87002015-11-264.9350Auro-EslicarbazepineAUR4.93502025-07-314.9350Apo-EslicarbazepineAPX4.93502025-06-304.93501064800mgTabAptiomSUO9.87002015-11-264.9350Auro-EslicarbazepineAUR4.93502025-07-314.9350Apo-EslicarbazepineAPX4.93502025-06-304.9350As adjunctive therapy in the treatment of patients with partial onset seizures who have had an inadequate response or have significant intolerance to at least 3 less costly anticonvulsant therapies; AND Patients are under the care of a physician experienced in the treatment of epilepsy. Note: Less costly anticonvulsant therapies may include the following: Phenytoin, Carbamazepine, Gabapentin, Lamotrigine, Vigabatrin, Topiramate, etc.LU Authorization Period: IndefiniteETHOSUXIMIDE1065250mgCapZarontinSLP.52551996-10-01.2628Mar-EthosuximideMAR.26282024-12-30.2628Odan-EthosuximideODN.26282024-12-30.2628106650mg/mLO/LZarontinSLP.07401996-10-01.0740GABAPENTIN1067100mgCapNeurontinUJC.56151996-10-01.0416PMS-GabapentinPMS.04162001-10-11.0416Apo-GabapentinAPX.04162002-07-29.0416Teva-GabapentinTEV.04162002-07-29.0416GabapentinSIV.04162009-11-19.0416Co GabapentinCOB.04162005-03-31.0416Ran-GabapentinRAN.04162010-03-02.0416Auro-GabapentinAUR.04162011-12-15.0416GabapentinSAI.04162011-08-04.0416Jamp-GabapentinJPC.04162012-01-19.0416Mar-GabapentinMAR.04162013-06-27.0416Mint-GabapentinMIN.04162023-11-30.0416Gabapentin Capsules USPACH.04162015-05-28.0416AG-GabapentinANG.04162021-01-29.0416Jamp Gabapentin CapsulesJPC.04162024-04-30.0416NRA-GabapentinNRA.04162025-07-31.04161068300mgCapNeurontinUJC1.34301996-10-01.1012PMS-GabapentinPMS.10122001-10-11.1012Apo-GabapentinAPX.10122002-07-29.1012Teva-GabapentinTEV.10122002-07-29.1012GabapentinSIV.10122009-11-19.1012Co GabapentinCOB.10122005-03-31.1012Ran-GabapentinRAN.10122010-03-02.1012Auro-GabapentinAUR.10122011-12-15.1012GabapentinSAI.10122011-08-04.1012Jamp-GabapentinJPC.10122012-01-19.1012Mar-GabapentinMAR.10122013-06-27.1012Mint-GabapentinMIN.10122023-11-30.1012Gabapentin Capsules USPACH.10122015-05-28.1012AG-GabapentinANG.10122021-01-29.1012Jamp Gabapentin CapsulesJPC.10122024-04-30.1012NRA-GabapentinNRA.10122025-07-31.10121069400mgCapNeurontinUJC1.60051996-10-01.1206PMS-GabapentinPMS.12062001-10-11.1206Apo-GabapentinAPX.12062002-07-29.1206Teva-GabapentinTEV.12062002-07-29.1206GabapentinSIV.12062009-11-19.1206Co GabapentinCOB.12062005-03-31.1206Ratio-GabapentinRPH.12062005-07-14.1206Ran-GabapentinRAN.12062010-03-02.1206Auro-GabapentinAUR.12062011-12-15.1206GabapentinSAI.12062011-08-04.1206Jamp-GabapentinJPC.12062012-01-19.1206Mar-GabapentinMAR.12062013-06-27.1206Mint-GabapentinMIN.12062023-11-30.1206Gabapentin Capsules USPACH.12062015-05-28.1206AG-GabapentinANG.12062021-01-29.1206Jamp Gabapentin CapsulesJPC.12062024-04-30.1206NRA-GabapentinNRA.12062025-07-31.12061070600mgTabNeurontinUJC2007-06-06Teva-GabapentinTEV1.30452007-06-06Apo-GabapentinAPX1.30452008-08-28GabapentinSIV1.30452020-08-28Gabapentin Tablets USPACH1.30452012-12-21Jamp-Gabapentin TabletsJPC1.30452013-06-27GLN-GabapentinGLP1.30452016-05-31Auro-Gabapentin TabletsAUR1.30452019-04-30GabapentinSAI1.30452020-07-31GabapentinJPC1.30452023-06-301071800mgTabNeurontinUJC2007-06-06Teva-GabapentinTEV1.73932007-06-06Apo-GabapentinAPX1.73932008-08-28GabapentinSIV1.73932020-08-28Gabapentin Tablets USPACH1.73932012-12-21Jamp-Gabapentin TabletsJPC1.73932013-06-27GLN-GabapentinGLP1.73932016-05-31Auro-Gabapentin TabletsAUR1.73932019-04-30GabapentinSAI1.73932020-07-31GabapentinJPC1.73932023-06-30LACOSAMIDE107250mgTabVimpatUCB2.52502012-04-24.6313Teva-LacosamideTEV.63132018-11-29.6313Sandoz LacosamideSDZ.63132018-11-29.6313Auro-LacosamideAUR.63132018-11-29.6313Pharma-LacosamidePMS.63132018-11-29.6313ZDS-LacosamideZDS.63132019-12-20.6313Jamp-LacosamideJPC.63132020-05-29.6313Ach-LacosamideACH.63132021-07-30.6313Mint-LacosamideMIN.63132020-01-31.6313NRA-LacosamideNRA.63132021-04-30.6313LacosamideSAI.63132021-11-30.63131073100mgTabVimpatUCB3.50002012-04-24.8750Teva-LacosamideTEV.87502018-11-29.8750Sandoz LacosamideSDZ.87502018-11-29.8750Auro-LacosamideAUR.87502018-11-29.8750Pharma-LacosamidePMS.87502018-11-29.8750ZDS-LacosamideZDS.87502019-12-20.8750Jamp-LacosamideJPC.87502020-05-29.8750Ach-LacosamideACH.87502021-07-30.8750Mint-LacosamideMIN.87502020-01-31.8750NRA-LacosamideNRA.87502021-04-30.8750LacosamideSAI.87502021-11-30.87501074150mgTabVimpatUCB4.70502012-04-241.1763Teva-LacosamideTEV1.17632018-11-291.1763Sandoz LacosamideSDZ1.17632018-11-291.1763Auro-LacosamideAUR1.17632018-11-291.1763Pharma-LacosamidePMS1.17632018-11-291.1763ZDS-LacosamideZDS1.17632019-12-201.1763Jamp-LacosamideJPC1.17632020-05-291.1763Ach-LacosamideACH1.17632021-07-301.1763Mint-LacosamideMIN1.17632020-01-311.1763NRA-LacosamideNRA1.17632021-04-301.1763LacosamideSAI1.17632021-11-301.17631075200mgTabVimpatUCB5.80002012-04-241.4500Teva-LacosamideTEV1.45002018-11-291.4500Sandoz LacosamideSDZ1.45002018-11-291.4500Auro-LacosamideAUR1.45002018-11-291.4500Pharma-LacosamidePMS1.45002018-11-291.4500ZDS-LacosamideZDS1.45002019-12-201.4500Jamp-LacosamideJPC1.45002020-05-291.4500Ach-LacosamideACH1.45002021-07-301.4500Mint-LacosamideMIN1.45002020-01-311.4500NRA-LacosamideNRA1.45002021-04-301.4500LacosamideSAI1.45002021-11-301.4500As adjunctive therapy in the treatment of patients with partial onset seizures who have had an inadequate response or have significant intolerance to at least 3 less costly anticonvulsant therapies; AND Patients are under the care of a physician experienced in the treatment of epilepsy. Note: Less costly anticonvulsant therapies may include the following: Phenytoin, Carbamazepine, Gabapentin, Lamotrigine, Vigabatrin, Topiramate, etc.LU Authorization Period: IndefiniteLAMOTRIGINE107625mgTabLamictalGSK.54021996-10-01.0698Ratio-LamotrigineRPH.06982003-04-16.0698Apo-LamotrigineAPX.06982003-01-30.0698PMS-LamotriginePMS.06982004-04-06.0698Teva-LamotrigineTEV.06982004-04-06.0698Mylan-LamotrigineMYL.06982005-07-14.0698LamotrigineSAI.06982011-08-04.0698Auro-LamotrigineAUR.06982012-08-27.0698LamotrigineSIV.06982020-08-28.0698Jamp LamotrigineJPC.06982024-08-30.06981077100mgTabLamictalGSK2.15801996-10-01.2787Apo-LamotrigineAPX.27872003-01-30.2787PMS-LamotriginePMS.27872004-04-06.2787Teva-LamotrigineTEV.27872004-04-06.2787Mylan-LamotrigineMYL.27872005-07-14.2787LamotrigineSAI.27872011-08-04.2787Auro-LamotrigineAUR.27872012-08-27.2787LamotrigineSIV.27872020-08-28.2787Jamp LamotrigineJPC.27872024-08-30.27871078150mgTabLamictalGSK3.18031996-10-01.4107Apo-LamotrigineAPX.41072003-01-30.4107PMS-LamotriginePMS.41072004-04-06.4107Teva-LamotrigineTEV.41072004-04-06.4107Mylan-LamotrigineMYL.41072005-07-14.4107LamotrigineSAI.41072011-08-04.4107Auro-LamotrigineAUR.41072012-08-27.4107LamotrigineSIV.41072020-08-28.4107Jamp LamotrigineJPC.41072024-08-30.4107LEVETIRACETAM1079100mg/mLOral SolPDP-LevetiracetamPEN.81422022-12-21.4071Pharma-LevetiracetamPMS.40712025-12-30.4071Mint-Levetiracetam SolutionMIN.40712025-10-31.4071For patients unable to swallow or tolerate oral solid dosage forms and who are using this as adjunctive therapy in the treatment of seizure disorders where control by other listed anticonvulsants has been unsatisfactory.LU Authorization Period: 1 yearAs adjunctive therapy in the treatment of seizure disorders in pediatric patients (less than 18 years of age) where control by other listed anticonvulsants has been unsatisfactory and where the appropriate dose cannot be achieved using listed solid oral levetiracetam dosage formats.LU Authorization Period: 1 year1080250mgTabKeppraUCB1.78362007-11-10.3210Act LevetiracetamACV.32102007-12-19.3210Apo-LevetiracetamAPX.32102007-11-10.3210PMS-LevetiracetamPMS.32102007-11-10.3210LevetiracetamSAI.32102011-08-04.3210Auro-LevetiracetamAUR.32102012-04-24.3210Ach-LevetiracetamACH.32102013-06-27.3210Jamp-LevetiracetamJPC.32102013-06-27.3210Nat-LevetiracetamNAT.32102015-10-29.3210Mint-LevetiracetamMIN.32102021-11-30.3210LevetiracetamSIV.32102020-08-28.3210Sandoz LevetiracetamSDZ.32102017-09-28.3210Riva-LevetiracetamRIA.32102019-12-20.3210NRA-LevetiracetamNRA.32102021-05-31.3210Jamp Levetiracetam TabletsJPC.32102022-08-31.3210M-LevetiracetamMAT.32102022-11-30.32101081500mgTabKeppraUCB2.17252007-11-10.3911Act LevetiracetamACV.39112007-12-19.3911Apo-LevetiracetamAPX.39112007-11-10.3911PMS-LevetiracetamPMS.39112007-11-10.3911LevetiracetamSAI.39112011-08-04.3911Auro-LevetiracetamAUR.39112012-04-24.3911Ach-LevetiracetamACH.39112013-06-27.3911Jamp-LevetiracetamJPC.39112013-06-27.3911Nat-LevetiracetamNAT.39112015-10-29.3911Mint-LevetiracetamMIN.39112021-11-30.3911LevetiracetamSIV.39112020-08-28.3911Sandoz LevetiracetamSDZ.39112017-09-28.3911Riva-LevetiracetamRIA.39112019-12-20.3911NRA-LevetiracetamNRA.39112021-05-31.3911Jamp Levetiracetam TabletsJPC.39112022-08-31.3911M-LevetiracetamMAT.39112022-11-30.39111082750mgTabKeppraUCB3.00892007-11-10.5416Act LevetiracetamACV.54162007-12-19.5416Apo-LevetiracetamAPX.54162007-11-10.5416PMS-LevetiracetamPMS.54162007-11-10.5416LevetiracetamSAI.54162011-08-04.5416Auro-LevetiracetamAUR.54162012-04-24.5416Ach-LevetiracetamACH.54162013-06-27.5416Jamp-LevetiracetamJPC.54162013-06-27.5416Nat-LevetiracetamNAT.54162015-10-29.5416Mint-LevetiracetamMIN.54162021-11-30.5416LevetiracetamSIV.54162020-08-28.5416Sandoz LevetiracetamSDZ.54162017-09-28.5416Riva-LevetiracetamRIA.54162019-12-20.5416NRA-LevetiracetamNRA.54162021-05-31.5416Jamp Levetiracetam TabletsJPC.54162022-08-31.5416M-LevetiracetamMAT.54162022-11-30.5416As adjunctive therapy in the treatment of seizure disorders where control by other listed anticonvulsants has been unsatisfactory.LU Authorization Period: Indefinite10831000mgTabSandoz LevetiracetamSDZ.72212020-08-28.7221As adjunctive therapy in the treatment of seizure disorders where control by other listed anticonvulsants has been unsatisfactory.LU Authorization Period: IndefiniteOXCARBAZEPINE1084150mgTabTrileptalNOV2008-06-27Apo-OxcarbazepineAPX.62092008-06-27.6209Jamp-OxcarbazepineJPC.62102015-10-29.62101085300mgTabTrileptalNOV2008-06-27Apo-OxcarbazepineAPX.91022008-06-27.9102Jamp-OxcarbazepineJPC.91022015-10-29.91021086600mgTabTrileptalNOV2008-06-27Apo-OxcarbazepineAPX1.82042008-06-271.8204Jamp-OxcarbazepineJPC1.82042015-10-291.8204PERAMPANEL10872mgTabFycompaEIS10.38692014-02-275.7128Taro-PerampanelTAR5.71282024-01-315.712810884mgTabFycompaEIS10.38692014-02-275.7128Taro-PerampanelTAR5.71282024-01-315.712810896mgTabFycompaEIS10.38692014-02-275.7128Taro-PerampanelTAR5.71282024-01-315.712810908mgTabFycompaEIS10.38692014-02-275.7128Taro-PerampanelTAR5.71282024-01-315.7128109110mgTabFycompaEIS10.38692014-02-275.7128Taro-PerampanelTAR5.71282024-01-315.7128109212mgTabFycompaEIS10.38692014-02-275.7128Taro-PerampanelTAR5.71282024-01-315.7128As adjunctive therapy in the treatment of patients with partial onset seizures who have had an inadequate response or have significant intolerance to at least 3 less costly anticonvulsant therapies; AND Patients are under the care of a physician experienced in the treatment of epilepsy. Note: Less costly anticonvulsant therapies may include the following: Phenytoin, Carbamazepine, Gabapentin, Lamotrigine, Vigabatrin, Topiramate, etc.LU Authorization Period: IndefiniteFor adjunctive therapy in the management of primary generalized tonic-clonic (PGTC) seizures in patients with epilepsy who have had an inadequate response or have significant intolerance to at least 3 less costly anticonvulsant therapies; AND Patients are under the care of a physician experienced in the treatment of epilepsy. Note: Less costly anticonvulsant therapies may include the following: Phenytoin, Carbamazepine, Gabapentin, Lamotrigine, Vigabatrin, Topiramate, etc.LU Authorization Period: IndefinitePHENOBARBITAL1093120mg/mLInj Sol-1mL PkPhenobarbital InjectionSDZ15.70002018-01-3115.7000For the management of patients receiving palliative care*.LU Authorization Period: 1 year*The patient must have a progressive life-limiting illness and require this medication for palliative purposes.PHENYTOIN (DIPHENYLHYDANTOIN)10946mg/mLO/LDilantin-30 SuspensionUJC.05881996-10-01.0588109525mg/mLO/LDilantin-125 SuspensionUJC.06971996-10-01.0444Taro-PhenytoinTAR.04442005-11-08.0444109650mgTabDilantin InfatabsUJC.10921996-10-01.1092PHENYTOIN (DIPHENYLHYDANTOIN) SODIUM109730mgCapDilantinUJC.23691996-10-01.23691098100mgCapDilantinUJC.12471996-10-01.0665Phenytoin SodiumAAP.06652017-09-28.0665109950mg/mLInj Sol (Preservative Free)Phenytoin Sodium Injection USPSDZ6.07852017-02-286.0785For the management of patients receiving palliative care*.LU Authorization Period: 1 year*The patient must have a progressive life-limiting illness and require this medication for palliative purposes.For the treatment of patients receiving care at home* who have failed or are unable to tolerate oral alternatives, and who require an injectable option to manage their condition.LU Authorization Period: 1 year*e.g., home care recipients, long-term care home residents.PREGABALIN110025mgCapLyricaUJC1.02222013-04-30.1481PMS-PregabalinPMS.14812013-04-30.1481Teva-PregabalinTEV.14812013-04-30.1481Sandoz PregabalinSDZ.14812013-04-30.1481Ran-PregabalinRAN.14812013-04-30.1481Apo-PregabalinAPX.14812013-04-30.1481Co PregabalinCOB.14812013-04-30.1481PregabalinSIV.14812020-07-31.1481PregabalinSAI.14812016-05-31.1481Mar-PregabalinMAR.14812014-05-29.1481Mint-PregabalinMIN.14812014-08-28.1481Auro-PregabalinAUR.14812015-05-28.1481Jamp-PregabalinJPC.14812016-01-28.1481Ach-PregabalinACH.14812021-08-31.1481M-PregabalinMAT.14812021-09-30.1481NRA-PregabalinNRA.14812020-07-31.1481AG-PregabalinANG.14812020-11-30.1481Nat-PregabalinNAT.14812020-02-28.1481110150mgCapLyricaUJC1.60342013-04-30.2324PMS-PregabalinPMS.23242013-04-30.2324Teva-PregabalinTEV.23242013-04-30.2324Sandoz PregabalinSDZ.23242013-04-30.2324Ran-PregabalinRAN.23242013-04-30.2324Apo-PregabalinAPX.23242013-04-30.2324Co PregabalinCOB.23242013-04-30.2324PregabalinSIV.23242020-07-31.2324PregabalinSAI.23242016-05-31.2324Mar-PregabalinMAR.23242014-05-29.2324Mint-PregabalinMIN.23242014-08-28.2324Auro-PregabalinAUR.23242015-05-28.2324Jamp-PregabalinJPC.23242016-01-28.2324Ach-PregabalinACH.23242021-08-31.2324M-PregabalinMAT.23242021-09-30.2324NRA-PregabalinNRA.23242020-07-31.2324AG-PregabalinANG.23242020-11-30.2324Nat-PregabalinNAT.23242020-02-28.2324110275mgCapLyricaUJC2.07472013-04-30.3007PMS-PregabalinPMS.30072013-04-30.3007Teva-PregabalinTEV.30072013-04-30.3007Sandoz PregabalinSDZ.30072013-04-30.3007Ran-PregabalinRAN.30072013-04-30.3007Apo-PregabalinAPX.30072013-04-30.3007Co PregabalinCOB.30072013-04-30.3007PregabalinSIV.30072020-07-31.3007PregabalinSAI.30072016-05-31.3007Mar-PregabalinMAR.30072014-05-29.3007Mint-PregabalinMIN.30072014-08-28.3007Auro-PregabalinAUR.30072015-05-28.3007Jamp-PregabalinJPC.30072016-01-28.3007Ach-PregabalinACH.30072021-08-31.3007M-PregabalinMAT.30072021-09-30.3007NRA-PregabalinNRA.30072020-07-31.3007AG-PregabalinANG.30072020-11-30.3007Nat-PregabalinNAT.30072020-02-28.30071103150mgCapLyricaUJC2.85972013-04-30.4145PMS-PregabalinPMS.41452013-04-30.4145Teva-PregabalinTEV.41452013-04-30.4145Sandoz PregabalinSDZ.41452013-04-30.4145Ran-PregabalinRAN.41452013-04-30.4145Apo-PregabalinAPX.41452013-04-30.4145Co PregabalinCOB.41452013-04-30.4145PregabalinSIV.41452020-07-31.4145PregabalinSAI.41452016-05-31.4145Mar-PregabalinMAR.41452014-05-29.4145Mint-PregabalinMIN.41452014-08-28.4145Auro-PregabalinAUR.41452015-05-28.4145Jamp-PregabalinJPC.41452016-01-28.4145Ach-PregabalinACH.41452021-08-31.4145M-PregabalinMAT.41452021-09-30.4145NRA-PregabalinNRA.41452020-07-31.4145AG-PregabalinANG.41452020-11-30.4145Nat-PregabalinNAT.41452020-02-28.41451104225mgCapLyricaUJC2013-04-30Teva-PregabalinTEV1.72702013-04-30Ran-PregabalinRAN1.72702013-04-30Apo-PregabalinAPX1.72702013-04-30PMS-PregabalinPMS1.72702013-04-30Co PregabalinCOB1.72702013-04-30Mar-PregabalinMAR1.72702014-05-29Ach-PregabalinACH1.72702021-08-31Nat-PregabalinNAT1.72702020-02-281105300mgCapLyricaUJC2.85972013-04-30.4145PMS-PregabalinPMS.41452013-04-30.4145Teva-PregabalinTEV.41452013-04-30.4145Sandoz PregabalinSDZ.41452013-04-30.4145Ran-PregabalinRAN.41452013-04-30.4145Apo-PregabalinAPX.41452013-04-30.4145Co PregabalinCOB.41452013-04-30.4145PregabalinSIV.41452020-07-31.4145PregabalinSAI.41452016-05-31.4145Mar-PregabalinMAR.41452014-05-29.4145Jamp-PregabalinJPC.41452016-01-28.4145Ach-PregabalinACH.41452021-08-31.4145NRA-PregabalinNRA.41452022-07-29.4145AG-PregabalinANG.41452021-05-31.4145Nat-PregabalinNAT.41452020-02-28.4145M-PregabalinMAT.41452024-05-31.4145PRIMIDONE1106125mgTabPrimidoneAAP.05641996-10-01.0564MysolineWAY1996-10-011107250mgTabPrimidoneAAP.08871996-10-01.0887MysolineWAY1996-10-01RUFINAMIDE1108200mgTabBanzelEIS1.90472025-01-311.0083Auro-RufinamideAUR1.00832025-01-311.00831109400mgTabBanzelEIS4.15032025-01-312.1970Auro-RufinamideAUR2.19702025-01-312.1970TOPIRAMATE111015mgSprinkle CapTopamax SprinkleJNO2.24252000-11-302.2425111125mgSprinkle CapTopamax SprinkleJNO2.34452000-11-302.3445In children age 16 and under, as adjunctive therapy in the treatment of seizure disorders where control by other listed anticonvulsants has been unsatisfactory.LU Authorization Period: Indefinite111250mgTabTopamaxJNO2024-11-29PMS-TopiramatePMS1.24342025-02-28Jamp-Topiramate TabletsJPC1.24342024-11-29111325mgTabTopamaxJNO2.35611998-12-31.2433Teva-TopiramateTEV.24332005-11-08.2433PMS-TopiramatePMS.24332005-11-08.2433Mylan-TopiramateMYL.24332005-11-08.2433Apo-TopiramateAPX.24332006-06-14.2433Mint-TopiramateMIN.24332009-03-02.2433Jamp Topiramate TabletsJPC.24332023-06-30.2433Auro-TopiramateAUR.24332011-09-15.2433TopiramateSAI.24332011-08-04.2433TopiramateSIV.24332020-08-28.2433Ach-TopiramateACH.24332013-03-20.2433Sandoz Topiramate TabletsSDZ.24332015-01-28.2433Mar-TopiramateMAR.24332015-02-26.2433Jamp-TopiramateJPC.24332015-05-28.2433AG-TopiramateANG.24332020-12-18.2433NRA-TopiramateNRA.24332024-04-30.24331114100mgTabTopamaxJNO4.41801998-12-31.4583Teva-TopiramateTEV.45832005-11-08.4583PMS-TopiramatePMS.45832005-11-08.4583Mylan-TopiramateMYL.45832005-11-08.4583Apo-TopiramateAPX.45832006-06-14.4583Mint-TopiramateMIN.45832009-03-02.4583Jamp Topiramate TabletsJPC.45832024-04-30.4583Auro-TopiramateAUR.45832011-09-15.4583TopiramateSAI.45832011-08-04.4583TopiramateSIV.45832020-08-28.4583Ach-TopiramateACH.45832013-03-20.4583Ran-TopiramateRAN.45832013-06-27.4583Sandoz Topiramate TabletsSDZ.45832015-01-28.4583Mar-TopiramateMAR.45832015-02-26.4583Jamp-TopiramateJPC.45832015-05-28.4583AG-TopiramateANG.45832020-12-18.4583NRA-TopiramateNRA.45832024-04-30.45831115200mgTabTopamaxJNO6.52351998-12-31.6748Teva-TopiramateTEV.67482005-11-08.6748PMS-TopiramatePMS.67482005-11-08.6748Mylan-TopiramateMYL.67482005-11-08.6748Apo-TopiramateAPX.67482006-06-14.6748Mint-TopiramateMIN.67482009-03-02.6748Jamp Topiramate TabletsJPC.67482024-01-31.6748Auro-TopiramateAUR.67482011-09-15.6748TopiramateSAI.67482011-08-04.6748Ach-TopiramateACH.67482013-03-20.6748Ran-TopiramateRAN.67482013-06-27.6748Sandoz Topiramate TabletsSDZ.67482015-01-28.6748Mar-TopiramateMAR.67482015-02-26.6748Jamp-TopiramateJPC.67482015-05-28.6748NRA-TopiramateNRA.67482024-04-30.6748TopiramateSIV.67482026-01-30.6748VALPROATE SODIUM111650mg/mLO/LDepakeneBGP.15051996-10-01.0398PMS-Valproic AcidPMS.03981999-04-15.0398Apo-ValproicAPX.06051999-09-15.0398Jamp Valproic Acid Oral SolutionJPC.03982023-11-30.0398Odan-Valproic AcidODN.03982024-12-30.0398VALPROIC ACID1117250mgCapDepakeneABB1996-10-01PMS-Valproic AcidPMS.29051998-12-31.2905Apo-ValproicAPX.29051999-04-15.29051118500mgEnt CapDepakeneABB1996-10-01PMS-Valproic AcidPMS.81021997-08-28.8102VIGABATRIN1119500mg/SachetPd for Oral SolVigabatrin for Oral Solution, USP 500mgDRR5.00002023-10-315.00001120500mgTabSabrilOVA.95661996-10-01.9566As adjunctive therapy in the treatment of seizure disorders where control by other listed anticonvulsants has been unsatisfactory.Because a large number of patients may become refractory to the anticonvulsant effects of the drug over a period of time, the effectiveness of this drug must be re-evaluated after a period of six months.LU Authorization Period: Indefinite1121500mgTabVigabatrin Tablets, USPDRR5.00002023-11-305.0000PSYCHOTHERAPEUTIC AGENTS ANTIDEPRESSANTSAMITRIPTYLINE112210mgTabElavilAAP.06641996-10-01.0305PMS-AmitriptylinePMS.03052024-10-31.0305Mar-AmitriptylineMAR.03052015-04-30.0305Jamp-AmitriptylineJPC.03052025-12-30.0305112325mgTabElavilAAP.12111996-10-01.0580PMS-AmitriptylinePMS.05802015-04-30.0580Mar-AmitriptylineMAR.05802015-04-30.0580Jamp-AmitriptylineJPC.05802025-12-30.0580112450mgTabElavilAAP.23471996-10-01.1078PMS-AmitriptylinePMS.10782015-04-30.1078Mar-AmitriptylineMAR.10782015-04-30.1078Jamp-AmitriptylineJPC.10782025-12-30.1078BUPROPION HCL1125150mgER TabWellbutrin XLVAL.63352007-11-10.2926Act Bupropion XLACV.29262016-07-28.2926Taro-Bupropion XLSPC.29262019-07-31.29261126300mgER TabWellbutrin XLVAL1.26742007-11-10.5853Act Bupropion XLACV.58532016-07-28.5853Taro-Bupropion XLSPC.58532019-07-31.58531127100mgTabWellbutrin SRBIO2000-04-17Odan Bupropion SRODN.52602006-08-24.52601128150mgTabWellbutrin SRVAL2000-04-17Odan Bupropion SRODN.91692006-08-24.9169For the treatment of depression.LU Authorization Period: IndefiniteCITALOPRAM HYDROBROMIDE112910mgTabCelexaVLH2024-12-30PMS-CitalopramPMS.44642025-02-28Mar-CitalopramMAR.44642025-03-31CitalopramSIV.44642025-02-28Natco-CitalopramNAT.44642024-12-30CitalopramJPC.44642024-12-30CitalopramSAI.44642026-01-30M-CitalopramMAT.44642025-05-30113020mgTabCelexaVLH1.87762000-01-17.1332Apo-CitalopramAPX.13322004-07-20.1332PMS-CitalopramPMS.13322004-07-20.1332Co CitalopramCOB.13322004-07-20.1332Sandoz CitalopramSDZ.13322004-07-20.1332Auro-CitalopramAUR.13322012-03-26.1332Ran-CitaloRAN.13322007-05-04.1332Teva-CitalopramTEV.13322007-11-10.1332Riva-CitalopramRIA.13322021-08-31.1332Jamp-CitalopramJPC.13322009-01-30.1332CitalopramSAI.13322011-08-04.1332Accel Citalopram TabletsACC.13322013-01-29.1332Septa-CitalopramSET.13322011-03-15.1332Mar-CitalopramMAR.13322012-01-19.1332CitalopramSIV.13322020-11-30.1332Nat-CitalopramNAT.13322014-06-26.1332Mint-CitalopramMIN.13322015-12-22.1332CitalopramJPC.13322015-01-28.1332Natco-CitalopramNAT.13322023-10-31.1332CCP-CitalopramCCP.13322017-11-30.1332M-CitalopramMAT.13322023-12-29.1332NRA-CitalopramNRA.13322023-01-31.1332113140mgTabCelexaVLH1.87762000-01-17.1332Apo-CitalopramAPX.13322004-07-20.1332PMS-CitalopramPMS.13322004-07-20.1332Co CitalopramCOB.13322004-07-20.1332Sandoz CitalopramSDZ.13322004-07-20.1332Auro-CitalopramAUR.13322012-03-26.1332Ran-CitaloRAN.13322007-05-04.1332Teva-CitalopramTEV.13322008-01-15.1332Riva-CitalopramRIA.13322021-08-31.1332Jamp-CitalopramJPC.13322009-01-30.1332CitalopramSAI.13322011-08-04.1332Accel Citalopram TabletsACC.13322013-01-29.1332Septa-CitalopramSET.13322011-03-15.1332Mar-CitalopramMAR.13322012-01-19.1332CitalopramSIV.13322020-11-30.1332Nat-CitalopramNAT.13322014-06-26.1332Mint-CitalopramMIN.13322015-12-22.1332CitalopramJPC.13322015-01-28.1332Natco-CitalopramNAT.13322023-10-31.1332CCP-CitalopramCCP.13322017-11-30.1332M-CitalopramMAT.13322023-12-29.1332NRA-CitalopramNRA.13322023-01-31.1332CLOMIPRAMINE HCL113225mgAnafranil TabAPX.40201996-10-01.3417Taro-Clomipramine CapTAR.34172020-06-30.3417113350mgAnafranil TabAPX.74011996-10-01.6291Taro-Clomipramine CapTAR.62912020-06-30.6291113410mgTabAnafranilAPX.29491996-10-01.2949DESIPRAMINE113525mgTabPertofraneGEI1996-10-01NorpraminSAV1999-01-07DesipramineAAP.44411996-12-19.4441113650mgTabNorpraminSAV1999-01-07DesipramineAAP.78271996-12-19.7827113775mgTabNorpraminHMR1999-01-07DesipramineAAP1.04081996-12-191.0408DESVENLAFAXINE113850mgER TabPristiqPFI2017-12-21Teva-DesvenlafaxineTEV2.34092022-04-29Apo-DesvenlafaxineAPX2.34092017-12-21DesvenlafaxineAPX2.34092022-04-29Jamp DesvenlafaxineJPC2.34092022-05-31Taro-DesvenlafaxineTAR2.34092023-10-31DesvenlafaxineSAI2.34092023-05-31Sandoz DesvenlafaxineSDZ2.34092024-02-29DesvenlafaxineSIV2.34092025-05-301139100mgER TabPristiqPFI2017-12-21Teva-DesvenlafaxineTEV2.34092022-04-29Apo-DesvenlafaxineAPX2.34092017-12-21DesvenlafaxineAPX2.34092022-04-29Jamp DesvenlafaxineJPC2.34092022-05-31Taro-DesvenlafaxineTAR2.34092023-10-31DesvenlafaxineSAI2.34092023-05-31Sandoz DesvenlafaxineSDZ2.34092024-02-29DesvenlafaxineSIV2.34092025-05-30DOXEPIN HCL114010mgCapSinequanAAP.40751996-10-01.2038Apo-DoxepinAPX.20381996-10-01.2038Mar-DoxepinMAR.20382025-09-29.2038114125mgCapSinequanAAP.50001996-10-01.2500Apo-DoxepinAPX.25001996-10-01.2500Mar-DoxepinMAR.25002025-09-29.2500114250mgCapSinequanAAP.92741996-10-01.4637Apo-DoxepinAPX.46371996-10-01.4637Mar-DoxepinMAR.46372025-09-29.4637114375mgCapSinequanAAP1996-10-01Apo-DoxepinAPX1.13631996-10-01Mar-DoxepinMAR1.13632025-09-29Jamp DoxepinJPC1.13632026-03-311144100mgCapSinequanAAP1996-10-01Apo-DoxepinAPX1.49441996-10-01Mar-DoxepinMAR1.49442025-09-29Jamp DoxepinJPC1.49442026-03-31DULOXETINE114530mgDR CapCymbaltaLIL2.60042009-08-18.3611PMS-DuloxetinePMS.48142016-06-29.3611Auro-DuloxetineAUR.48142016-06-29.3611Duloxetine DRTEV.48142016-06-29.3611Ran-DuloxetineRAN.48142016-06-29.3611Mint-DuloxetineMIN.48142016-06-29.3611Sandoz DuloxetineSDZ.48142016-06-29.3611Apo-DuloxetineAPX.48142016-06-29.3611Mar-DuloxetineMAR.48142016-08-30.3611Jamp-DuloxetineJPC.48142016-07-28.3611DuloxetineSIV.48142020-06-30.3611Teva-DuloxetineTEV.48142020-06-30.3611Taro-DuloxetineTAR.48142025-09-29.3611M-DuloxetineMAT.48142021-11-30.3611AG-DuloxetineANG.48142020-11-30.3611NRA-DuloxetineNRA.48142020-07-31.3611DuloxetineSAI.48142019-11-29.3611Jamp Duloxetine CapsulesJPC.48142024-01-31.3611Accel-DuloxetineACC.36112022-05-31.3611114660mgDR CapCymbaltaLIL5.27792009-08-18.7327PMS-DuloxetinePMS.97692016-06-29.7327Auro-DuloxetineAUR.97692016-06-29.7327Duloxetine DRTEV.97692016-06-29.7327Ran-DuloxetineRAN.97692016-06-29.7327Mint-DuloxetineMIN.97692016-06-29.7327Sandoz DuloxetineSDZ.97692016-06-29.7327Apo-DuloxetineAPX.97692016-06-29.7327Mar-DuloxetineMAR.97692016-08-30.7327Jamp-DuloxetineJPC.97692016-07-28.7327DuloxetineSIV.97692020-06-30.7327Teva-DuloxetineTEV.97692020-06-30.7327Taro-DuloxetineTAR.97692025-09-29.7327M-DuloxetineMAT.97692021-11-30.7327AG-DuloxetineANG.97692020-11-30.7327NRA-DuloxetineNRA.97692020-07-31.7327DuloxetineSAI.97692019-11-29.7327Jamp Duloxetine CapsulesJPC.97692024-01-31.7327Accel-DuloxetineACC.73272022-05-31.7327ESCITALOPRAM114710mgOrally Disintegrating TabCipralex MELTZVLH2014-01-03Act Escitalopram ODTACV1.31992016-11-301.3199114820mgOrally Disintegrating TabletCipralex MELTZVLH2014-01-03Act Escitalopram ODTACV1.40522016-11-301.4052114910mgTabCipralexVLH2.38252008-11-04.3109Apo-EscitalopramAPX.31092014-11-27.3109Mylan-EscitalopramMYL.31092014-11-27.3109Teva-EscitalopramTEV.31092014-11-27.3109Sandoz EscitalopramSDZ.31092014-11-27.3109Ran-EscitalopramRAN.31092014-11-27.3109Auro-EscitalopramAUR.31092014-12-18.3109Mint-EscitalopramMIN.31092016-02-25.3109Mar-EscitalopramMAR.31092014-11-27.3109EscitalopramSIV.31092020-06-30.3109Jamp-EscitalopramJPC.31092014-11-27.3109EscitalopramSAI.31092016-09-29.3109Ach-EscitalopramACH.31092017-12-21.3109Nat-EscitalopramNAT.31092015-10-29.3109PMS-EscitalopramPMS.31092018-09-27.3109M-EscitalopramMAT.31092021-09-30.3109NRA-EscitalopramNRA.31092020-06-30.3109Jamp EscitalopramJPC.31092024-02-29.3109Natco-EscitalopramNAT.31092025-11-28.3109115020mgTabCipralexVLH2.54382008-11-04.3310Apo-EscitalopramAPX.33102014-11-27.3310Mylan-EscitalopramMYL.33102014-11-27.3310Teva-EscitalopramTEV.33102014-11-27.3310Sandoz EscitalopramSDZ.33102014-11-27.3310Ran-EscitalopramRAN.33102014-11-27.3310Auro-EscitalopramAUR.33102014-12-18.3310Mint-EscitalopramMIN.33102016-02-25.3310Mar-EscitalopramMAR.33102014-11-27.3310EscitalopramSIV.33102020-06-30.3310Jamp-EscitalopramJPC.33102014-11-27.3310EscitalopramSAI.33102016-09-29.3310Ach-EscitalopramACH.33102017-12-21.3310Nat-EscitalopramNAT.33102015-10-29.3310PMS-EscitalopramPMS.33102018-09-27.3310M-EscitalopramMAT.33102021-09-30.3310NRA-EscitalopramNRA.33102020-06-30.3310Jamp EscitalopramJPC.33102024-02-29.3310Natco-EscitalopramNAT.33102025-11-28.3310FLUOXETINE HCLBecause of the long half-life of the fluoxetine metabolite, steady-state concentrations occur only after 4-6 weeks. Use with caution in anorexic patients. Fluoxetine therapy should be discontinued for 5 weeks before starting irreversible monoamine oxidase inhibitors (MAOI). Similarly irreversible MAOI should be discontinued for 2 weeks before starting fluoxetine.115110mgCapProzacLIL2008-02-12PMS-FluoxetinePMS1.17732008-02-12Apo-FluoxetineAPX1.17732008-02-12Teva-FluoxetineTEV1.17732008-02-12Co FluoxetineCOB1.17732013-06-27FluoxetineSAI1.17732017-06-29FluoxetineSIV1.17732021-02-26Mint-FluoxetineMIN1.17732012-05-29Auro-FluoxetineAUR1.17732012-12-21Mar-FluoxetineMAR1.17732012-11-27Ach-FluoxetineACH1.17732012-12-21Jamp-FluoxetineJPC1.17732013-06-27Bio-FluoxetineBMP1.17732016-03-30Sandoz FluoxetineSDZ1.17732019-06-28AG-FluoxetineANG1.17732020-10-30NRA-FluoxetineNRA1.17732021-01-29M-FluoxetineMAT1.17732023-03-31115220mgCapProzacLIL2.48651996-10-01.3311PMS-FluoxetinePMS.33111996-10-01.3311Apo-FluoxetineAPX.33111996-10-01.3311Teva-FluoxetineTEV.33111996-10-01.3311Co FluoxetineCOB.33112001-03-07.3311FluoxetineSAI.33112011-08-04.3311FluoxetineSIV.33112021-02-26.3311Mint-FluoxetineMIN.33112012-05-29.3311Ach-FluoxetineACH.33112012-07-27.3311Auro-FluoxetineAUR.33112012-09-28.3311Jamp-FluoxetineJPC.33112012-08-27.3311Mar-FluoxetineMAR.33112012-11-27.3311Ran-FluoxetineRAN.33112013-09-27.3311Bio-FluoxetineBMP.33112016-02-25.3311Sandoz FluoxetineSDZ.33112019-06-28.3311AG-FluoxetineANG.33112020-10-30.3311NRA-FluoxetineNRA.33112021-01-29.3311M-FluoxetineMAT.33112023-04-28.3311115340mgCapPMS-FluoxetinePMS.66222021-02-26.6622115460mgCapPMS-FluoxetinePMS.99332021-02-26.9933115520mg/5mLOral SolProzacLIL2017-04-27Apo-FluoxetineAPX.21582018-04-30.2158Odan-FluoxetineODN.21582017-04-27.2158Jamp Fluoxetine SolutionJPC.21582025-06-30.2158FLUVOXAMINE MALEATEFluvoxamine therapy should be discontinued for 2 weeks before starting irreversible monoamine oxidase inhibitors (MAOI). Similarly irreversible MAOI should be discontinued for 2 weeks before starting fluvoxamine.115650mgTabLuvoxBGP1.14891996-10-01.5410Apo-FluvoxamineAPX.54101998-12-31.5410Teva-FluvoxamineTEV.54102004-10-14.54101157100mgTabLuvoxBGP2.06591996-10-01.9728Apo-FluvoxamineAPX.97281998-12-31.9728Teva-FluvoxamineTEV.97282004-10-14.9728IMIPRAMINE115810mgTabTofranilNOV1996-10-01Apo-Imipramine TabletsAPX.12571996-10-01.1257Jamp ImipramineJPC.12572025-04-30.1257115925mgTabTofranilNOV1996-10-01Apo-Imipramine TabletsAPX.23161996-10-01.2316Jamp ImipramineJPC.23162025-04-30.2316116050mgTabTofranilNOV1996-10-01Apo-Imipramine TabletsAPX.45191996-10-01.4519Jamp ImipramineJPC.45192025-04-30.4519MIRTAZAPINE116115mgOrally Disintegrating TabRemeron RDOCI.55292005-02-22.4046Auro-Mirtazapine ODAUR.40462011-06-08.4046116230mgOrally Disintegrating TabRemeron RDOCI1.10522005-02-22.8087Auro-Mirtazapine ODAUR.80872011-06-08.8087116345mgOrally Disintegrating TabRemeron RDOCI1.65802005-02-221.2132Auro-Mirtazapine ODAUR1.21322011-06-081.2132116415mgTabRemeronORG2024-10-31Auro-MirtazapineAUR.37502025-01-31MirtazapineSIV.37502025-03-31MirtazapineSAI.37502025-07-31Teva-MirtazapineTEV.37502024-10-31116530mgTabRemeronOCI1.89872002-07-29.3100PMS-MirtazapinePMS.31002004-07-20.3100Sandoz MirtazapineSDZ.31002004-07-20.3100Mylan-MirtazapineMYL.31002004-09-14.3100Teva-MirtazapineTEV.31002004-12-21.3100Apo-MirtazapineAPX.31002007-01-02.3100MirtazapineSAI.31002020-06-30.3100Auro-MirtazapineAUR.31002014-01-03.3100MirtazapineSIV.31002020-12-18.3100NRA-MirtazapineNRA.31002023-09-28.3100116645mgTabRemeronORG2024-10-31Auro-MirtazapineAUR1.12502025-01-31MirtazapineSIV1.12502025-03-31Teva-MirtazapineTEV1.12502024-10-31MOCLOBEMIDE1167100mgTabManerixHLR1996-10-01MoclobemideAAP.34001998-12-31.34001168150mgTabManerixMAB.91261996-10-01.5295MoclobemideAAP.52951998-12-31.52951169300mgTabManerixMAB1.79211997-04-101.0399MoclobemideAAP1.03992000-01-171.0399NORTRIPTYLINE117010mgCapAventylAAP.29951996-10-01.2995117125mgCapAventylAAP.60541996-10-01.6054PAROXETINE HCL117210mgTabPaxilSMJ2007-06-06Apo-ParoxetineAPX1.04302007-06-06PMS-ParoxetinePMS1.04302007-06-06Teva-ParoxetineTEV1.04302007-06-06Co ParoxetineCOB1.04302007-06-06ParoxetineSAI1.04302011-08-04Jamp-ParoxetineJPC1.04302012-08-27Auro-ParoxetineAUR1.04302012-12-21ParoxetineSIV1.04302020-12-18Mar-ParoxetineMAR1.04302014-01-03Mint-ParoxetineMIN1.04302014-05-29Sandoz Paroxetine TabletsSDZ1.04302015-01-28M-ParoxetineMAT1.04302021-11-30AG-ParoxetineANG1.04302020-11-30NRA-ParoxetineNRA1.04302020-07-31Jamp Paroxetine TabletsJPC1.04302021-07-30117320mgTabPaxilGSK2.50211996-10-01.3250Apo-ParoxetineAPX.32502004-04-06.3250PMS-ParoxetinePMS.32502004-04-06.3250Teva-ParoxetineTEV.32502004-04-06.3250Co ParoxetineCOB.32502005-04-28.3250ParoxetineSAI.32502011-08-04.3250Jamp-ParoxetineJPC.32502012-08-27.3250Auro-ParoxetineAUR.32502012-09-28.3250ParoxetineSIV.32502020-12-18.3250Mar-ParoxetineMAR.32502014-01-03.3250Mint-ParoxetineMIN.32502014-05-29.3250Sandoz Paroxetine TabletsSDZ.32502015-01-28.3250M-ParoxetineMAT.32502021-10-29.3250AG-ParoxetineANG.32502020-11-30.3250NRA-ParoxetineNRA.32502020-07-31.3250Jamp Paroxetine TabletsJPC.32502022-02-28.3250117430mgTabPaxilGSK2.65771996-10-01.3453Apo-ParoxetineAPX.34532004-04-06.3453PMS-ParoxetinePMS.34532004-04-06.3453Teva-ParoxetineTEV.34532004-04-06.3453ParoxetineSAI.34532011-08-04.3453Jamp-ParoxetineJPC.34532012-08-27.3453Auro-ParoxetineAUR.34532012-09-28.3453ParoxetineSIV.34532020-12-18.3453Mar-ParoxetineMAR.34532014-01-03.3453Mint-ParoxetineMIN.34532014-05-29.3453Sandoz Paroxetine TabletsSDZ.34532015-01-28.3453M-ParoxetineMAT.34532021-10-29.3453AG-ParoxetineANG.34532020-11-30.3453NRA-ParoxetineNRA.34532020-07-31.3453Jamp Paroxetine TabletsJPC.34532022-02-28.3453PHENELZINE SULFATE117515mgTabNardilSLP.4905Consult the scientific literature regarding cautions and contraindications prior to prescribing and/or dispensing irreversible monoamine oxidase inhibitors. 1996-10-01.4905RASAGILINE MESYLATE11760.5mgTabAzilectTEI9.99042016-03-306.1285Apo-RasagilineAPX6.12852016-03-306.1285Teva-RasagilineTEV6.12852016-07-286.1285ASN-RasagilineASL6.12852026-02-276.1285Jamp RasagilineJPC6.12852020-10-306.128511771mgTabAzilectTEI9.99042016-03-306.1285Apo-RasagilineAPX6.12852016-03-306.1285Teva-RasagilineTEV6.12852016-07-286.1285ASN-RasagilineASL6.12852026-02-276.1285Jamp RasagilineJPC6.12852020-10-306.1285SERTRALINE HCLSertraline therapy should be discontinued for 2 weeks before starting irreversible monoamine oxidase inhibitors (MAOI). Similarly irreversible MAOI should be discontinued for 2 weeks before starting sertraline.117825mgCapZoloftUJC1.04601996-10-01.1516Apo-SertralineAPX.15162000-01-17.1516Teva-SertralineTEV.15162000-01-17.1516PMS-SertralinePMS.15162003-01-30.1516Sandoz SertralineSDZ.15162003-01-30.1516Co SertralineCOB.15162007-04-02.1516SertralineSAI.15162011-08-04.1516Jamp-SertralineJPC.15162012-09-28.1516SertralineSIV.15162020-06-30.1516Auro-SertralineAUR.15162012-12-21.1516Mar-SertralineMAR.15162013-03-20.1516Mint-SertralineMIN.15162013-06-27.1516SertralineJPC.15162018-02-28.1516AG-SertralineANG.15162020-12-18.1516NRA-SertralineNRA.15162021-03-29.1516M-SertralineMAT.15162023-04-28.1516117950mgCapZoloftUJC2.09191996-10-01.3032Apo-SertralineAPX.30322000-01-17.3032Teva-SertralineTEV.30322000-01-17.3032PMS-SertralinePMS.30322003-01-30.3032Sandoz SertralineSDZ.30322003-01-30.3032Co SertralineCOB.30322007-04-02.3032SertralineSAI.30322011-08-04.3032Jamp-SertralineJPC.30322012-09-28.3032SertralineSIV.30322020-06-30.3032Auro-SertralineAUR.30322012-12-21.3032Mar-SertralineMAR.30322013-03-20.3032Mint-SertralineMIN.30322013-06-27.3032SertralineJPC.30322018-02-28.3032AG-SertralineANG.30322020-12-18.3032NRA-SertralineNRA.30322021-03-29.3032M-SertralineMAT.30322023-04-28.30321180100mgCapZoloftUJC2.27911996-10-01.3303Apo-SertralineAPX.33032000-01-17.3303Teva-SertralineTEV.33032000-01-17.3303PMS-SertralinePMS.33032003-01-30.3303Sandoz SertralineSDZ.33032003-01-30.3303Co SertralineCOB.33032007-04-02.3303SertralineSAI.33032011-08-04.3303Jamp-SertralineJPC.33032012-09-28.3303Ran-SertralineRAN.33032012-01-19.3303SertralineSIV.33032020-06-30.3303Auro-SertralineAUR.33032012-12-21.3303Mar-SertralineMAR.33032013-03-20.3303Mint-SertralineMIN.33032013-06-27.3303SertralineJPC.33032018-02-28.3303AG-SertralineANG.33032020-12-18.3303NRA-SertralineNRA.33032021-03-29.3303M-SertralineMAT.33032023-04-28.3303TRANYLCYPROMINE SULFATE118110mgTabParnateGSK.5374Consult the scientific literature regarding cautions and contraindications prior to prescribing and/or dispensing irreversible monoamine oxidase inhibitors. 1996-10-01.5374TRAZODONE HYDROCHLORIDE118250mgTabDesyrelBQU1996-10-01PMS-TrazodonePMS.05541996-10-01.0554Teva-TrazodoneTEV.05541996-10-01.0554Apo-TrazodoneAPX.05541996-10-01.0554TrazodoneSAI.05542011-10-25.0554Jamp TrazodoneJPC.05542022-01-31.05541183100mgTabDesyrelBQU1996-10-01PMS-TrazodonePMS.09891996-10-01.0989Teva-TrazodoneTEV.09891996-10-01.0989Apo-TrazodoneAPX.09891996-10-01.0989TrazodoneSAI.09892011-10-25.0989Jamp TrazodoneJPC.09892022-01-31.09891184150mgTabDesyrel DividoseBQU1996-10-01Teva-TrazodoneTEV.14531996-10-01.1453Apo-Trazodone DAPX.14531996-10-01.1453TrazodoneSAI.14532011-10-25.1453Jamp TrazodoneJPC.14532022-01-31.1453TRIMIPRAMINE118575mgCapSurmontilRPP1996-10-01TrimipramineAAP.79721996-10-01.7972118612.5mgTabTrimipramineAAP.22031996-10-01.2203SurmontilRPP1996-10-01118725mgTabTrimipramineAAP.30251996-10-01.3025SurmontilRPP1996-10-01118850mgTabTrimipramineAAP.59221996-10-01.5922SurmontilRPP1996-10-011189100mgTabTrimipramineAAP1.01071996-10-011.0107SurmontilRPP1996-10-01VENLAFAXINE HCL119037.5mgER CapEffexor XRUJC1.16252000-01-17.0913Teva-Venlafaxine XRTEV.09132007-01-02.0913PMS-Venlafaxine XRPMS.09132007-11-10.0913ACT Venlafaxine XRTEV.09132008-04-09.0913Sandoz Venlafaxine XRSDZ.09132008-08-28.0913Apo-Venlafaxine XRAPX.09132010-04-23.0913Venlafaxine XRSAI.09132011-08-04.0913Taro-Venlafaxine XRSPC.09132012-04-24.0913Venlafaxine XRSIV.09132020-06-30.0913Auro-Venlafaxine XRAUR.09132016-05-31.0913M-Venlafaxine XRMAT.09132021-11-30.0913Venlafaxine XRRIA.09132024-11-29.0913Venlafaxine XRJPC.09132022-02-28.0913PMSC-Venlafaxine XRPMS.09132022-11-30.0913Mint-Venlafaxine XRMIN.09132025-04-30.0913119175mgER CapEffexor XRUJC2.32422000-01-17.1825Teva-Venlafaxine XRTEV.18252007-01-02.1825PMS-Venlafaxine XRPMS.18252007-11-10.1825ACT Venlafaxine XRTEV.18252008-04-09.1825Sandoz Venlafaxine XRSDZ.18252008-08-28.1825Apo-Venlafaxine XRAPX.18252010-04-23.1825Venlafaxine XRSAI.18252011-08-04.1825Taro-Venlafaxine XRSPC.18252012-04-24.1825Venlafaxine XRSIV.18252020-06-30.1825Auro-Venlafaxine XRAUR.18252016-05-31.1825M-Venlafaxine XRMAT.18252021-11-30.1825Venlafaxine XRRIA.18252024-11-29.1825Venlafaxine XRJPC.18252022-02-28.1825PMSC-Venlafaxine XRPMS.18252022-10-31.1825Mint-Venlafaxine XRMIN.18252025-04-30.18251192150mgER CapEffexor XRUJC2.45462000-01-17.1927Teva-Venlafaxine XRTEV.19272007-01-02.1927PMS-Venlafaxine XRPMS.19272007-11-10.1927ACT Venlafaxine XRTEV.19272008-04-09.1927Sandoz Venlafaxine XRSDZ.19272008-08-28.1927Apo-Venlafaxine XRAPX.19272010-04-23.1927Venlafaxine XRSAI.19272011-08-04.1927Taro-Venlafaxine XRSPC.19272012-04-24.1927Venlafaxine XRSIV.19272020-06-30.1927Auro-Venlafaxine XRAUR.19272016-05-31.1927M-Venlafaxine XRMAT.19272021-11-30.1927Venlafaxine XRRIA.19272024-11-29.1927Venlafaxine XRJPC.19272022-02-28.1927PMSC-Venlafaxine XRPMS.19272022-10-31.1927Mint-Venlafaxine XRMIN.19272025-04-30.1927VILAZODONE HYDROCHLORIDE119310mgTabViibrydABV2024-12-30Apo-VilazodoneAPX3.04822024-12-30119420mgTabViibrydABV2024-12-30Apo-VilazodoneAPX3.04822024-12-30119540mgTabViibrydABV2024-12-30Apo-VilazodoneAPX4.05772024-12-30VORTIOXETINE HYDROBROMIDE11965mgTabTrintellixVLH2.88242021-01-291.5853Apo-VortioxetineAPX1.58532025-05-301.5853119710mgTabTrintellixVLH3.01922021-01-291.6606Apo-VortioxetineAPX1.66062025-05-301.6606119820mgTabTrintellixVLH3.27792021-01-291.8028Apo-VortioxetineAPX1.80282025-05-301.8028PSYCHOTHERAPEUTIC AGENTS TRANQUILIZERSALPRAZOLAM11990.25mgTabXanaxUJC.36781996-10-01.0633Apo-AlprazAPX.06331996-10-01.0633Teva-AlprazolamTEV.06331996-10-01.0633Nat-AlprazolamNAT.06332015-10-29.063312000.5mgTabXanaxUJC.43991996-10-01.0757Apo-AlprazAPX.07571996-10-01.0757Teva-AlprazolamTEV.07571996-10-01.0757Nat-AlprazolamNAT.07572015-10-29.075712011mgTabXanaxUJC2008-03-25Apo-AlprazAPX.65852008-03-25Jamp AlprazolamJPC.46032025-01-31Nat-AlprazolamNAT.30992015-10-2912022mgTabXanax TSUJC2008-03-25Apo-Alpraz TSAPX1.17042008-03-25Jamp AlprazolamJPC.92712025-01-31Nat-AlprazolamNAT.55082016-11-30ARIPIPRAZOLE1203720mg/2.4mLInj Sol-Pref SyrAbilify AsimtufiiOTS912.3600For the maintenance treatment of schizophrenia in patients who are stabilized on oral aripiprazole who have: A history of non-adherence; AND one of the following: - Inadequate control or significant side-effects from two or more formulary oral antipsychotic medications, including at least one atypical agent; OR - Inadequate control or significant side-effects from one or more conventional depot antipsychotic agents2025-12-30912.36001204960mg/3.2mLInj Sol-Pref SyrAbilify AsimtufiiOTS912.3600For the maintenance treatment of schizophrenia in patients who are stabilized on oral aripiprazole who have: A history of non-adherence; AND one of the following: - Inadequate control or significant side-effects from two or more formulary oral antipsychotic medications, including at least one atypical agent; OR - Inadequate control or significant side-effects from one or more conventional depot antipsychotic agents2025-12-30912.36001205300mg/VialProlong-Rel Inj Pd-Vial PkFor the maintenance treatment of schizophrenia in patients who are stabilized on oral aripiprazole who have: A history of non-adherence; AND one of the following: a) Inadequate control or significant side-effects from two or more formulary oral antipsychotic medications, including at least one atypical agent; OR b) Inadequate control or significant side-effects from one or more conventional depot antipsychotic agents.Abilify MaintenaOTS509.12422015-07-29509.12421206400mg/VialProlong-Rel Inj Pd-Vial PkFor the maintenance treatment of schizophrenia in patients who are stabilized on oral aripiprazole who have: A history of non-adherence; AND one of the following: a) Inadequate control or significant side-effects from two or more formulary oral antipsychotic medications, including at least one atypical agent; OR b) Inadequate control or significant side-effects from one or more conventional depot antipsychotic agents.Abilify MaintenaOTS509.12422015-07-29509.124212072mgTabNotes: Subject to the specific drug's product monograph, for the treatment of schizophrenia and related psychotic disorders after failure, intolerance or contraindication to at least one less expensive antipsychotic alternative. Not indicated for the treatment of dementia or dementia-related behavioral problems in the elderly. Prescribers should be informed and stay current with a drug's official indications in accordance with Health Canada's approved product monograph.AbilifyOTS3.31432011-10-25.8092Auro-AripiprazoleAUR.80922018-09-27.8092Teva-AripiprazoleTEV.80922018-10-31.8092PMS-AripiprazolePMS.80922018-09-27.8092Apo-AripiprazoleAPX.80922018-06-29.8092NRA-AripiprazoleNRA.80922024-03-28.8092Sandoz AripiprazoleSDZ.80922018-09-27.8092Mint-AripiprazoleMIN.80922020-06-30.8092AripiprazoleSAI.80922021-06-30.8092AripiprazoleSIV.80922023-09-28.8092Jamp AripiprazoleJPC.80922026-01-30.809212085mgTabNotes: Subject to the specific drug's product monograph, for the treatment of schizophrenia and related psychotic disorders after failure, intolerance or contraindication to at least one less expensive antipsychotic alternative. Not indicated for the treatment of dementia or dementia-related behavioral problems in the elderly. Prescribers should be informed and stay current with a drug's official indications in accordance with Health Canada's approved product monograph.AbilifyOTS3.70522011-10-25.9046Auro-AripiprazoleAUR.90462018-09-27.9046Teva-AripiprazoleTEV.90462018-10-31.9046PMS-AripiprazolePMS.90462018-09-27.9046Apo-AripiprazoleAPX.90462018-06-29.9046NRA-AripiprazoleNRA.90462024-03-28.9046Sandoz AripiprazoleSDZ.90462018-09-27.9046Mint-AripiprazoleMIN.90462020-06-30.9046AripiprazoleSAI.90462021-06-30.9046AripiprazoleSIV.90462023-09-28.9046Jamp AripiprazoleJPC.90462026-01-30.9046120910mgTabNotes: Subject to the specific drug's product monograph, for the treatment of schizophrenia and related psychotic disorders after failure, intolerance or contraindication to at least one less expensive antipsychotic alternative. Not indicated for the treatment of dementia or dementia-related behavioral problems in the elderly. Prescribers should be informed and stay current with a drug's official indications in accordance with Health Canada's approved product monograph.AbilifyOTS4.40492011-10-251.0754Auro-AripiprazoleAUR1.07542018-09-271.0754Teva-AripiprazoleTEV1.07542018-10-311.0754PMS-AripiprazolePMS1.07542018-09-271.0754Apo-AripiprazoleAPX1.07542018-06-291.0754NRA-AripiprazoleNRA1.07542024-03-281.0754Sandoz AripiprazoleSDZ1.07542018-09-271.0754Mint-AripiprazoleMIN1.07542020-06-301.0754AripiprazoleSAI1.07542021-06-301.0754AripiprazoleSIV1.07542023-09-281.0754Jamp AripiprazoleJPC1.07542026-01-301.0754121015mgTabNotes: Subject to the specific drug's product monograph, for the treatment of schizophrenia and related psychotic disorders after failure, intolerance or contraindication to at least one less expensive antipsychotic alternative. Not indicated for the treatment of dementia or dementia-related behavioral problems in the elderly. Prescribers should be informed and stay current with a drug's official indications in accordance with Health Canada's approved product monograph.AbilifyOTS5.19852011-10-251.2692Auro-AripiprazoleAUR1.26922018-09-271.2692Teva-AripiprazoleTEV1.26922018-09-271.2692PMS-AripiprazolePMS1.26922018-09-271.2692Apo-AripiprazoleAPX1.26922018-06-291.2692NRA-AripiprazoleNRA1.26922024-03-281.2692Sandoz AripiprazoleSDZ1.26922018-09-271.2692Mint-AripiprazoleMIN1.26922020-06-301.2692AripiprazoleSAI1.26922021-06-301.2692AripiprazoleSIV1.26922023-09-281.2692Jamp AripiprazoleJPC1.26922026-01-301.2692121120mgTabNotes: Subject to the specific drug's product monograph, for the treatment of schizophrenia and related psychotic disorders after failure, intolerance or contraindication to at least one less expensive antipsychotic alternative. Not indicated for the treatment of dementia or dementia-related behavioral problems in the elderly. Prescribers should be informed and stay current with a drug's official indications in accordance with Health Canada's approved product monograph.AbilifyOTS4.10282011-10-251.0017Auro-AripiprazoleAUR1.00172018-09-271.0017Teva-AripiprazoleTEV1.00172018-09-271.0017PMS-AripiprazolePMS1.00172018-09-271.0017Apo-AripiprazoleAPX1.00172018-06-291.0017NRA-AripiprazoleNRA1.00172024-03-281.0017Sandoz AripiprazoleSDZ1.00172018-09-271.0017Mint-AripiprazoleMIN1.00172020-06-301.0017AripiprazoleSAI1.00172021-06-301.0017AripiprazoleSIV1.00172023-09-281.0017Jamp AripiprazoleJPC1.00172026-01-301.0017121230mgTabNotes: Subject to the specific drug's product monograph, for the treatment of schizophrenia and related psychotic disorders after failure, intolerance or contraindication to at least one less expensive antipsychotic alternative. Not indicated for the treatment of dementia or dementia-related behavioral problems in the elderly. Prescribers should be informed and stay current with a drug's official indications in accordance with Health Canada's approved product monograph.AbilifyOTS4.10282011-10-251.0017Auro-AripiprazoleAUR1.00172018-09-271.0017Teva-AripiprazoleTEV1.00172018-10-311.0017PMS-AripiprazolePMS1.00172018-09-271.0017Apo-AripiprazoleAPX1.00172018-06-291.0017NRA-AripiprazoleNRA1.00172024-03-281.0017Sandoz AripiprazoleSDZ1.00172018-09-271.0017Mint-AripiprazoleMIN1.00172020-06-301.0017AripiprazoleSAI1.00172021-06-301.0017AripiprazoleSIV1.00172023-09-281.0017Jamp AripiprazoleJPC1.00172026-01-301.0017ASENAPINE12135mgSL TabFor the acute treatment of manic or mixed episodes associated with bipolar I disorder as either: Monotherapy, after a trial of lithium or divalproex sodium has failed, and trials of less expensive atypical antipsychotic agents have failed due to intolerance or lack of response; OR Co-therapy with lithium or divalproex sodium, after trials of less expensive atypical antipsychotic agents have failed due to intolerance or lack of response. SaphrisOCI1.59102014-02-271.5910121410mgSL TabFor the acute treatment of manic or mixed episodes associated with bipolar I disorder as either: Monotherapy, after a trial of lithium or divalproex sodium has failed, and trials of less expensive atypical antipsychotic agents have failed due to intolerance or lack of response; OR Co-therapy with lithium or divalproex sodium, after trials of less expensive atypical antipsychotic agents have failed due to intolerance or lack of response.SaphrisOCI1.59102014-02-271.5910BREXPIPRAZOLE12150.25mgTabRexultiOTS3.50002019-04-303.500012160.5mgTabRexultiOTS3.50002019-04-303.500012171mgTabRexultiOTS3.50002019-04-303.500012182mgTabRexultiOTS3.50002019-04-303.500012193mgTabRexultiOTS3.50002019-04-303.500012204mgTabRexultiOTS3.50002019-04-303.5000BROMAZEPAM12211.5mgTabLectopamHLR1996-10-01Apo-BromazepamAPX.10281996-10-01.102812223mgTabLectopamHLR1996-10-01Apo-BromazepamAPX.08971996-10-01.0897Teva-BromazepamTEV.08971998-12-31.089712236mgTabLectopamHLR1996-10-01Apo-BromazepamAPX.13101996-10-01.1310Teva-BromazepamTEV.13101998-12-31.1310CARIPRAZINE12241.5mgCapVraylarABV5.09602024-10-315.096012253mgCapVraylarABV5.09602024-10-315.096012264.5mgCapVraylarABV5.09602024-10-315.096012276mgCapVraylarABV5.09602024-10-315.0960CHLORDIAZEPOXIDE12285mgCapLibriumHLR1996-10-01ChlordiazepoxideAAP.08251996-10-01.0825122910mgCapLibriumHLR1996-10-01ChlordiazepoxideAAP.11151996-10-01.1115123025mgCapLibriumHLR1996-10-01ChlordiazepoxideAAP.22161996-10-01.2216CHLORPROMAZINE123125mgTabTeva-ChlorpromazineTEV.24541996-10-01.2454LargactilRPP1999-07-22123250mgTabTeva-ChlorpromazineTEV.28081996-10-01.2808LargactilRPP1999-07-221233100mgTabTeva-ChlorpromazineTEV.74751996-10-01.7475LargactilRPP1999-07-22CLORAZEPATE DIPOTASSIUM12343.75mgCapTranxeneABB1996-10-01ClorazepateAAP.19721996-10-01.197212357.5mgCapTranxeneABB1996-10-01ClorazepateAAP.23881996-10-01.2388123615mgCapTranxeneABB1996-10-01ClorazepateAAP.45021996-10-01.4502CLOZAPINE123750mgAA-Clozapine TabletAAP1.32062021-12-17Clozaril TabletHLS2021-12-17Gen-Clozapine ODTMYL1.31882026-02-271238200mgAA-Clozapine TabletAAP5.28922021-12-17Clozaril TabletHLS2021-12-17Gen-Clozapine ODTMYL5.28922026-02-27123925mgClozaril TabletNOV2007-09-04Gen-Clozapine TabletMYL.65942007-09-04AA-Clozapine TabletAAP.65942007-09-04Gen-Clozapine ODTMYL.65942026-02-271240100mgClozaril TabletNOV2007-09-04Gen-Clozapine TabletMYL2.64462007-09-04AA-Clozapine TabletAAP2.64462007-09-04Gen-Clozapine ODTMYL2.64462026-02-27DIAZEPAM12415mg/mLInj Sol (Preservative Free)Diazepam Injection USPSDZ1.64152017-02-281.6415For the management of patients receiving palliative care*.LU Authorization Period: 1 year*The patient must have a progressive life-limiting illness and require this medication for palliative purposes.12425mg/mLRect Gel-2x 5mg PkDiastatBHC218.31062000-11-30218.3106124310mg/2mLRect Gel-2x10mg PkDiastatBHC218.31062025-12-30218.3106124415mg/3mLRect Gel-2x15mg PkDiastatBHC218.31062025-12-30218.310612452mgTabValiumHLR2005-02-22DiazepamAAP.05321996-10-01.053212465mgTabValiumHLR1996-10-01DiazepamAAP.16621996-10-01.1662124710mgTabValiumHLR1996-10-01DiazepamAAP.12041996-10-01.1204FLUPENTIXOL DECANOATE124820mg/mLInj Sol-1mL Amp PkFluanxol DepotVLH10.47621996-10-0110.47621249100mg/mLInj Sol-1mL Amp PkFluanxol DepotVLH52.38071996-10-0152.3807FLUPENTIXOL DIHYDROCHLORIDE12500.5mgTabFluanxolVLH.36191996-10-01.361912513mgTabFluanxolVLH.78171996-10-01.7817FLUPHENAZINE HCL12521mgTabModiten HCLBQU2006-06-15FluphenazineAAP.17391996-10-01.173912532mgTabModiten HCLBQU2006-06-15FluphenazineAAP.22521996-10-01.225212545mgTabModiten HCLBQU1996-10-01FluphenazineAAP.17201996-10-01.1720HALOPERIDOL12555mg/mLInj Sol-1mL PkHaldolOMC1996-10-01HaloperidolSDZ4.83001996-12-194.830012560.5mgTabHaldolOMC1996-10-01Teva-HaloperidolTEV.14301996-10-01.143012571mgTabHaldolOMC1996-10-01Teva-HaloperidolTEV.21481996-10-01.214812582mgTabHaldolOMC1996-10-01Teva-HaloperidolTEV.32111996-10-01.321112595mgTabHaldolOMC1996-10-01Teva-HaloperidolTEV.51211996-10-01.5121126010mgTabHaldolOMC1996-10-01Teva-HaloperidolTEV.74501996-10-01.7450126120mgTabHaldolOMC1996-10-01Teva-HaloperidolTEV1.30471996-10-011.3047HALOPERIDOL DECANOATE1262100mg/mL OilyInj Sol-5mL PkHaldol-LAOMC1996-10-01Haloperidol LASDZ84.61501998-12-3184.6150HYDROXYZINE HCL126310mgCapAtaraxPFI1996-10-01HydroxyzineAAP1996-10-01Novo-HydroxyzinNOP1996-10-01126425mgCapAtaraxPFI1996-10-01HydroxyzineAAP1996-10-01126550mgCapAtaraxPFI1996-10-01HydroxyzineAAP1996-10-01Novo-HydroxyzinNOP1996-10-01LORAZEPAM12660.5mgTabApo-LorazepamAPX.03591996-10-01.0359Teva-LorazepamTEV.03591996-10-01.0359PMS-LorazepamPMS.03592002-04-04.0359AtivanPFI.04791996-10-01.035912671mgTabTeva-LorazepamTEV.04471996-10-01.0447Apo-LorazepamAPX.04471996-10-01.0447PMS-LorazepamPMS.04472002-04-04.0447AtivanPFI.05651996-10-01.044712682mgTabTeva-LorazepamTEV.06991996-10-01.0699Apo-LorazepamAPX.06991996-10-01.0699PMS-LorazepamPMS.06992002-04-04.0699AtivanPFI.08851996-10-01.0699LOXAPINE SUCCINATE12695mgTabLoxapacWAY1998-03-17XylacPEN.18011999-04-15.1801127010mgTabLoxapacWAY1998-11-19XylacPEN.32331999-04-15.3233127125mgTabLoxapacWAY1998-11-19XylacPEN.50121999-04-15.5012127250mgTabLoxapacWAY1998-03-17XylacPEN.61971999-04-15.6197LURASIDONE HYDROCHLORIDE127320mgTabFor the management of the manifestations of schizophrenia after failure, intolerance or contraindication to at least one less expensive antipsychotic alternative. Not indicated for the treatment of dementia or dementia-related behavioral problems in the elderly.LatudaSUO4.25002018-03-291.2250Taro-LurasidoneTAR1.22502022-06-301.2250PMS-LurasidonePMS1.22502022-06-301.2250Auro-LurasidoneAUR1.22502023-12-291.2250Jamp LurasidoneJPC1.22502022-06-301.2250Sandoz LurasidoneSDZ1.22502022-05-311.2250NRA-LurasidoneNRA1.22502025-02-281.2250LurasidoneSAI1.22502025-02-281.2250127440mgTabFor the management of the manifestations of schizophrenia after failure, intolerance or contraindication to at least one less expensive antipsychotic alternative. Not indicated for the treatment of dementia or dementia-related behavioral problems in the elderly.LatudaSUO4.90002014-05-291.2250Taro-LurasidoneTAR1.22502022-06-301.2250PMS-LurasidonePMS1.22502022-06-301.2250Auro-LurasidoneAUR1.22502023-12-291.2250Jamp LurasidoneJPC1.22502022-06-301.2250Sandoz LurasidoneSDZ1.22502022-05-311.2250NRA-LurasidoneNRA1.22502025-02-281.2250LurasidoneSAI1.22502025-02-281.2250127560mgTabFor the management of the manifestations of schizophrenia after failure, intolerance or contraindication to at least one less expensive antipsychotic alternative. Not indicated for the treatment of dementia or dementia-related behavioral problems in the elderly.LatudaSUO4.90002018-03-291.2250Taro-LurasidoneTAR1.22502022-06-301.2250PMS-LurasidonePMS1.22502022-06-301.2250Auro-LurasidoneAUR1.22502023-12-291.2250Jamp LurasidoneJPC1.22502022-06-301.2250Sandoz LurasidoneSDZ1.22502022-05-311.2250NRA-LurasidoneNRA1.22502025-02-281.2250LurasidoneSAI1.22502025-02-281.2250127680mgTabFor the management of the manifestations of schizophrenia after failure, intolerance or contraindication to at least one less expensive antipsychotic alternative. Not indicated for the treatment of dementia or dementia-related behavioral problems in the elderly.LatudaSUO4.50002014-05-291.2250Taro-LurasidoneTAR1.22502022-06-301.2250PMS-LurasidonePMS1.22502022-06-301.2250Auro-LurasidoneAUR1.22502023-12-291.2250Jamp LurasidoneJPC1.22502022-06-301.2250Sandoz LurasidoneSDZ1.22502022-05-311.2250NRA-LurasidoneNRA1.22502025-02-281.2250LurasidoneSAI1.22502025-02-281.22501277120mgTabFor the management of the manifestations of schizophrenia after failure, intolerance or contraindication to at least one less expensive antipsychotic alternative. Not indicated for the treatment of dementia or dementia-related behavioral problems in the elderly.LatudaSUO2014-05-29Taro-LurasidoneTAR1.22502022-06-301.2250PMS-LurasidonePMS1.22502022-06-301.2250Auro-LurasidoneAUR1.22502023-12-291.2250Jamp LurasidoneJPC1.22502022-10-311.2250Sandoz LurasidoneSDZ1.22502023-07-311.2250OLANZAPINE12785mgRapid Dissolve TabZyprexa ZydisLIL4.58822001-10-11.3574PMS-Olanzapine ODTPMS.35742010-01-05.3574Act Olanzapine ODTTEV.35742010-01-05.3574Sandoz Olanzapine ODTSDZ.35742010-01-05.3574Olanzapine ODTSIV.35742020-12-18.3574Olanzapine ODTSAI.35742022-05-31.3574Apo-Olanzapine ODTAPX.35742011-06-08.3574Jamp-Olanzapine ODTJPC.35742013-08-29.3574Ran-Olanzapine ODTRAN.35742014-01-03.3574Mint-Olanzapine ODTMIN.35742015-07-29.3574Auro-Olanzapine ODTAUR.35742016-05-31.3574NRA-Olanzapine ODTNRA.35742024-08-30.3574127910mgRapid Dissolve TabZyprexa ZydisLIL9.16832001-10-11.7143PMS-Olanzapine ODTPMS.71432010-01-05.7143Novo-Olanzapine ODNOP.71432010-03-02.7143Act Olanzapine ODTTEV.71432010-01-05.7143Sandoz Olanzapine ODTSDZ.71432010-01-05.7143Olanzapine ODTSIV.71432020-12-18.7143Olanzapine ODTSAI.71432022-11-30.7143Apo-Olanzapine ODTAPX.71432011-06-08.7143Jamp-Olanzapine ODTJPC.71432013-08-29.7143Ran-Olanzapine ODTRAN.71432014-01-03.7143Mint-Olanzapine ODTMIN.71432015-07-29.7143Auro-Olanzapine ODTAUR.71432016-05-31.7143NRA-Olanzapine ODTNRA.71432024-08-30.7143128015mgRapid Dissolve TabZyprexa ZydisLIL13.85782005-02-221.0711PMS-Olanzapine ODTPMS1.07112010-01-051.0711Novo-Olanzapine ODNOP1.07112010-03-021.0711Act Olanzapine ODTTEV1.07112010-01-051.0711Sandoz Olanzapine ODTSDZ1.07112010-01-051.0711Olanzapine ODTSIV1.07112020-12-181.0711Olanzapine ODTSAI1.07112022-05-311.0711Apo-Olanzapine ODTAPX1.07112011-06-081.0711Jamp-Olanzapine ODTJPC1.07112013-08-291.0711Ran-Olanzapine ODTRAN1.07112014-01-031.0711Mint-Olanzapine ODTMIN1.07112015-07-291.0711Auro-Olanzapine ODTAUR1.07112016-05-311.0711NRA-Olanzapine ODTNRA1.07112024-08-301.0711128120mgRapid Dissolve TabZyprexa ZydisLIL2010-01-05Act Olanzapine ODTTEV7.59782010-01-05Sandoz Olanzapine ODTSDZ7.59782010-01-05Olanzapine ODTSIV7.59772020-12-18Apo-Olanzapine ODTAPX7.59772011-06-08Jamp-Olanzapine ODTJPC7.59772013-08-29Ran-Olanzapine ODTRAN7.59792014-01-03Mint-Olanzapine ODTMIN7.59772015-07-29Auro-Olanzapine ODTAUR7.59772017-05-31NRA-Olanzapine ODTNRA7.59772024-08-3012822.5mgTabZyprexaLIL2.34561998-12-31.1772Teva-OlanzapineTEV.17722007-07-12.1772Apo-OlanzapineAPX.17722010-01-05.1772PMS-OlanzapinePMS.17722009-11-19.1772Sandoz OlanzapineSDZ.17722010-10-28.1772Co OlanzapineCOB.17722010-04-23.1772OlanzapineSAI.17722016-04-01.1772OlanzapineSIV.17722020-06-30.1772Mint-OlanzapineMIN.17722019-12-20.1772Jamp Olanzapine FCJPC.17722015-10-29.1772AG-Olanzapine FCANG.17722021-09-30.1772NRA-OlanzapineNRA.17722024-08-30.177212835mgTabZyprexaLIL4.61371997-04-10.3544Teva-OlanzapineTEV.35442007-07-12.3544Apo-OlanzapineAPX.35442010-01-05.3544PMS-OlanzapinePMS.35442009-11-19.3544Sandoz OlanzapineSDZ.35442010-10-28.3544Co OlanzapineCOB.35442010-04-23.3544OlanzapineSAI.35442016-04-01.3544OlanzapineSIV.35442020-06-30.3544Ran-OlanzapineRAN.35442013-08-29.3544Mint-OlanzapineMIN.35442019-12-20.3544Jamp Olanzapine FCJPC.35442015-10-29.3544AG-Olanzapine FCANG.35442021-09-30.3544NRA-OlanzapineNRA.35442024-08-30.354412847.5mgTabZyprexaLIL6.92071997-04-10.5316Teva-OlanzapineTEV.53162007-07-12.5316Apo-OlanzapineAPX.53162010-01-05.5316PMS-OlanzapinePMS.53162009-11-19.5316Sandoz OlanzapineSDZ.53162010-10-28.5316Co OlanzapineCOB.53162010-04-23.5316OlanzapineSAI.53162016-04-01.5316OlanzapineSIV.53162020-06-30.5316Mint-OlanzapineMIN.53162019-12-20.5316Jamp Olanzapine FCJPC.53162015-10-29.5316NRA-OlanzapineNRA.53162024-08-30.5316128520mgTabZyprexaLIL2010-01-05Co OlanzapineCOB10.30932010-01-05Apo-OlanzapineAPX10.30932010-01-05Teva-OlanzapineTEV10.30932011-09-15OlanzapineSIV10.30932023-08-31Jamp Olanzapine FCJPC10.30932015-11-26NRA-OlanzapineNRA10.30932025-01-31128610mgTabZyprexaLIL9.22771997-04-10.7088Teva-OlanzapineTEV.70882007-07-12.7088Apo-OlanzapineAPX.70882010-01-05.7088PMS-OlanzapinePMS.70882009-11-19.7088Sandoz OlanzapineSDZ.70882010-10-28.7088Co OlanzapineCOB.70882010-04-23.7088OlanzapineSAI.70882016-04-01.7088OlanzapineSIV.70882020-06-30.7088Ran-OlanzapineRAN.70882013-08-29.7088Mint-OlanzapineMIN.70882019-12-20.7088Jamp Olanzapine FCJPC.70882015-10-29.7088AG-Olanzapine FCANG.70882021-09-30.7088NRA-OlanzapineNRA.70882024-08-30.7088128715mgTabZyprexaLIL14.07712003-09-041.0631Teva-OlanzapineTEV1.06312007-07-121.0631Apo-OlanzapineAPX1.06312010-01-051.0631PMS-OlanzapinePMS1.06312009-11-191.0631Sandoz OlanzapineSDZ1.06312010-10-281.0631Co OlanzapineCOB1.06312010-04-231.0631OlanzapineSAI1.06312016-04-011.0631OlanzapineSIV1.06312020-06-301.0631Ran-OlanzapineRAN1.06312013-08-291.0631Mint-OlanzapineMIN1.06312019-12-201.0631Jamp Olanzapine FCJPC1.06312015-10-291.0631NRA-OlanzapineNRA1.06312024-08-301.0631OXAZEPAM128810mgTabApo-OxazepamAPX.03501996-10-01.0350SeraxWAY1996-10-01128915mgTabApo-OxazepamAPX.05501996-10-01.0550SeraxWAY1996-10-01129030mgTabApo-OxazepamAPX.07501996-10-01.0750SeraxWAY1996-10-01PALIPERIDONE12913mgER TabInvegaJAN4.55702009-08-184.557012926mgER TabInvegaJAN6.81602009-08-186.816012939mgER TabInvegaJAN9.08502009-08-189.0850PALIPERIDONE PALMITATE129450mgInj Pref SyrFor the treatment of schizophrenia or schizoaffective disorders in patients who have: A history of non-adherence; AND one of the following: (a) Inadequate control or significant side-effects from two or more formulary oral antipsychotic medications, including at least one atypical agent; OR (b) Inadequate control or significant side-effects from one or more conventional depot antipsychotic agents.Invega SustennaJAN327.45002012-01-19327.4500129575mgInj Pref SyrFor the treatment of schizophrenia or schizoaffective disorders in patients who have: A history of non-adherence; AND one of the following: (a) Inadequate control or significant side-effects from two or more formulary oral antipsychotic medications, including at least one atypical agent; OR (b) Inadequate control or significant side-effects from one or more conventional depot antipsychotic agents.Invega SustennaJAN491.18002012-01-19491.18001296100mgInj Pref SyrFor the treatment of schizophrenia or schizoaffective disorders in patients who have: A history of non-adherence; AND one of the following: (a) Inadequate control or significant side-effects from two or more formulary oral antipsychotic medications, including at least one atypical agent; OR (b) Inadequate control or significant side-effects from one or more conventional depot antipsychotic agents.Invega SustennaJAN544.44002012-01-19544.44001297150mgInj Pref SyrFor the treatment of schizophrenia or schizoaffective disorders in patients who have: A history of non-adherence; AND one of the following: (a) Inadequate control or significant side-effects from two or more formulary oral antipsychotic medications, including at least one atypical agent; OR (b) Inadequate control or significant side-effects from one or more conventional depot antipsychotic agents.Invega SustennaJAN725.91002012-01-19725.91001298175mg/0.875mLInj Susp-Pref SyrFor the treatment of schizophrenia or schizoaffective disorders in patients who have: A history of non-adherence AND One of the following: a) Inadequate control or significant side-effects from two or more formulary oral antipsychotic medications, including at least one atypical agent; OR b) Inadequate control or significant side-effects from one or more conventional depot antipsychotic agents. AND Adequate treatment of using 1-month paliperidone palmitate prolonged-release injectable suspension has been established for at least four months.Invega TrinzaJAN953.73002018-03-29953.73001299263mg/1.315mLInj Susp-Pref SyrFor the treatment of schizophrenia or schizoaffective disorders in patients who have: A history of non-adherence AND One of the following: a) Inadequate control or significant side-effects from two or more formulary oral antipsychotic medications, including at least one atypical agent; OR b) Inadequate control or significant side-effects from one or more conventional depot antipsychotic agents. AND Adequate treatment of using 1-month paliperidone palmitate prolonged-release injectable suspension has been established for at least four months.Invega TrinzaJAN1430.61002018-03-291430.61001300350mg/1.75mLInj Susp-Pref SyrFor the treatment of schizophrenia or schizoaffective disorders in patients who have: A history of non-adherence AND One of the following: a) Inadequate control or significant side-effects from two or more formulary oral antipsychotic medications, including at least one atypical agent; OR b) Inadequate control or significant side-effects from one or more conventional depot antipsychotic agents. AND Adequate treatment of using 1-month paliperidone palmitate prolonged-release injectable suspension has been established for at least four months.Invega TrinzaJAN1430.61002018-03-291430.61001301525mg/2.625mLInj Susp-Pref SyrFor the treatment of schizophrenia or schizoaffective disorders in patients who have: A history of non-adherence AND One of the following: a) Inadequate control or significant side-effects from two or more formulary oral antipsychotic medications, including at least one atypical agent; OR b) Inadequate control or significant side-effects from one or more conventional depot antipsychotic agents. AND Adequate treatment of using 1-month paliperidone palmitate prolonged-release injectable suspension has been established for at least four months.Invega TrinzaJAN1907.49002018-03-291907.4900PERICYAZINE13025mgCapNeuleptilSLP.25661996-10-01.2566130310mgCapNeuleptilSLP.44281996-10-01.4428130410mg/mLO/LNeuleptilSLP.44501996-10-01.4450PERPHENAZINE13052mgTabTrilafonSCH1996-10-01PerphenazineAAP.06831996-10-01.068313064mgTabTrilafonSCH1996-10-01PerphenazineAAP.08261996-10-01.082613078mgTabTrilafonSCH1996-10-01PerphenazineAAP.09081996-10-01.0908130816mgTabTrilafonSCH1996-10-01PerphenazineAAP.13891996-10-01.1389PIMOZIDE13092mgTabOrapAAP.22791996-10-01.2279PimozideAAP.30932004-04-06.227913104mgTabOrapAAP.41361996-10-01.4136PimozideAAP.41362004-04-06.4136PROCHLORPERAZINE13115mgTabProchlorazineAAP.16592001-06-07.1659StemetilAVE1996-10-01131210mgTabProchlorazineAAP.20252001-06-07.2025StemetilAVE1996-10-01QUETIAPINE131350mgER TabSeroquel XRAZC1.15232008-06-27.2501Teva-Quetiapine XRTEV.25012013-04-30.2501Sandoz Quetiapine XRTSDZ.25012013-10-31.2501Quetiapine XRSIV.25012020-06-30.2501Ach-Quetiapine Fumarate XRACH.25012021-03-29.2501Apo-Quetiapine XRAPX.25012018-08-30.2501NRA-Quetiapine XRNRA.25012021-10-29.2501Quetiapine Fumarate XRSAI.25012022-03-31.2501Quetiapine XRJPC.25012022-06-30.2501Mint-Quetiapine XRMIN.25012022-07-29.2501M-Quetiapine Fumarate XRMAT.25012023-05-31.25011314150mgER TabSeroquel XRAZC2.26982010-12-14.4926Teva-Quetiapine XRTEV.49262013-04-30.4926Sandoz Quetiapine XRTSDZ.49262013-10-31.4926Quetiapine XRSIV.49262020-06-30.4926Ach-Quetiapine Fumarate XRACH.49262021-03-29.4926Apo-Quetiapine XRAPX.49262018-08-30.4926NRA-Quetiapine XRNRA.49262021-10-29.4926Quetiapine Fumarate XRSAI.49262022-03-31.4926Quetiapine XRJPC.49262022-06-30.4926Mint-Quetiapine XRMIN.49262022-07-29.4926M-Quetiapine Fumarate XRMAT.49262023-05-31.49261315200mgER TabSeroquel XRAZC3.06932008-06-27.6661Teva-Quetiapine XRTEV.66612013-04-30.6661Sandoz Quetiapine XRTSDZ.66612013-10-31.6661Quetiapine XRSIV.66612020-06-30.6661Ach-Quetiapine Fumarate XRACH.66612021-03-29.6661Apo-Quetiapine XRAPX.66612018-08-30.6661NRA-Quetiapine XRNRA.66612021-10-29.6661Quetiapine Fumarate XRSAI.66612022-03-31.6661Quetiapine XRJPC.66612022-06-30.6661Mint-Quetiapine XRMIN.66612022-07-29.6661M-Quetiapine Fumarate XRMAT.66612023-05-31.66611316300mgER TabSeroquel XRAZC4.50452008-06-27.9776Teva-Quetiapine XRTEV.97762013-04-30.9776Sandoz Quetiapine XRTSDZ.97762013-10-31.9776Quetiapine XRSIV.97762020-06-30.9776Ach-Quetiapine Fumarate XRACH.97762021-03-29.9776Apo-Quetiapine XRAPX.97762018-08-30.9776NRA-Quetiapine XRNRA.97762021-10-29.9776Quetiapine Fumarate XRSAI.97762022-03-31.9776Quetiapine XRJPC.97762022-06-30.9776Mint-Quetiapine XRMIN.97762022-07-29.9776M-Quetiapine Fumarate XRMAT.97762023-05-31.97761317400mgER TabSeroquel XRAZC6.11502008-06-271.3270Teva-Quetiapine XRTEV1.32702013-04-301.3270Sandoz Quetiapine XRTSDZ1.32702013-10-311.3270Quetiapine XRSIV1.32702020-06-301.3270Ach-Quetiapine Fumarate XRACH1.32702021-03-291.3270Apo-Quetiapine XRAPX1.32702018-08-301.3270NRA-Quetiapine XRNRA1.32702021-10-291.3270Quetiapine Fumarate XRSAI1.32702022-03-311.3270Quetiapine XRJPC1.32702022-06-301.3270Mint-Quetiapine XRMIN1.32702023-01-311.3270M-Quetiapine Fumarate XRMAT1.32702023-05-311.3270131825mgTabSeroquelAZC.54911998-12-31.0494Teva-QuetiapineTEV.04942008-12-03.0494PMS-QuetiapinePMS.04942008-12-03.0494Apo-QuetiapineAPX.04942008-12-03.0494Sandoz QuetiapineSDZ.04942008-12-03.0494Act QuetiapineTEV.04942008-12-03.0494QuetiapineSIV.04942010-06-14.0494Jamp-QuetiapineJPC.04942010-04-23.0494QuetiapineSAI.04942011-08-04.0494Quetiapine TabletsACH.04942012-09-28.0494Jamp Quetiapine FumarateJPC.04942021-12-17.0494Auro-QuetiapineAUR.04942012-12-21.0494Ran-QuetiapineRAN.04942013-08-29.0494Mar-QuetiapineMAR.04942013-07-30.0494Mint-QuetiapineMIN.04942016-04-01.0494Nat-QuetiapineNAT.04942015-10-29.0494Bio-QuetiapineBMP.04942016-02-25.0494AG-QuetiapineANG.04942020-12-18.0494NRA-QuetiapineNRA.04942020-10-30.0494Apo-Quetiapine FumarateAPX.04942021-08-31.04941319100mgTabSeroquelAZC1.46491998-12-31.1318Teva-QuetiapineTEV.13182008-12-03.1318PMS-QuetiapinePMS.13182008-12-03.1318Apo-QuetiapineAPX.13182008-12-03.1318Sandoz QuetiapineSDZ.13182008-12-03.1318Act QuetiapineTEV.13182008-12-03.1318QuetiapineSIV.13182010-06-14.1318Jamp-QuetiapineJPC.13182010-04-23.1318QuetiapineSAI.13182011-08-04.1318Quetiapine TabletsACH.13182012-09-28.1318Jamp Quetiapine FumarateJPC.13182021-12-17.1318Auro-QuetiapineAUR.13182012-12-21.1318Ran-QuetiapineRAN.13182013-08-29.1318Mar-QuetiapineMAR.13182013-07-30.1318Mint-QuetiapineMIN.13182016-04-01.1318Nat-QuetiapineNAT.13182015-10-29.1318Bio-QuetiapineBMP.13182016-02-25.1318Apo-Quetiapine FumarateAPX.13182021-08-31.13181320150mgTabSeroquelAZC2002-04-04Teva-QuetiapineTEV1.72882008-12-03Quetiapine TabletsACH1.35182012-08-27Nat-QuetiapineNAT1.62222015-10-291321200mgTabSeroquelAZC2.94161998-12-31.2647Teva-QuetiapineTEV.26472008-12-03.2647PMS-QuetiapinePMS.26472008-12-03.2647Apo-QuetiapineAPX.26472008-12-03.2647Sandoz QuetiapineSDZ.26472008-12-03.2647Act QuetiapineTEV.26472008-12-03.2647QuetiapineSIV.26472010-06-14.2647Jamp-QuetiapineJPC.26472010-04-23.2647QuetiapineSAI.26472011-08-04.2647Quetiapine TabletsACH.26472012-09-28.2647Jamp Quetiapine FumarateJPC.26472021-12-17.2647Auro-QuetiapineAUR.26472012-12-21.2647Ran-QuetiapineRAN.26472013-08-29.2647Mar-QuetiapineMAR.26472013-07-30.2647Mint-QuetiapineMIN.26472016-04-01.2647Nat-QuetiapineNAT.26472015-10-29.2647Bio-QuetiapineBMP.26472016-02-25.2647Apo-Quetiapine FumarateAPX.26472021-08-31.26471322300mgTabSeroquelAZC4.29252002-07-29.3863Teva-QuetiapineTEV.38632008-12-03.3863PMS-QuetiapinePMS.38632008-12-03.3863Apo-QuetiapineAPX.38632008-12-03.3863Sandoz QuetiapineSDZ.38632008-12-03.3863Act QuetiapineTEV.38632008-12-03.3863QuetiapineSIV.38632010-06-14.3863Jamp-QuetiapineJPC.38632010-04-23.3863QuetiapineSAI.38632011-08-04.3863Quetiapine TabletsACH.38632012-09-28.3863Jamp Quetiapine FumarateJPC.38632021-12-17.3863Auro-QuetiapineAUR.38632012-12-21.3863Ran-QuetiapineRAN.38632013-08-29.3863Mar-QuetiapineMAR.38632013-07-30.3863Mint-QuetiapineMIN.38632016-04-01.3863Nat-QuetiapineNAT.38632015-10-29.3863Bio-QuetiapineBMP.38632016-02-25.3863Apo-Quetiapine FumarateAPX.38632021-08-31.3863RISPERIDONE13231mg/mLO/LRisperdalJAN1999-04-15PMS-RisperidonePMS.70802006-09-06.7080Jamp-RisperidoneJPC.70802018-05-31.708013240.5mgOrally Disintegrating TabRisperdal M-TabJAN2004-07-20Mylan-Risperidone ODTMYL.55882014-03-27.558813251mgOrally Disintegrating TabRisperdal M-TabJAN2004-07-20Mylan-Risperidone ODTMYL.51502014-03-27.515013262mgOrally Disintegrating TabRisperdal M-TabJAN2004-07-20Mylan-Risperidone ODTMYL1.01882014-03-271.018813273mgOrally Disintegrating TabRisperdal M-TabJAN2006-04-19Mylan-Risperidone ODTMYL1.52752014-03-271.527513284mgOrally Disintegrating TabRisperdal M-TabJAN2006-04-19Mylan-Risperidone ODTMYL2.04252014-03-272.0425132925mgPd for Inj-Vial PkFor the treatment of schizophrenia or schizoaffective disorders in patients who have: A history of non-adherence; AND one of the following: (a) Inadequate control or significant side-effects from two or more formulary oral antipsychotic medications, including at least one atypical agent; OR (b) Inadequate control or significant side-effects from one or more conventional depot antipsychotic agents.Risperdal ConstaJAN208.35002008-08-28208.3500133037.5mgPd for Inj-Vial PkFor the treatment of schizophrenia or schizoaffective disorders in patients who have: A history of non-adherence; AND one of the following: (a) Inadequate control or significant side-effects from two or more formulary oral antipsychotic medications, including at least one atypical agent; OR (b) Inadequate control or significant side-effects from one or more conventional depot antipsychotic agents.Risperdal ConstaJAN312.51002008-08-28312.5100133150mgPd for Inj-Vial PkFor the treatment of schizophrenia or schizoaffective disorders in patients who have: A history of non-adherence; AND one of the following: (a) Inadequate control or significant side-effects from two or more formulary oral antipsychotic medications, including at least one atypical agent; OR (b) Inadequate control or significant side-effects from one or more conventional depot antipsychotic agents.Risperdal ConstaJAN416.68002008-08-28416.680013320.25mgTabRisperdalJAN2000-07-17PMS-RisperidonePMS.08782006-09-06.0878Apo-RisperidoneAPX.08782006-09-06.0878Teva-RisperidoneTEV.08782006-09-06.0878Sandoz RisperidoneSDZ.08782008-08-28.0878Ran-RisperidoneRAN.08782010-01-05.0878RisperidoneSAI.08782011-08-04.0878Jamp-RisperidoneJPC.08782011-08-04.0878Mint-RisperidonMIN.08782011-08-04.0878Mar-RisperidoneMAR.08782012-01-19.0878RisperidoneSIV.08782024-01-31.087813330.5mgTabRisperdalJAN2000-07-17PMS-RisperidonePMS.14702006-09-06.1470Teva-RisperidoneTEV.14702006-09-06.1470Apo-RisperidoneAPX.14702006-09-06.1470Sandoz RisperidoneSDZ.14702008-08-28.1470Ran-RisperidoneRAN.14702010-01-05.1470RisperidoneSAI.14702011-08-04.1470Jamp-RisperidoneJPC.14702011-08-04.1470Mint-RisperidonMIN.14702011-08-04.1470Mar-RisperidoneMAR.14702012-01-19.1470RisperidoneSIV.14702024-01-31.147013341mgTabRisperdalJAN1996-10-01PMS-RisperidonePMS.20312006-09-06.2031Teva-RisperidoneTEV.20312006-09-06.2031Sandoz RisperidoneSDZ.20312006-09-06.2031Apo-RisperidoneAPX.20312006-09-06.2031Ran-RisperidoneRAN.20312010-01-05.2031RisperidoneSAI.20312011-08-04.2031Jamp-RisperidoneJPC.20312011-08-04.2031Mint-RisperidonMIN.20312011-08-04.2031Mar-RisperidoneMAR.20312012-01-19.2031RisperidoneSIV.20312024-01-31.203113352mgTabRisperdalJAN1996-10-01PMS-RisperidonePMS.40622006-09-06.4062Teva-RisperidoneTEV.40622006-09-06.4062Sandoz RisperidoneSDZ.40622006-09-06.4062Apo-RisperidoneAPX.40622006-09-06.4062Ran-RisperidoneRAN.40622010-01-05.4062RisperidoneSAI.40622011-08-04.4062Jamp-RisperidoneJPC.40622011-08-04.4062Mint-RisperidonMIN.40622011-08-04.4062Mar-RisperidoneMAR.40622012-01-19.4062RisperidoneSIV.40622024-01-31.406213363mgTabRisperdalJAN1996-10-01PMS-RisperidonePMS.60832006-09-06.6083Teva-RisperidoneTEV.60832006-09-06.6083Sandoz RisperidoneSDZ.60832006-09-06.6083Apo-RisperidoneAPX.60832006-09-06.6083Ran-RisperidoneRAN.60832010-01-05.6083RisperidoneSAI.60832011-08-04.6083Jamp-RisperidoneJPC.60832011-08-04.6083Mint-RisperidonMIN.60832011-08-04.6083Mar-RisperidoneMAR.60832012-01-19.6083RisperidoneSIV.60832024-01-31.608313374mgTabRisperdalJAN1996-10-01PMS-RisperidonePMS.81112006-09-06.8111Teva-RisperidoneTEV.81112006-09-06.8111Sandoz RisperidoneSDZ.81112006-09-06.8111Apo-RisperidoneAPX.81112006-09-06.8111Ran-RisperidoneRAN.81112010-01-05.8111RisperidoneSAI.81112011-08-04.8111Jamp-RisperidoneJPC.81112011-08-04.8111Mint-RisperidonMIN.81112011-08-04.8111Mar-RisperidoneMAR.81112012-01-19.8111RisperidoneSIV.81112024-01-31.8111TRIFLUOPERAZINE13381mgTabTrifluoperazineAAP.13401996-10-01.1340StelazineSMJ1996-10-0113392mgTabTrifluoperazineAAP.17931996-10-01.1793StelazineSMJ1996-10-0113405mgTabTrifluoperazineAAP.23751996-10-01.2375StelazineSMJ1996-10-01134110mgTabTrifluoperazineAAP.28461996-10-01.2846StelazineSMJ1996-10-01ZIPRASIDONE HCL MONOHYDRATE134220mgCapZeldoxUJC2.23982010-07-201.3784Auro-ZiprasidoneAUR1.37842018-05-311.3784134340mgCapZeldoxUJC2.56582010-07-201.5786Auro-ZiprasidoneAUR1.57862018-05-311.5786134460mgCapZeldoxUJC2.56582010-07-201.5786Auro-ZiprasidoneAUR1.57862018-05-311.5786134580mgCapZeldoxUJC2.56582010-07-201.5786Auro-ZiprasidoneAUR1.57862018-05-311.5786ZUCLOPENTHIXOL DECANOATE1346200mg/mLInj-1mL PkClopixol DepotVLH21.74182017-12-2121.7418ZUCLOPENTHIXOL DIHYDROCHLORIDE134710mgTabClopixolVLH.55922017-12-21.5592134825mgTabClopixolVLH1.39792017-12-211.3979PSYCHOTHERAPEUTIC AGENTS OTHER PSYCHOTROPICSLITHIUM CARBONATE1349150mgCapCarbolithVAL.15911996-10-01.0667PMS-Lithium CarbonatePMS.06671997-04-10.0667Apo-Lithium CarbonateAPX.06672001-10-11.06671350150mgCapLithaneSLP.18921996-10-01.0667Apo-Lithium CarbonateAPX.06672003-09-04.06671351300mgCapCarbolithVAL.12361996-10-01.0657PMS-Lithium CarbonatePMS.06571997-04-10.0657Apo-Lithium CarbonateAPX.06572001-10-11.06571352300mgCapLithaneSLP.18921996-10-01.0657Apo-Lithium CarbonateAPX.06572003-09-04.06571353300mgER TabDuralithJNO2008-06-27LithmaxAAP.28802008-06-27.2880TRYPTOPHAN1354500mgCapTryptanVAL1996-10-01Ratio-TryptophanRPH.49872008-12-03Apo-TryptophanAPX.49872008-06-271355500mgTabTryptanVAL2008-06-27Ratio-TryptophanRPH.49872008-12-03Apo-TryptophanAPX.49872008-06-271356750mgTabTryptanVAL2017-05-31Apo-TryptophanAPX1.24442017-05-3113571gTabTryptanVAL1996-10-01Ratio-TryptophanRPH.89782000-04-17Apo-TryptophanAPX.89782008-06-27C.N.S. STIMULANTSStimulant medication should only be used when diagnostic criteria for narcolepsy or attention deficit disorder have been met and when stimulant medication has been demonstrated to produce clinical benefits. The use of conventional-release medication should almost always precede the use of extended-release preparations.DEXTROAMPHETAMINE SULFATE135810mgSR CapNotes: Patients greater than 6 years of age diagnosed with ADHD according to DSM-IV criteria and where symptoms are not due to other medical conditions which affect concentration, and who require 12-hour continuous coverage due to academic and/or psychosocial needs, and who meet the following: 1) Patients who demonstrate significant and problematic disruptive behaviour or who have problems with inattention that interfere with learning; AND 2) Prescribed by or in consultation with a specialist in pediatric psychiatry, pediatrics or a general practitioner with expertise in ADHD; AND 3) Have been tried on methylphenidate immediate release (IR) or methylphenidate slow release (SR) or Dexedrine IR, and have experienced unsatisfactory results due to poor symptom control, side effects, administrative barriers, or societal barriers. Administrative barriers include: - inability of a school to dose the child at lunch; - the school lunch hour does not coincide with the dosing schedule; - poor compliance with noon or afternoon doses; - the patient is unable to swallow tablets. Societal barriers include: - the patient or patient's caregiver(s) has(have) a history of substance abuse or diversion of listed immediate-release alternatives; - the patient or patient's caregiver(s) is/are at risk of substance abuse or diversion of listed immediate-release alternatives.Dexedrine SpansulesPPI1.24512013-06-27.8096Teva-Dextroamphetamine SRTEV.80962018-04-30.8096135915mgSR CapNotes: Patients greater than 6 years of age diagnosed with ADHD according to DSM-IV criteria and where symptoms are not due to other medical conditions which affect concentration, and who require 12-hour continuous coverage due to academic and/or psychosocial needs, and who meet the following: 1) Patients who demonstrate significant and problematic disruptive behaviour or who have problems with inattention that interfere with learning; AND 2) Prescribed by or in consultation with a specialist in pediatric psychiatry, pediatrics or a general practitioner with expertise in ADHD; AND 3) Have been tried on methylphenidate immediate release (IR) or methylphenidate slow release (SR) or Dexedrine IR, and have experienced unsatisfactory results due to poor symptom control, side effects, administrative barriers, or societal barriers. Administrative barriers include: - inability of a school to dose the child at lunch; - the school lunch hour does not coincide with the dosing schedule; - poor compliance with noon or afternoon doses; - the patient is unable to swallow tablets. Societal barriers include: - the patient or patient's caregiver(s) has(have) a history of substance abuse or diversion of listed immediate-release alternatives; - the patient or patient's caregiver(s) is/are at risk of substance abuse or diversion of listed immediate-release alternatives.Dexedrine SpansulesPPI1.52222013-06-27.9898Teva-Dextroamphetamine SRTEV.98982018-04-30.989813605mgTabDexedrinePPI.84321996-10-01.5081DextroamphetamineAAP.50812016-03-30.5081LISDEXAMFETAMINE DIMESYLATE136110mgCapNotes: Patients greater than or equal to 6 years of age diagnosed with ADHD according to DSM-IV criteria and where symptoms are not due to other medical conditions which affect concentration, and who require 12-hour continuous coverage due to academic and/or psychosocial needs, and who meet the following: 1) Patients who demonstrate significant and problematic disruptive behaviour or who have problems with inattention that interfere with learning; AND 2) Prescribed by or in consultation with a specialist in pediatric psychiatry, pediatrics or a general practitioner with expertise in ADHD; AND 3) Have been tried on methylphenidate immediate release (IR) or methylphenidate slow release (SR) or Dexedrine IR or Dexedrine SR (Spansules), and have experienced unsatisfactory results due to poor symptom control, side effects, administrative barriers, or societal barriers. Administrative barriers include: - inability of a school to dose the child at lunch; - the school lunch hour does not coincide with the dosing schedule; - poor compliance with noon or afternoon doses; - the patient is unable to swallow tablets. Societal barriers include: - the patient or patient's caregiver(s) has(have) a history of substance abuse or diversion of listed immediate-release alternatives; - the patient or patient's caregiver(s) is/are at risk of substance abuse or diversion of listed immediate-release alternatives. VyvanseTAK2.41052016-03-30.5692Jamp LisdexamfetamineJPC.56922025-09-29.5692Teva-LisdexamfetamineTEV.56922024-07-31.5692Sandoz Lisdexamfetamine CapsulesSDZ.56922024-07-31.5692Apo-Lisdexamfetamine CapsulesAPX.56922025-03-31.5692136220mgCapNotes: Patients greater than or equal to 6 years of age diagnosed with ADHD according to DSM-IV criteria and where symptoms are not due to other medical conditions which affect concentration, and who require 12-hour continuous coverage due to academic and/or psychosocial needs, and who meet the following: 1) Patients who demonstrate significant and problematic disruptive behaviour or who have problems with inattention that interfere with learning; AND 2) Prescribed by or in consultation with a specialist in pediatric psychiatry, pediatrics or a general practitioner with expertise in ADHD; AND 3) Have been tried on methylphenidate immediate release (IR) or methylphenidate slow release (SR) or Dexedrine IR or Dexedrine SR (Spansules), and have experienced unsatisfactory results due to poor symptom control, side effects, administrative barriers, or societal barriers. Administrative barriers include: - inability of a school to dose the child at lunch; - the school lunch hour does not coincide with the dosing schedule; - poor compliance with noon or afternoon doses; - the patient is unable to swallow tablets. Societal barriers include: - the patient or patient's caregiver(s) has(have) a history of substance abuse or diversion of listed immediate-release alternatives; - the patient or patient's caregiver(s) is/are at risk of substance abuse or diversion of listed immediate-release alternatives.VyvanseTAK2.99852011-06-08.7081Jamp LisdexamfetamineJPC.70812025-09-29.7081Teva-LisdexamfetamineTEV.70812024-07-31.7081Sandoz Lisdexamfetamine CapsulesSDZ.70812024-07-31.7081Apo-Lisdexamfetamine CapsulesAPX.70812025-03-31.7081136330mgCapNotes:- Patients greater than or equal to 6 years of age diagnosed with ADHD according to DSM-IV criteria and where symptoms are not due to other medical conditions which affect concentration, and who require 12-hour continuous coverage due to academic and/or psychosocial needs, and who meet the following: 1) Patients who demonstrate significant and problematic disruptive behaviour or who have problems with inattention that interfere with learning; AND 2) Prescribed by or in consultation with a specialist in pediatric psychiatry, pediatrics or a general practitioner with expertise in ADHD; AND 3) Have been tried on methylphenidate immediate release (IR) or methylphenidate slow release (SR) or Dexedrine IR or Dexedrine SR (Spansules), and have experienced unsatisfactory results due to poor symptom control, side effects, administrative barriers, or societal barriers. Administrative barriers include: - inability of a school to dose the child at lunch; - the school lunch hour does not coincide with the dosing schedule; - poor compliance with noon or afternoon doses; - the patient is unable to swallow tablets. Societal barriers include: - the patient or patient's caregiver(s) has(have) a history of substance abuse or diversion of listed immediate-release alternatives; - the patient or patient's caregiver(s) is/are at risk of substance abuse or diversion of listed immediate-release alternatives.VyvanseTAK3.58642011-06-08.8469Jamp LisdexamfetamineJPC.84692025-09-29.8469Teva-LisdexamfetamineTEV.84692024-07-31.8469Sandoz Lisdexamfetamine CapsulesSDZ.84692024-10-31.8469Apo-Lisdexamfetamine CapsulesAPX.84692025-03-31.8469136440mgCapNotes: Patients greater than or equal to 6 years of age diagnosed with ADHD according to DSM-IV criteria and where symptoms are not due to other medical conditions which affect concentration, and who require 12-hour continuous coverage due to academic and/or psychosocial needs, and who meet the following: 1) Patients who demonstrate significant and problematic disruptive behaviour or who have problems with inattention that interfere with learning; AND 2) Prescribed by or in consultation with a specialist in pediatric psychiatry, pediatrics or a general practitioner with expertise in ADHD; AND 3) Have been tried on methylphenidate immediate release (IR) or methylphenidate slow release (SR) or Dexedrine IR or Dexedrine SR (Spansules), and have experienced unsatisfactory results due to poor symptom control, side effects, administrative barriers, or societal barriers. Administrative barriers include: - inability of a school to dose the child at lunch; - the school lunch hour does not coincide with the dosing schedule; - poor compliance with noon or afternoon doses; - the patient is unable to swallow tablets. Societal barriers include: - the patient or patient's caregiver(s) has(have) a history of substance abuse or diversion of listed immediate-release alternatives; - the patient or patient's caregiver(s) is/are at risk of substance abuse or diversion of listed immediate-release alternatives.VyvanseTAK4.17442011-06-08.9857Jamp LisdexamfetamineJPC.98572025-09-29.9857Teva-LisdexamfetamineTEV.98572024-07-31.9857Sandoz Lisdexamfetamine CapsulesSDZ.98572024-07-31.9857Apo-Lisdexamfetamine CapsulesAPX.98572025-03-31.9857136550mgCapNotes: Patients greater than or equal to 6 years of age diagnosed with ADHD according to DSM-IV criteria and where symptoms are not due to other medical conditions which affect concentration, and who require 12-hour continuous coverage due to academic and/or psychosocial needs, and who meet the following: 1) Patients who demonstrate significant and problematic disruptive behaviour or who have problems with inattention that interfere with learning; AND 2) Prescribed by or in consultation with a specialist in pediatric psychiatry, pediatrics or a general practitioner with expertise in ADHD; AND 3) Have been tried on methylphenidate immediate release (IR) or methylphenidate slow release (SR) or Dexedrine IR or Dexedrine SR (Spansules), and have experienced unsatisfactory results due to poor symptom control, side effects, administrative barriers, or societal barriers. Administrative barriers include: - inability of a school to dose the child at lunch; - the school lunch hour does not coincide with the dosing schedule; - poor compliance with noon or afternoon doses; - the patient is unable to swallow tablets. Societal barriers include: - the patient or patient's caregiver(s) has(have) a history of substance abuse or diversion of listed immediate-release alternatives; - the patient or patient's caregiver(s) is/are at risk of substance abuse or diversion of listed immediate-release alternatives.VyvanseTAK4.76232011-06-081.1246Jamp LisdexamfetamineJPC1.12462025-09-291.1246Teva-LisdexamfetamineTEV1.12462024-07-311.1246Sandoz Lisdexamfetamine CapsulesSDZ1.12462024-07-311.1246Apo-Lisdexamfetamine CapsulesAPX1.12462025-03-311.1246136660mgCapNotes: Patients greater than or equal to 6 years of age diagnosed with ADHD according to DSM-IV criteria and where symptoms are not due to other medical conditions which affect concentration, and who require 12-hour continuous coverage due to academic and/or psychosocial needs, and who meet the following: 1) Patients who demonstrate significant and problematic disruptive behaviour or who have problems with inattention that interfere with learning; AND 2) Prescribed by or in consultation with a specialist in pediatric psychiatry, pediatrics or a general practitioner with expertise in ADHD; AND 3) Have been tried on methylphenidate immediate release (IR) or methylphenidate slow release (SR) or Dexedrine IR or Dexedrine SR (Spansules), and have experienced unsatisfactory results due to poor symptom control, side effects, administrative barriers, or societal barriers. Administrative barriers include: - inability of a school to dose the child at lunch; - the school lunch hour does not coincide with the dosing schedule; - poor compliance with noon or afternoon doses; - the patient is unable to swallow tablets. Societal barriers include: - the patient or patient's caregiver(s) has(have) a history of substance abuse or diversion of listed immediate-release alternatives; - the patient or patient's caregiver(s) is/are at risk of substance abuse or diversion of listed immediate-release alternatives.VyvanseTAK5.35022011-06-081.2634Jamp LisdexamfetamineJPC1.26342025-09-291.2634Teva-LisdexamfetamineTEV1.26342024-07-311.2634Sandoz Lisdexamfetamine CapsulesSDZ1.26342024-07-311.2634Apo-Lisdexamfetamine CapsulesAPX1.26342025-03-311.2634136770mgCapVyvanseTAK2024-07-31Jamp LisdexamfetamineJPC4.69682025-09-29Teva LisdexamfetamineTEV4.69682024-07-31Sandoz Lisdexamfetamine CapsulesSDZ4.69682024-07-31Apo-Lisdexamfetamine CapsulesAPX4.69682024-08-30136810mgChew TabNotes: Patients greater than or equal to 6 years of age diagnosed with ADHD according to DSM-IV criteria and where symptoms are not due to other medical conditions which affect concentration, and who require 12-hour continuous coverage due to academic and/or psychosocial needs, and who meet the following: 1) Patients who demonstrate significant and problematic disruptive behaviour or who have problems with inattention that interfere with learning; AND 2) Prescribed by or in consultation with a specialist in pediatric psychiatry, pediatrics or a general practitioner with expertise in ADHD; AND 3) Have been tried on methylphenidate immediate release (IR) or methylphenidate slow release (SR) or Dexedrine IR or Dexedrine SR (Spansules), and have experienced unsatisfactory results due to poor symptom control, side effects, administrative barriers, or societal barriers. Administrative barriers include: - inability of a school to dose the child at lunch; - the school lunch hour does not coincide with the dosing schedule; - poor compliance with noon or afternoon doses; - the patient is unable to swallow tablets. Societal barriers include: - the patient or patient's caregiver(s) has(have) a history of substance abuse or diversion of listed immediate-release alternatives; - the patient or patient's caregiver(s) is/are at risk of substance abuse or diversion of listed immediate-release alternatives.VyvanseTAK2.41052020-03-311.1385Taro-Lisdexamfetamine Chewable TabletsTAR1.13852024-07-311.1385Apo-Lisdexamfetamine Chewable TabletsAPX1.13852025-06-301.1385136920mgChew TabNotes: Patients greater than or equal to 6 years of age diagnosed with ADHD according to DSM-IV criteria and where symptoms are not due to other medical conditions which affect concentration, and who require 12-hour continuous coverage due to academic and/or psychosocial needs, and who meet the following: 1) Patients who demonstrate significant and problematic disruptive behaviour or who have problems with inattention that interfere with learning; AND 2) Prescribed by or in consultation with a specialist in pediatric psychiatry, pediatrics or a general practitioner with expertise in ADHD; AND 3) Have been tried on methylphenidate immediate release (IR) or methylphenidate slow release (SR) or Dexedrine IR or Dexedrine SR (Spansules), and have experienced unsatisfactory results due to poor symptom control, side effects, administrative barriers, or societal barriers. Administrative barriers include: - inability of a school to dose the child at lunch; - the school lunch hour does not coincide with the dosing schedule; - poor compliance with noon or afternoon doses; - the patient is unable to swallow tablets. Societal barriers include: - the patient or patient's caregiver(s) has(have) a history of substance abuse or diversion of listed immediate-release alternatives; - the patient or patient's caregiver(s) is/are at risk of substance abuse or diversion of listed immediate-release alternatives.VyvanseTAK2.99852020-03-311.4161Taro-Lisdexamfetamine Chewable TabletsTAR1.41612024-07-311.4161Apo-Lisdexamfetamine Chewable TabletsAPX1.41612025-06-301.4161137030mgChew TabNotes: Patients greater than or equal to 6 years of age diagnosed with ADHD according to DSM-IV criteria and where symptoms are not due to other medical conditions which affect concentration, and who require 12-hour continuous coverage due to academic and/or psychosocial needs, and who meet the following: 1) Patients who demonstrate significant and problematic disruptive behaviour or who have problems with inattention that interfere with learning; AND 2) Prescribed by or in consultation with a specialist in pediatric psychiatry, pediatrics or a general practitioner with expertise in ADHD; AND 3) Have been tried on methylphenidate immediate release (IR) or methylphenidate slow release (SR) or Dexedrine IR or Dexedrine SR (Spansules), and have experienced unsatisfactory results due to poor symptom control, side effects, administrative barriers, or societal barriers. Administrative barriers include: - inability of a school to dose the child at lunch; - the school lunch hour does not coincide with the dosing schedule; - poor compliance with noon or afternoon doses; - the patient is unable to swallow tablets. Societal barriers include: - the patient or patient's caregiver(s) has(have) a history of substance abuse or diversion of listed immediate-release alternatives; - the patient or patient's caregiver(s) is/are at risk of substance abuse or diversion of listed immediate-release alternatives.VyvanseTAK3.58642020-03-311.6938Taro-Lisdexamfetamine Chewable TabletsTAR1.69382024-07-311.6938Apo-Lisdexamfetamine Chewable TabletsAPX1.69382025-06-301.6938137140mgChew TabNotes: Patients greater than or equal to 6 years of age diagnosed with ADHD according to DSM-IV criteria and where symptoms are not due to other medical conditions which affect concentration, and who require 12-hour continuous coverage due to academic and/or psychosocial needs, and who meet the following: 1) Patients who demonstrate significant and problematic disruptive behaviour or who have problems with inattention that interfere with learning; AND 2) Prescribed by or in consultation with a specialist in pediatric psychiatry, pediatrics or a general practitioner with expertise in ADHD; AND 3) Have been tried on methylphenidate immediate release (IR) or methylphenidate slow release (SR) or Dexedrine IR or Dexedrine SR (Spansules), and have experienced unsatisfactory results due to poor symptom control, side effects, administrative barriers, or societal barriers. Administrative barriers include: - inability of a school to dose the child at lunch; - the school lunch hour does not coincide with the dosing schedule; - poor compliance with noon or afternoon doses; - the patient is unable to swallow tablets. Societal barriers include: - the patient or patient's caregiver(s) has(have) a history of substance abuse or diversion of listed immediate-release alternatives; - the patient or patient's caregiver(s) is/are at risk of substance abuse or diversion of listed immediate-release alternatives.VyvanseTAK4.17442020-03-311.9715Taro-Lisdexamfetamine Chewable TabletsTAR1.97152024-07-311.9715Apo-Lisdexamfetamine Chewable TabletsAPX1.97152025-06-301.9715137250mgChew TabNotes: Patients greater than or equal to 6 years of age diagnosed with ADHD according to DSM-IV criteria and where symptoms are not due to other medical conditions which affect concentration, and who require 12-hour continuous coverage due to academic and/or psychosocial needs, and who meet the following: 1) Patients who demonstrate significant and problematic disruptive behaviour or who have problems with inattention that interfere with learning; AND 2) Prescribed by or in consultation with a specialist in pediatric psychiatry, pediatrics or a general practitioner with expertise in ADHD; AND 3) Have been tried on methylphenidate immediate release (IR) or methylphenidate slow release (SR) or Dexedrine IR or Dexedrine SR (Spansules), and have experienced unsatisfactory results due to poor symptom control, side effects, administrative barriers, or societal barriers. Administrative barriers include: - inability of a school to dose the child at lunch; - the school lunch hour does not coincide with the dosing schedule; - poor compliance with noon or afternoon doses; - the patient is unable to swallow tablets. Societal barriers include: - the patient or patient's caregiver(s) has(have) a history of substance abuse or diversion of listed immediate-release alternatives; - the patient or patient's caregiver(s) is/are at risk of substance abuse or diversion of listed immediate-release alternatives.VyvanseTAK4.76232020-03-312.2491Taro-Lisdexamfetamine Chewable TabletsTAR2.24912024-07-312.2491Apo-Lisdexamfetamine Chewable TabletsAPX2.24912025-06-302.2491137360mgChew TabNotes: Patients greater than or equal to 6 years of age diagnosed with ADHD according to DSM-IV criteria and where symptoms are not due to other medical conditions which affect concentration, and who require 12-hour continuous coverage due to academic and/or psychosocial needs, and who meet the following: 1) Patients who demonstrate significant and problematic disruptive behaviour or who have problems with inattention that interfere with learning; AND 2) Prescribed by or in consultation with a specialist in pediatric psychiatry, pediatrics or a general practitioner with expertise in ADHD; AND 3) Have been tried on methylphenidate immediate release (IR) or methylphenidate slow release (SR) or Dexedrine IR or Dexedrine SR (Spansules), and have experienced unsatisfactory results due to poor symptom control, side effects, administrative barriers, or societal barriers. Administrative barriers include: - inability of a school to dose the child at lunch; - the school lunch hour does not coincide with the dosing schedule; - poor compliance with noon or afternoon doses; - the patient is unable to swallow tablets. Societal barriers include: - the patient or patient's caregiver(s) has(have) a history of substance abuse or diversion of listed immediate-release alternatives; - the patient or patient's caregiver(s) is/are at risk of substance abuse or diversion of listed immediate-release alternatives.VyvanseTAK5.35022020-03-312.5268Taro-Lisdexamfetamine Chewable TabletsTAR2.52682024-07-312.5268Apo-Lisdexamfetamine Chewable TabletsAPX2.52682025-06-302.5268METHYLPHENIDATE HCL137425mgCR CapNotes: Patients greater than or equal to 6 years of age diagnosed with ADHD according to DSM-IV criteria and where symptoms are not due to other medical conditions which affect concentration, and who require 12-hour continuous coverage due to academic and/or psychosocial needs, and who meet the following: 1) Patients who demonstrate significant and problematic disruptive behaviour or who have problems with inattention that interfere with learning AND 2) Prescribed by or in consultation with a specialist in pediatric psychiatry, pediatrics or a general practitioner with expertise in ADHD AND 3) Have been tried on methylphenidate immediate release (IR) or methylphenidate slow release (SR) or Dexedrine IR or Dexedrine SR (Spansules), and have experienced unsatisfactory results due to poor symptom control, side effects, administrative barriers, or societal barriers. Administrative barriers include: - inability of a school to dose the child at lunch; - the school lunch hour does not coincide with the dosing schedule; - poor compliance with noon or afternoon doses; - the patient is unable to swallow tablets. Societal barriers include: - the patient or patient's caregiver(s) has/have a history of substance abuse or diversion of listed immediate-release alternatives; - the patient or patient's caregiver(s) is/are at risk of substance abuse or diversion of listed immediate-release alternatives.FoquestELV3.03572023-04-283.0357137535mgCR CapNotes: Patients greater than or equal to 6 years of age diagnosed with ADHD according to DSM-IV criteria and where symptoms are not due to other medical conditions which affect concentration, and who require 12-hour continuous coverage due to academic and/or psychosocial needs, and who meet the following: 1) Patients who demonstrate significant and problematic disruptive behaviour or who have problems with inattention that interfere with learning AND 2) Prescribed by or in consultation with a specialist in pediatric psychiatry, pediatrics or a general practitioner with expertise in ADHD AND 3) Have been tried on methylphenidate immediate release (IR) or methylphenidate slow release (SR) or Dexedrine IR or Dexedrine SR (Spansules), and have experienced unsatisfactory results due to poor symptom control, side effects, administrative barriers, or societal barriers. Administrative barriers include: - inability of a school to dose the child at lunch; - the school lunch hour does not coincide with the dosing schedule; - poor compliance with noon or afternoon doses; - the patient is unable to swallow tablets. Societal barriers include: - the patient or patient's caregiver(s) has/have a history of substance abuse or diversion of listed immediate-release alternatives; - the patient or patient's caregiver(s) is/are at risk of substance abuse or diversion of listed immediate-release alternatives.FoquestELV3.33882023-04-283.3388137645mgCR CapNotes: Patients greater than or equal to 6 years of age diagnosed with ADHD according to DSM-IV criteria and where symptoms are not due to other medical conditions which affect concentration, and who require 12-hour continuous coverage due to academic and/or psychosocial needs, and who meet the following: 1) Patients who demonstrate significant and problematic disruptive behaviour or who have problems with inattention that interfere with learning AND 2) Prescribed by or in consultation with a specialist in pediatric psychiatry, pediatrics or a general practitioner with expertise in ADHD AND 3) Have been tried on methylphenidate immediate release (IR) or methylphenidate slow release (SR) or Dexedrine IR or Dexedrine SR (Spansules), and have experienced unsatisfactory results due to poor symptom control, side effects, administrative barriers, or societal barriers. Administrative barriers include: - inability of a school to dose the child at lunch; - the school lunch hour does not coincide with the dosing schedule; - poor compliance with noon or afternoon doses; - the patient is unable to swallow tablets. Societal barriers include: - the patient or patient's caregiver(s) has/have a history of substance abuse or diversion of listed immediate-release alternatives; - the patient or patient's caregiver(s) is/are at risk of substance abuse or diversion of listed immediate-release alternatives.FoquestELV3.62882023-04-283.6288137755mgCR CapNotes: Patients greater than or equal to 6 years of age diagnosed with ADHD according to DSM-IV criteria and where symptoms are not due to other medical conditions which affect concentration, and who require 12-hour continuous coverage due to academic and/or psychosocial needs, and who meet the following: 1) Patients who demonstrate significant and problematic disruptive behaviour or who have problems with inattention that interfere with learning AND 2) Prescribed by or in consultation with a specialist in pediatric psychiatry, pediatrics or a general practitioner with expertise in ADHD AND 3) Have been tried on methylphenidate immediate release (IR) or methylphenidate slow release (SR) or Dexedrine IR or Dexedrine SR (Spansules), and have experienced unsatisfactory results due to poor symptom control, side effects, administrative barriers, or societal barriers. Administrative barriers include: - inability of a school to dose the child at lunch; - the school lunch hour does not coincide with the dosing schedule; - poor compliance with noon or afternoon doses; - the patient is unable to swallow tablets. Societal barriers include: - the patient or patient's caregiver(s) has/have a history of substance abuse or diversion of listed immediate-release alternatives; - the patient or patient's caregiver(s) is/are at risk of substance abuse or diversion of listed immediate-release alternatives.FoquestELV3.92712023-04-283.9271137870mgCR CapNotes: Patients greater than or equal to 6 years of age diagnosed with ADHD according to DSM-IV criteria and where symptoms are not due to other medical conditions which affect concentration, and who require 12-hour continuous coverage due to academic and/or psychosocial needs, and who meet the following: 1) Patients who demonstrate significant and problematic disruptive behaviour or who have problems with inattention that interfere with learning AND 2) Prescribed by or in consultation with a specialist in pediatric psychiatry, pediatrics or a general practitioner with expertise in ADHD AND 3) Have been tried on methylphenidate immediate release (IR) or methylphenidate slow release (SR) or Dexedrine IR or Dexedrine SR (Spansules), and have experienced unsatisfactory results due to poor symptom control, side effects, administrative barriers, or societal barriers. Administrative barriers include: - inability of a school to dose the child at lunch; - the school lunch hour does not coincide with the dosing schedule; - poor compliance with noon or afternoon doses; - the patient is unable to swallow tablets. Societal barriers include: - the patient or patient's caregiver(s) has/have a history of substance abuse or diversion of listed immediate-release alternatives; - the patient or patient's caregiver(s) is/are at risk of substance abuse or diversion of listed immediate-release alternatives.FoquestELV4.37652023-04-284.3765137985mgCR CapNotes: Patients greater than or equal to 6 years of age diagnosed with ADHD according to DSM-IV criteria and where symptoms are not due to other medical conditions which affect concentration, and who require 12-hour continuous coverage due to academic and/or psychosocial needs, and who meet the following: 1) Patients who demonstrate significant and problematic disruptive behaviour or who have problems with inattention that interfere with learning AND 2) Prescribed by or in consultation with a specialist in pediatric psychiatry, pediatrics or a general practitioner with expertise in ADHD AND 3) Have been tried on methylphenidate immediate release (IR) or methylphenidate slow release (SR) or Dexedrine IR or Dexedrine SR (Spansules), and have experienced unsatisfactory results due to poor symptom control, side effects, administrative barriers, or societal barriers. Administrative barriers include: - inability of a school to dose the child at lunch; - the school lunch hour does not coincide with the dosing schedule; - poor compliance with noon or afternoon doses; - the patient is unable to swallow tablets. Societal barriers include: - the patient or patient's caregiver(s) has/have a history of substance abuse or diversion of listed immediate-release alternatives; - the patient or patient's caregiver(s) is/are at risk of substance abuse or diversion of listed immediate-release alternatives.FoquestELV4.81542023-04-284.81541380100mgCR CapNotes: Patients greater than or equal to 6 years of age diagnosed with ADHD according to DSM-IV criteria and where symptoms are not due to other medical conditions which affect concentration, and who require 12-hour continuous coverage due to academic and/or psychosocial needs, and who meet the following: 1) Patients who demonstrate significant and problematic disruptive behaviour or who have problems with inattention that interfere with learning AND 2) Prescribed by or in consultation with a specialist in pediatric psychiatry, pediatrics or a general practitioner with expertise in ADHD AND 3) Have been tried on methylphenidate immediate release (IR) or methylphenidate slow release (SR) or Dexedrine IR or Dexedrine SR (Spansules), and have experienced unsatisfactory results due to poor symptom control, side effects, administrative barriers, or societal barriers. Administrative barriers include: - inability of a school to dose the child at lunch; - the school lunch hour does not coincide with the dosing schedule; - poor compliance with noon or afternoon doses; - the patient is unable to swallow tablets. Societal barriers include: - the patient or patient's caregiver(s) has/have a history of substance abuse or diversion of listed immediate-release alternatives; - the patient or patient's caregiver(s) is/are at risk of substance abuse or diversion of listed immediate-release alternatives.FoquestELV5.24902023-04-285.2490138110mgER CapNote: Patients > 6 years of age diagnosed with ADHD according to DSM-IV criteria and where symptoms are not due to other medical conditions which affect concentration, and who require 12-hour continuous coverage due to academic and/or psychosocial needs, and who meet the following: 1) Patients who demonstrate significant and problematic disruptive behaviour or who have problems with inattention that interfere with learning AND 2) Prescribed by or in consultation with a specialist in pediatric psychiatry, pediatrics or a general practitioner with expertise in ADHD AND 3) Have been tried on methylphenidate immediate release (IR) or methylphenidate slow release (SR) or Dexedrine IR or Dexedrine SR (Spansules), and have experienced unsatisfactory results due to poor symptom control, side effects, administrative barriers, or societal barriers. Administrative barriers include: - inability of a school to dose the child at lunch; - the school lunch hour does not coincide with the dosing schedule; - poor compliance with noon or afternoon doses; - the patient is unable to swallow tablets. Societal barriers include: - the patient or patient's caregiver(s) has(have) a history of substance abuse or diversion of listed immediate-release alternatives; - the patient or patient's caregiver(s) is/are at risk of substance abuse or diversion of listed immediate-release alternatives. BiphentinELV1.02862009-08-18.5128PMS-Methylphenidate CRPMS.51282023-12-29.5128138215mgER CapNote: Patients > 6 years of age diagnosed with ADHD according to DSM-IV criteria and where symptoms are not due to other medical conditions which affect concentration, and who require 12-hour continuous coverage due to academic and/or psychosocial needs, and who meet the following: 1) Patients who demonstrate significant and problematic disruptive behaviour or who have problems with inattention that interfere with learning AND 2) Prescribed by or in consultation with a specialist in pediatric psychiatry, pediatrics or a general practitioner with expertise in ADHD AND 3) Have been tried on methylphenidate immediate release (IR) or methylphenidate slow release (SR) or Dexedrine IR or Dexedrine SR (Spansules), and have experienced unsatisfactory results due to poor symptom control, side effects, administrative barriers, or societal barriers. Administrative barriers include: - inability of a school to dose the child at lunch; - the school lunch hour does not coincide with the dosing schedule; - poor compliance with noon or afternoon doses; - the patient is unable to swallow tablets. Societal barriers include: - the patient or patient's caregiver(s) has(have) a history of substance abuse or diversion of listed immediate-release alternatives; - the patient or patient's caregiver(s) is/are at risk of substance abuse or diversion of listed immediate-release alternatives. BiphentinELV1.47502009-08-18.7354PMS-Methylphenidate CRPMS.73542023-12-29.7354138320mgER CapNote: Patients > 6 years of age diagnosed with ADHD according to DSM-IV criteria and where symptoms are not due to other medical conditions which affect concentration, and who require 12-hour continuous coverage due to academic and/or psychosocial needs, and who meet the following: 1) Patients who demonstrate significant and problematic disruptive behaviour or who have problems with inattention that interfere with learning AND 2) Prescribed by or in consultation with a specialist in pediatric psychiatry, pediatrics or a general practitioner with expertise in ADHD AND 3) Have been tried on methylphenidate immediate release (IR) or methylphenidate slow release (SR) or Dexedrine IR or Dexedrine SR (Spansules), and have experienced unsatisfactory results due to poor symptom control, side effects,administrative barriers, or societal barriers. Administrative barriers include: - inability of a school to dose the child at lunch; - the school lunch hour does not coincide with the dosing schedule; - poor compliance with noon or afternoon doses; - the patient is unable to swallow tablets. Societal barriers include: - the patient or patient's caregiver(s) has(have) a history of substance abuse or diversion of listed immediate-release alternatives; - the patient or patient's caregiver(s) is/are at risk of substance abuse or diversion of listed immediate-release alternatives. BiphentinELV1.90062009-08-18.9477PMS-Methylphenidate CRPMS.94772023-12-29.9477138430mgER CapNote: Patients > 6 years of age diagnosed with ADHD according to DSM-IV criteria and where symptoms are not due to other medical conditions which affect concentration, and who require 12-hour continuous coverage due to academic and/or psychosocial needs, and who meet the following: 1) Patients who demonstrate significant and problematic disruptive behaviour or who have problems with inattention that interfere with learning AND 2) Prescribed by or in consultation with a specialist in pediatric psychiatry, pediatrics or a general practitioner with expertise in ADHD AND 3) Have been tried on methylphenidate immediate release (IR) or methylphenidate slow release (SR) or Dexedrine IR or Dexedrine SR (Spansules), and have experienced unsatisfactory results due to poor symptom control, side effects, administrative barriers, or societal barriers. Administrative barriers include: - inability of a school to dose the child at lunch; - the school lunch hour does not coincide with the dosing schedule; - poor compliance with noon or afternoon doses; - the patient is unable to swallow tablets. Societal barriers include: - the patient or patient's caregiver(s) has(have) a history of substance abuse or diversion of listed immediate-release alternatives; - the patient or patient's caregiver(s) is/are at risk of substance abuse or diversion of listed immediate-release alternatives. BiphentinELV2.61182009-08-181.3021PMS-Methylphenidate CRPMS1.30212023-12-291.3021138540mgER CapNote: Patients > 6 years of age diagnosed with ADHD according to DSM-IV criteria and where symptoms are not due to other medical conditions which affect concentration, and who require 12-hour continuous coverage due to academic and/or psychosocial needs, and who meet the following: 1) Patients who demonstrate significant and problematic disruptive behaviour or who have problems with inattention that interfere with learning AND 2) Prescribed by or in consultation with a specialist in pediatric psychiatry, pediatrics or a general practitioner with expertise in ADHD AND 3) Have been tried on methylphenidate immediate release (IR) or methylphenidate slow release (SR) or Dexedrine IR or Dexedrine SR (Spansules), and have experienced unsatisfactory results due to poor symptom control, side effects, administrative barriers, or societal barriers. Administrative barriers include: - inability of a school to dose the child at lunch; - the school lunch hour does not coincide with the dosing schedule; - poor compliance with noon or afternoon doses; - the patient is unable to swallow tablets. Societal barriers include: - the patient or patient's caregiver(s) has(have) a history of substance abuse or diversion of listed immediate-release alternatives; - the patient or patient's caregiver(s) is/are at risk of substance abuse or diversion of listed immediate-release alternatives. BiphentinELV3.32722009-08-181.6588PMS-Methylphenidate CRPMS1.65882023-12-291.6588138650mgER CapNote: Patients > 6 years of age diagnosed with ADHD according to DSM-IV criteria and where symptoms are not due to other medical conditions which affect concentration, and who require 12-hour continuous coverage due to academic and/or psychosocial needs, and who meet the following: 1) Patients who demonstrate significant and problematic disruptive behaviour or who have problems with inattention that interfere with learning AND 2) Prescribed by or in consultation with a specialist in pediatric psychiatry, pediatrics or a general practitioner with expertise in ADHD AND 3) Have been tried on methylphenidate immediate release (IR) or methylphenidate slow release (SR) or Dexedrine IR or Dexedrine SR (Spansules), and have experienced unsatisfactory results due to poor symptom control, side effects, administrative barriers, or societal barriers. Administrative barriers include: - inability of a school to dose the child at lunch; - the school lunch hour does not coincide with the dosing schedule; - poor compliance with noon or afternoon doses; - the patient is unable to swallow tablets. Societal barriers include: - the patient or patient's caregiver(s) has(have) a history of substance abuse or diversion of listed immediate-release alternatives; - the patient or patient's caregiver(s) is/are at risk of substance abuse or diversion of listed immediate-release alternatives. BiphentinELV4.03742009-08-182.0130PMS-Methylphenidate CRPMS2.01302023-12-292.0130138760mgER CapNote: Patients > 6 years of age diagnosed with ADHD according to DSM-IV criteria and where symptoms are not due to other medical conditions which affect concentration, and who require 12-hour continuous coverage due to academic and/or psychosocial needs, and who meet the following: 1) Patients who demonstrate significant and problematic disruptive behaviour or who have problems with inattention that interfere with learning AND 2) Prescribed by or in consultation with a specialist in pediatric psychiatry, pediatrics or a general practitioner with expertise in ADHD AND 3) Have been tried on methylphenidate immediate release (IR) or methylphenidate slow release (SR) or Dexedrine IR or Dexedrine SR (Spansules), and have experienced unsatisfactory results due to poor symptom control, side effects, administrative barriers, or societal barriers. Administrative barriers include: - inability of a school to dose the child at lunch; - the school lunch hour does not coincide with the dosing schedule; - poor compliance with noon or afternoon doses; - the patient is unable to swallow tablets. Societal barriers include: - the patient or patient's caregiver(s) has(have) a history of substance abuse or diversion of listed immediate-release alternatives; - the patient or patient's caregiver(s) is/are at risk of substance abuse or diversion of listed immediate-release alternatives. BiphentinELV4.69842009-08-182.3425PMS-Methylphenidate CRPMS2.34252023-12-292.3425138880mgER CapNote: Patients > 6 years of age diagnosed with ADHD according to DSM-IV criteria and where symptoms are not due to other medical conditions which affect concentration, and who require 12-hour continuous coverage due to academic and/or psychosocial needs, and who meet the following: 1) Patients who demonstrate significant and problematic disruptive behaviour or who have problems with inattention that interfere with learning AND 2) Prescribed by or in consultation with a specialist in pediatric psychiatry, pediatrics or a general practitioner with expertise in ADHD AND 3) Have been tried on methylphenidate immediate release (IR) or methylphenidate slow release (SR) or Dexedrine IR or Dexedrine SR (Spansules), and have experienced unsatisfactory results due to poor symptom control, side effects, administrative barriers, or societal barriers. Administrative barriers include: - inability of a school to dose the child at lunch; - the school lunch hour does not coincide with the dosing schedule; - poor compliance with noon or afternoon doses; - the patient is unable to swallow tablets. Societal barriers include: - the patient or patient's caregiver(s) has(have) a history of substance abuse or diversion of listed immediate-release alternatives; - the patient or patient's caregiver(s) is/are at risk of substance abuse or diversion of listed immediate-release alternatives. BiphentinELV6.19442009-08-183.0883PMS-Methylphenidate CRPMS3.08832023-12-293.0883138920mgER TabRitalin SRNOV1996-10-01AA-Methylphenidate SRAAP.67962006-07-19.6796139018mgSR TabNotes: Patients greater than or equal to 6 years of age diagnosed with ADHD according to DSM-IV criteria and where symptoms are not due to other medical conditions which affect concentration, and who require 12-hour continuous coverage due to academic and/or psychosocial needs, and who meet the following: 1) Patients who demonstrate significant and problematic disruptive behaviour or who have problems with inattention that interfere with learning; AND 2) Prescribed by or in consultation with a specialist in pediatric psychiatry, pediatrics or a general practitioner with expertise in ADHD; AND 3) Have been tried on methylphenidate immediate release (IR) or methylphenidate slow release (SR) or Dexedrine IR or Dexedrine SR (Spansules), and have experienced unsatisfactory results due to poor symptom control, side effects, administrative barriers, or societal barriers. Administrative barriers include: - inability of a school to dose the child at lunch; - the school lunch hour does not coincide with the dosing schedule; - poor compliance with noon or afternoon doses; - the patient is unable to swallow tablets. Societal barriers include: - the patient or patient's caregiver(s) has(have) a history of substance abuse or diversion of listed immediate-release alternatives; - the patient or patient's caregiver(s) is/are at risk of substance abuse or diversion of listed immediate-release alternatives.ConcertaJAN3.29952009-04-011.0493Act Methylphenidate ERTEV1.04932018-05-311.0493Apo-Methylphenidate ERAPX1.04932016-09-291.0493139127mgSR TabNotes: Patients greater than or equal to 6 years of age diagnosed with ADHD according to DSM-IV criteria and where symptoms are not due to other medical conditions which affect concentration, and who require 12-hour continuous coverage due to academic and/or psychosocial needs, and who meet the following: 1) Patients who demonstrate significant and problematic disruptive behaviour or who have problems with inattention that interfere with learning; AND 2) Prescribed by or in consultation with a specialist in pediatric psychiatry, pediatrics or a general practitioner with expertise in ADHD; AND 3) Have been tried on methylphenidate immediate release (IR) or methylphenidate slow release (SR) or Dexedrine IR or Dexedrine SR (Spansules), and have experienced unsatisfactory results due to poor symptom control, side effects, administrative barriers, or societal barriers. Administrative barriers include: - inability of a school to dose the child at lunch; - the school lunch hour does not coincide with the dosing schedule; - poor compliance with noon or afternoon doses; - the patient is unable to swallow tablets. Societal barriers include: - the patient or patient's caregiver(s) has(have) a history of substance abuse or diversion of listed immediate-release alternatives; - the patient or patient's caregiver(s) is/are at risk of substance abuse or diversion of listed immediate-release alternatives.ConcertaJAN3.80762009-04-011.2109Act Methylphenidate ERTEV1.21092018-05-311.2109Apo-Methylphenidate ERAPX1.21092016-09-291.2109139236mgSR TabNotes: Patients greater than or equal to 6 years of age diagnosed with ADHD according to DSM-IV criteria and where symptoms are not due to other medical conditions which affect concentration, and who require 12-hour continuous coverage due to academic and/or psychosocial needs, and who meet the following: 1) Patients who demonstrate significant and problematic disruptive behaviour or who have problems with inattention that interfere with learning; AND 2) Prescribed by or in consultation with a specialist in pediatric psychiatry, pediatrics or a general practitioner with expertise in ADHD; AND 3) Have been tried on methylphenidate immediate release (IR) or methylphenidate slow release (SR) or Dexedrine IR or Dexedrine SR (Spansules), and have experienced unsatisfactory results due to poor symptom control, side effects, administrative barriers, or societal barriers. Administrative barriers include: - inability of a school to dose the child at lunch; - the school lunch hour does not coincide with the dosing schedule; - poor compliance with noon or afternoon doses; - the patient is unable to swallow tablets. Societal barriers include: - the patient or patient's caregiver(s) has(have) a history of substance abuse or diversion of listed immediate-release alternatives; - the patient or patient's caregiver(s) is/are at risk of substance abuse or diversion of listed immediate-release alternatives.ConcertaJAN4.31632009-04-011.3726Act Methylphenidate ERTEV1.37262018-05-311.3726Apo-Methylphenidate ERAPX1.37262016-09-291.3726139354mgSR TabNotes: Patients greater than or equal to 6 years of age diagnosed with ADHD according to DSM-IV criteria and where symptoms are not due to other medical conditions which affect concentration, and who require 12-hour continuous coverage due to academic and/or psychosocial needs, and who meet the following: 1) Patients who demonstrate significant and problematic disruptive behaviour or who have problems with inattention that interfere with learning; AND 2) Prescribed by or in consultation with a specialist in pediatric psychiatry, pediatrics or a general practitioner with expertise in ADHD; AND 3) Have been tried on methylphenidate immediate release (IR) or methylphenidate slow release (SR) or Dexedrine IR or Dexedrine SR (Spansules), and have experienced unsatisfactory results due to poor symptom control, side effects, administrative barriers, or societal barriers. Administrative barriers include: - inability of a school to dose the child at lunch; - the school lunch hour does not coincide with the dosing schedule; - poor compliance with noon or afternoon doses; - the patient is unable to swallow tablets. Societal barriers include: - the patient or patient's caregiver(s) has(have) a history of substance abuse or diversion of listed immediate-release alternatives; - the patient or patient's caregiver(s) is/are at risk of substance abuse or diversion of listed immediate-release alternatives.ConcertaJAN5.33262009-04-011.6958Apo-Methylphenidate ERAPX1.69582010-10-281.6958Act Methylphenidate ERTEV1.69582018-05-311.6958139410mgTabRitalinNOV.45561996-10-01.2216PMS-MethylphenidatePMS.22161996-10-01.2216Apo-MethylphenidateAPX.22162005-03-31.2216139520mgTabRitalinNOV2008-01-15PMS-MethylphenidatePMS.35362008-01-15Apo-MethylphenidateAPX.35362008-01-15MIXED SALT AMPHETAMINE13965mgER CapNotes: Patients > 6 years of age diagnosed with ADHD according to DSM-IV criteria and where symptoms are not due to other medical conditions which affect concentration, and who require 12-hour continuous coverage due to academic and/or psychosocial needs, and who meet the following: 1) Patients who demonstrate significant and problematic disruptive behaviour or who have problems with inattention that interfere with learning; AND 2) Prescribed by or in consultation with a specialist in pediatric psychiatry, pediatrics or a general practitioner with expertise in ADHD; AND 3) Have been tried on methylphenidate immediate release (IR) or methylphenidate slow release (SR) or Dexedrine IR or Dexedrine SR (Spansules), and have experienced unsatisfactory results due to poor symptom control, side effects, administrative barriers, or societal barriers. Administrative barriers include: - inability of a school to dose the child at lunch; - the school lunch hour does not coincide with the dosing schedule; - poor compliance with noon or afternoon doses; - the patient is unable to swallow tablets. Societal barriers include: - the patient or patient's caregiver(s) has(have) a history of substance abuse or diversion of listed immediate-release alternatives; - the patient or patient's caregiver(s) is/are at risk of substance abuse or diversion of listed immediate-release alternatives.Adderall XRTAK2.53712009-04-01.5372Act Amphetamine XRACV.53722015-10-29.5372Apo-Amphetamine XRAPX.53722019-07-31.5372Sandoz Amphetamine XRSDZ.53722017-02-28.5372139710mgER CapNotes: Patients > 6 years of age diagnosed with ADHD according to DSM-IV criteria and where symptoms are not due to other medical conditions which affect concentration, and who require 12-hour continuous coverage due to academic and/or psychosocial needs, and who meet the following: 1) Patients who demonstrate significant and problematic disruptive behaviour or who have problems with inattention that interfere with learning; AND 2) Prescribed by or in consultation with a specialist in pediatric psychiatry, pediatrics or a general practitioner with expertise in ADHD; AND 3) Have been tried on methylphenidate immediate release (IR) or methylphenidate slow release (SR) or Dexedrine IR or Dexedrine SR (Spansules), and have experienced unsatisfactory results due to poor symptom control, side effects, administrative barriers, or societal barriers. Administrative barriers include: - inability of a school to dose the child at lunch; - the school lunch hour does not coincide with the dosing schedule; - poor compliance with noon or afternoon doses; - the patient is unable to swallow tablets. Societal barriers include: - the patient or patient's caregiver(s) has(have) a history of substance abuse or diversion of listed immediate-release alternatives; - the patient or patient's caregiver(s) is/are at risk of substance abuse or diversion of listed immediate-release alternatives.Adderall XRTAK2.88332009-04-01.6105Act Amphetamine XRACV.61052015-10-29.6105Apo-Amphetamine XRAPX.61052019-07-31.6105Sandoz Amphetamine XRSDZ.61052017-02-28.6105139815mgER CapNotes: Patients > 6 years of age diagnosed with ADHD according to DSM-IV criteria and where symptoms are not due to other medical conditions which affect concentration, and who require 12-hour continuous coverage due to academic and/or psychosocial needs, and who meet the following: 1) Patients who demonstrate significant and problematic disruptive behaviour or who have problems with inattention that interfere with learning; AND 2) Prescribed by or in consultation with a specialist in pediatric psychiatry, pediatrics or a general practitioner with expertise in ADHD; AND 3) Have been tried on methylphenidate immediate release (IR) or methylphenidate slow release (SR) or Dexedrine IR or Dexedrine SR (Spansules), and have experienced unsatisfactory results due to poor symptom control, side effects, administrative barriers, or societal barriers. Administrative barriers include: - inability of a school to dose the child at lunch; - the school lunch hour does not coincide with the dosing schedule; - poor compliance with noon or afternoon doses; - the patient is unable to swallow tablets. Societal barriers include: - the patient or patient's caregiver(s) has(have) a history of substance abuse or diversion of listed immediate-release alternatives; - the patient or patient's caregiver(s) is/are at risk of substance abuse or diversion of listed immediate-release alternatives.Adderall XRTAK3.22962009-04-01.6838Act Amphetamine XRACV.68382015-10-29.6838Apo-Amphetamine XRAPX.68382019-07-31.6838Sandoz Amphetamine XRSDZ.68382017-02-28.6838139920mgER CapNotes: Patients > 6 years of age diagnosed with ADHD according to DSM-IV criteria and where symptoms are not due to other medical conditions which affect concentration, and who require 12-hour continuous coverage due to academic and/or psychosocial needs, and who meet the following: 1) Patients who demonstrate significant and problematic disruptive behaviour or who have problems with inattention that interfere with learning; AND 2) Prescribed by or in consultation with a specialist in pediatric psychiatry, pediatrics or a general practitioner with expertise in ADHD; AND 3) Have been tried on methylphenidate immediate release (IR) or methylphenidate slow release (SR) or Dexedrine IR or Dexedrine SR (Spansules), and have experienced unsatisfactory results due to poor symptom control, side effects, administrative barriers, or societal barriers. Administrative barriers include: - inability of a school to dose the child at lunch; - the school lunch hour does not coincide with the dosing schedule; - poor compliance with noon or afternoon doses; - the patient is unable to swallow tablets. Societal barriers include: - the patient or patient's caregiver(s) has(have) a history of substance abuse or diversion of listed immediate-release alternatives; - the patient or patient's caregiver(s) is/are at risk of substance abuse or diversion of listed immediate-release alternatives.Adderall XRTAK3.57582009-04-01.7572Act Amphetamine XRACV.75722015-10-29.7572Apo-Amphetamine XRAPX.75722019-07-31.7572Sandoz Amphetamine XRSDZ.75722017-02-28.7572140025mgER CapNotes: Patients > 6 years of age diagnosed with ADHD according to DSM-IV criteria and where symptoms are not due to other medical conditions which affect concentration, and who require 12-hour continuous coverage due to academic and/or psychosocial needs, and who meet the following: 1) Patients who demonstrate significant and problematic disruptive behaviour or who have problems with inattention that interfere with learning; AND 2) Prescribed by or in consultation with a specialist in pediatric psychiatry, pediatrics or a general practitioner with expertise in ADHD; AND 3) Have been tried on methylphenidate immediate release (IR) or methylphenidate slow release (SR) or Dexedrine IR or Dexedrine SR (Spansules), and have experienced unsatisfactory results due to poor symptom control, side effects, administrative barriers, or societal barriers. Administrative barriers include: - inability of a school to dose the child at lunch; - the school lunch hour does not coincide with the dosing schedule; - poor compliance with noon or afternoon doses; - the patient is unable to swallow tablets. Societal barriers include: - the patient or patient's caregiver(s) has(have) a history of substance abuse or diversion of listed immediate-release alternatives; - the patient or patient's caregiver(s) is/are at risk of substance abuse or diversion of listed immediate-release alternatives.Adderall XRTAK3.92202009-04-01.8305Act Amphetamine XRACV.83052015-10-29.8305Apo-Amphetamine XRAPX.83052019-07-31.8305Sandoz Amphetamine XRSDZ.83052017-02-28.8305140130mgER CapNotes: Patients > 6 years of age diagnosed with ADHD according to DSM-IV criteria and where symptoms are not due to other medical conditions which affect concentration, and who require 12-hour continuous coverage due to academic and/or psychosocial needs, and who meet the following: 1) Patients who demonstrate significant and problematic disruptive behaviour or who have problems with inattention that interfere with learning; AND 2) Prescribed by or in consultation with a specialist in pediatric psychiatry, pediatrics or a general practitioner with expertise in ADHD; AND 3) Have been tried on methylphenidate immediate release (IR) or methylphenidate slow release (SR) or Dexedrine IR or Dexedrine SR (Spansules), and have experienced unsatisfactory results due to poor symptom control, side effects, administrative barriers, or societal barriers. Administrative barriers include: - inability of a school to dose the child at lunch; - the school lunch hour does not coincide with the dosing schedule; - poor compliance with noon or afternoon doses; - the patient is unable to swallow tablets. Societal barriers include: - the patient or patient's caregiver(s) has(have) a history of substance abuse or diversion of listed immediate-release alternatives; - the patient or patient's caregiver(s) is/are at risk of substance abuse or diversion of listed immediate-release alternatives.Adderall XRTAK4.26832009-04-01.9038Act Amphetamine XRACV.90382015-10-29.9038Apo-Amphetamine XRAPX.90382019-07-31.9038Sandoz Amphetamine XRSDZ.90382017-02-28.9038MODAFINIL1402100mgTabAlertecBJH1.82702008-06-27.9293Apo-ModafinilAPX.92932008-06-27.9293Teva-ModafinilTEV.92932014-09-25.9293Auro-ModafinilAUR.92932014-12-18.9293Mar-ModafinilMAR.92932015-01-28.9293Jamp ModafinilJPC.92932021-04-30.9293ModafinilSAI.92932023-01-31.9293SEDATIVES AND HYPNOTICSBUSPIRONE HYDROCHLORIDE140310mgTabBusparBQU2007-11-10Apo-BuspironeAPX.27132007-11-16.2713PMS-BuspironePMS.27132007-11-16.2713Teva-BuspironeTEV.27132007-11-10.2713BuspironeSAI.27132016-07-28.2713Auro-BuspironeAUR.27132021-02-26.2713Jamp BuspironeJPC.27132021-12-17.2713Mint-BuspironeMIN.27132022-05-31.2713AMB-BuspironeAMB.27132025-04-30.2713ESZOPICLONE14041mgTabLunestaSMT2024-10-31Mar-EszopicloneMAR1.43652024-10-3114052mgTabLunestaSMT2024-10-31Mar-EszopicloneMAR1.43652024-10-3114063mgTabLunestaSMT2024-10-31Mar-EszopicloneMAR1.43652024-10-31FLURAZEPAM140715mgCapDalmaneVAL1996-10-01FlurazepamAAP.11661996-10-01.1166140830mgCapDalmaneVAL1996-10-01FlurazepamAAP.13641996-10-01.1364LORAZEPAM14094mg/mLInj Sol (with preservative)AtivanWAY2017-02-28Lorazepam Injection USPSDZ19.08002017-02-2819.0800Lorazepam Injection, USPFKC19.08002026-01-3019.0800For the management of patients receiving palliative care*.LU Authorization Period: 1 year*The patient must have a progressive life-limiting illness and require this medication for palliative purposes.14100.5mgSL TabAtivanPFI2013-10-31Lorazepam SublingualAAP.10992013-10-3114111mgSL TabAtivanPFI2013-10-31Lorazepam SublingualAAP.13852013-10-3114122mgSL TabAtivanPFI2013-10-31Lorazepam SublingualAAP.21522013-10-31METHOTRIMEPRAZINE141325mg/mLInj Sol-1mL PkNozinanNEU4.24591996-10-014.245914142mgTabNozinanAVE1996-10-01MethoprazineAAP.07211999-04-15.072114155mgTabNozinanSAV1996-10-01MethoprazineAAP.10431999-04-15.1043141625mgTabNozinanSAV1996-10-01MethoprazineAAP.26811999-04-15.2681141750mgTabNozinanSAV1996-10-01MethoprazineAAP.40601999-04-15.4060MIDAZOLAM14185mg/mLInj Sol (with Preservative)VersedHLR2017-05-31Midazolam InjectionSDZ4.10002017-05-314.1000Midazolam InjectionFKC4.10002014-01-034.1000For intermittent injection used for symptomatic relief in patients receiving palliative care*.LU Authorization Period: 1 year*The patient must have a progressive life-limiting illness and require this medication for palliative purposes.For continuous infusion in patients receiving palliative sedation*.LU Authorization Period: 1 year*The patient must have a progressive life-limiting illness and require this medication for palliative purposes.NITRAZEPAM14195mgTabMogadonAAP.18261996-10-01.1826142010mgTabMogadonAAP.27321996-10-01.2732PHENOBARBITAL14215mg/mLOral ElixirPhenobarb ElixirPEN.15352018-01-31.1535142215mgTabPhenobarbPEN.15082018-01-31.1508142330mgTabPhenobarbPEN.17952018-01-31.1795142460mgTabPhenobarbPEN.24332018-01-31.24331425100mgTabPhenobarbPEN.33292018-01-31.3329TEMAZEPAM142615mgCapRestorilAAP.24611996-10-01.2461142730mgCapRestorilAAP.29801996-10-01.2980TRIAZOLAM14280.125mgTabHalcionUPJ1996-10-01TriazolamAAP.14961996-10-01.149614290.25mgTabHalcionPFI1996-10-01TriazolamAAP.25511996-10-01.2551ZOLPIDEM TARTRATE14305mgSL TabSublinoxVAL2015-02-26Apo-Zolpidem ODTAPX1.18252015-02-26PMS-Zolpidem ODTPMS1.18272017-02-28Mint-Zolpidem ODTMIN1.18272021-09-30Jamp Zolpidem ODTJPC1.18272024-04-30143110mgSL TabSublinoxVAL2015-02-26Apo-Zolpidem ODTAPX1.18842015-02-26PMS-Zolpidem ODTPMS1.18832017-02-28Mint-Zolpidem ODTMIN1.18832021-09-30Jamp Zolpidem ODTJPC1.18832024-04-30ZOPICLONE14323.75mgTabImovaneSAV2025-05-30PMS-ZopiclonePMS.23432025-07-31Jamp ZopicloneJPC.23432025-05-3014335mgTabImovaneSAV2007-09-04PMS-ZopiclonePMS.22312007-09-04.2231Apo-ZopicloneAPX.22312007-09-04.2231Ratio-ZopicloneRPH.22312007-09-04.2231Sandoz ZopicloneSDZ.22312007-09-04.2231Ran-ZopicloneRAN.22312007-09-04.2231Co ZopicloneCOB.22312007-09-04.2231Riva-ZopicloneRIA.22312022-05-31.2231ZopicloneSAI.22312011-08-04.2231ZopicloneSIV.22312020-08-28.2231Mar-ZopicloneMAR.22312012-08-27.2231Septa-ZopicloneSET.22312013-04-30.2231Mint-ZopicloneMIN.22312012-12-21.2231Jamp-Zopiclone TabletsJPC.22312013-08-29.2231M-ZopicloneMAT.22312021-10-29.2231AG-ZopicloneANG.22312021-09-30.2231NRA-ZopicloneNRA.22312020-08-28.2231Jamp ZopicloneJPC.22312025-09-29.223114347.5mgTabImovaneSAV2007-09-04Sandoz Zopiclone TabletSDZ.46852007-09-04.4685Apo-ZopicloneAPX.46852007-09-04.4685PMS-ZopiclonePMS.46852007-09-04.4685Ratio-ZopicloneRPH.46852007-09-04.4685Ran-ZopicloneRAN.46852007-09-04.4685Co ZopicloneCOB.46852007-09-04.4685Riva-ZopicloneRIA.46852022-05-31.4685ZopicloneSAI.46852011-08-04.4685Jamp-ZopicloneJPC.46852012-08-27.4685ZopicloneSIV.46852020-08-28.4685Mar-ZopicloneMAR.46852012-08-27.4685Septa-ZopicloneSET.46852013-04-30.4685Mint-ZopicloneMIN.46852012-12-21.4685Jamp-Zopiclone TabletsJPC.46852015-03-31.4685M-ZopicloneMAT.46852021-10-29.4685AG-ZopicloneANG.46852021-09-30.4685NRA-ZopicloneNRA.46852020-08-28.4685Jamp ZopicloneJPC.46852025-06-30.4685ANTIPARKINSONIAN AGENTS DOPAMINE RECEPTOR AGONISTSROTIGOTINE14352mg/24hrTrans PatchNeuproUCB3.82802017-09-283.828014364mg/24hrTrans PatchNeuproUCB7.02902017-09-287.029014376mg/24hrTrans PatchNeuproUCB7.86202017-09-287.862014388mg/24hrTrans PatchNeuproUCB7.86202017-09-287.8620For adjunctive therapy to levodopa for the treatment of patients with advanced stage Parkinson's disease (APD).LU Authorization Period: IndefiniteMISCELLANEOUS CENTRAL NERVOUS SYSTEM DRUGSACAMPROSATE CALCIUM1439333mgDR TabCampralMYL1.01952018-06-291.0195For the treatment of alcohol use disorder in patients who: - Meet clinical criteria for alcohol use disorder; and - Express a commitment to abstain from alcohol; and - Have been abstinent from alcohol for at least 3 days prior to starting acamprosate; and - Have confirmed participation in counselling and treatment for alcohol use disorder* * An individualized treatment plan will have one or more of the following components: Counselling and follow-up with the patient's family physician, addiction physician, or psychiatrist; self-help groups such as Alcoholics Anonymous; and outpatient, day, or inpatient psychosocial rehabilitation programs.LU Authorization Period: 1 yearALMOTRIPTAN14406.25mgTabAxertJNO2013-09-27Mylan-AlmotriptanMYL9.78332013-09-279.7833Apo-AlmotriptanAPX9.78332013-09-279.7833144112.5mgTabAxertJNO2013-09-27Mylan-AlmotriptanMYL9.78332013-09-279.7833Sandoz AlmotriptanSDZ9.78252013-09-279.7825Apo-AlmotriptanAPX9.78332013-09-279.7833Teva-AlmotriptanTEV9.78332015-06-299.7833AlmotriptanSAI9.78332020-06-309.7833ATOMOXETINE HCL144210mgCapStratteraLIL2010-12-14Teva-AtomoxetineTEV.51062011-03-15.5106Apo-AtomoxetineAPX.51062010-12-14.5106PMS-AtomoxetinePMS.51062012-08-27.5106Sandoz AtomoxetineSDZ.51062012-07-27.5106AtomoxetineSIV.51062020-06-30.5106AtomoxetineSAI.51062020-06-30.5106Auro-AtomoxetineAUR.51062019-03-28.5106Jamp AtomoxetineJPC.51062023-04-28.5106144318mgCapStratteraLIL2010-12-14Teva-AtomoxetineTEV.57482011-03-15.5748Apo-AtomoxetineAPX.57482010-12-14.5748PMS-AtomoxetinePMS.57482012-08-27.5748Sandoz AtomoxetineSDZ.57482012-07-27.5748AtomoxetineSIV.57482020-06-30.5748AtomoxetineSAI.57482020-06-30.5748Auro-AtomoxetineAUR.57482019-03-28.5748Jamp AtomoxetineJPC.57482023-04-28.5748144425mgCapStratteraLIL2010-12-14Teva-AtomoxetineTEV.64202011-03-15.6420Apo-AtomoxetineAPX.64202010-12-14.6420PMS-AtomoxetinePMS.64202012-08-27.6420Sandoz AtomoxetineSDZ.64202012-07-27.6420AtomoxetineSIV.64202020-06-30.6420AtomoxetineSAI.64202020-06-30.6420Auro-AtomoxetineAUR.64202019-03-28.6420Jamp AtomoxetineJPC.64202023-04-28.6420144540mgCapStratteraLIL2010-12-14Teva-AtomoxetineTEV.73692011-03-15.7369Apo-AtomoxetineAPX.73692010-12-14.7369PMS-AtomoxetinePMS.73692012-08-27.7369Sandoz AtomoxetineSDZ.73692012-07-27.7369AtomoxetineSIV.73692020-06-30.7369AtomoxetineSAI.73692020-06-30.7369Auro-AtomoxetineAUR.73692019-03-28.7369Jamp AtomoxetineJPC.73692023-04-28.7369144660mgCapStratteraLIL2010-12-14Teva-AtomoxetineTEV.80922011-03-15.8092Apo-AtomoxetineAPX.80922010-12-14.8092PMS-AtomoxetinePMS.80922012-08-27.8092Sandoz AtomoxetineSDZ.80922012-07-27.8092AtomoxetineSIV.80922020-06-30.8092AtomoxetineSAI.80922020-06-30.8092Auro-AtomoxetineAUR.80922019-03-28.8092Jamp AtomoxetineJPC.80922023-04-28.8092144780mgCapStratteraLIL2010-12-14Apo-AtomoxetineAPX3.99612010-12-14Teva-AtomoxetinTEV3.99602013-09-27Sandoz AtomoxetineSDZ3.99632012-07-27AtomoxetineSAI3.99602020-06-30Auro-AtomoxetineAUR3.99602019-03-28Jamp AtomoxetineJPC3.99602022-09-291448100mgCapStratteraLIL2010-12-14Apo-AtomoxetineAPX4.35212010-12-14Teva-AtomoxetinTEV4.35202013-09-27Sandoz AtomoxetineSDZ4.35242012-07-27AtomoxetineSAI4.35202020-06-30Auro-AtomoxetineAUR4.35202019-03-28Jamp AtomoxetineJPC4.35202022-09-29DIMETHYL FUMARATE1449120mgDR CapTecfideraBIG18.38662021-11-309.1933GLN-Dimethyl FumarateGLP9.19332021-11-309.1933Ach-Dimethyl FumarateACH9.19332021-12-179.1933PMS-Dimethyl FumaratePMS9.19332021-11-309.1933Mar-Dimethyl FumarateMAR9.19332021-11-309.1933Apo-Dimethyl FumarateAPX9.19332021-11-309.1933Sandoz Dimethyl Fumarate DR CapsulesSDZ9.19332021-11-309.1933Jamp Dimethyl FumarateJPC9.19332021-12-179.1933Auro-Dimethyl FumarateAUR4.42662024-08-304.42661450240mgDR CapTecfideraBIG36.77342021-11-3018.3867GLN-Dimethyl FumarateGLP18.38672021-11-3018.3867Ach-Dimethyl FumarateACH18.38672021-12-1718.3867PMS-Dimethyl FumaratePMS18.38672021-11-3018.3867Mar-Dimethyl FumarateMAR18.38672021-11-3018.3867Apo-Dimethyl FumarateAPX18.38672021-11-3018.3867Sandoz Dimethyl Fumarate DR CapsulesSDZ18.38672021-11-3018.3867Jamp Dimethyl FumarateJPC18.38672021-12-1718.3867Auro-Dimethyl FumarateAUR8.68882024-08-308.6888ELETRIPTAN145120mgTabRelpaxUJC2013-01-29Gd-EletriptanUJC10.08502013-01-29Teva-EletriptanTEV10.08502013-11-28Apo-EletriptanAPX10.08502013-05-31Auro-EletriptanAUR10.08502019-04-30Jamp EletriptanJPC10.08502021-07-30EletriptanSAI10.08502021-06-30Apo-Eletriptan TabletsAPX10.08502022-05-31145240mgTabRelpaxUJC2013-01-29Gd-EletriptanUJC10.08502013-01-29Teva-EletriptanTEV10.08502013-11-28Apo-EletriptanAPX10.08502013-05-31Auro-EletriptanAUR10.08502019-04-30Jamp EletriptanJPC10.08502021-07-30EletriptanSAI10.08502021-06-30Apo-Eletriptan TabletsAPX10.08502022-05-31ENTACAPONE1453200mgTabComtanSDZ1.68372003-04-16.4010Teva-EntacaponeTEV.40102012-05-29.4010Sandoz EntacaponeSDZ.40102012-05-29.4010Mint-EntacaponeMIN.40102024-03-28.4010For the treatment of patients with Parkinson's disease with 25% of the waking day in the off state despite maximally tolerated doses of levodopa.LU Authorization Period: IndefiniteFROVATRIPTAN SUCCINATE14542.5mgTabFrovaEDO2014-08-28Teva-FrovatriptanEDO12.50332016-03-30Apo-FrovatriptanAPX12.50332014-08-28Jamp FrovatriptanJPC12.50332021-02-26Mint-FrovatriptanMIN12.50332022-08-31FrovatriptanSAI12.50332023-08-31MEMANTINE HCL145510mgTabEbixaVLH2010-01-05Ratio-MemantineRPH1.63572010-01-05PMS-MemantinePMS1.63572010-01-05Co MemantineCOB1.63572010-06-14Apo-MemantineAPX1.63572011-12-15Sandoz Memantine FCTSDZ1.63572015-02-26Med-MemantineGMP1.63572015-05-28Ran-MemantineRAN1.63572014-09-25MemantineSAI1.63572020-06-30MemantineSIV1.63572020-06-30Mint-MemantineMIN1.63572024-12-30NARATRIPTAN HYDROCHLORIDE14561mgTabAmergeGSK2010-03-02Teva-NaratriptanTEV12.49902010-03-0212.499014572.5mgTabAmergeGSK2010-03-02Teva-NaratriptanTEV8.21252010-03-028.2125Sandoz NaratriptanSDZ8.21252010-04-238.2125Apo-NaratriptanAPX8.21252013-06-278.2125PIZOTYLINE14581mgTabSandomigran DSPPI1.19321996-10-011.1932PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE14590.25mgTabMirapexBOE1.34742000-04-17.1950Apo-PramipexoleAPX.19502007-04-02.1950Act PramipexoleTEV.19502009-06-23.1950PramipexoleSIV.19502020-06-30.1950Sandoz PramipexoleSDZ.19502008-11-04.1950PramipexoleSAI.19502022-06-30.1950Auro-PramipexoleAUR.19502014-06-26.195014600.5mgTabMirapexBOE2007-09-04Apo-PramipexoleAPX1.38602007-09-04Act PramipexoleTEV1.38602009-06-23PramipexoleSIV1.38602020-06-30Sandoz PramipexoleSDZ1.38602009-05-20PramipexoleSAI1.38602022-06-30Auro-PramipexoleAUR1.38602017-05-3114611mgTabApo-PramipexoleAPX.39012007-04-02.3901Act PramipexoleTEV.39012009-06-23.3901PramipexoleSIV.39012020-06-30.3901Sandoz PramipexoleSDZ.39012008-11-04.3901PramipexoleSAI.39012022-06-30.3901Auro-PramipexoleAUR.39012014-06-26.3901MirapexBOE2007-03-0914621.5mgTabApo-PramipexoleAPX.39012007-04-02.3901Act PramipexoleTEV.39012009-06-23.3901PramipexoleSIV.39012020-06-30.3901Sandoz PramipexoleSDZ.39012008-11-04.3901PramipexoleSAI.39012022-06-30.3901Auro-PramipexoleAUR.39012014-06-26.3901MirapexBOE2007-03-09RIZATRIPTAN14635mgOrally Disintegrating TabMaxalt RPDOCI23.68882012-03-2611.1650Sandoz Rizatriptan ODTSDZ11.11502012-03-2611.1150Co Rizatriptan ODTCOB11.11502012-03-2611.1150Mylan-Rizatriptan ODTMYL11.11502012-03-2611.1150PMS-Rizatriptan RDTPMS11.11502012-12-2111.1150Apo-Rizatriptan RPDAPX11.11502013-06-2711.1150Teva-Rizatriptan ODTTEV11.11502014-12-1811.1150Nat-Rizatriptan ODTNAT11.16502015-04-3011.1650Mint-Rizatriptan ODTMIN11.11502015-09-3011.1150Rizatriptan ODTSAI11.11502020-08-2811.1150Rizatriptan ODTSIV11.11502020-11-3011.1150CCP-RizatriptanCCP11.11502019-07-3111.1150Mar-Rizatriptan ODTMAR11.11502018-04-3011.1150Jamp-Rizatriptan ODTJPC11.11502018-06-2911.1150Accel-Rizatriptan ODTACC7.78002020-01-317.7800146410mgOrally Disintegrating TabMaxalt RPDOCI23.68882012-03-2611.1650Sandoz Rizatriptan ODTSDZ11.11502012-03-2611.1150Co Rizatriptan ODTCOB11.11502012-03-2611.1150Mylan-Rizatriptan ODTMYL11.11502012-03-2611.1150PMS-Rizatriptan RDTPMS11.11502012-12-2111.1150Apo-Rizatriptan RPDAPX11.11502013-06-2711.1150Teva-Rizatriptan ODTTEV11.11502014-12-1811.1150Nat-Rizatriptan ODTNAT11.16502015-04-3011.1650Mint-Rizatriptan ODTMIN11.11502015-09-3011.1150Rizatriptan ODTSAI11.11502020-08-2811.1150Rizatriptan ODTSIV11.11502020-11-3011.1150CCP-RizatriptanCCP11.11502019-07-3111.1150Mar-Rizatriptan ODTMAR11.11502018-04-3011.1150Jamp-Rizatriptan ODTJPC11.11502018-06-2911.1150Accel-Rizatriptan ODTACC7.78002020-01-317.7800NRA-Rizatriptan ODTNRA11.11502023-01-3111.1150AG-Rizatriptan ODTANG11.11502021-06-3011.115014655mgTabMaxaltFRS2012-05-29Jamp-RizatriptanJPC11.11502012-09-2811.1150Apo-RizatriptanAPX12.59702012-12-2112.5970Jamp-Rizatriptan IRJPC11.11502015-01-2811.1150146610mgTabMaxaltOCI23.68882012-05-2911.1150Mar-RizatriptanMAR11.11502012-05-2911.1150Jamp-RizatriptanJPC11.11502012-09-2811.1150Act RizatriptanTEV11.11502012-08-2711.1150Apo-RizatriptanAPX11.11502012-12-2111.1150Jamp-Rizatriptan IRJPC11.11502015-01-2811.1150Auro-RizatriptanAUR11.11502016-10-2711.1150RizatriptanSAI11.11502021-10-2911.1150SUMATRIPTAN SUCCINATE14676mg/0.5mLInj Sol-Pref Syr 0.5mL PkImitrexGLW52.86002013-04-3042.4650Taro-SumatriptanTAR42.46502013-04-3042.4650146825mgTabPMS-SumatriptanPMS8.99002007-06-068.9900Co SumatriptanCOB8.99002007-06-068.9900Mylan-SumatriptanMYL8.99002007-06-068.9900ImitrexGSK2007-06-06146925mgTabImitrex DFGSK2007-06-06Teva-Sumatriptan DFTEV8.99002007-06-06Jamp Sumatriptan DFJPC8.99002025-01-31147050mgTabImitrexGSK2007-06-06PMS-SumatriptanPMS9.06502007-06-069.0650Co SumatriptanCOB9.06502007-06-069.0650Sandoz SumatriptanSDZ9.06502007-06-069.0650Apo-SumatriptanAPX9.06502007-06-069.0650Mylan-SumatriptanMYL9.06502007-06-069.0650Ratio-SumatriptanRPH9.06502007-06-069.0650SumatriptanSAI9.06502011-08-049.0650Jamp SumatriptanJPC9.06502024-12-309.0650SumatriptanSIV9.06502024-05-319.0650147150mgTabImitrex DFGSK19.78172007-06-069.0650Teva-Sumatriptan DFTEV9.06502007-06-069.0650Sumatriptan DFSIV9.06502020-06-309.0650Jamp Sumatriptan DFJPC9.06502025-01-319.06501472100mgTabImitrexGSK2007-06-06PMS-SumatriptanPMS9.98672007-06-069.9867Co SumatriptanCOB9.98672007-06-069.9867Sandoz SumatriptanSDZ9.98672007-06-069.9867Apo-SumatriptanAPX9.98672007-06-069.9867Mylan-SumatriptanMYL9.98672007-06-069.9867Ratio-SumatriptanRPH9.98672007-06-069.9867SumatriptanSAI9.98672011-08-049.9867Jamp SumatriptanJPC9.98662024-12-309.9866SumatriptanSIV9.98672024-05-319.98671473100mgTabImitrex DFGSK21.79332007-06-069.9866Teva-Sumatriptan DFTEV9.98662007-06-069.9866Sumatriptan DFSIV9.98662020-06-309.9866Jamp Sumatriptan DFJPC9.98662025-01-319.9866ZOLMITRIPTAN14742.5mgOrally Disintegrating TabZomig RapimeltAZC17.73252011-09-156.8633Teva-Zolmitriptan ODTEV6.86332011-10-256.8633Sandoz Zolmitriptan ODTSDZ6.86252011-09-156.8625Apo-Zolmitriptan RapidAPX6.86332012-12-216.8633Mint-Zolmitriptan ODTMIN6.86252014-06-266.8625Jamp-Zolmitriptan ODTJPC6.86332015-01-286.8633Septa-Zolmitriptan-ODTSET6.86332014-12-186.8633Zolmitriptan ODTSAI6.86332020-08-286.863314752.5mgTabZomigAZC17.73252011-09-156.8633Teva-ZolmitriptanTEV6.85832011-10-256.8583Sandoz ZolmitriptanSDZ6.85862011-09-156.8586Apo-ZolmitriptanAPX6.85832012-05-296.8583Mar-ZolmitriptanMAR6.85832014-06-266.8583Mint-ZolmitriptanMIN6.85832014-05-296.8583Nat-ZolmitriptanNAT6.86332015-04-306.8633Jamp-ZolmitriptanJPC6.85832014-07-306.8583ZolmitriptanSAI6.85832020-08-286.8583CCP-ZolmitriptanCCP6.85862019-07-316.8586Jamp ZolmitriptanJPC6.85832020-05-296.8583Auro-ZolmitriptanAUR6.86332021-08-316.8633NRA-ZolmitriptanNRA6.86002023-01-316.8600DIAGNOSTIC AGENTSADRENAL INSUFFICIENCYCOSYNTROPIN ZINC HYDROXIDE14761mg/mLInj Susp-1mL PkSynacthen DepotQUO680.00001996-10-01680.0000ELECTROLYTIC, CALORIC AND WATER BALANCEREPLACEMENT AGENTSELECTROLYTE & DEXTROSE1477O/LPedialyte RegularABB.00792018-08-30.0079Pedialyte FlavoredABB.00792018-08-30.0079PEG-ELECTROLYTES1478Pd-4L PkColytePEN1996-10-01PegLyte PowderPEN17.73311996-10-0117.7331POTASSIUM-REMOVING RESINSLANTHANUM1479250mgChew TabFosrenolTAK2020-08-28Nat-LanthanumNAT1.20342020-08-281.20341480500mgChew TabFosrenolTAK2020-07-31Nat-LanthanumNAT2.40692020-07-312.40691481750mgChew TabFosrenolTAK2020-07-31Nat-LanthanumNAT3.62192020-07-313.621914821000mgChew TabFosrenolTAK2020-07-31Nat-LanthanumNAT4.80182020-07-314.8018POLYSTYRENE SODIUM SULFONATE1483250mg/mLO/LSolystatPEN2019-07-31Odan-Sodium Polystyrene SulfonateODN.19542019-07-31.195414841mEq/gOral Pd-454g PkSolystatPEN29.41752021-02-2629.4175KayexalateSAV43.63001996-10-0129.4175Odan-Sodium Polystyrene SulfonateODN29.41752019-05-3129.4175Jamp Sodium Polystyrene SulfonateJPC29.41752021-08-3129.4175SEVELAMER CARBONATE1485800mgTabRenvelaSAV1.31252019-01-311.2634Accel-SevelamerACC1.26342021-06-071.2634CALORIC AGENTSOLIVE OIL & SOYBEAN OIL148616% & 4% w/wInj Emuls-250mL PkClinoleic 20%BAX25.00002020-06-3025.0000148716% & 4% w/wInj Emuls-500mL PkClinoleic 20%BAX30.00002020-06-3030.0000As part of a parenteral nutrition regimen for adult patients when oral or enteral nutrition is not possible, insufficient, or contraindicated.LU Authorization Period: IndefiniteSOYBEAN OIL & MEDIUM CHAIN TRIGLYCERIDES & OLIVE OIL & FISH OIL14886% & 6% & 5% & 3% w/vInj Emuls-250mL PkSMOFLipid 20%FKC27.50002018-03-2927.500014896% & 6% & 5% & 3% w/vInj Emuls-500mL PkSMOFLipid 20%FKC33.33002018-03-2933.3300As part of a parenteral nutrition regimen for adult patients where oral or enteral nutrition is not possible, insufficient or contra-indicated.LU Authorization Period: IndefiniteDIURETICSAMILORIDE HCL14905mgTabMidamorAAP.32972004-08-11.3297AMILORIDE HCL & HYDROCHLOROTHIAZIDE14915mg & 50mgTab.0484ModuretPRE1996-10-01AA-AmilzideAAP.0969.04841996-10-01.0969CHLORTHALIDONE149250mgTab.1277HygrotonGEI1996-10-01Apo-ChlorthalidoneAPX.1277.12771996-10-01.1277Jamp ChlorthalidoneJPC.1277.12772023-06-30.1277FUROSEMIDE149310mg/mLInj Sol (Preservative Free)Furosemide Injection USPSDZ.60552017-02-28.6055Furosemide Injection USPJPC.60552024-03-28.6055For the management of patients receiving palliative care*.LU Authorization Period: 1 year*The patient must have a progressive life-limiting illness and require this medication for palliative purposes.For the treatment of patients receiving care at home* who have failed or are unable to tolerate oral alternatives, and who require an injectable option to manage their condition.LU Authorization Period: 1 year*e.g., home care recipients, long-term care home residents.149410mg/mLO/LLasixSAV.34651999-01-07.3465149520mgTabTeva-FurosemideTEV.02191996-10-01.0218Apo-FurosemideAPX.02191996-10-01.0218LasixSAV1999-01-06FurosemideSAI.02182020-10-30.0218Mint-FurosemideMIN.02192018-11-29.0218149640mgTabTeva-FurosemideTEV.03271996-10-01.0327Apo-FurosemideAPX.03271996-10-01.0327LasixSAV1999-01-07FurosemideSAI.03272020-10-30.0327Mint-FurosemideMIN.03272018-11-29.03271497500mgTabLasix SpecialSAV3.57001999-01-073.5700For patients with severely impaired renal function refractory to conventional dosages of the drug.LU Authorization Period: IndefiniteHYDROCHLOROTHIAZIDE149812.5mgTabPMS-HydrochlorothiazidePMS2010-04-23Apo-HydroAPX.03222010-04-23Mint-HydrochlorothiazideMIN.03222014-09-25149925mgTab.0157HydroDIURILMSD1996-10-01Teva-HydrochlorothiazideTEV.0157.01571996-10-01.0157Apo-Hydro 25APX.0157.01571996-10-01.0157PMS-HydrochlorothiazidePMS.0157.01572007-09-04.0157Mint-HydrochlorothiazideMIN.0157.01572015-03-31.0157150050mgTabHydroDIURILMSD1996-10-01Teva-HydrochlorothiazideTEV.02171996-10-01.0217Apo-Hydro 50APX.02171996-10-01.0217PMS-HydrochlorothiazidePMS.02172007-09-04.0217HYDROCHLOROTHIAZIDE & SPIRONOLACTONE150125mg & 25mgTab.0686Aldactazide-25PFI1996-10-01Teva-Spironolactone/HCTZTEV.1372.06861996-10-01.1372150250mg & 50mgTabAldactazide-50PFI1996-10-01Teva-Spironolactone/HCTZTEV.29031996-10-01.2903HYDROCHLOROTHIAZIDE & TRIAMTERENE150325mg & 50mgTab.0608Apo-TriazideAPX.0608.06081996-10-01.0608Teva-Triamterene/HCTZTEV.0608.06081996-10-01.0608DyazideSMJ1996-10-01INDAPAMIDE15041.25mgTabLozideSEV1996-10-01Mylan-IndapamideMYL.14901999-09-15.1490Apo-IndapamideAPX.14902003-04-16.149015052.5mgTab.2364LozideSEV1996-10-01Mylan-IndapamideMYL.2364.23641996-10-01.2364Apo-IndapamideAPX.2364.23641996-12-19.2364METOLAZONE15062.5mgTabZaroxolynSAV.22941996-10-01.2294MIDODRINE HCL15072.5mgTabAmatineSHI1996-10-01Apo-MidodrineAPX.11532006-08-24.1153Mar-MidodrineMAR.11532018-11-29.1153Jamp MidodrineJPC.11532022-04-29.1153MidodrineSAI.11532023-07-31.115315085mgTabAmatineSHI1996-10-01Apo-MidodrineAPX.19212006-08-24.1921Mar-MidodrineMAR.19212018-11-29.1921Jamp MidodrineJPC.19212022-04-29.1921MidodrineSAI.19212023-07-31.1921For the treatment of patients disabled by moderate to severe neurogenic orthostatic hypotension (i.e. drop in systolic BP less than or equal to 20mm Hg from supine to standing position), in whom conventional nonpharmacologic and pharmacologic (i.e. fludrocortisone) therapies have proven ineffective or are poorly tolerated.LU Authorization Period: IndefiniteSPIRONOLACTONESpironolactone can double digoxin blood levels within two weeks, and commonly causes mastalgia and gynaecomastia in men.150925mgTabAldactonePFI.27461996-10-01.0405Teva-SpironolactoneTEV.04051996-10-01.0405Mint-SpironolactoneMIN.04052020-04-30.0405Jamp SpironolactoneJPC.04052022-08-31.04051510100mgTabAldactonePFI.64101996-10-01.0955Teva-SpironolactoneTEV.09551996-10-01.0955Mint-SpironolactoneMIN.09552020-04-30.0955Jamp SpironolactoneJPC.09552022-08-31.0955TOLVAPTAN151115mg & 15mg14-Tabs PkJinarcOTS2025-07-31Lupin-TolvaptanLUP863.81252025-07-31151230mg & 15mg14-Tabs PkJinarcOTS2025-07-31Lupin-TolvaptanLUP863.81252025-07-31151345mg & 15mg14-Tabs PkJinarcOTS2025-07-31Lupin-TolvaptanLUP863.81252025-07-31151460mg & 30mg14-Tabs PkJinarcOTS2025-07-31Lupin-TolvaptanLUP864.00002025-07-31151590mg & 30mg14-Tabs PkJinarcOTS2025-07-31Lupin-TolvaptanLUP864.00002025-07-31COUGH PREPARATIONSANTI FIBROTIC AGENTSNINTEDANIB1516100mgCapOfevBOE28.41682026-01-3014.2084Auro-NintedanibAUR14.20842026-02-2714.2084Jamp NintedanibJPC14.20842026-01-3014.20841517150mgCapOfevBOE56.83362026-01-3028.4168Auro-NintedanibAUR28.41682026-02-2728.4168Jamp NintedanibJPC28.41682026-01-3028.4168PIRFENIDONE1518267mgTabEsbrietHLR13.42402021-06-306.7120Sandoz Pirfenidone TabletsSDZ6.71202021-06-306.7120Jamp PirfenidoneJPC6.71202021-08-316.7120PMS-PirfenidonePMS6.71202022-12-216.7120Auro-PirfenidoneAUR6.71192024-03-286.7119M-PirfenidoneMAT6.71202025-03-316.71201519801mgTabEsbrietHLR40.27202021-06-3020.1361Sandoz Pirfenidone TabletsSDZ20.13602021-06-3020.1360Jamp PirfenidoneJPC20.13602021-08-3120.1360PMS-PirfenidonePMS20.13602022-12-2120.1360Auro-PirfenidoneAUR20.13612024-03-2820.1361M-PirfenidoneMAT20.13602025-03-3120.1360ANTITUSSIVESDEXTROMETHORPHAN HBR15203mg/mLO/LDM-SyrupPDA2006-06-15Koffex DMROG.01901996-10-01.0190HYDROCODONE BITARTRATE15211mg/mLO/LHycodanBQU1996-10-01PMS-HydrocodonePMS.06172012-02-29.0617EXPECTORANTSGUAIFENESIN152220mg/mLO/LRobitussinWHB1996-10-01GuaifenesinROG1996-10-01Guaifenesin Sugar FreeROG1996-10-01EYE, EAR, NOSE AND THROAT PREPARATIONSAFLIBERCEPT15232mg/0.05mLInj Sol-0.05mL Pref Syr (Preservative-Free)EydenzeltCEI850.80002026-01-30850.800015242mg/0.05mLInj Sol-0.05mL Pref Syr (Preservative-Free)EnzeevuSDZ850.80002026-01-30850.800015252mg/0.05mLInj Sol-0.05mL Vial Pk (Preservative-Free)EydenzeltCEI850.80002026-01-30850.8000For the treatment of patients with neovascular (wet) age-related macular degeneration (AMD) in a treatment-naive eye. Initial diagnosis should be confirmed by an appropriate diagnostic procedure and administration should be done by a qualified ophthalmologist experienced in intravitreal injections. Patients receiving concurrent administration of other anti-VEGF intravitreal injections are not eligible for reimbursement. Treatment should be initiated with a monthly intravitreal injection for the first 3 consecutive doses, followed by one injection every 2 months. The interval between two doses should not be shorter than one month. Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy. Coverage will be provided for patients responding to therapy with another anti-VEGF agent who switch to this product. Coverage will NOT be provided for patients who have failed to respond to other anti-VEGF agents.LU Authorization Period: 1 yearFor the treatment of patients with clinically significant macular edema secondary to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO). Patients receiving concurrent administration of other anti-VEGF intravitreal injections are not eligible for reimbursement. Treatment should be initiated with an intravitreal injection once every month. The interval between two doses should not be shorter than one month. The treatment interval may be extended up to 3 months based on visual and anatomic outcomes. Prescribers are advised to periodically assess the need for continued therapy. Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy. Coverage will be provided for patients responding to therapy with another anti-VEGF agent who switch to this product. Coverage will NOT be provided for patients who have failed to respond to other anti-VEGF agents.LU Authorization Period: 1 yearFor the treatment of patients with clinically significant diabetic macular edema (DME) for whom laser photocoagulation is also indicated; and a hemoglobin A1c of less than 12 percent. Patients receiving concurrent administration of other anti-VEGF intravitreal injections are not eligible for reimbursement. Treatment should be initiated with a monthly intravitreal injection for the first 5 consecutive doses, followed by one injection every 2 months. The interval between two doses should not be shorter than one month. Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy. Coverage will be provided for patients responding to therapy with another anti-VEGF agent who switch to this product. Coverage will NOT be provided for patients who have failed to respond to other anti-VEGF agents.LU Authorization Period: 1 yearANTI-INFECTIVES ANTIBIOTICSCIPROFLOXACIN AND DEXAMETHASONE15260.3% w/v & 0.1% w/vOtic Susp-7.5mL Pk (With Preservative)CiprodexNOV31.97002018-06-2914.4203Taro-Ciprofloxacin/DexamethasoneTAR14.42032020-12-1814.4203Sandoz Ciprofloxacin/DexamethasoneSDZ14.42032021-03-2914.4203The treatment of otitis externa in patients: - With known perforated tympanic membrane or ventilation tubes; OR - Requiring chronic therapy (i.e., more than 14 days); OR - Who have been receiving more than 7 days of topical aminoglycoside therapy without improvement, where there is concern of a resistant pathogen; OR - With documented pre-existing hearing impairment.LU Authorization Period: 1 yearFRAMYCETIN SULFATE15270.5%Oph Oint-5g PkSoframycinSLP19.61002005-09-2719.610015280.5%Oph SolSoframycinSLP1.36632005-09-271.3663FRAMYCETIN SULFATE & GRAMICIDIN & DEXAMETHASONE15295mg & 50mcg & 0.5mg/mLOph/Ot SolSofracortSAV2.2212The risk of ototoxicity with topical aminoglycoside may increase with prolonged therapy. Topical use of antibiotics increases the likelihood of development of bacterial resistance, especially with prolonged use, sometimes rendering the systemic use of this antibiotic class useless in these patients.2001-10-112.2212GATIFLOXACIN15300.3% w/vOph SolZymar (with preservative)ALL2019-12-20Apo-Gatifloxacin (with preservative)APX2.03202019-12-20Jamp GatifloxacinJPC2.03202024-09-27GENTAMICIN & BETAMETHASONE SODIUM PHOSPHATE15313mg & 1mg/mLOph/Ot DropsGarasoneSCH1.2813The risk of ototoxicity with topical aminoglycoside may increase with prolonged therapy. Topical use of antibiotics increases the likelihood of development of bacterial resistance, especially with prolonged use, sometimes rendering the systemic use of this antibiotic class useless in these patients. 1996-10-011.2813GENTAMICIN SULFATE15320.3%Oph Oint-3.5g PkGaramycinSCH4.00001996-10-014.0000MOXIFLOXACIN HYDROCHLORIDE15330.5%Oph Sol-3mL Pk (Preservative-Free)VigamoxNOV2015-12-22Act MoxifloxacinACV11.27002015-12-22Apo-MoxifloxacinAPX11.27002016-01-28Sandoz MoxifloxacinSDZ11.27002015-12-22PMS-MoxifloxacinPMS11.27012016-05-31Jamp-MoxifloxacinJPC11.27002019-04-30AG-MoxifloxacinANG11.27002020-11-30MoxifloxacinSAI11.27002023-01-31POLYMYXIN B SULFATE & BACITRACIN (ZINC)153410000U & 500U/gOph Oint 3.5g PkPolysporinPFI5.54002007-01-025.5400POLYMYXIN B SULFATE & GRAMICIDIN153510000U & 0.025mg/mLOph/Ot SolPolysporin Eye and Ear Drops SterileJAJ.91392007-01-02.9139TOBRAMYCIN15360.3%Oph OintTobrexNOV2.75141996-10-012.751415370.3%Oph SolTobrexNOV1.94001996-10-011.3620Sandoz TobramycinSDZ1.36202002-04-041.3620TOBRAMYCIN & DEXAMETHASONE15380.3% & 0.1%Oph OintTobraDexNOV3.31711996-10-013.317115390.3% & 0.1%Oph SuspTobraDexNOV2.25001996-10-012.2500ANTI-INFECTIVES OTHER ANTI-INFECTIVESCIPROFLOXACINCiprofloxacin is not intended for the treatment of asymptomatic bacteriuria in the absence of risk factors. Avoid use in pregnancy and children < 18 years of age. Ciprofloxacin inhibits theophylline clearance and also affects phenytoin kinetics. Theophylline doses should be decreased and blood levels of phenytoin or theophylline monitored when either of these drugs is used concomitantly with ciprofloxacin.15400.3%Oph Sol-5mL PkCiloxanNOV2009-01-30Apo-CiprofloxAPX1.76002010-06-14Sandoz CiprofloxacinSDZ9.30002012-09-28OFLOXACIN15410.3%Oph SolOcufloxALL2.87201996-12-192.8720For the treatment of conjunctivitis caused by susceptible strain(s) of Staphylococcus aureus, Staphylococcus epidermidis, Streptococcus pneumoniae and Hemophilus influenzae which is/are resistant or unresponsive to listed alternative agents.LU Authorization Period: 1 yearANTI-INFLAMMATORY AGENTSTopical corticosteroid can reactivate pre-existing viral keratitis. These agents should be used with caution in patients with a history of previous corneal ulceration. In some patients, prolonged use of these agents can result in significant problems such as increased intraocular pressure.AZELASTINE HCL & FLUTICASONE PROPIONATE1542137mcg/Actuation&50mcg/ActuationNas-Sp-120 Dose PkDymistaBGP2023-08-31Mylan-Azelastine/FluticasoneMYL89.92152023-08-31Apo-Azelastine/FluticasoneAPX89.92152023-10-31BECLOMETHASONE DIPROPIONATE154350mcgNas-Sp-200 Dose PkMylan-Beclo AQMYL12.26001996-12-1912.2600Beconase AqueousGLW1998-03-17Apo-Beclomethasone Nasal SprayAPX12.26002020-07-3112.2600BROMFENAC15440.07% w/vOph Sol (With Preservative)ProlensaBSH2023-07-31Apo-BromfenacAPX8.50002023-07-31BUDESONIDE154564mcg/Metered DoseNas Sp-120 Dose PkRhinocort AquaMCL11.04001998-12-3111.04001546100mcg/Metered DoseNas Sp-165 Dose PkRhinocort AquaAST1996-10-01Mylan-Budesonide AQMYL12.74001998-12-3112.7400DEXAMETHASONE15470.1%Oph Oint-3.5g PkMaxidexNOV9.72001996-10-019.720015480.1%Oph SuspMaxidexNOV1.79001996-10-011.7900FLUMETHASONE PIVALATE & IODOCHLORHYDROXYQUIN15490.02% & 1%Ot SolLocacorten Vioform EardropsPPI2.63001996-10-012.6300FLUOROMETHOLONE15500.1%Oph SuspFMLALL3.68581996-10-013.6858FLUOROMETHOLONE ACETATE15510.1%Oph SuspFlarexNOV2.02401996-10-012.0240FLUTICASONE PROPIONATE155250mcg/ActuationNas Sp-120 Dose PkFlonaseGSK2007-11-10Apo-FluticasoneAPX21.97002007-11-10Ratio-FluticasoneRPH21.97002007-11-10Teva-FluticasoneTEV21.97002017-12-21KETOROLAC TROMETHAMINE15530.5%Oph SolAcularALL3.67801996-10-012.8997KetorolacAAP2.89972004-07-202.899715540.45% w/vOph Sol-0.4mL Vial Pk (Preservative-Free)AcuvailABV.25932013-04-30.2593LODOXAMIDE TROMETHAMINE15550.1%Oph SolAlomideNOV1.48901996-10-011.4890MOMETASONE FUROATE155650mcg/DoseNas Sp-140 Dose PkNasonexOCI2013-11-28Apo-MometasoneAPX21.69002013-11-28Sandoz MometasoneSDZ21.68602017-01-31Teva-MometasoneTEV21.69002018-11-29MometasoneSAI21.69002022-04-29MometasoneSIV21.68602025-07-31PREDNISOLONE ACETATE15571%Oph SuspPred ForteALL1996-10-01Ratio-PrednisoloneRPH1.94001996-10-011.9400TRIAMCINOLONE ACETONIDE155855mcg/Metered DoseNas Sp-120 Dose Pk (with Preservative)Nasacort AQSCO2016-08-30Apo-Triamcinolone AQAPX18.00002016-08-3018.0000ANTI-INFLAMMATORY AGENTS ANTI-INFLAMMATORY AGENTS, MISCELLANEOUSCYCLOSPORINE15590.05% w/vOph Emuls-0.4mL PkRestasisALL2018-01-31Teva-CyclosporineTEV4.16582018-01-31LOCAL ANESTHETICSBENZYDAMINE HCL15600.15%Oral RinseTantumGRA1996-10-01PharixiaPEN1998-12-31PMS-BenzydaminePMS.09602018-03-29Odan-BenzydamineODN.09602017-11-30For the symptomatic relief of treatment induced mucositis in cancer patients.LU Authorization Period: 1 yearMIOTICSPILOCARPINE HCL15612%Oph SolIsopto CarpineNOV.33201996-10-01.3320PilocarpinePHS1999-04-1515624%Oph SolIsopto CarpineNOV.33601996-10-01.3360MYDRIATICSATROPINE SULFATE15631%Oph SolIsopto AtropineALC.89001996-10-01.5490AtropinePHS.54902020-07-31.5490CYCLOPENTOLATE HCL15641%Oph SolCyclogylNOV2022-10-31Odan-CyclopentolateODN.89252022-10-31VASOCONSTRICTORSNAPHAZOLINE HCL15650.1%Oph SolAlbalonALL1996-10-01Naphcon ForteALC1996-10-01VasoconIOB1996-10-01OTHER EYE, EAR, NOSE AND THROAT AGENTSACETAZOLAMIDE1566250mgTabAcetazolamideAAP.14141996-10-01.1414DiamoxWAY2000-11-30AFLIBERCEPT15672mg/0.05mLInj Sol-0.05mL Pref Syr (Preservative-Free)AflivuAPX850.80002025-08-29850.800015682mg/0.05mLInj Sol-0.05mL Pref Syr (Preservative-Free)YesafiliBCL850.80002025-08-29850.8000For the treatment of patients with neovascular (wet) age-related macular degeneration (AMD) in a treatment-naive eye. Initial diagnosis should be confirmed by an appropriate diagnostic procedure and administration should be done by a qualified ophthalmologist experienced in intravitreal injections. Patients receiving concurrent administration of other anti-VEGF intravitreal injections are not eligible for reimbursement. Treatment should be initiated with a monthly intravitreal injection for the first 3 consecutive doses, followed by one injection every 2 months. The interval between two doses should not be shorter than one month. Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy. Coverage will be provided for patients responding to therapy with another anti-VEGF agent who switch to this product. Coverage will NOT be provided for patients who have failed to respond to other anti-VEGF agents.LU Authorization Period: 1 yearFor the treatment of patients with clinically significant macular edema secondary to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO). Patients receiving concurrent administration of other anti-VEGF intravitreal injections are not eligible for reimbursement. Treatment should be initiated with an intravitreal injection once every month. The interval between two doses should not be shorter than one month. The treatment interval may be extended up to 3 months based on visual and anatomic outcomes. Prescribers are advised to periodically assess the need for continued therapy. Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy. Coverage will be provided for patients responding to therapy with another anti-VEGF agent who switch to this product. Coverage will NOT be provided for patients who have failed to respond to other anti-VEGF agents.LU Authorization Period: 1 yearFor the treatment of patients with clinically significant diabetic macular edema (DME) for whom laser photocoagulation is also indicated; and a hemoglobin A1c of less than 12 percent. Patients receiving concurrent administration of other anti-VEGF intravitreal injections are not eligible for reimbursement. Treatment should be initiated with a monthly intravitreal injection for the first 5 consecutive doses, followed by one injection every 2 months. The interval between two doses should not be shorter than one month. Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy. Coverage will be provided for patients responding to therapy with another anti-VEGF agent who switch to this product. Coverage will NOT be provided for patients who have failed to respond to other anti-VEGF agents.LU Authorization Period: 1 year156940mg/mLInj Sol-0.05mL Pref Syr (Preservative-Free)EyleaBAH1418.00002021-05-311418.0000For the treatment of patients with neovascular (wet) age-related macular degeneration (AMD) in a verteporfin PDT (Visudyne)-naive eye, but only for patients established on Eylea (aflibercept) therapy prior to August 29, 2025. Initial diagnosis should be confirmed by an appropriate diagnostic procedure and administration should be done by a qualified ophthalmologist experienced in intravitreal injections. Patients receiving concurrent administration of verteporfin PDT (Visudyne) or ranibizumab (Lucentis) are not eligible for reimbursement. Treatment should be initiated with a monthly intravitreal injection for the first 3 consecutive doses, followed by one injection every 2 months. The interval between two doses should not be shorter than one month. Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy. For clarity, coverage will be provided for patients responding to therapy with Lucentis who switch to Eylea. Coverage will NOT be provided for patients who have failed to respond to Lucentis.LU Authorization Period: 1 yearFor the treatment of patients with clinically significant macular edema secondary to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO), but only for patients established on Eylea (aflibercept) therapy prior to August 29, 2025. Treatment should be initiated with an intravitreal injection once every month. The interval between two doses should not be shorter than one month. The treatment interval may be extended up to 3 months based on visual and anatomic outcomes. Prescribers are advised to periodically assess the need for continued therapy. Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy. For clarity, coverage will be provided for patients responding to therapy with Lucentis who switch to Eylea. Coverage will NOT be provided for patients who have failed to respond to Lucentis.LU Authorization Period: 1 yearFor the treatment of patients with clinically significant diabetic macular edema (DME) for whom laser photocoagulation is also indicated; and a hemoglobin A1c of less than 12 percent, but only for patients established on Eylea (aflibercept) therapy prior to August 29, 2025. Treatment should be initiated with a monthly intravitreal injection for the first 5 consecutive doses, followed by one injection every 2 months. The interval between two doses should not be shorter than one month. Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy. For clarity, coverage will be provided for patients responding to therapy with Lucentis who switch to Eylea. Coverage will NOT be provided for patients who have failed to respond to Lucentis.LU Authorization Period: 1 year15708mg/0.07mLInj Sol-0.07mL Pref SyrEylea HDBAH1250.00002025-07-311250.000015718mg/0.07mLInj Sol-0.07mL Vial PkEylea HDBAH1250.00002024-12-301250.0000For the treatment of patients with neovascular (wet) age-related macular degeneration (AMD) in a treatment-naive eye. Initial diagnosis should be confirmed by an appropriate diagnostic procedure and administration should be done by a qualified ophthalmologist experienced in intravitreal injections. Patients receiving concurrent administration of other anti-VEGF intravitreal injections are not eligible for reimbursement. Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy. Coverage will be provided for patients responding to therapy with another anti-VEGF agent who switch to Eylea HD. Coverage will not be provided for patients who have failed to respond to other anti-VEGF agents. Recommended Dose: Treatment should be initiated with a monthly intravitreal injection for the first 3 consecutive doses, followed by one injection every 8 to 16 weeks. LU Authorization Period: 1 yearFor the treatment of patients with clinically significant diabetic macular edema (DME) for whom laser photocoagulation is also indicated; and a hemoglobin A1c of less than 12 percent. Patients receiving concurrent administration of other anti-VEGF intravitreal injections are not eligible for reimbursement. Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy. Coverage will be provided for patients responding to therapy with another anti-VEGF agent who switch to Eylea HD. Coverage will not be provided for patients who have failed to respond to other anti-VEGF agents. Recommended Dose: Treatment should be initiated with a monthly intravitreal injection for the first 3 consecutive doses, followed by one injection every 8 to 16 weeks. LU Authorization Period: 1 year15722mg/0.05mLSol for Intravitreal Inj-0.05mL Vial PkAflivuAPX850.80002025-08-29850.800015732mg/0.05mLSol for Intravitreal Inj-0.05mL Vial PkYesafiliBCL850.80002025-08-29850.8000For the treatment of patients with neovascular (wet) age-related macular degeneration (AMD) in a treatment-naive eye. Initial diagnosis should be confirmed by an appropriate diagnostic procedure and administration should be done by a qualified ophthalmologist experienced in intravitreal injections. Patients receiving concurrent administration of other anti-VEGF intravitreal injections are not eligible for reimbursement. Treatment should be initiated with a monthly intravitreal injection for the first 3 consecutive doses, followed by one injection every 2 months. The interval between two doses should not be shorter than one month. Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy. Coverage will be provided for patients responding to therapy with another anti-VEGF agent who switch to this product. Coverage will NOT be provided for patients who have failed to respond to other anti-VEGF agents.LU Authorization Period: 1 yearFor the treatment of patients with clinically significant macular edema secondary to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO). Patients receiving concurrent administration of other anti-VEGF intravitreal injections are not eligible for reimbursement. Treatment should be initiated with an intravitreal injection once every month. The interval between two doses should not be shorter than one month. The treatment interval may be extended up to 3 months based on visual and anatomic outcomes. Prescribers are advised to periodically assess the need for continued therapy. Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy. Coverage will be provided for patients responding to therapy with another anti-VEGF agent who switch to this product. Coverage will NOT be provided for patients who have failed to respond to other anti-VEGF agents.LU Authorization Period: 1 yearFor the treatment of patients with clinically significant diabetic macular edema (DME) for whom laser photocoagulation is also indicated; and a hemoglobin A1c of less than 12 percent. Patients receiving concurrent administration of other anti-VEGF intravitreal injections are not eligible for reimbursement. Treatment should be initiated with a monthly intravitreal injection for the first 5 consecutive doses, followed by one injection every 2 months. The interval between two doses should not be shorter than one month. Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy. Coverage will be provided for patients responding to therapy with another anti-VEGF agent who switch to this product. Coverage will NOT be provided for patients who have failed to respond to other anti-VEGF agents.LU Authorization Period: 1 year157440mg/mLSol for Intravitreal Inj-0.05mL Vial PkEyleaBAH1418.00002015-07-291418.0000For the treatment of patients with neovascular (wet) age-related macular degeneration (AMD) in a verteporfin PDT (Visudyne)-naive eye, but only for patients established on Eylea (aflibercept) therapy prior to August 29, 2025. Initial diagnosis should be confirmed by an appropriate diagnostic procedure and administration should be done by a qualified ophthalmologist experienced in intravitreal injections. Patients receiving concurrent administration of verteporfin PDT (Visudyne) or ranibizumab (Lucentis) are not eligible for reimbursement. Treatment should be initiated with a monthly intravitreal injection for the first 3 consecutive doses, followed by one injection every 2 months. The interval between two doses should not be shorter than one month. Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy. For clarity, coverage will be provided for patients responding to therapy with Lucentis who switch to Eylea. Coverage will NOT be provided for patients who have failed to respond to Lucentis.LU Authorization Period: 1 yearFor the treatment of patients with clinically significant macular edema secondary to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO), but only for patients established on Eylea (aflibercept) therapy prior to August 29, 2025. Treatment should be initiated with an intravitreal injection once every month. The interval between two doses should not be shorter than one month. The treatment interval may be extended up to 3 months based on visual and anatomic outcomes. Prescribers are advised to periodically assess the need for continued therapy. Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy. For clarity, coverage will be provided for patients responding to therapy with Lucentis who switch to Eylea. Coverage will NOT be provided for patients who have failed to respond to Lucentis.LU Authorization Period: 1 yearFor the treatment of patients with clinically significant diabetic macular edema (DME) for whom laser photocoagulation is also indicated; and a hemoglobin A1c of less than 12 percent, but only for patients established on Eylea (aflibercept) therapy prior to August 29, 2025. Treatment should be initiated with a monthly intravitreal injection for the first 5 consecutive doses, followed by one injection every 2 months. The interval between two doses should not be shorter than one month. Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy. For clarity, coverage will be provided for patients responding to therapy with Lucentis who switch to Eylea. Coverage will NOT be provided for patients who have failed to respond to Lucentis.LU Authorization Period: 1 yearBETAXOLOL HCL15750.25%Oph SuspBetoptic SNOV2.55801996-10-012.5580BIMATOPROST15760.03%Oph SolLumiganALL2004-04-06VistitanSDZ9.19362016-09-299.193615770.01%Oph Sol-5mL PkLumigan RCALL60.18922010-09-0960.189215780.01%Oph Sol-7.5mL PkLumigan RCALL90.28382012-01-1990.2838As first line treatment of elevated intraocular pressure in patients who cannot tolerate an ophthalmic beta-blocking agent or where beta-blocking agents are contraindicated.LU Authorization Period: IndefiniteAs second line monotherapy or combination therapy in patients who do not have an adequate intraocular pressure lowering response to ophthalmic beta-blocking agents.LU Authorization Period: IndefiniteFor use as adjunctive therapy with an ophthalmic beta-blocking agent in an urgent situation (e.g. patients with a high baseline intraocular pressure) where monotherapy is unlikely to be effective.LU Authorization Period: IndefiniteBRIMONIDINE15790.15%Oph SolAlphagan PALL2.60172004-11-042.0305Brimonidine PAAP2.03052008-10-012.030515800.2%Oph SolAlphaganALL3.79701998-12-311.1550Sandoz BrimonidineSDZ1.15502008-08-281.1550Jamp-BrimonidineJPC1.15502023-05-311.1550Med-BrimonidineGMP1.15502022-03-311.1550Brimonidine Tartrate Ophthalmic SolutionTCI1.15502022-01-311.1550As first line treatment of elevated intraocular pressure in patients who cannot tolerate an ophthalmic beta-blocking agent or where beta-blocking agents are contraindicated.LU Authorization Period: IndefiniteAs second line monotherapy or combination therapy in patients who do not have an adequate intraocular pressure lowering response to ophthalmic beta-blocking agents.LU Authorization Period: IndefiniteFor use as adjunctive therapy with an ophthalmic beta-blocking agent in an urgent situation (e.g. patients with a high baseline intraocular pressure) where monotherapy is unlikely to be effective.LU Authorization Period: IndefiniteBRIMONIDINE TARTRATE & TIMOLOL MALEATE15810.2% & 0.5%Oph Sol-10mL PkApo-Brimonidine-TimopAPX23.29002022-12-2123.2900Jamp Brimonidine/TimololJPC23.29002023-08-3123.2900CombiganALL46.58002008-08-2823.2900As second-line therapy for patients who do not have an adequate intraocular pressure lowering response to monotherapy with ophthalmic beta-blocking agents.LU Authorization Period: IndefiniteFor use as initial therapy in an urgent situation (e.g. patients with a high baseline intraocular pressure) where monotherapy is unlikely to be effective.LU Authorization Period: IndefiniteBRINZOLAMIDE15821%Oph SuspAzoptNOV3.55602000-01-173.5560As first line treatment of elevated intraocular pressure in patients who cannot tolerate an ophthalmic beta-blocking agent or where beta-blocking agents are contraindicated.LU Authorization Period: IndefiniteAs second line monotherapy or combination therapy in patients who do not have an adequate intraocular pressure lowering response to ophthalmic beta-blocking agents.LU Authorization Period: IndefiniteFor use as adjunctive therapy with an ophthalmic beta-blocking agent in an urgent situation (e.g. patients with a high baseline intraocular pressure) where monotherapy is unlikely to be effective.LU Authorization Period: IndefiniteBRINZOLAMIDE & BRIMONIDINE TARTRATE15831.0% & 0.2%Oph Susp-10mL PkSimbrinzaNOV50.69002015-10-2950.6900As second-line therapy for patients who do not have an adequate intraocular pressure lowering response to monotherapy with brinzolamide or brimonidine.LU Authorization Period: IndefiniteFor use as initial therapy in an urgent situation (e.g. patients with a high baseline intraocular pressure) where monotherapy is unlikely to be effective.LU Authorization Period: IndefiniteBRINZOLAMIDE & TIMOLOL MALEATE15841% & 0.5%Oph Susp-5mL PkAzargaNOV20.40002010-06-1420.4000As second-line therapy for patients who do not have an adequate intraocular pressure lowering response to monotherapy with ophthalmic beta-blocking agents.LU Authorization Period: IndefiniteFor use as initial therapy in an urgent situation (e.g. patients with a high baseline intraocular pressure) where monotherapy is unlikely to be effective.LU Authorization Period: IndefiniteBROLUCIZUMAB15856mg/0.05mLInj Sol-0.05mL Pref Syr (Preservative-Free)BeovuNOV1390.00002021-12-171390.0000For the treatment of patients with mild-to-moderate neovascular (wet) age-related macular degeneration (AMD) in a treatment-naive eye. Initial diagnosis should be confirmed by an appropriate diagnostic procedure and administration should be done by a qualified opthalmologist experienced in intravitreal injections. Patients receiving concurrent administration of verteporfin PDT (Visudyne), ranibizumab (Lucentis) or aflibercept (Eylea) are not eligible for reimbursement. Treatment should be initiated with a monthly intravitreal injection for the first 3 consecutive doses, followed by one injection every 3 months. The interval between two doses should not be shorter than eight weeks. Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy and should be discontinued if any of the following occurs: i. reduction in best corrected visual acuity (BCVA) in the treated eye to less than 15 letters (absolute) on two consecutive visits attributed to AMD in the absence of other pathology ii. reduction of BCVA of 30 letters or more compared to baseline and/or best recorded level since baseline as this may indicate either poor treatment effect or adverse event or both iii. evidence of deterioration of the lesion morphology despite treatment over three consecutive visits. For clarity, coverage will be provided for patients responding to therapy with Lucentis or Eylea who switch to Beovu. Coverage will NOT be provided for patients who have failed to respond to Lucentis or Eylea. LU Authorization Period: 1 yearFor the treatment of patients with clinically significant diabetic macular edema (DME) for whom laser photocoagulation is also indicated; and who have a hemoglobin A1c of less than 12 percent. Treatment should be initiated with an intravitreal injection every 6 weeks for the first 5 consecutive doses, followed by one injection every 8 to 12 weeks. An interval of 8 weeks may be considered for those with disease activity, whereas an interval of up to 12 weeks may be considered for those without disease activity. After the first 5 initiation doses, the interval between two doses should not be shorter than 8 weeks. Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy. For clarity, coverage will be provided for patients responding to therapy with another anti-VEGF agent who switch to Beovu. Coverage will NOT be provided for patients who have failed to respond to another anti-VEGF agent.LU Authorization Period: 1 yearCHLORHEXIDINE GLUCONATE15860.12%Oral RinsePeridexZIL2024-02-29PMS-ChlorhexidinePMS.02532024-02-29PMS-Chlorhexidine Without AlcoholPMS.02532024-03-28DEXTRAN 70 & HYDROXYPROPYL METHYLCELLULOSE & POLYQUAD15870.1%/0.3%/0.001%Oph SolTears Naturale IIALC.46471996-10-01.4647For patients with objective evidence of keratoconjunctivitis sicca as confirmed by filamentary keratopathy on slit lamp examination or biopsy.LU Authorization Period: IndefiniteDICLOFENAC SODIUM15880.1%Oph SolThe prescriber should be aware that diclofenac sodium 0.1% ophthalmic solution products may be preservative-free or preservative-containing. If applicable, the prescriber should choose the most appropriate formulation (preservative-free or preservative containing) for use in the specific clinical situation in which the product was prescribed.Voltaren OphthaNOV4.35001996-10-011.2397Apo-Diclofenac OphthalmicAPX1.23972015-10-291.2397Sandoz Diclofenac OphthaSDZ1.23972016-11-301.2397DiclofenacPHS1.2397Diclofenac sodium 0.1% ophthalmic solution (DIN 02475065) is in a unit dose container of 0.3mL and it is preservative-free. Its Drug Benefit Price is displayed on a per mL basis. Dispensers must ensure that the unit of reimbursement for this product is accurate in the submitted claims. (For example, when dispensing a package of 10 x 0.3mL containers, a unit of 3 must be selected in the Health Network System claim to reflect that 3mL is being dispensed.)2019-12-201.2397Mint-DiclofenacMIN1.23972020-11-301.2397Jamp DiclofenacJPC1.23972024-03-281.2397DORZOLAMIDE HCL15892%Oph SolTrusoptELV6.12671996-12-191.4757Sandoz DorzolamideSDZ1.47572014-07-301.4757Jamp-DorzolamideJPC1.47572020-02-281.4757Med-DorzolamideGMP1.47572023-08-311.4757DorzolamideJPC1.47572023-11-301.4757As first line treatment of elevated intraocular pressure in patients who cannot tolerate an ophthalmic beta-blocking agent or where beta-blocking agents are contraindicated.LU Authorization Period: IndefiniteAs second line monotherapy or combination therapy in patients who do not have an adequate intraocular pressure lowering response to ophthalmic beta-blocking agents.LU Authorization Period: IndefiniteFor use as adjunctive therapy with an ophthalmic beta-blocking agent in an urgent situation (e.g. patients with a high baseline intraocular pressure) where monotherapy is unlikely to be effective.LU Authorization Period: IndefiniteDORZOLAMIDE HCL & TIMOLOL MALEATE15902% & 0.5%Oph SolCosoptELV9.86392000-01-172.0951Apo-Dorzo-TimopAPX2.09512011-12-152.0951Sandoz Dorzolamide/TimololSDZ2.09512014-07-302.0951Co DorzotimololCOB2.09512014-01-032.0951Med-Dorzolamide-TimololGMP2.09512016-10-272.0951Riva-Dorzolamide/TimololRIA2.09512021-08-312.0951Mint-Dorzolamide/TimololMIN2.09512016-10-272.0951Jamp Dorzolamide-TimololJPC2.09512020-02-282.0951Dorzolamide-TimololJPC2.09512023-08-312.0951M-Dorzolamide-TimololMAT2.09512023-12-292.095115912% & 0.5%Oph Sol-0.2mL PkCosopt Preservative FreeELV.89302010-04-23.8930As second-line therapy for patients who do not have an adequate intraocular pressure lowering response to monotherapy with ophthalmic beta-blocking agents.LU Authorization Period: IndefiniteFor use as initial therapy in an urgent situation (e.g. patients with a high baseline intraocular pressure) where monotherapy is unlikely to be effective.LU Authorization Period: IndefiniteFARICIMAB15926mg/0.05mLInj Sol-0.05mL Pref Syr (Preservative-Free)VabysmoHLR1350.00002025-10-311350.000015936mg/0.05mLInj Sol-0.24mL Vial Pk (Preservative-Free)VabysmoHLR1350.00002023-06-301350.0000For the treatment of patients with neovascular (wet) age-related macular degeneration (AMD) in a treatment-naive eye. Initial diagnosis should be confirmed by an appropriate diagnostic procedure and administration should be done by a qualified ophthalmologist experienced in intravitreal injections. Patients receiving concurrent administration of verteporfin PDT (Visudyne), ranibizumab (Lucentis), aflibercept (Eylea) or brolucizumab (Beovu) are not eligible for reimbursement. Treatment should be initiated with an intravitreal injection every 4 weeks for the first 4 doses, followed by one injection every 8 to 16 weeks based upon disease activity. Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy. For clarity, coverage will be provided for patients responding to therapy with another anti-VEGF agent who switch to Vabysmo. Coverage will NOT be provided for patients who have failed to respond to other anti-VEGF agents. LU Authorization Period: 1 yearFor the treatment of patients with clinically significant diabetic macular edema (DME) for whom laser photocoagulation is also indicated; and who have a hemoglobin A1c of less than 12 percent. Vabysmo is to be administered using one of the following dosing regimens: Treatment should be initiated with an intravitreal injection every 4 weeks for the first 6 doses, followed by an intravitreal injection at a dosing interval of every 8 weeks. OR Treatment should be initiated with an intravitreal injection every 4 weeks for the first 4 doses or until macular edema is resolved. Thereafter, the dosing interval may be extended up to every 16 weeks (4 months) in up to 4-week increments. If anatomic and/or visual outcomes deteriorate, then the treatment interval should be shortened accordingly. Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy. For clarity, coverage will be provided for patients responding to therapy with another anti-VEGF agent who switch to Vabysmo. Coverage will NOT be provided for patients who have failed to respond to other anti-VEGF agents. LU Authorization Period: 1 yearFor the treatment of patients with clinically significant macular edema secondary to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO). Treatment should be initiated with an intravitreal injection every 4 weeks until stable visual acuity improvement and disease control are achieved. The treatment interval may be extended up to 16 weeks (4 months) in up to 4-week increments at a time in patients without disease activity. If anatomic and/or visual outcomes deteriorate, the treatment interval should be shortened accordingly. The interval between doses should not be shorter than one month. Patients should be assessed regularly. Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy. For clarity, coverage will be provided for patients responding to therapy with another anti-VEGF agent who switch to this product. Coverage will NOT be provided for patients who have failed to respond to other anti-VEGF agents.LU Authorization Period: 1 yearIPRATROPIUM BROMIDE15940.03%Nasal SprayAtroventBOE1996-10-01PMS-IpratropiumPMS.91272000-07-17.9127For the treatment of non-allergic vasomotor rhinitisLU Authorization Period: 1 year15950.06%Nasal SprayAtroventBOE2009-06-23IpraventAAP2.97002009-06-23KETOTIFEN15960.25mg/mLOph Sol-5mL PkZaditorLBT2013-07-30Ketotifen Ophthalmic SolutionSTE21.17002013-07-30Jamp Ketotifen OphthalmicJPC25.78002024-06-28LATANOPROST15970.005%Oph Sol-2.5mL PkXalatanUJC36.27362000-01-179.5830Co LatanoprostCOB9.58302012-01-199.5830Apo-LatanoprostAPX9.58302011-12-159.5830Riva-LatanoprostRIA9.58302021-08-319.5830Sandoz LatanoprostSDZ9.58302012-11-279.5830Gd-LatanoprostUJC9.58302011-12-159.5830Med-LatanoprostGMP9.58302015-03-319.5830Jamp LatanoprostJPC9.58302020-03-319.5830M-LatanoprostMAT9.58302022-03-319.5830As first line treatment of elevated intraocular pressure in patients who cannot tolerate an ophthalmic beta-blocking agent or where beta-blocking agents are contraindicated.LU Authorization Period: IndefiniteAs second line monotherapy or combination therapy in patients who do not have an adequate intraocular pressure lowering response to ophthalmic beta-blocking agents.LU Authorization Period: IndefiniteFor use as adjunctive therapy with an ophthalmic beta-blocking agent in an urgent situation (e.g. patients with a high baseline intraocular pressure) where monotherapy is unlikely to be effective.LU Authorization Period: IndefiniteLATANOPROST & TIMOLOL MALEATE159850mcg/mL & 5mg/mLOph Sol-2.5mL PkXalacomUJC41.05782004-11-0411.0670Gd-Latanoprost/TimololUJC11.07002013-08-2911.0670Sandoz Latanoprost/TimololSDZ11.07002013-04-3011.0670Apo-Latanoprost-TimopAPX11.07002014-10-2911.0670Act Latanoprost/TimololACV11.07002015-11-2611.0670Jamp-Latanoprost/TimololJPC11.07002020-03-3111.0670Med-Latanoprost-TimololGMP11.07002020-03-3111.0670M-Latanoprost-TimololMAT11.06702022-03-3111.0670As second-line therapy for patients who do not have an adequate intraocular pressure lowering response to monotherapy with ophthalmic beta-blocking agents.LU Authorization Period: IndefiniteFor use as initial therapy in an urgent situation (e.g. patients with a high baseline intraocular pressure) where monotherapy is unlikely to be effective.LU Authorization Period: IndefiniteLATANOPROSTENE BUNOD15990.024%w/vOph SolVyzultaBSH5.25002019-12-205.2500As first line treatment of elevated intraocular pressure in patients who cannot tolerate an ophthalmic beta-blocking agent or where beta-blocking agents are contraindicated.LU Authorization Period: IndefiniteAs second line monotherapy or combination therapy in patients who do not have an adequate intraocular pressure lowering response to ophthalmic beta-blocking agents.LU Authorization Period: IndefiniteFor use as adjunctive therapy with an ophthalmic beta-blocking agent in an urgent situation (e.g. patients with a high baseline intraocular pressure) where monotherapy is unlikely to be effective.LU Authorization Period: IndefiniteLEVOBUNOLOL HCL16000.5%Oph SolBetaganALL3.81531996-10-013.8153METHAZOLAMIDE160150mgTabNeptazaneWAY1999-12-16MethazolamideAAP.49132003-01-30.4913METHYLCELLULOSE16020.5%Oph SolIsopto TearsALC.54541996-10-01.545416031%Oph-SolIsopto TearsALC.51471996-10-01.5147For patients with objective evidence of keratoconjunctivitis sicca as confirmed by filamentary keratopathy on slit lamp examination or biopsy.LU Authorization Period: IndefiniteOLOPATADINE HCL16040.2%Oph Sol-2.5mL PkPatadayNOV2014-05-29Apo-OlopatadineAPX26.13002014-05-29Act Olopatadine 0.2%ACV26.13002014-05-29Sandoz Olopatadine 0.2%SDZ26.13002014-06-26Mint-Olopatadine 0.2%MIN26.13002022-03-31Olopatadine 0.2%SAI26.13002024-05-3116050.1%Oph Sol-5mL PkPatanolNOV2013-01-29Apo-OlopatadineAPX26.13002013-01-29Sandoz OlopatadineSDZ26.13002013-04-30Co Olopatadine 0.1%COB26.13002014-02-27Mint-OlopatadineMIN26.13002014-11-27Jamp-OlopatadineJPC26.13002017-03-28OlopatadineSAI26.13002022-05-31PETROLATUM/MINERAL OIL160655% & 42.5%Oph Oint-3.5g PkLacri-LubeALL7.90001996-10-017.9000160780%/20%Oph Oint-3.5g PkSoothe Night TimeBLI5.78001996-10-015.7800For patients with objective evidence of keratoconjunctivitis sicca as confirmed by filamentary keratopathy on slit lamp examination or biopsy.LU Authorization Period: IndefinitePOLYVINYL ALCOHOL16081.4%Oph-SolLiquifilm TearsALL.63731996-10-01.6373For patients with objective evidence of keratoconjunctivitis sicca as confirmed by filamentary keratopathy on slit lamp examination or biopsy.LU Authorization Period: IndefinitePOLYVINYL ALCOHOL & POLYVINYLPYRROLIDONE1609Oph-SolTears PlusALL.38401996-10-01.3840For patients with objective evidence of keratoconjunctivitis sicca as confirmed by filamentary keratopathy on slit lamp examination or biopsy.LU Authorization Period: IndefiniteRANIBIZUMAB161010mg/mLInj Sol-0.23mL Vial Pk (Preservative-Free)ByoovizSAM900.00002023-07-31900.0000161110mg/mLInj Sol-0.23mL Vial Pk (Preservative-Free)RanoptoTEI900.00002024-03-28900.0000For the treatment of patients with neovascular (wet) age-related macular degeneration (AMD) in a verteporfin PDT (Visudyne)-naive eye. Initial diagnosis should be confirmed by an appropriate diagnostic procedure and administration should be done by a qualified ophthalmologist experienced in intravitreal injections. Patients receiving concurrent administration with another anti-VEGF agent are not eligible for reimbursement. Treatment should be initiated with a loading phase of one injection per month for three consecutive months, followed by a maintenance phase. During the maintenance phase, patients should be monitored for best corrected visual acuity or continued disease activity. If there is clinical or diagnostic evidence of disease activity such as a loss of greater than 5 letters in visual acuity (Early Treatment Diabetic Retinopathy Score (ETDRS) chart or one Snellen line equivalent), ranibizumab may be administered. The interval between two doses should not be shorter than one month. Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy. For clarity, coverage will be provided for patients responding to therapy with another anti-VEGF agent who switch to this product. Coverage will NOT be provided for patients who have failed to respond to other anti-VEGF agents.LU Authorization Period: 1 yearFor the treatment of patients with clinically significant diabetic macular edema (DME) for whom laser photocoagulation is also indicated; and who have a hemoglobin A1c of less than 11 percent. Treatment to be given monthly and continued until maximum visual acuity is achieved, confirmed by stable visual acuity for three consecutive monthly assessments performed while on ranibizumab treatment. Thereafter patients should be monitored monthly for visual acuity. Treatment is resumed with monthly injections when monitoring indicates a loss of visual acuity due to DME and continued until stable visual acuity is reached again for three consecutive monthly assessments. Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy. For clarity, coverage will be provided for patients responding to therapy with another anti-VEGF agent who switch to this product. Coverage will NOT be provided for patients who have failed to respond to other anti-VEGF agents.LU Authorization Period: 1 yearFor the treatment of patients with clinically significant macular edema secondary to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO). Treatment to be given monthly and continued until maximum visual acuity is achieved, confirmed by stable visual acuity for three consecutive monthly assessments performed while on ranibizumab treatment. Thereafter patients should be monitored monthly for visual acuity. Treatment is resumed with monthly injections when monitoring indicates a loss of visual acuity due to macular edema secondary to retinal vein occlusion and continued until stable visual acuity is reached again for three consecutive monthly assessments. Treatment with anti-VEGF agents should only be continued in patients who maintain adequate response to therapy. For clarity, coverage will be provided for patients responding to therapy with another anti-VEGF agent who switch to this product. Coverage will NOT be provided for patients who have failed to respond to other anti-VEGF agents.LU Authorization Period: 1 yearFor the treatment of patients with visual impairment due to choroidal neovascularization secondary to pathologic myopia. Treatment is initiated with a single intravitreal injection. Monitoring is recommended monthly for the first 2 months and at least every 3 months thereafter during the first year. If monitoring reveals signs of disease activity (e.g. reduced visual acuity and/or signs of lesion activity), further treatment is recommended at a frequency of 1 injection per month until no disease activity is seen.LU Authorization Period: 1 yearSODIUM CROMOGLYCATE16122%Oph SolCromolyn Eye DropsPEN.95001996-10-01.9500OpticromALL1998-02-17TIMOLOL MALEATE16130.25%Oph Gellan SolTimoptic-XEPFPTimolol maleate can potentiate bronchospasm in asthmatic patients and should not be used in patients with a history of asthma.1996-10-01Timolol Maleate-EXALC2.9540Timolol maleate can potentiate bronchospasm in asthmatic patients and should not be used in patients with a history of asthma.2006-08-242.954016140.5%Oph Gellan SolTimoptic-XEELV9.3115Timolol maleate can potentiate bronchospasm in asthmatic patients and should not be used in patients with a history of asthma.1996-10-013.5320Timolol Maleate-EXALC3.5320Timolol maleate can potentiate bronchospasm in asthmatic patients and should not be used in patients with a history of asthma.2006-08-243.532016150.25%Oph SolTimopticMFCTimolol maleate can potentiate bronchospasm in asthmatic patients and should not be used in patients with a history of asthma. Highest historical DBP for this product is $2.7650.1996-10-01Sandoz TimololSDZ2.3503Timolol maleate can potentiate bronchospasm in asthmatic patients and should not be used in patients with a history of asthma.1999-04-152.350316160.5%Oph SolTimopticELV7.2910Timolol maleate can potentiate bronchospasm in asthmatic patients and should not be used in patients with a history of asthma.1996-10-011.2145Apo-TimopAPX1.2145Timolol maleate can potentiate bronchospasm in asthmatic patients and should not be used in patients with a history of asthma.1996-10-011.2145Sandoz TimololSDZ1.2145Timolol maleate can potentiate bronchospasm in asthmatic patients and should not be used in patients with a history of asthma.1999-04-151.2145Jamp-TimololJPC1.2145Timolol maleate can potentiate bronchospasm in asthmatic patients and should not be used in patients with a history of asthma.2020-06-301.2145TIMOLOL MALEATE & TRAVOPROST16170.5% & 0.004%Oph SolDuoTravALC2009-01-30Apo-Travoprost-TimopAPX8.84252019-04-308.842516180.5% & 0.004%Oph Sol-5mL PkDuoTrav PQNOV56.7000This product is stable for 120 days after opening. Please refer to the product monograph for more information.2014-11-2744.2125Apo-Travoprost-Timop PQAPX44.2125This product is stable for 120 days after opening. Please refer to the product monograph for more information.2020-06-3044.2125As second-line therapy for patients who do not have an adequate intraocular pressure lowering response to monotherapy with ophthalmic beta-blocking agents.LU Authorization Period: IndefiniteFor use as initial therapy in an urgent situation (e.g. patients with a high baseline intraocular pressure) where monotherapy is unlikely to be effective.LU Authorization Period: IndefiniteTRAVOPROST16190.003%Oph Sol (with Preservative)IZBANOV3.94002019-04-303.9400As first line treatment of elevated intraocular pressure in patients who cannot tolerate an ophthalmic beta-blocking agent or where beta-blocking agents are contraindicated.LU Authorization Period: IndefiniteAs second line monotherapy or combination therapy in patients who do not have an adequate intraocular pressure lowering response to ophthalmic beta-blocking agents.LU Authorization Period: IndefiniteFor use as adjunctive therapy with an ophthalmic beta-blocking agent in an urgent situation (e.g. patients with a high baseline intraocular pressure) where monotherapy is unlikely to be effective.LU Authorization Period: Indefinite16200.004%Oph Sol-5mL PkSandoz TravoprostSDZ28.76002014-10-2928.7600Jamp Travoprost ZJPC28.76002025-07-3128.7600Travatan ZNOV58.96002009-08-1828.7600As first line treatment of elevated intraocular pressure in patients who cannot tolerate an ophthalmic beta-blocking agent or where beta-blocking agents are contraindicated.LU Authorization Period: IndefiniteAs second line monotherapy or combination therapy in patients who do not have an adequate intraocular pressure lowering response to ophthalmic beta-blocking agents.LU Authorization Period: IndefiniteFor use as adjunctive therapy with an ophthalmic beta-blocking agent in an urgent situation (e.g. patients with a high baseline intraocular pressure) where monotherapy is unlikely to be effective.LU Authorization Period: IndefiniteGASTROINTESTINAL DRUGSANTACIDS AND ADSORBENTSALUMINUM HYDROXIDE & MAGNESIUM HYDROXIDE162140mg & 40mg/mLO/LNeutralca-SDES1996-10-01MaaloxNOV1998-03-171622120mg & 60mg/mLO/LDiovol EXHOR1996-10-01Maalox TCNOV1998-03-171623400mg & 400mgTabGelusil Extra StrengthPDA1996-10-01MaaloxNOV1998-03-17ANTIDIARRHEA AGENTSDIPHENOXYLATE HYDROCHLORIDE & ATROPINE SULFATE16242.5mg & 0.025mgTabLomotilPFI.57291996-10-01.5729For the treatment of diarrhea associated with:An ileostomy or a colostomy;.LU Authorization Period: 1 yearBowel resection, including short bowel syndrome;LU Authorization Period: 1 yearInflammatory Bowel Diseases, i.e. Crohn's Disease and Ulcerative Colitis;LU Authorization Period: 1 yearCancer, including chemotherapy or radiation therapy;LU Authorization Period: 1 yearHIV/AIDS;LU Authorization Period: 1 yearAcute diarrhea in patients in congregated housing, i.e. Long Term Care Facilities (LTCF), or for patients receiving Home Care;LU Authorization Period: 1 yearFecal incontinence.LU Authorization Period: 1 yearLOPERAMIDE HCL16252mgCapletImodiumJAN1996-10-01Teva-LoperamideTEV.09521997-08-28.0952Apo-LoperamideAPX.09521996-12-19.0952PMS-LoperamidePMS.09521998-12-31.0952For the treatment of diarrhea associated with:An ileostomy or a colostomy;.LU Authorization Period: 1 yearBowel resection, including short bowel syndrome;LU Authorization Period: 1 yearInflammatory Bowel Diseases, i.e. Crohn's Disease and Ulcerative Colitis;LU Authorization Period: 1 yearCancer, including chemotherapy or radiation therapy;LU Authorization Period: 1 yearHIV/AIDS;LU Authorization Period: 1 yearAcute diarrhea in patients in congregated housing, i.e. Long Term Care Facilities (LTCF), or for patients receiving Home Care;LU Authorization Period: 1 yearFecal incontinence.LU Authorization Period: 1 yearCATHARTICSBISACODYL16265mgEnt TabDulcolaxSCO.20091996-10-01.2009162710mgSupDulcolaxSCO1.22671996-10-01.4206Bisacodyl SuppositoryJPC.42062022-04-29.4206Bisacodyl 10mgCCP.42062020-08-28.4206AMB-BisacodylAMB.42062025-06-30.4206DOCUSATE SODIUM (DIOCTYL SODIUM SULFOSUCCINATE)1628100mgCapDocusate SodiumTAR.03281996-10-01.0328SoflaxPMS.03281996-10-01.0328ColaceWEL.13422006-04-19.0328Jamp-Docusate SodiumJPC.03282023-01-31.032816294mg/mLO/LColaceWEL.02381998-11-19.0238163010mg/mLO/LColaceWEL.18131998-11-19.1813GRAIN & CITRUS FIBRE1631TabNovo-FibreNOP.07061996-10-01.0706FibyraxLED1996-10-01LACTULOSE1632667mg/mLO/LPMS-LactulosePMS.01471996-10-01.0147MAGNESIUM OXIDE & CITRIC ACID & SODIUM PICOSULFATE16333.5g & 12g & 10mgPd for Sol-12g SachetPico-SalaxFEI15.01802006-04-1912.9700Purg-OdanODN12.97002010-06-1412.9700MINERAL OIL1634100%EnemaFleet Enema Mineral OilCBF.04521996-10-01.0452PSYLLIUM MUCILLOID1635Oral PdMetamucil Fibre Therapy-Original TexturePGI.02462002-07-29.0246SENNOSIDES A & B16368.6mgTabSenokotINO.04641996-10-01.0464Jamp-SennaJPC.04642022-04-29.0464SODIUM BIPHOSPHATE & SODIUM PHOSPHATE1637160mg & 60mg/mLPed Rect SolFleet Enema PediatricCBF.06301996-10-01.06301638160mg & 60mg/mLRect Sol (with Preservative)Fleet EnemaCBF.03131996-10-01.0313DIGESTANTSLIPASE & AMYLASE & PROTEASE163935000 & 35700 & 2240 UnitsDR CapCreon Minimicrospheres 35BGP.97412021-10-29.9741Replacement therapy for pancreatic insufficiency secondary to pancreatic surgery (resection).LU Authorization Period: IndefiniteReplacement therapy for pancreatic insufficiency due to chronic pancreatitis.LU Authorization Period: IndefiniteReplacement therapy for pancreatic insufficiency due to carcinoma of the pancreas.LU Authorization Period: IndefiniteReplacement therapy for pancreatic insufficiency due to cystic fibrosis.LU Authorization Period: IndefinitePANCRELIPASE EQUIVALENT TO LIPASE & AMYLASE & PROTEASE164010000 & 40000 & 35000 USP UnitsCapCotazymORG.29721996-10-01.297216418000 & 30000 & 30000 USP UnitsEnt Microsph CapCotazym ECS 8ORG.53651996-10-01.5365164220000 & 55000 & 55000 USP UnitsEnt Microsph CapCotazym ECS 20ORG1.40671997-04-101.4067Replacement therapy for pancreatic insufficiency secondary to pancreatic surgery (resection).LU Authorization Period: IndefiniteReplacement therapy for pancreatic insufficiency due to chronic pancreatitis.LU Authorization Period: IndefiniteReplacement therapy for pancreatic insufficiency due to carcinoma of the pancreas.LU Authorization Period: IndefiniteReplacement therapy for pancreatic insufficiency due to cystic fibrosis.LU Authorization Period: Indefinite16434000 & 12000 & 12000 USP UnitsEnt Microsph CapPancrease MT4VIU.72741996-10-01.7274Replacement therapy for pancreatic insufficiency secondary to pancreatic surgery (resection).LU Authorization Period: IndefiniteReplacement therapy for pancreatic insufficiency due to chronic pancreatitis.LU Authorization Period: IndefiniteReplacement therapy for pancreatic insufficiency due to carcinoma of the pancreas.LU Authorization Period: Indefinite164410000 & 33200 & 37500 USP UnitsEnt Minimicrosph CapCreon 10SPH.29541998-12-31.2954164525000 & 74000 & 62500 USP UnitsEnt Minimicrosph CapCreon 25SPH.92291996-10-01.922916465100 & 500 & 320 Units/100mgGran - 100mg/ScoopCreon Minimicrospheres MicroBGP.19122017-04-27.1912Replacement therapy for pancreatic insufficiency secondary to pancreatic surgery (resection).LU Authorization Period: IndefiniteReplacement therapy for pancreatic insufficiency due to chronic pancreatitis.LU Authorization Period: IndefiniteReplacement therapy for pancreatic insufficiency due to carcinoma of the pancreas.LU Authorization Period: IndefiniteReplacement therapy for pancreatic insufficiency due to cystic fibrosis.LU Authorization Period: Indefinite164710440 & 56400 & 57100 USP UnitsTabViokaceNSA.40541997-03-14.4054164816mgTabViokaceNSA.62222001-03-07.6222Replacement therapy for pancreatic insufficiency secondary to pancreatic surgery (resection).LU Authorization Period: IndefiniteReplacement therapy for pancreatic insufficiency due to chronic pancreatitis.LU Authorization Period: IndefiniteReplacement therapy for pancreatic insufficiency due to carcinoma of the pancreas.LU Authorization Period: IndefiniteANTIEMETICS AND ANTINAUSEANTSAPREPITANT1649125mg & 80mgCapEmend Tri-PackMEK106.98392014-09-25106.9839In combination with a 5HT3 receptor antagonist and dexamethasone for highly emetogenic chemotherapy (HEC) regimens: - Cisplatin-based chemotherapy where a single daily dose is greater than or equal to 70 mg per meter squared - Cisplatin and cyclophosphamide combinations where the single daily dose is greater than or equal to 50mg per meter squared - Cisplatin (any dose) given for 3 to 5 consecutive days - Non-cisplatin based highly emetogenic chemotherapy (such as those containing anthracycline greater than or equal to 60mg per meter squared plus cyclophosphamide) Dosage: Recommend aprepitant 125mg orally on Day 1 of HEC followed by 80mg orally on Days 2 to 3 post-chemotherapy for each cycle. LU Authorization Period: 1 yearFor patients receiving moderately emetogenic chemotherapy (MEC) regimens AND who have had inadequate symptom control using a 5HT3 antagonist and dexamethasone in a previous cycle. Dosage: Recommend aprepitant 125mg orally on Day 1 of MEC followed by 80mg orally on Days 2 to 3 post-chemotherapy for each cycle.LU Authorization Period: 1 yearDIMENHYDRINATE165050mg/mLInj Sol (with Preservative)Dimenhydrinate Inj 50mg USPSDZ1.38002017-02-281.3800For the management of patients receiving palliative care*.LU Authorization Period: 1 year*The patient must have a progressive life-limiting illness and require this medication for palliative purposes.165150mg/mLInj Sol (with Preservative)Dimenhydrinate Injection USPSDZ1.38002026-01-301.3800For the management of patients receiving palliative care*.LU Authorization Period: 1 year*The patient must have a progressive life-limiting illness and require this medication for palliative purposes.DOXYLAMINE SUCCINATE AND PYRIDOXINE HCL165210mg & 10mgSR TabDiclectinDUI1.28031996-10-01.3201PMS-Doxylamine-PyridoxinePMS.32012017-09-28.3201Apo-Doxylamine/B6APX.32012017-08-30.3201ALOG-Doxylamine/PyridoxineANA.32012025-07-31.3201GRANISETRON HCL16531mgTabKytrilHLR1996-10-01Apo-GranisetronAPX4.50002009-05-204.5000Nat-GranisetronNAT4.50002016-07-284.5000Jamp GranisetronJPC4.50002020-12-184.5000For the treatment of emesis in cancer patients receiving highly emetogenic chemotherapy.LU Authorization Period: 1 yearFor patients receiving intravenous chemotherapy or radiation therapy who have not experienced adequate control with other available anti-emetics.LU Authorization Period: 1 yearFor patients receiving intravenous chemotherapy or radiation therapy who experience intolerable side effects with other anti- emetics.LU Authorization Period: 1 yearFor the treatment of emesis in patients receiving radiation therapy which consists of single fraction treatment to the abdominal cavity, hemi-body irradiation and total body irradiation.The therapeutic value of GRANISETRON HCL more than 24 hours after the last dose of chemotherapy is unproven.LU Authorization Period: 1 yearFor the treatment of emesis in cancer patients receiving moderately emetogenic chemotherapy (MEC) regimens.LU Authorization Period: 1 yearMECLIZINE HCL165425mgTabBonaminePFI.29191996-10-01.2919NABILONE16550.25mgCapCesametVAL2013-05-31Ran-NabiloneRAN1.39622013-08-29PMS-NabilonePMS1.46602021-03-29Teva-NabiloneTEV1.39622013-05-3116560.5mgCapCesametVAL4.26302005-09-271.8886PMS-NabilonePMS1.88862012-05-291.8886Teva-NabiloneTEV1.88862012-06-261.888616571mgCapCesametVAL8.52541996-10-013.6669PMS-NabilonePMS3.66692012-05-293.6669Teva-NabiloneTEV3.66692012-06-263.6669NETUPITANT & PALONOSETRON HYDROCHLORIDE1658300mg & 0.5mgCapAkynzeoKNT144.00752019-06-28144.0075In combination with dexamethasone for once per-cycle treatment in adult patients for: - Prevention of acute and delayed nausea and vomting associated with highly emetogenic cancer chemotherapy (HEC). Highly emetogenic chemotherapy (HEC) regimens: - Cisplatin-based chemotherapy where a single daily dose is greater than or equal to 70mg per meter squared - Cisplatin and cyclophosphamide combinations where the single daily dose of cisplatin is greater than or equal to 50mg per meter squared - Non-cisplatin based highly emetogenic chemotherapy (such as those containing anthracycline greater than or equal to 60mg per meter squared plus cyclophosphamide). Dosage: Recommend Netupitant/Palonosetron 300mg/0.5mg orally on Day 1 approximately 1 hour prior to the start of each HEC.LU Authorization Period: 1 yearIn combination with dexamethasone for once per-cycle treatment in adult patients for: - Prevention of acute nausea and vomiting associated with moderately emetogenic cancer therapy (MEC) that is uncontrolled by a 5-hydroxytryptamine-3 (5-HT3) receptor antagonist (RA) alone in a previous cycle. Dosage: Recommend Netupitant/Palonosetron 300mg/0.5mg orally on Day 1 approximately 1 hour prior to the start of each MEC cycle.LU Authorization Period: 1 yearONDANSETRON HCL DIHYDRATE16592mg/mLInj Sol-2mL PkZofranNOV2009-05-20Ondansetron Injection USPSTE13.21802018-11-29Auro-Ondansetron InjectionAUR13.21802022-06-3016602mg/mLInj Sol-4mL PkAuro-Ondansetron InjectionAUR26.43602022-06-30ZofranNOV2009-05-20Ondansetron Injection USPSTE26.43602018-11-29ONDANSETRON HYDROCHLORIDE16614mgZofran ODT (Tablet)SDZ2000-04-17Ondissolve ODF (Film)TAK3.27202013-09-272.5450Ondansetron ODT (Tablet)SDZ3.27202019-07-312.5450Mint-Ondansetron ODT (Tablet)MIN3.27202020-04-302.5450Auro-Ondansetron ODT (Tablet)AUR3.27202022-03-312.5450Mar-Ondansetron ODT TabletMAR3.27202022-05-312.5450Ondansetron ODT (Tablet)JPC3.27202022-06-302.5450PMS-Ondansetron ODT TabletPMS3.27202022-05-312.5450Ondansetron ODT (Tablet)SAI3.27202023-11-302.5450Accel-Ondansetron ODT (Tablet)ACC2.54502024-02-292.5450Jamp Ondansetron ODF (Film)JPC3.27202024-06-282.545016628mgZofran ODT (Tablet)SDZ2000-04-17Ondissolve ODF (Film)TAK4.99302013-09-273.8840Ondansetron ODT (Tablet)SDZ4.99302019-07-313.8840Mint-Ondansetron ODT (Tablet)MIN4.99302020-04-303.8840Auro-Ondansetron ODT (Tablet)AUR4.99302022-03-313.8840Mar-Ondansetron ODT TabletMAR4.99302022-05-313.8840Ondansetron ODT (Tablet)JPC4.99302022-06-303.8840PMS-Ondansetron ODT TabletPMS4.99302022-05-313.8840Ondansetron ODT (Tablet)SAI4.99302023-11-303.8840Accel-Ondansetron ODT (Tablet)ACC3.88402024-02-293.8840Jamp Ondansetron ODF (Film)JPC4.99302024-06-283.884016634mg/5mLO/LZofranNOV1997-08-28Apo-OndansetronAPX.79522009-05-20.7952Jamp OndansetronJPC.79522020-06-30.7952Mint-Ondansetron SolutionMIN.79522024-12-30.795216644mgTabZofranNOV1997-01-20PMS-OndansetronPMS3.34952006-06-142.5450Sandoz OndansetronSDZ3.34952006-07-192.5450Apo-OndansetronAPX3.34952007-03-092.5450Teva-OndansetronTEV3.34952009-09-302.5450Mylan-OndansetronMYL3.34952007-09-042.5450Mint-OndansetronMIN3.34952008-12-232.5450Jamp-OndansetronJPC3.34952009-01-302.5450Mar-OndansetronMAR3.34952012-01-192.5450Septa-OndansetronSET3.34952012-03-262.5450Nat-OndansetronNAT3.34952015-06-292.5450OndansetronSAI3.27202020-06-302.5450Accel-OndansetronACC2.54502019-12-202.5450OndansetronSIV3.34952024-05-312.545016658mgTabZofranNOV1997-01-20PMS-OndansetronPMS5.11102006-06-143.8840Sandoz OndansetronSDZ5.11102006-06-143.8840Apo-OndansetronAPX5.11102007-03-093.8840Teva-OndansetronTEV5.11102009-09-303.8840Mylan-OndansetronMYL5.11102007-09-043.8840Mint-OndansetronMIN5.11102008-12-233.8840Jamp-OndansetronJPC5.11102009-03-023.8840Mar-OndansetronMAR5.11102012-01-193.8840Septa-OndansetronSET5.11102012-03-263.8840Nat-OndansetronNAT5.11102015-06-293.8840OndansetronSAI4.99302020-06-303.8840Accel-OndansetronACC3.88402019-12-203.8840OndansetronSIV5.11102024-05-313.8840For the treatment of emesis in cancer patients receiving highly emetogenic chemotherapy.LU Authorization Period: 1 yearFor patients receiving intravenous chemotherapy or radiation therapy who have not experienced adequate control with other available anti-emetics.LU Authorization Period: 1 yearFor patients receiving intravenous chemotherapy or radiation therapy who experience intolerable side effects with other anti-emetics.LU Authorization Period: 1 yearFor the treatment of emesis in patients receiving radiation therapy which consists of single fraction treatment to the abdominal cavity, hemi-body irradiation and total body irradiation.The therapeutic value of Ondansetron Hydrochloride more than 24 hours after the last dose of chemotherapy is unproven.LU Authorization Period: 1 yearFor the treatment of emesis in cancer patients receiving moderately emetogenic chemotherapy (MEC) regimens.LU Authorization Period: 1 yearFor the treatment of emesis in patients receiving palliative care who are refractory to, intolerant to, or have a contraindication to at least two other anti-emetics. Note: Pharmacists and prescribers should be informed of and stay current with a drug product's official indications in accordance with Health Canada's approved product monograph. Some aspects of the above criteria may differ from the official indications as described in the product monograph for the ondansetron product. The Executive Officer's funding of drug products is informed by advice from experts that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of drug products.LU Authorization Period: 1 yearMISCELLANEOUS G.I. DRUGS5-AMINOSALICYLIC ACID16661g/Actuation14 Actuation-Foam Enema Canister PkMezeraAVP103.86002020-05-29103.86001667500mgDel-Release TabPentasaFEI.77701996-10-01.777016681.2gDelayed & ER TabMezavantTAK2.05202009-04-012.052016691gDR TabMezeraAVP1.30112025-04-301.30111670500mgDR TabMezeraAVP.67602024-01-31.676016711g/100mLEnemaPentasaFEI6.86001996-12-196.860016724g/100mLEnemaPentasaFEI9.47001996-12-199.47001673500mgEnt TabSalofalkBFI.76851996-10-01.768516741gER TabPentasaFEI1.55402013-11-281.554016754gRect Susp-PkSalofalkBFI10.03891996-10-0110.038916761gSupMezeraAVP1.90762019-08-301.90761677500mgSupSalofalkBFI1.88961996-10-011.889616781gSupPentasaFEI2.70201996-12-192.702016791000mgSupSalofalkBFI2.77542005-09-272.77541680400mgTabAsacolWAR1996-10-01Teva-5-ASATEV.47582008-12-23.4758BUDESONIDE16812mg/ActRectal Foam-14 Act CanisterUcerisBHC99.96002024-03-2899.9600CIMETIDINECimetidine is less expensive than alternatives, and is effective and well tolerated in most patients. Adequate acid suppression can be achieved by giving cimetidine as opposed to using other longer acting H2-antagonists. Long-term use of these drugs for prevention of recurrent peptic ulcers should be reviewed; specific cure of Helicobacter pylori infection with antibiotics is a more effective and less costly approach.1682200mgTabCimetidineAAP.41121996-10-01.4112TagametSMJ1996-10-011683300mgTabCimetidineAAP.34231996-10-01.3423TagametSMJ1996-10-011684400mgTabCimetidineAAP.29301996-10-01.2930TagametSMJ1996-10-011685600mgTabCimetidineAAP.34051996-10-01.3405TagametSMJ1996-10-011686800mgTabCimetidineAAP.25301996-10-01.2530TagametSMJ1996-10-01DEXLANSOPRAZOLE168730mgDR CapDexilantTAK2024-01-31Apo-DexlansoprazoleAPX2.23802024-03-28DexlansoprazoleALH2.05262024-01-31168860mgDR CapDexilantTAK2024-01-31Apo-DexlansoprazoleAPX2.23802024-03-28DexlansoprazoleALH2.05262024-01-31DOMPERIDONE MALEATE168910mgTabMotiliumJAN1996-10-01Teva-DomperidoneTEV.04281996-10-01.0428Apo-DomperidoneAPX.04281998-12-31.0428DomperidoneSIV.04282020-10-30.0428Ran-DomperidoneRAN.04282006-03-01.0428DomperidoneSAI.04282011-10-25.0428Jamp-DomperidoneJPC.04282012-12-21.0428Mar-DomperidoneMAR.04282013-07-30.0428PRZ-DomperidonePRZ.04282019-05-31.0428ESOMEPRAZOLE169040mgNexium DR TabAZC2011-03-15Apo-Esomeprazole DR TabAPX1.86902011-03-15Teva-Esomeprazole DR TabTEV1.86902016-01-28Ran-Esomeprazole DR TabRAN1.86902015-04-30Esomeprazole DR TabSAI1.86902021-04-30Esomeprazole DR TabSIV1.86902020-06-30Sandoz Esomeprazole DR TabSDZ1.86902018-11-29Myl-Esomeprazole DR TabMYL1.86902020-06-30M-Esomeprazole DR TabMAT1.86902022-05-31Esomeprazole DR TabJPC1.86902022-03-31PMSC-Esomeprazole DRPMS1.86902023-04-28169120mgDR TabNexiumAZC2011-03-15Apo-EsomeprazoleAPX1.86902011-03-15Teva-EsomeprazoleTEV1.86902016-01-28Ran-EsomeprazoleRAN1.86902015-04-30EsomeprazoleSIV1.86902020-06-30Sandoz EsomeprazoleSDZ1.86902018-11-29Myl-EsomeprazoleMYL1.86902020-06-30M-EsomeprazoleMAT1.86902022-05-31EsomeprazoleJPC1.86902022-03-31PMSC-Esomeprazole DRPMS1.86902023-04-28EsomeprazoleSAI1.86902024-02-29FAMOTIDINECimetidine is less expensive than alternatives, and is effective and well tolerated in most patients. Adequate acid suppression can be achieved by giving cimetidine as opposed to using other longer acting H2-antagonists. Long-term use of these drugs for prevention of recurrent peptic ulcers should be reviewed; specific cure of Helicobacter pylori infection with antibiotics is a more effective and less costly approach.169220mgTabPepcidMFC1996-10-01Apo-FamotidineAPX.26581996-10-01.2658Teva-FamotidineTEV.26581996-10-01.2658FamotidineSAI.26582011-12-15.2658Jamp FamotidineJPC.26582021-10-29.2658AG-FamotidineANG.26582021-12-17.2658Mint-FamotidineMIN.26582024-07-31.2658FamotidineSIV.26582025-01-31.2658169340mgTabPepcidMFC1996-10-01Apo-FamotidineAPX.48341996-10-01.4834Teva-FamotidineTEV.48341996-10-01.4834FamotidineSAI.48342011-12-15.4834Jamp FamotidineJPC.48342021-10-29.4834AG-FamotidineANG.48342021-12-17.4834Mint-FamotidineMIN.48342024-07-31.4834FamotidineSIV.48342025-01-31.4834LACTULOSE1694667mg/mLO/LRatio-LactuloseRPH.01451996-10-01.0145CephulacMRR1996-10-01Apo-Lactulose SolutionAPX.01452005-03-31.0145Pharma-LactulosePMS.01452013-06-27.0145Jamp-LactuloseJPC.01452012-09-28.0145LactuloseSAI.01452023-06-30.0145PMS-Lactulose-PharmaPMS.01452019-01-31.0145LANSOPRAZOLE169515mgDR CapPrevacidTPA2.48741996-10-01.5000Teva-LansoprazoleTEV.50002010-01-05.5000Apo-LansoprazoleAPX.50002009-08-18.5000Mylan-LansoprazoleMYL.50002010-09-09.5000LansoprazoleSAI.50002011-08-04.5000Sandoz LansoprazoleSDZ.50002012-08-27.5000LansoprazoleSIV.50002020-06-30.5000Taro-LansoprazoleSPC.50002013-08-29.5000169630mgDR CapPrevacidTPA2.48741996-10-01.5000Teva-LansoprazoleTEV.50002010-01-05.5000Apo-LansoprazoleAPX.50002009-08-18.5000Mylan-LansoprazoleMYL.50002010-09-09.5000LansoprazoleSAI.50002011-08-04.5000Sandoz LansoprazoleSDZ.50002012-08-27.5000Taro-LansoprazoleSPC.50002013-08-29.5000LansoprazoleSIV.50002020-06-30.5000Gastroesophageal Reflux Disease (GERD) For the treatment of erosive GERD or upper GI malignancy; OR For the treatment of non-erosive GERD after failure of H2-receptor antagonist therapy. Patients with GERD should be reassessed within 6 months after initial treatment with a PPI. The reassessment could include confirmation of need for PPI with endoscopy, a trial of PPI withdrawal, or step-down therapy to H2-receptor antagonist therapy. Note: There is a lack of published evidence to support double-dose PPI therapy in this setting.LU Authorization Period: 1 yearH. pylori-positive Peptic Ulcers For the treatment of H. pylori-positive peptic ulcers where H. pylori is documented, by serology, urea breath test or endoscopy, for a course of up to 14 days in combination with antimicrobial therapy. Retreatment of H. pylori-positive peptic ulcers must be documented by persistent H. pylori infection on urea breath test or endoscopy. Maximum duration: 14 days (for retreatment, a four-week period must elapse since the end of the previous treatment).LU Authorization Period: 1 yearConfirmed Peptic Ulcers or NSAID-induced Ulcer Prophylaxis: For the treatment of confirmed peptic ulcers and NSAID-induced ulcers; OR For the prophylaxis of NSAID-induced ulcers for patients at increased risk of GI bleeding. Note: There is a lack of published evidence to support double-dose PPI therapy in this setting.LU Authorization Period: 1 yearOther Gastrointestinal Disorders: For the treatment of gastroduodenal Crohns disease, short-gut syndrome, scleroderma, or pancreatitis. Note: There is a lack of published evidence to support double-dose PPI therapy in these settings.LU Authorization Period: 1 yearSevere Conditions: For the treatment of severe esophagitis, Zollinger-Ellison syndrome, esophageal stricture, persistent symptoms of GERD or persistent erosive esophagitis, or upon hospital discharge following a gastrointestinal bleed. For patients receiving double-dose therapy, the need to continue treatment at higher doses should be reassessed after eight weeks. For re-treatment at higher doses, a four-week period should have elapsed from the end of the previous treatment. Reassessment could include a procedural assessment of the condition or step-down therapy to lower-dose proton pump inhibitor (PPI) therapy.LU Authorization Period: 1 yearLANSOPRAZOLE & CLARITHROMYCIN & AMOXICILLIN169730mg & 500mg & 500mgTab/Cap PkHp-PACTPA1999-04-15AA-LansoprazoleAmoxicillinClarithromycinAAP67.91002018-09-2767.9100For the treatment of H. pylori-positive peptic ulcers where H. pylori is documented, by serology, breath test or endoscopy, for a course of up to 14 days. Maximum duration: 14 days.LU Authorization Period: 1 yearFor the retreatment of H. pylori-positive peptic ulcers where H. pylori recurrence or persistence is documented, by breath test or endoscopy, for a course of up to 14 days. Maximum duration: 14 days (after a four-week period has elapsed since the end of the previous treatment)Retreatment decisions should be based upon positive symptoms and positive endoscopy or positive urea breath test. Retreatment should not be based on a positive serology test, as serology tests may remain positive indefinitely. An alternative antibiotic regimen is recommended when initial therapy fails due to concerns of antimicrobial resistance.LU Authorization Period: 1 yearMESALAZINE1698800mgDR TabOctasaTIP1.13582024-04-301.135816991600mgDR TabOctasaTIP2.37402024-04-302.3740METOCLOPRAMIDE HCL17005mg/mLInj Sol (Preservative Free)Metoclopramide HCL InjectionSDZ2.37482017-02-282.3748Metoclopramide Hydrochloride InjectionJPC2.37482024-04-302.3748For the management of patients receiving palliative care*.LU Authorization Period: 1 year*The patient must have a progressive life-limiting illness and require this medication for palliative purposes.For the treatment of patients receiving care at home* who have failed or are unable to tolerate oral alternatives, and who require an injectable option to manage their condition.LU Authorization Period: 1 year*e.g., home care recipients, long-term care home residents.17015mgTabMaxeranHMR1996-10-01PMS-Metoclopramide TabletsPMS.02571999-09-15.0257Mar-MetoclopramideMAR.02572021-10-29.0257PRZ-MetoclopramidePRZ.02572025-08-29.0257170210mgTabMaxeranHMR1996-10-01PRZ-MetoclopramidePRZ.15132025-07-31.1513MISOPROSTOL1703100mcgTabCytotecSEA1996-10-01MisoprostolAAP.26362002-04-04.26361704200mcgTabCytotecSEA1996-10-01MisoprostolAAP.43892002-04-04.4389NIZATIDINECimetidine is less expensive than alternatives, and is effective and well tolerated in most patients. Adequate acid suppression can be achieved by giving cimetidine as opposed to using other longer acting H2-antagonists. Long-term use of these drugs for prevention of recurrent peptic ulcers should be reviewed; specific cure of Helicobacter pylori infection with antibiotics is a more effective and less costly approach.1705150mgCapAxidPEN.90471996-10-01.90471706300mgCapAxidPHE1.52061996-10-011.5206OLSALAZINE SODIUM1707250mgCapDipentumAPU.53302009-05-20.5330OMEPRAZOLE170810mgLosec DR TabAZC2010-04-23Teva-Omeprazole DR TabTEV.81672014-04-30170920mgLosec DR TabCHE1996-10-01Apo-Omeprazole CapAPX.22872004-07-20.2287Ratio-Omeprazole DR TabRPH.22872007-03-09.2287Teva-Omeprazole DR TabTEV.22872011-03-15.2287Sandoz Omeprazole DR CapSDZ.22872007-11-10.2287Omeprazole-20 DR CapSIV.22872020-04-30.2287Omeprazole Magnesium Delayed Release TabACH.22872014-08-28.2287Jamp-Omeprazole DR TabJPC.22872014-04-30.2287Nat-Omeprazole DR TabNAT.22872015-10-29.2287Omeprazole Magnesium Delayed Release TabSAI.22872021-05-31.2287PMS-Omeprazole DR CapPMS.22872010-01-05.2287171020mgLosec DR CapCHE2004-07-20Omeprazole DR CapSAI.22872011-08-04.2287Ran-Omeprazole DR CapRAN.22872013-08-29.2287Apo-Omeprazole CapAPX.22872007-11-10.2287Sandoz Omeprazole DR CapSDZ.22872008-12-03.2287Gastroesophageal Reflux Disease (GERD) For the treatment of erosive GERD or upper GI malignancy; OR For the treatment of non-erosive GERD after failure of H2-receptor antagonist therapy. Patients with GERD should be reassessed within 6 months after initial treatment with a PPI. The reassessment could include confirmation of need for PPI with endoscopy, a trial of PPI withdrawal, or step-down therapy to H2-receptor antagonist therapy. Note: There is a lack of published evidence to support double-dose PPI therapy in this setting.LU Authorization Period: 1 yearConfirmed Peptic Ulcers or NSAID-induced Ulcer Prophylaxis: For the treatment of confirmed peptic ulcers and NSAID-induced ulcers; OR For the prophylaxis of NSAID-induced ulcers for patients at increased risk of GI bleeding. Note: There is a lack of published evidence to support double-dose PPI therapy in this setting.LU Authorization Period: 1 yearOther Gastrointestinal Disorders: For the treatment of gastroduodenal Crohns disease, short-gut syndrome, scleroderma, or pancreatitis. Note: There is a lack of published evidence to support double-dose PPI therapy in these settings.LU Authorization Period: 1 yearSevere Conditions: For the treatment of severe esophagitis, Zollinger-Ellison syndrome, esophageal stricture, persistent symptoms of GERD or persistent erosive esophagitis, or upon hospital discharge following a gastrointestinal bleed. For patients receiving double-dose therapy, the need to continue treatment at higher doses should be reassessed after eight weeks. For re-treatment at higher doses, a four-week period should have elapsed from the end of the previous treatment. Reassessment could include a procedural assessment of the condition or step-down therapy to lower-dose proton pump inhibitor (PPI) therapy.LU Authorization Period: 1 year171110mgDR CapLosecAZC2009-05-20Sandoz OmeprazoleSDZ.94702009-05-20OMEPRAZOLE MAGNESIUM171220mgLosec DR TabCHE2006-10-23Ratio-Omeprazole DR TabRPH.22872007-03-09.2287Jamp-Omeprazole DR TabJPC.22872014-04-30.2287Omeprazole Magnesium Delayed Release TabACH.22872014-08-28.2287Nat-Omeprazole DR TabNAT.22872015-10-29.2287Omeprazole-20 DR CapSIV.22872020-04-30.2287Omeprazole Magnesium Delayed Release TabSAI.22872021-05-31.2287H. pylori-positive Peptic Ulcers For the treatment of H. pylori-positive peptic ulcers where H. pylori is documented, by serology, urea breath test or endoscopy, for a course of up to 14 days in combination with antimicrobial therapy. Retreatment of H. pylori-positive peptic ulcers must be documented by persistent H. pylori infection on urea breath test or endoscopy. Maximum duration: 14 days (for retreatment, a four-week period must elapse since the end of the previous treatment).LU Authorization Period: 1 yearPANTOPRAZOLE MAGNESIUM171340mgEnt Coated TabTectaNYC.82602010-06-14.1875Mylan-Pantoprazole TMYL.18752015-10-29.1875Teva-Pantoprazole MagnesiumTEV.18752016-01-28.1875Pantoprazole MagnesiumALH.18752015-11-26.1875Pantoprazole TSAI.18752020-06-30.1875Pantoprazole TSIV.18752022-03-31.1875PANTOPRAZOLE SODIUM171420mgEnt TabPantolocNYC2008-06-27Teva-PantoprazoleTEV1.27502008-08-28Apo-PantoprazoleAPX1.27502008-06-27Sandoz PantoprazoleSDZ1.27502008-11-04Ran-PantoprazoleRAN1.27502008-11-04Jamp Pantoprazole SodiumJPC1.27502021-11-30Jamp-PantoprazoleJPC1.27502014-04-30Mar-PantoprazoleMAR1.27502014-03-27Pantoprazole-20SIV1.27502020-06-30PantoprazoleSAI1.27502024-01-31171540mgEnt TabPantolocNYC2.08031997-08-28.2016Teva-PantoprazoleTEV.20162008-06-27.2016Apo-PantoprazoleAPX.20162008-05-16.2016Co PantoprazoleCOB.20162008-08-28.2016Sandoz PantoprazoleSDZ.20162008-08-28.2016Ran-PantoprazoleRAN.20162008-04-09.2016PMS-PantoprazolePMS.20162008-08-28.2016Jamp-PantoprazoleJPC.20162014-02-27.2016PantoprazoleSAI.20162020-05-29.2016Jamp Pantoprazole SodiumJPC.20162021-04-30.2016Auro-PantoprazoleAUR.20162014-05-29.2016Mar-PantoprazoleMAR.20162014-04-01.2016Mint-PantoprazoleMIN.20162014-04-30.2016Pantoprazole-40SIV.20162020-06-30.2016PantoprazoleRIA.20162025-08-29.2016M-PantoprazoleMAT.20162019-03-28.2016NRA-PantoprazoleNRA.20162020-10-30.2016AG-Pantoprazole SodiumANG.20162021-01-29.2016Gastroesophageal Reflux Disease (GERD) For the treatment of erosive GERD or upper GI malignancy; OR For the treatment of non-erosive GERD after failure of H2-receptor antagonist therapy. Patients with GERD should be reassessed within 6 months after initial treatment with a PPI. The reassessment could include confirmation of need for PPI with endoscopy, a trial of PPI withdrawal, or step-down therapy to H2-receptor antagonist therapy. Note: There is a lack of published evidence to support double-dose PPI therapy in this setting.LU Authorization Period: 1 yearH. pylori-positive Peptic Ulcers For the treatment of H. pylori-positive peptic ulcers where H. pylori is documented, by serology, urea breath test or endoscopy, for a course of up to 14 days in combination with antimicrobial therapy. Retreatment of H. pylori-positive peptic ulcers must be documented by persistent H. pylori infection on urea breath test or endoscopy. Maximum duration: 14 days (for retreatment, a four-week period must elapse since the end of the previous treatment).LU Authorization Period: 1 yearConfirmed Peptic Ulcers or NSAID-induced Ulcer Prophylaxis: For the treatment of confirmed peptic ulcers and NSAID-induced ulcers; OR For the prophylaxis of NSAID-induced ulcers for patients at increased risk of GI bleeding. Note: There is a lack of published evidence to support double-dose PPI therapy in this setting.LU Authorization Period: 1 yearOther Gastrointestinal Disorders: For the treatment of gastroduodenal Crohns disease, short-gut syndrome, scleroderma, or pancreatitis. Note: There is a lack of published evidence to support double-dose PPI therapy in these settings.LU Authorization Period: 1 yearSevere Conditions: For the treatment of severe esophagitis, Zollinger-Ellison syndrome, esophageal stricture, persistent symptoms of GERD or persistent erosive esophagitis, or upon hospital discharge following a gastrointestinal bleed. For patients receiving double-dose therapy, the need to continue treatment at higher doses should be reassessed after eight weeks. For re-treatment at higher doses, a four-week period should have elapsed from the end of the previous treatment. Reassessment could include a procedural assessment of the condition or step-down therapy to lower-dose proton pump inhibitor (PPI) therapy.LU Authorization Period: 1 yearPRUCALOPRIDE17161mgTabResotranAMD2020-02-28Apo-PrucaloprideAPX2.01452020-02-28Jamp PrucaloprideJPC2.01452021-04-30NRA-PrucaloprideNRA2.01452024-12-30PrucaloprideSAI2.01452026-02-2717172mgTabResotranAMD2020-02-28Apo-PrucaloprideAPX3.10252020-02-28Jamp PrucaloprideJPC3.10252021-04-30NRA-PrucaloprideNRA3.10252024-12-30PrucaloprideSAI3.10252026-02-27RABEPRAZOLE SODIUM171810mgTabParietJAN1.65982002-07-29.0669Teva-Rabeprazole ECTEV.06692008-01-15.0669Ran-RabeprazoleRAN.06692008-01-15.0669Sandoz RabeprazoleSDZ.06692008-10-01.0669Apo-RabeprazoleAPX.06692010-06-14.0669Rabeprazole ECSAI.06692011-08-04.0669RabeprazoleSIV.06692020-05-29.0669Jamp RabeprazoleJPC.06692023-03-31.0669171920mgTabParietJAN3.31972007-01-02.1338Teva-Rabeprazole ECTEV.13382008-01-15.1338Ran-RabeprazoleRAN.13382008-01-15.1338Sandoz RabeprazoleSDZ.13382008-10-01.1338Apo-RabeprazoleAPX.13382010-06-14.1338Rabeprazole ECSAI.13382011-08-04.1338RabeprazoleSIV.13382020-05-29.1338Jamp RabeprazoleJPC.13382023-02-28.1338RANITIDINE HCL172015mg/mLOral SolZantacGSK1997-01-20Teva-Ranitidine SolutionTEV.14802004-12-21.1480Apo-RanitidineAPX.14802007-09-04.14801721150mgTabApo-RanitidineAPX.11971996-10-01.1197Teva-RanitidineTEV.11971996-10-01.1197ZantacGSK1997-07-12PMS-RanitidinePMS.11972001-03-07.1197Sandoz RanitidineSDZ.11972001-10-11.1197Co RanitidineCOB.11972004-07-20.1197Ran-RanitidineRAN.11972010-01-05.1197Mar-RanitidineMAR.11972019-01-31.1197Jamp-RanitidineJPC.11972018-12-21.1197Mint-RanitidineMIN.11972023-01-31.11971722300mgTabApo-RanitidineAPX.22531996-10-01.2253Teva-RanitidineTEV.22531996-10-01.2253ZantacGSK1998-03-17PMS-RanitidinePMS.22532001-03-07.2253Sandoz RanitidineSDZ.22532001-10-11.2253Co RanitidineCOB.22532004-07-20.2253Ran-RanitidineRAN.22532010-01-05.2253Mar-RanitidineMAR.22532019-01-31.2253Jamp-RanitidineJPC.22532018-12-21.2253Mint-RanitidineMIN.22532023-01-31.2253SUCRALFATE17231g/5mLOral SuspSulcrate Suspension PlusBFI.13661996-10-01.136617241gTabTeva-SucralfateTEV.30891996-10-01.3089SulcrateBFI.77041996-10-01.3089Apo-SucralfateAPX.30891996-10-01.3089GOLD COMPOUNDSAURANOFIN17253mgCapRidauraXED7.05101996-10-017.0510HEAVY METAL ANTAGONISTSDEFERASIROX172690mgTabJadenuNOV10.89202019-07-312.6303Apo-Deferasirox (Type J)APX2.63032019-07-312.6303Sandoz Deferasirox (Type J)SDZ2.63032021-07-302.6303Taro-Deferasirox (Type J)TAR2.63032021-03-292.6303Auro-Deferasirox (Type J)AUR2.63032025-02-282.6303PMS-Deferasirox (Type J)PMS2.63032022-10-312.63031727180mgTabJadenuNOV21.78502019-07-315.2610Apo-Deferasirox (Type J)APX5.26102019-07-315.2610Sandoz Deferasirox (Type J)SDZ5.26102021-07-305.2610Taro-Deferasirox (Type J)TAR5.26102021-03-295.2610Auro-Deferasirox (Type J)AUR5.26102025-02-285.2610PMS-Deferasirox (Type J)PMS5.26102022-11-305.26101728360mgTabJadenuNOV43.57302019-07-3110.5228Apo-Deferasirox (Type J)APX10.52282019-07-3110.5228Sandoz Deferasirox (Type J)SDZ10.52282021-07-3010.5228Taro-Deferasirox (Type J)TAR10.52282021-03-2910.5228Auro-Deferasirox (Type J)AUR10.52282025-02-2810.5228PMS-Deferasirox (Type J)PMS10.52282022-10-3110.52281729125mgTab for SuspExjadeNOV11.03752017-08-305.2408Apo-DeferasiroxAPX5.24082017-08-305.2408Sandoz DeferasiroxSDZ5.24082017-08-305.24081730250mgTab for SuspExjadeNOV22.07572017-08-3010.4820Apo-DeferasiroxAPX10.48202017-08-3010.4820Sandoz DeferasiroxSDZ10.48202017-08-3010.48201731500mgTab for SuspExjadeNOV44.15072017-08-3020.9649Apo-DeferasiroxAPX20.96492017-08-3020.9649Sandoz DeferasiroxSDZ20.96492017-08-3020.9649DEFERIPRONE17321000mgTabFerriproxAPO33.47402025-03-3118.4107Taro-DeferiproneTAR18.41072025-03-3118.4107PENICILLAMINE1733250mgCapCuprimineATO4.83021996-10-014.8302HORMONES AND SUBSTITUTESCORTICOSTEROIDSBECLOMETHASONE DIPROPIONATE173450mcg/Metered DoseAero Inh-200 Dose PkQVARGRA43.91102001-03-0743.91101735100mcg/Metered DoseAero Inh-200 Dose PkQVARGRA87.55682001-03-0787.5568BUDESONIDE17360.125mg/mLInh SuspPulmicort NebuampAZC.27781998-12-31.1143Teva-BudesonideTEV.11432018-04-30.1143Taro-BudesonideTAR.11432021-07-30.114317370.25mg/mLInh SuspPulmicort NebuampAZC.55601996-10-01.3593Taro-BudesonideTAR.35932021-07-30.359317380.5mg/mLInh SuspPulmicort NebuampAZC1.10951996-10-01.4559Teva-BudesonideTEV.45592018-03-29.4559Taro-BudesonideTAR.45592021-07-30.4559For the vast majority of patients, a metered dose inhaler is the preferred therapy. Nebulizer therapy will be reimbursed for patients who are unable to use a metered dose inhaler, including an inhaler with a spacer attachment, or a turbuhaler.Children aged 6 years or less;LU Authorization Period: IndefinitePatients who have a tracheostomy;LU Authorization Period: IndefinitePatients with cystic fibrosis in whom nebulizer therapy is indicated;LU Authorization Period: IndefinitePatients with severe mental or physical disabilities;LU Authorization Period: IndefinitePatients who have previously used nebulizer therapy within the last 12 month period.LU Authorization Period: Indefinite1739100mcg/Metered DosePd Inh-200 Dose PkPulmicort TurbuhalerAZC39.00001996-10-0139.00001740200mcg/Metered DosePd Inh-200 Dose PkPulmicort TurbuhalerAZC79.76001996-10-0179.76001741400mcg/Metered DosePd Inh-200 Dose PkPulmicort TurbuhalerAZC116.42001996-10-01116.4200CICLESONIDE1742100mcg/ActuationInh-120 Dose PkAlvescoCOV55.28072007-06-0655.28071743200mcg/ActuationInh-120 Dose PkAlvescoCOV91.47392007-06-0691.4739174450mcg/ActuationMetered Dose Nas Sp-120 Dose PkOmnarisCOP31.24442009-09-3031.2444DEXAMETHASONE17450.5mgTabDecadronMSD1996-10-01PMS-DexamethasonePMS.15641998-12-31.1564Apo-DexamethasoneAPX.15642005-04-28.156417464mgTabDecadronMSD1996-10-01PMS-DexamethasonePMS.61121998-12-31.6112Apo-DexamethasoneAPX.61122004-10-14.6112DEXAMETHASONE 21-PHOSPHATE17474mg/mLInj SolDecadronMSD1996-10-01Dexamethasone SodiumSDZ1.69001998-12-311.6900Dexamethasone SodiumSTE1.69001996-12-191.6900FLUDROCORTISONE ACETATE17480.1mgTabFlorinefPPI.58061996-10-01.3131Jamp FludrocortisoneJPC.31312025-07-31.3131FLUTICASONE FUROATE1749100mcgBlister Pd Inh-30 Dose PkArnuity ElliptaGSK50.81002016-09-2950.81001750200mcgBlister Pd Inh-30 Dose PkArnuity ElliptaGSK101.59002016-09-29101.5900FLUTICASONE PROPIONATE175150mcg/Metered DoseInh-120 Dose PkFlovent HFAGSK33.75002002-07-2914.2080PMS-Fluticasone HFAPMS14.20802023-03-3114.2080Apo-Fluticasone HFAAPX14.20802025-04-3014.20801752125mcg/Metered DoseInh-120 Dose PkFlovent HFAGSK58.21002002-07-2923.4100PMS-Fluticasone HFAPMS23.41002022-06-3023.4100Apo-Fluticasone HFAAPX23.41002022-12-2123.41001753250mcg/Metered DoseInh-120 Dose PkFlovent HFAGSK116.42002002-07-2945.0200PMS-FluticasonePMS45.02002021-03-2945.0200Apo-Fluticasone HFAAPX45.02002021-05-3145.0200175455mcg/ActuationPd Inh-60 Dose PkAermony RespiclickTEV16.95602021-03-2916.95601755113mcg/ActuationPd Inh-60 Dose PkAermony RespiclickTEV30.96192021-03-2930.96191756232mcg/ActuationPd Inh-60 Dose PkAermony RespiclickTEV48.15242021-03-2948.15241757250mcg/BlisterPd Inh-60 Dose PkFlovent DiskusGSK58.21001999-04-1558.21001758500mcg/BlisterPd Inh-60 Dose PkFlovent DiskusGSK90.55001999-04-1590.5500HYDROCORTISONE175910mgTabCortefPFI.22592003-09-04.1639Auro-HydrocortisoneAUR.16392023-06-30.1639176010mgTabCortefPFI.21852022-06-30.2185176120mgTabCortefPFI.40781996-10-01.2958Auro-HydrocortisoneAUR.29582023-06-30.2958INDACATEROL ACETATE & GLYCOPYRRONIUM BROMIDE & MOMETASONE FUROATE1762150mcg & 50mcg & 160mcgInh Pd-CapEnerzair BreezhalerNOV3.42772022-02-283.4277For the treatment of asthma in adult patients inadequately controlled with a maintenance combination of a long-acting beta-2 agonist (LABA) and a medium or high dose of an inhaled corticosteroid (ICS), who experienced one or more asthma exacerbations in the previous 12 months.LU Authorization Period: IndefiniteINDACATEROL ACETATE & MOMETASONE FUROATE1763150mcg & 160mcgInh Pd-CapAtectura BreezhalerNOV1.34192022-02-281.34191764150mcg & 320mcgInh Pd-CapAtectura BreezhalerNOV1.84732022-02-281.84731765150mcg & 80mcgInh Pd-CapAtectura BreezhalerNOV1.07312022-02-281.0731For once-daily maintenance treatment of asthma in patients aged 12 years and older with reversible obstructive airways disease.LU Authorization Period: IndefiniteMETHYLPREDNISOLONE17664mgTabMedrolPFI.53641996-10-01.5364METHYLPREDNISOLONE ACETATE176740mg/mLInj Susp-1mL PkDepo-MedrolPFI6.74801996-10-016.7480176880mg/mLInj Susp-1mL PkDepo-MedrolPFI12.93591996-10-0112.93591769100mg/5mLInj Susp-5mL PkDepo-MedrolPFI15.09001996-10-0115.0900MOMETASONE FUROATE1770400mcg/Metered DosePd Inh-30 Dose PkAsmanex TwisthalerOCI42.4320NOTES: The general direction of the therapy of asthma has been toward the use of anti-inflammatory agents, especially inhaled steroids, which are not associated with systemic side effects to the same degree as oral steroids. The proper technique of inhalation or use of a spacer is very important to the efficacy of these agents. Physicians and pharmacists should ensure that patients are appropriately instructed in the use of these devices.2012-12-2142.43201771200mcg/Metered DosePd Inh-60 Dose PkAsmanex TwisthalerOCI42.4320NOTES: The general direction of the therapy of asthma has been toward the use of anti-inflammatory agents, especially inhaled steroids, which are not associated with systemic side effects to the same degree as oral steroids. The proper technique of inhalation or use of a spacer is very important to the efficacy of these agents. Physicians and pharmacists should ensure that patients are appropriately instructed in the use of these devices.2012-12-2142.43201772400mcg/Metered DosePd Inh-60 Dose PkAsmanex TwisthalerOCI84.8280NOTES: The general direction of the therapy of asthma has been toward the use of anti-inflammatory agents, especially inhaled steroids, which are not associated with systemic side effects to the same degree as oral steroids. The proper technique of inhalation or use of a spacer is very important to the efficacy of these agents. Physicians and pharmacists should ensure that patients are appropriately instructed in the use of these devices.2012-12-2184.8280PREDNISOLONE SODIUM PHOSPHATE17736.7mg/5mLO/LPediapred Oral LiquidSAV2003-01-30PMS-PrednisolonePMS.12592004-07-20.1259PREDNISONE17741mgTabWinpredAAP.12761996-10-01.127617755mgTabTeva-PrednisoneTEV.02201996-10-01.0220DeltasoneUPJ1996-10-01Apo-PrednisoneAPX.02201996-10-01.0220177650mgTabTeva-PrednisoneTEV.19001996-10-01.1735DeltasoneUPJ1996-10-01Apo-PrednisoneAPX.17351996-10-01.1735TRIAMCINOLONE ACETONIDE177740mg/mLInj Susp-1mL PkKenalog-40BQU8.96101996-10-018.9610177850mg/5mLInj Susp-5mL PkKenalog-10BQU19.45001996-10-0119.45001779200mg/5mLInj Susp-5mL PkKenalog-40BQU31.65001996-10-0131.6500TRIAMCINOLONE HEXACETONIDE178020mg/mL1mL-Amp PkTrispanMDX18.00002020-06-3018.0000For intra-articular, intrasynovial, or periarticular use in adults and adolescents for the symptomatic treatment of subacute and chronic inflammatory joint diseases including: - Rheumatoid arthritis - Juvenile Idiopathic Arthritis (JIA)* - Osteoarthritis and post-traumatic arthritis - Synovitis, tendinitis, bursitis and epicondylitis *Note: triamcinolone hexacetonide injectable suspension may also be used as an intra-articular injection in children aged 3-12 years with Juvenile Idiopathic Arthritis.LU Authorization Period: IndefiniteANDROGENSDANAZOL178150mgCapCyclomenSAV1.07201996-10-011.07201782100mgCapCyclomenSAV1.59101996-10-011.59101783200mgCapCyclomenSAV2.54251996-10-012.5425TESTOSTERONE17841%2.5g Foil PacketAndrogelSPH2.55142005-02-221.6726Taro-Testosterone GelTAR1.67262017-12-211.672617851%5.0g Foil PacketAndrogelSPH4.51172005-02-222.9575Taro-Testosterone GelTAR2.95752017-12-212.957517861%Top Gel-5g PkTestimPPI4.40452009-09-304.4045For male patients with confirmed low morning serum testosterone levels associated with documented, symptomatic hypothalamic, pituitary or testicular disease, or in HIV-infected patients. Note: Older males with nonspecific symptoms of fatigue, malaise, depression who have a low normal random testosterone level do not satisfy these criteria.LU Authorization Period: 1 yearTESTOSTERONE CYPIONATE1787100mg/mLOily Inj Sol-10mL PkDepo-TestosteronePFI48.13001996-10-0134.8780Taro-Testosterone Cypionate InjectionTAR34.87802021-04-3034.8780For male patients with confirmed low morning serum testosterone levels associated with documented, symptomatic hypothalamic, pituitary or testicular disease, or in HIV-infected patients. Note: Older males with nonspecific symptoms of fatigue, malaise, depression who have a low normal random testosterone level do not satisfy these criteria.LU Authorization Period: 1 yearTESTOSTERONE ENANTHATE17881000mg/5mLOily Inj Sol-5mL PkDelatestrylVAL1996-10-01Testosterone Enanthate Injection, USPHIK35.59432024-10-3135.5943For male patients with confirmed low morning serum testosterone levels associated with documented, symptomatic hypothalamic, pituitary or testicular disease, or in HIV-infected patients. Note: Older males with nonspecific symptoms of fatigue, malaise, depression who have a low normal random testosterone level do not satisfy these criteria.LU Authorization Period: 1 yearTESTOSTERONE UNDECANOATE178940mgCapAndriolORG1996-10-01PMS-TestosteronePMS.47002010-04-23.4700Taro-TestosteroneTAR.47002014-10-29.4700For male patients with confirmed low morning serum testosterone levels associated with documented, symptomatic hypothalamic, pituitary or testicular disease, or in HIV-infected patients. Note: Older males with nonspecific symptoms of fatigue, malaise, depression who have a low normal random testosterone level do not satisfy these criteria.LU Authorization Period: 1 yearCONTRACEPTIVESETHINYL ESTRADIOL & ETONOGESTREL17900.120mg & 0.015mg/24 hrSlow Release Vag RingNuvaringOCI2021-11-30HaloetteSLP14.21202021-11-30ETONOGESTREL179168mg/ImplantER Subdermal ImplantNexplanonOCI345.63002021-12-17345.6300LEVONORGESTREL179219.5mgInsertKyleenaBAY348.61002018-05-31348.6100179352mgInsertMirenaBAY372.55002001-10-11372.5500ESTROGENSCONJUGATED ESTROGENS17940.625mgSR TabPremarinPFI.40882015-01-28.4088For short-term use in women who are experiencing symptoms of menopause. Note: Recent evidence has demonstrated that use of hormone replacement therapy (HRT) increases the rate of coronary events, breast cancer, dementia, stroke, venous thromboembolism and referrals for abnormal vaginal bleeding. These risks should be discussed with patients and reviewed periodically.LU Authorization Period: 1 year17950.625mg/gVag CrPremarin Vaginal CreamPFI.91101996-10-01.9110ESTRADIOL17960.5mgTabEstraceAPC2016-04-29Lupin-EstradiolLUP.11992016-04-29.119917971mgTabEstraceAPC2016-04-29Lupin-EstradiolLUP.23132016-04-29.231317982mgTabEstraceAPC2016-04-29Lupin-EstradiolLUP.40832016-04-29.408317992mgVag RingEstringPFI106.54001996-10-01106.5400ESTRADIOL 17-B180010mcgVag Tab with ApplicatorVagifem 10NOO4.90612011-09-154.9061ESTRADIOL HEMIHYDRATE18014mcgVag InsertImvexxyKNT3.69422023-11-303.6942180210mcgVag InsertImvexxyKNT3.69422023-11-303.6942ESTRADIOL HEMIHYDRATE & PROGESTERONE18031mg & 100mgCapBijuvaKNT.91432024-02-29.9143GONADOTROPINS AND ANTIGONADOTROPINSRELUGOLIX1804120mgTabOrgovyxSMT9.00002025-03-319.0000RELUGOLIX & ESTRADIOL & NORETHINDRONE ACETATE180540mg & 1mg & 0.5mgTabMyfembreeKNT9.31502026-01-309.3150ANTI-DIABETIC AGENTS ORAL ANTI-DIABETIC AGENTSACARBOSE180650mgTabGlucobayBAY1996-12-19Mar-AcarboseMAR.14822020-03-31.14821807100mgTabGlucobayBAY1996-12-19Mar-AcarboseMAR.20532020-03-31.2053For the treatment of non-insulin-dependent diabetes mellitus (NIDDM):In patients who cannot tolerate or have failed treatment with other oral hypoglycemic agents or in whom other oral hypoglycemic agents are contraindicated;LU Authorization Period: IndefiniteIn patients who require combination therapy with more than one oral hypoglycemic agent to control their serum glucose concentrations.LU Authorization Period: IndefiniteCANAGLIFLOZIN1808100mgTabTreatment of Type 2 diabetes in patients on maximally tolerated doses of metformin who have: . Inadequate glycemic control (defined as HbA1c greater than 0.07) and intolerance or contraindication to a sulfonylurea; OR . Inadequate glycemic control (HbA1c greater than 0.07) and on maximal doses of sulfonylurea and for whom insulin is not an option.InvokanaJAN2.89102015-07-291.4455Auro-CanagliflozinAUR1.44552026-02-271.4455Jamp CanagliflozinJPC1.44552026-02-271.44551809300mgTabTreatment of Type 2 diabetes in patients on maximally tolerated doses of metformin who have: . Inadequate glycemic control (defined as HbA1c greater than 0.07) and intolerance or contraindication to a sulfonylurea; OR . Inadequate glycemic control (HbA1c greater than 0.07) and on maximal doses of sulfonylurea and for whom insulin is not an option.InvokanaJAN3.00602015-07-291.5030Auro-CanagliflozinAUR1.50302026-02-271.5030Jamp CanagliflozinJPC1.50302026-02-271.5030DAPAGLIFLOZIN18105mgTabAdded on to metformin for patients: - Who have inadequate glycemic control on metformin and - Who have a contraindication or intolerance to a sulfonylurea or - For whom insulin is not an option. Added on to a sulfonylurea for patients: - Who have inadequate glycemic control on a sulfonylurea and - Who have a contraindication or intolerance to metformin or - For whom insulin is not an option. For the treatment of adult patients with New York Heart Association (NYHA) class II and III heart failure, as an adjunct to standard of care therapy, for the treatment of heart failure with reduced ejection fraction (HFrEF) [Left ventricular ejection fraction (LVEF less than or equal to 40%)]. Standard of care therapies include beta-blockers, angiotensin converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs), plus a mineralocorticoid receptor antagonist.ForxigaAZC2.73002016-11-30.5220Sandoz DapagliflozinSDZ.68252023-07-31.5220GLN-DapagliflozinGLP.68252023-07-31.5220Apo-DapagliflozinAPX.68252023-07-31.5220Jamp DapagliflozinJPC.68252023-07-31.5220Auro-DapagliflozinAUR.68252023-07-31.5220PMS-DapagliflozinPMS.68252023-07-31.5220M-DapagliflozinMAT.68252023-07-31.5220NRA-DapagliflozinNRA.68252023-11-30.5220Accel-DapagliflozinACC.52202026-03-31.5220181110mgTabAdded on to metformin for patients: - Who have inadequate glycemic control on metformin and - Who have a contraindication or intolerance to a sulfonylurea or - For whom insulin is not an option. Added on to a sulfonylurea for patients: - Who have inadequate glycemic control on a sulfonylurea and - Who have a contraindication or intolerance to metformin or - For whom insulin is not an option. For the treatment of adult patients with New York Heart Association (NYHA) class II and III heart failure, as an adjunct to standard of care therapy, for the treatment of heart failure with reduced ejection fraction (HFrEF) [Left ventricular ejection fraction (LVEF less than or equal to 40%)]. Standard of care therapies include beta-blockers, angiotensin converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs), plus a mineralocorticoid receptor antagonist.ForxigaAZC2.73002016-11-30.5220Sandoz DapagliflozinSDZ.68252023-07-31.5220GLN-DapagliflozinGLP.68252023-07-31.5220Apo-DapagliflozinAPX.68252023-07-31.5220Jamp DapagliflozinJPC.68252023-07-31.5220Auro-DapagliflozinAUR.68252023-07-31.5220PMS-DapagliflozinPMS.68252023-07-31.5220M-DapagliflozinMAT.68252023-07-31.5220NRA-DapagliflozinNRA.68252023-11-30.5220Accel-DapagliflozinACC.52202026-03-31.5220DAPAGLIFLOZIN & METFORMIN18125mg & 1000mgTabFor the treatment of patients with type 2 diabetes mellitus who are already stabilized on therapy with metformin and dapagliflozin, to replace the individual components of dapagliflozin and metformin for those patients who have inadequate glycemic control on metformin, a contraindication or intolerance to a sulfonylurea, and for whom insulin is not an option.XigduoAZC1.28632017-07-31.6432Auro-Dapagliflozin / MetforminAUR.64322023-08-31.6432Apo-Dapagliflozin-MetforminAPX.64322023-12-29.643218135mg & 850mgTabFor the treatment of patients with type 2 diabetes mellitus who are already stabilized on therapy with metformin and dapagliflozin, to replace the individual components of dapagliflozin and metformin for those patients who have inadequate glycemic control on metformin, a contraindication or intolerance to a sulfonylurea, and for whom insulin is not an option.XigduoAZC1.28632017-07-31.6432Auro-Dapagliflozin / MetforminAUR.64322023-08-31.6432Apo-Dapagliflozin-MetforminAPX.64322024-01-31.6432EMPAGLIFLOZIN181410mgTabTreatment of Type 2 diabetes in patients on maximally tolerated doses of metformin who have: - Inadequate glycemic control (defined as HbA1c greater than 0.07) and intolerance or contraindication to a sulfonylurea; OR - Inadequate glycemic control (HbA1c greater than 0.07) and on maximal doses of sulfonylurea and for whom insulin is not an option. Used as an adjunct to diet, exercise, and standard care therapy to reduce the incidence of cardiovascular (CV) death in patients with Type 2 diabetes and established cardiovascular disease who have inadequate glycemic control (HbA1c greater than 0.07) despite an adequate trial of metformin. Established CV disease is defined as one of the following: - history of MI - multi-vessel coronary artery disease in two or more major coronary arteries (irrespective of revascularization status) - single-vessel coronary artery disease with significant stenosis and either a positive non-invasive stress test or discharged from hospital with a documented diagnosis of unstable angina within 12 months prior to selection - last episode of unstable angina greater than 2 months prior with confirmed evidence of coronary multi-vessel or single-vessel disease - history of ischemic or hemorrhagic stroke - occlusive peripheral artery disease.JardianceBOE2.88682016-05-312.8868181525mgTabTreatment of Type 2 diabetes in patients on maximally tolerated doses of metformin who have: - Inadequate glycemic control (defined as HbA1c greater than 0.07) and intolerance or contraindication to a sulfonylurea; OR - Inadequate glycemic control (HbA1c greater than 0.07) and on maximal doses of sulfonylurea and for whom insulin is not an option. Used as an adjunct to diet, exercise, and standard care therapy to reduce the incidence of cardiovascular (CV) death in patients with Type 2 diabetes and established cardiovascular disease who have inadequate glycemic control (HbA1c greater than 0.07) despite an adequate trial of metformin. Established CV disease is defined as one of the following: - history of MI - multi-vessel coronary artery disease in two or more major coronary arteries (irrespective of revascularization status) - single-vessel coronary artery disease with significant stenosis and either a positive non-invasive stress test or discharged from hospital with a documented diagnosis of unstable angina within 12 months prior to selection - last episode of unstable angina greater than 2 months prior with confirmed evidence of coronary multi-vessel or single-vessel disease - history of ischemic or hemorrhagic stroke - occlusive peripheral artery disease.JardianceBOE2.88682016-05-312.8868EMPAGLIFLOZIN & METFORMIN18165mg & 1000mgTabTreatment of Type 2 diabetes in patients on maximally tolerated doses of metformin who have: - Inadequate glycemic control (defined as HbA1c greater than 0.07) and intolerance or contraindication to a sulfonylurea; OR - Inadequate glycemic control (HbA1c greater than 0.07) and on maximal doses of sulfonylurea and for whom insulin is not an option. Used as an adjunct to diet, exercise, and standard care therapy to reduce the incidence of cardiovascular (CV) death in patients with Type 2 diabetes and established cardiovascular disease who have inadequate glycemic control (HbA1c greater than 0.07) despite an adequate trial of metformin. Established CV disease is defined as one of the following: - history of MI - multi-vessel coronary artery disease in two or more major coronary arteries (irrespective of revascularization status) - single-vessel coronary artery disease with significant stenosis and either a positive non-invasive stress test or discharged from hospital with a documented diagnosis of unstable angina within 12 months prior to selection - last episode of unstable angina greater than 2 months prior with confirmed evidence of coronary multi-vessel or single-vessel disease - history of ischemic or hemorrhagic stroke - occlusive peripheral artery disease.SynjardyBOE1.45352018-10-311.453518175mg & 500mgTabTreatment of Type 2 diabetes in patients on maximally tolerated doses of metformin who have: - Inadequate glycemic control (defined as HbA1c greater than 0.07) and intolerance or contraindication to a sulfonylurea; OR - Inadequate glycemic control (HbA1c greater than 0.07) and on maximal doses of sulfonylurea and for whom insulin is not an option. Used as an adjunct to diet, exercise, and standard care therapy to reduce the incidence of cardiovascular (CV) death in patients with Type 2 diabetes and established cardiovascular disease who have inadequate glycemic control (HbA1c greater than 0.07) despite an adequate trial of metformin. Established CV disease is defined as one of the following: - history of MI - multi-vessel coronary artery disease in two or more major coronary arteries (irrespective of revascularization status) - single-vessel coronary artery disease with significant stenosis and either a positive non-invasive stress test or discharged from hospital with a documented diagnosis of unstable angina within 12 months prior to selection - last episode of unstable angina greater than 2 months prior with confirmed evidence of coronary multi-vessel or single-vessel disease - history of ischemic or hemorrhagic stroke - occlusive peripheral artery disease.SynjardyBOE1.45352018-10-311.453518185mg & 850mgTabTreatment of Type 2 diabetes in patients on maximally tolerated doses of metformin who have: - Inadequate glycemic control (defined as HbA1c greater than 0.07) and intolerance or contraindication to a sulfonylurea; OR - Inadequate glycemic control (HbA1c greater than 0.07) and on maximal doses of sulfonylurea and for whom insulin is not an option. Used as an adjunct to diet, exercise, and standard care therapy to reduce the incidence of cardiovascular (CV) death in patients with Type 2 diabetes and established cardiovascular disease who have inadequate glycemic control (HbA1c greater than 0.07) despite an adequate trial of metformin. Established CV disease is defined as one of the following: - history of MI - multi-vessel coronary artery disease in two or more major coronary arteries (irrespective of revascularization status) - single-vessel coronary artery disease with significant stenosis and either a positive non-invasive stress test or discharged from hospital with a documented diagnosis of unstable angina within 12 months prior to selection - last episode of unstable angina greater than 2 months prior with confirmed evidence of coronary multi-vessel or single-vessel disease - history of ischemic or hemorrhagic stroke - occlusive peripheral artery disease.SynjardyBOE1.45352018-10-311.4535181912.5mg & 1000mgTabTreatment of Type 2 diabetes in patients on maximally tolerated doses of metformin who have: - Inadequate glycemic control (defined as HbA1c greater than 0.07) and intolerance or contraindication to a sulfonylurea; OR - Inadequate glycemic control (HbA1c greater than 0.07) and on maximal doses of sulfonylurea and for whom insulin is not an option. Used as an adjunct to diet, exercise, and standard care therapy to reduce the incidence of cardiovascular (CV) death in patients with Type 2 diabetes and established cardiovascular disease who have inadequate glycemic control (HbA1c greater than 0.07) despite an adequate trial of metformin. Established CV disease is defined as one of the following: - history of MI - multi-vessel coronary artery disease in two or more major coronary arteries (irrespective of revascularization status) - single-vessel coronary artery disease with significant stenosis and either a positive non-invasive stress test or discharged from hospital with a documented diagnosis of unstable angina within 12 months prior to selection - last episode of unstable angina greater than 2 months prior with confirmed evidence of coronary multi-vessel or single-vessel disease - history of ischemic or hemorrhagic stroke - occlusive peripheral artery disease.SynjardyBOE1.45352018-10-311.4535182012.5mg & 500mgTabTreatment of Type 2 diabetes in patients on maximally tolerated doses of metformin who have: - Inadequate glycemic control (defined as HbA1c greater than 0.07) and intolerance or contraindication to a sulfonylurea; OR - Inadequate glycemic control (HbA1c greater than 0.07) and on maximal doses of sulfonylurea and for whom insulin is not an option. Used as an adjunct to diet, exercise, and standard care therapy to reduce the incidence of cardiovascular (CV) death in patients with Type 2 diabetes and established cardiovascular disease who have inadequate glycemic control (HbA1c greater than 0.07) despite an adequate trial of metformin. Established CV disease is defined as one of the following: - history of MI - multi-vessel coronary artery disease in two or more major coronary arteries (irrespective of revascularization status) - single-vessel coronary artery disease with significant stenosis and either a positive non-invasive stress test or discharged from hospital with a documented diagnosis of unstable angina within 12 months prior to selection - last episode of unstable angina greater than 2 months prior with confirmed evidence of coronary multi-vessel or single-vessel disease - history of ischemic or hemorrhagic stroke - occlusive peripheral artery disease.SynjardyBOE1.45352018-10-311.4535182112.5mg & 850mgTabTreatment of Type 2 diabetes in patients on maximally tolerated doses of metformin who have: - Inadequate glycemic control (defined as HbA1c greater than 0.07) and intolerance or contraindication to a sulfonylurea; OR - Inadequate glycemic control (HbA1c greater than 0.07) and on maximal doses of sulfonylurea and for whom insulin is not an option. Used as an adjunct to diet, exercise, and standard care therapy to reduce the incidence of cardiovascular (CV) death in patients with Type 2 diabetes and established cardiovascular disease who have inadequate glycemic control (HbA1c greater than 0.07) despite an adequate trial of metformin. Established CV disease is defined as one of the following: - history of MI - multi-vessel coronary artery disease in two or more major coronary arteries (irrespective of revascularization status) - single-vessel coronary artery disease with significant stenosis and either a positive non-invasive stress test or discharged from hospital with a documented diagnosis of unstable angina within 12 months prior to selection - last episode of unstable angina greater than 2 months prior with confirmed evidence of coronary multi-vessel or single-vessel disease - history of ischemic or hemorrhagic stroke - occlusive peripheral artery disease.SynjardyBOE1.45352018-10-311.4535GLICLAZIDE182260mgER TabDiamicron MRSEV.29322011-08-04.0632Apo-Gliclazide MRAPX.06322015-05-28.0632Mint-Gliclazide MRMIN.06322017-04-27.0632Jamp Gliclazide-MRJPC.06322024-12-30.0632Taro-Gliclazide MRSPC.06322017-09-28.0632Sandoz Gliclazide MRSDZ.06322017-08-30.0632Gliclazide MRSAI.06322022-09-29.0632182330mgSR TabDiamicron MRSEV.16282007-04-02.0931Apo-Gliclazide MRAPX.09312008-08-28.0931Mint-Gliclazide MRMIN.09312014-11-27.0931Jamp Gliclazide MRJPC.09312015-05-28.0931Mylan-Gliclazide MRMYL.09312020-10-30.0931Sandoz Gliclazide MRSDZ.09312020-07-31.0931Taro-Gliclazide MRSPC.09312020-08-28.0931Gliclazide MRSAI.09312022-09-29.0931182480mgTabDiamicronSEV2007-04-02Teva-GliclazideTEV.09312007-06-06.0931Apo-GliclazideAPX.09312007-06-06.0931GliclazideSAI.09312011-09-15.0931GLIMEPIRIDE18251mgTabAmarylSAV2007-06-06Sandoz GlimepirideSDZ.81872007-06-0618262mgTabAmarylSAV2007-06-06Sandoz GlimepirideSDZ.98002007-06-0618274mgTabAmarylSAV2007-06-06Sandoz GlimepirideSDZ1.04872007-06-06GLYBURIDE18282.5mgTabApo-GlyburideAPX.03211996-10-01.0321Teva-GlyburideTEV.03211996-10-01.0321DiabetaSAV1999-01-06Sandoz GlyburideSDZ.03212004-07-20.032118295mgTabApo-GlyburideAPX.05741996-10-01.0573Teva-GlyburideTEV.05741996-10-01.0573DiabetaSAV1999-01-06GlyburideSAI.05732011-10-25.0573LINAGLIPTIN18305mgTabTreatment of Type 2 diabetes in patients on maximally tolerated doses of metformin who have: . Inadequate glycemic control (defined as HbA1c greater than 0.07) and intolerance or contraindication to a sulfonylurea; OR . Inadequate glycemic control (HbA1c greater than 0.07) and on maximal doses of a sulfonylurea and for whom insulin is not an option. TrajentaBOE2.81202012-09-282.8120LINAGLIPTIN & METFORMIN18312.5mg & 1000mgTabTreatment of Type 2 diabetes in patients on maximally tolerated doses of metformin who have: . Inadequate glycemic control (defined as HbA1c greater than 0.07) and intolerance or contraindication to a sulfonylurea; OR . Inadequate glycemic control (HbA1c greater than 0.07) and on maximal doses of a sulfonylurea and for whom insulin is not an option.JentaduetoBOE1.47442014-03-271.474418322.5mg & 500mgTabTreatment of Type 2 diabetes in patients on maximally tolerated doses of metformin who have: . Inadequate glycemic control (defined as HbA1c greater than 0.07) and intolerance or contraindication to a sulfonylurea; OR . Inadequate glycemic control (HbA1c greater than 0.07) and on maximal doses of a sulfonylurea and for whom insulin is not an option.JentaduetoBOE1.47442014-03-271.474418332.5mg & 850mgTabTreatment of Type 2 diabetes in patients on maximally tolerated doses of metformin who have: . Inadequate glycemic control (defined as HbA1c greater than 0.07) and intolerance or contraindication to a sulfonylurea; OR . Inadequate glycemic control (HbA1c greater than 0.07) and on maximal doses of a sulfonylurea and for whom insulin is not an option.JentaduetoBOE1.47442014-03-271.4744METFORMIN HCL1834500mgER TabGlumetzaBIO2010-06-14Apo-Metformin ERAPX.65842010-06-14Mint-Metformin XRMIN.65842024-09-27Mar-Metformin XRMAR.65842024-11-29Taro-Metformin XRTAR.65842025-07-31Metformin ERSAI.65842026-01-3018351000mgER TabGlumetzaVAL2017-08-30Apo-Metformin ERAPX1.32332017-08-30Mint-Metformin XRMIN1.32332024-09-27Mar-Metformin XRMAR1.32332024-11-29Metformin ERSAI1.32332026-01-301836500mgTabNovo-MetforminNOP.02471996-10-01.0247GlucophageSAV.28211996-10-01.0247Apo-MetforminAPX.02471996-10-01.0247PMS-MetforminPMS.02471997-04-10.0247Ratio-MetforminRPH.02472001-06-07.0247Sandoz Metformin FCSDZ.02472003-09-04.0247Teva-MetforminTEV.02472004-12-21.0247Ran-MetforminRAN.02472006-03-01.0247MetforminSAI.02472011-08-04.0247Mar-MetforminMAR.02472012-07-27.0247Septa-MetforminSET.02472012-06-26.0247Jamp-MetforminJPC.02472012-08-27.0247Metformin FCSIV.02472020-11-30.0247Mint-MetforminMIN.02472012-09-28.0247Auro-MetforminAUR.02472015-07-29.0247PMSC-MetforminPMS.02472022-03-31.0247PRZ-MetforminPRZ.02472023-07-31.0247NRA-MetforminNRA.02472023-10-31.0247M-MetforminMAT.02472025-01-31.02471837850mgTabGlucophageSAV2007-12-19Apo-MetforminAPX.20902017-08-30PMS-MetforminPMS.20902008-04-09Ratio-MetforminRPH.20902007-12-19Sandoz Metformin FCSDZ.20902007-12-19Teva-MetforminTEV.20902007-12-19Ran-MetforminRAN.20902008-04-09MetforminSAI.20902011-08-04Mar-MetforminMAR.20902012-06-26Jamp-MetforminJPC.20902012-08-27Jamp-Metformin BlackberryJPC.20902012-08-27Metformin FCSIV.20902020-11-30Mint-MetforminMIN.20902012-09-28Ecl-MetforminECL.20902014-12-18Auro-MetforminAUR.20902015-08-26PMSC-MetforminPMS.20902022-03-31PRZ-MetforminPRZ.20902023-07-31NRA-MetforminNRA.20902023-10-31M-MetforminMAT.20902025-01-3118381000mgTabGlucophageSAV2025-08-29PRZ-MetforminPRZ.03992025-08-29M-MetforminMAT.03992025-12-30PIOGLITAZONE HCL183915mgTabActosTAK2.50702006-10-231.5716Teva-PioglitazoneTEV1.57162008-01-151.5716Sandoz PioglitazoneSDZ1.57162008-01-151.5716Teva-PioglitazoneTEV1.57162008-01-151.5716Apo-PioglitazoneAPX1.57162008-01-151.5716Accel PioglitazoneACC1.38002009-09-301.3800Mint-PioglitazoneMIN1.57162009-11-191.5716Auro-PioglitazoneAUR1.57162012-09-281.5716Pioglitazone Hydrochloride TabletsACH1.57162012-12-211.5716Jamp-PioglitazoneJPC1.57162013-04-301.5716184030mgTabActosTAK3.51242006-10-232.2017Teva-PioglitazoneTEV2.20172008-01-152.2017Sandoz PioglitazoneSDZ2.20172008-01-152.2017Teva-PioglitazoneTEV2.20172008-01-152.2017Apo-PioglitazoneAPX2.20172008-01-152.2017Accel PioglitazoneACC1.96002009-09-301.9600Mint-PioglitazoneMIN2.20172009-11-192.2017Pioglitazone Hydrochloride TabletsACH2.20172011-03-152.2017Jamp-PioglitazoneJPC2.20172011-12-152.2017Auro-PioglitazoneAUR2.20172012-09-282.2017184145mgTabActosTAK5.27102006-10-235.2710Teva-PioglitazoneTEV3.31052008-01-153.3105Sandoz PioglitazoneSDZ3.31052008-01-153.3105Teva-PioglitazoneTEV3.31052008-01-153.3105Apo-PioglitazoneAPX3.31052008-01-153.3105Accel PioglitazoneACC2.95002009-09-302.9500Mint-PioglitazoneMIN3.31052009-11-193.3105Pioglitazone Hydrochloride TabletsACH3.31052011-03-153.3105Jamp-PioglitazoneJPC3.31052011-12-153.3105Auro-PioglitazoneAUR3.31052012-09-283.3105REPAGLINIDE18420.5mgTabGlucoNormNOO2011-03-15Co RepaglinideCOB.20832011-03-15.2083Jamp RepaglinideJPC.20832011-03-15.2083Apo-RepaglinideAPX.20832012-02-29.2083Sandoz RepaglinideSDZ.20832011-08-04.2083Auro-RepaglinideAUR.20832015-01-28.208318431mgTabGlucoNormNOO2011-03-15Co RepaglinideCOB.21652011-03-15.2165Jamp RepaglinideJPC.21652011-03-15.2165Apo-RepaglinideAPX.21652012-02-29.2165Sandoz RepaglinideSDZ.21652011-08-04.2165Auro-RepaglinideAUR.21652015-01-28.216518442mgTabGlucoNormNOO2011-03-15Co RepaglinideCOB.24412011-03-15.2441Jamp RepaglinideJPC.24412011-03-15.2441Apo-RepaglinideAPX.24412012-02-29.2441Sandoz RepaglinideSDZ.24402011-08-04.2440Auro-RepaglinideAUR.24412015-01-28.2441ROSIGLITAZONE18452mgTabAvandiaGSK2007-01-02RosiglitazoneAAP1.22342017-02-281.223418464mgTabAvandiaGSK2007-01-02RosiglitazoneAAP1.91972017-02-281.919718478mgTabAvandiaGSK2007-01-02RosiglitazoneAAP2.74522017-02-282.7452SAXAGLIPTIN18482.5mgTabTreatment of Type 2 diabetes in patients on maximally tolerated doses of metformin who have: . Inadequate glycemic control (defined as HbA1c greater than 0.07) and intolerance or contraindication to a sulfonylurea. OnglyzaAZC2.93702012-12-211.2650Sandoz SaxagliptinSDZ1.26502021-05-311.2650Apo-SaxagliptinAPX1.26502021-05-311.265018495mgTabTreatment of Type 2 diabetes in patients on maximally tolerated doses of metformin who have: . Inadequate glycemic control (defined as HbA1c greater than 0.07) and intolerance or contraindication to a sulfonylurea. OnglyzaAZC3.52772012-02-291.5195Sandoz SaxagliptinSDZ1.51952021-05-311.5195Apo-SaxagliptinAPX1.51952021-05-311.5195SAXAGLIPTIN & METFORMIN18502.5mg & 1000mgTabTreatment of Type 2 diabetes in patients on maximally tolerated doses of metformin who have: . Inadequate glycemic control (defined as HbA1c greater than 0.07) and intolerance or contraindication to a sulfonylurea; OR . Inadequate glycemic control (HbA1c greater than 0.07) and on maximal doses of sulfonylurea and for whom insulin is not an option. KomboglyzeAZC1.47432014-11-271.474318512.5mg & 500mgTabTreatment of Type 2 diabetes in patients on maximally tolerated doses of metformin who have: . Inadequate glycemic control (defined as HbA1c greater than 0.07) and intolerance or contraindication to a sulfonylurea; OR . Inadequate glycemic control (HbA1c greater than 0.07) and on maximal doses of sulfonylurea and for whom insulin is not an option. KomboglyzeAZC1.47432014-11-271.474318522.5mg & 850mgTabTreatment of Type 2 diabetes in patients on maximally tolerated doses of metformin who have: . Inadequate glycemic control (defined as HbA1c greater than 0.07) and intolerance or contraindication to a sulfonylurea; OR . Inadequate glycemic control (HbA1c greater than 0.07) and on maximal doses of sulfonylurea and for whom insulin is not an option. KomboglyzeAZC1.47432014-11-271.4743SITAGLIPTIN185325mgTabTreatment of Type 2 diabetes in patients on maximally tolerated doses of metformin who have: . Inadequate glycemic control (defined as HbA1c greater than 0.07) and intolerance or contraindication to a sulfonylurea; OR . Inadequate glycemic control (HbA1c greater than 0.07) and on maximal doses of sulfonylurea and for whom insulin is not an option. JanuviaMFC3.40982013-09-27.8197Apo-SitagliptinAPX.81972026-01-30.8197PMS-SitagliptinPMS.81972025-01-31.8197Sandoz SitagliptinSDZ.81972023-03-31.8197Apo-Sitagliptin MalateAPX.81972022-12-21.8197Ach-SitagliptinACH.81972023-07-31.8197Teva-Sitagliptin MalateTEV.81972024-03-28.8197SitagliptinSIV.81972023-04-28.8197Auro-SitagliptinAUR.81972023-03-31.8197Taro-Sitagliptin FumarateTAR.81972023-03-31.8197Jamp SitagliptinJPC.81972023-03-31.8197SitagliptinSAI.81972025-02-28.8197Mint-SitagliptinMIN.81972026-03-31.8197NAT-SitagliptinNAT.81972026-02-27.8197185450mgTabTreatment of Type 2 diabetes in patients on maximally tolerated doses of metformin who have: . Inadequate glycemic control (defined as HbA1c greater than 0.07) and intolerance or contraindication to a sulfonylurea; OR . Inadequate glycemic control (HbA1c greater than 0.07) and on maximal doses of sulfonylurea and for whom insulin is not an option. JanuviaMFC3.40982013-09-27.8197Apo-SitagliptinAPX.81972026-01-30.8197PMS-SitagliptinPMS.81972025-01-31.8197Sandoz SitagliptinSDZ.81972023-03-31.8197Apo-Sitagliptin MalateAPX.81972022-12-21.8197Ach-SitagliptinACH.81972023-07-31.8197Teva-Sitagliptin MalateTEV.81972024-03-28.8197SitagliptinSIV.81972023-03-31.8197Auro-SitagliptinAUR.81972023-03-31.8197Taro-Sitagliptin FumarateTAR.81972023-03-31.8197Jamp SitagliptinJPC.81972023-03-31.8197SitagliptinSAI.81972025-02-28.8197Mint-SitagliptinMIN.81972026-03-31.8197NAT-SitagliptinNAT.81972026-02-27.81971855100mgTabTreatment of Type 2 diabetes in patients on maximal doses of metformin (2000mg/day)who have: . Inadequate glycemic control (defined as HbA1c greater than 0.07) and intolerance or contraindication to a sulfonylurea; or . Inadequate glycemic control (HbA1c greater than 0.07) and on maximal doses of a sulfonylurea and for whom insulin is not an option.JanuviaMFC3.40982010-06-14.8197Apo-SitagliptinAPX.81972026-01-30.8197PMS-SitagliptinPMS.81972025-01-31.8197Sandoz SitagliptinSDZ.81972023-03-31.8197Apo-Sitagliptin MalateAPX.81972022-12-21.8197Ach-SitagliptinACH.81972023-07-31.8197Teva-Sitagliptin MalateTEV.81972024-03-28.8197SitagliptinSIV.81972023-03-31.8197Auro-SitagliptinAUR.81972023-03-31.8197Taro-Sitagliptin FumarateTAR.81972023-03-31.8197Jamp SitagliptinJPC.81972023-03-31.8197NAT-SitagliptinNAT.81972026-02-27.8197SitagliptinSAI.81972025-02-28.8197Mint-SitagliptinMIN.81972026-03-31.8197SITAGLIPTIN & METFORMIN185650mg & 1000mgER TabTreatment of Type 2 diabetes in patients on maximally tolerated doses of metformin who have: . Inadequate glycemic control (defined as HbA1c greater than 0.07) and intolerance or contraindication to a sulfonylurea; OR . Inadequate glycemic control (HbA1c greater than 0.07) and on maximal doses of sulfonylurea and for whom insulin is not an option. Janumet XRMEK1.84962014-10-29.8893Apo-Sitagliptin/Metformin XRAPX.88932022-12-21.8893Sandoz Sitagliptin-Metformin XRSDZ.88932023-04-28.8893185750mg & 500mgER TabTreatment of Type 2 diabetes in patients on maximally tolerated doses of metformin who have: . Inadequate glycemic control (defined as HbA1c greater than 0.07) and intolerance or contraindication to a sulfonylurea; OR . Inadequate glycemic control (HbA1c greater than 0.07) and on maximal doses of sulfonylurea and for whom insulin is not an option.Janumet XRMEK1.84962016-12-22.8893Apo-Sitagliptin/Metformin XRAPX.88932022-12-21.8893Sandoz Sitagliptin-Metformin XRSDZ.88932023-04-28.88931858100mg & 1000mgER TabTreatment of Type 2 diabetes in patients on maximally tolerated doses of metformin who have: . Inadequate glycemic control (defined as HbA1c greater than 0.07) and intolerance or contraindication to a sulfonylurea; OR . Inadequate glycemic control (HbA1c greater than 0.07) and on maximal doses of sulfonylurea and for whom insulin is not an option.Janumet XRMEK3.69932016-12-221.7784Apo-Sitagliptin/Metformin XRAPX1.77852022-12-211.7784Sandoz Sitagliptin-Metformin XRSDZ1.77842023-04-281.7784185950mg & 1000mgTabTreatment of Type 2 diabetes in patients on maximally tolerated doses of metformin who have: . Inadequate glycemic control (defined as HbA1c greater than 0.07) and intolerance or contraindication to a sulfonylurea; OR . Inadequate glycemic control (HbA1c greater than 0.07) and on maximal doses of sulfonylurea and for whom insulin is not an option. JanumetMEK1.84962012-02-29.4446Apo-Sitagliptin-MetforminAPX.44462026-03-31.4446Sandoz Sitagliptin-MetforminSDZ.44462023-03-31.4446Apo-Sitagliptin Malate/Metformin HClAPX.44462022-12-21.4446Teva-Sitagliptin Malate / MetforminTEV.44462025-03-31.4446Sitagliptin-MetforminSIV.44462025-03-31.4446Reddy-Sitagliptin and Metformin HClDRR.44462025-04-30.4446Auro-Sitagliptin HCl and Metformin HClAUR.44462025-08-29.4446Jamp Sitagliptin HCl / MetforminJPC.44462025-08-29.4446186050mg & 500mgTabTreatment of Type 2 diabetes in patients on maximally tolerated doses of metformin who have: . Inadequate glycemic control (defined as HbA1c greater than 0.07) and intolerance or contraindication to a sulfonylurea; OR . Inadequate glycemic control (HbA1c greater than 0.07) and on maximal doses of sulfonylurea and for whom insulin is not an option.JanumetMEK1.84962012-02-29.4446Apo-Sitagliptin-MetforminAPX.44462026-03-31.4446Sandoz Sitagliptin-MetforminSDZ.44462023-03-31.4446Apo-Sitagliptin Malate/Metformin HClAPX.44462022-12-21.4446Teva-Sitagliptin Malate / MetforminTEV.44462025-03-31.4446Sitagliptin-MetforminSIV.44462025-03-31.4446Reddy-Sitagliptin and Metformin HClDRR.44462025-04-30.4446Auro-Sitagliptin HCl and Metformin HClAUR.44462025-08-29.4446Jamp Sitagliptin HCl / MetforminJPC.44462025-08-29.4446186150mg & 850mgTabTreatment of Type 2 diabetes in patients on maximally tolerated doses of metformin who have: . Inadequate glycemic control (defined as HbA1c greater than 0.07) and intolerance or contraindication to a sulfonylurea; OR . Inadequate glycemic control (HbA1c greater than 0.07) and on maximal doses of sulfonylurea and for whom insulin is not an option. JanumetMEK1.77852012-02-29.4446Apo-Sitagliptin-MetforminAPX.44462026-03-31.4446Sandoz Sitagliptin-MetforminSDZ.44462023-03-31.4446Apo-Sitagliptin Malate/Metformin HClAPX.44462022-12-21.4446Teva-Sitagliptin Malate / MetforminTEV.44462025-03-31.4446Sitagliptin-MetforminSIV.44462025-03-31.4446Reddy-Sitagliptin and Metformin HClDRR.44462025-04-30.4446Auro-Sitagliptin HCl and Metformin HClAUR.44462025-08-29.4446Jamp Sitagliptin HCl / MetforminJPC.44462025-08-29.4446ANTI-DIABETIC AGENTS INCRETIN MIMETICSINSULIN GLARGINE & LIXISENATIDE1862100U/mL & 33mcg/mLInj Sol-Pref Pen 5x3mL PkAs an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus inadequately controlled on basal insulin (less than 60 units daily) in combination with metformin.SoliquaSAC198.37002019-12-20198.3700SEMAGLUTIDE18630.68mg/mLInj Sol - Pref Pen 3mL PkOzempicNOO227.94002024-01-31227.9400For the treatment of adult patients with type 2 diabetes when adequate glycemic control is not achieved on the maximum tolerated dose of metformin or where metformin is contraindicated or inappropriate. Semaglutide is not funded in combination with another glucagon-like peptide-1 receptor agonist (GLP-1 RA) or dipeptidyl peptidase-4 (DPP-4) inhibitor. Injectable semaglutide is not funded in combination with oral semaglutide. Coverage is only provided for one dosage format. Reimbursed dose: As per the product monographLU Authorization Period: Indefinite18641.34mg/mLInj Sol-Pref Pen 1.5mL PkOzempicNOO227.94002019-09-30227.9400For the treatment of adult patients with type 2 diabetes when adequate glycemic control is not achieved on the maximum tolerated dose of metformin or where metformin is contraindicated or inappropriate. Semaglutide is not funded in combination with another glucagon-like peptide-1 receptor agonist (GLP-1 RA) or dipeptidyl peptidase-4 (DPP-4) inhibitor. Injectable semaglutide is not funded in combination with oral semaglutide. Coverage is only provided for one dosage format. Reimbursed dose: As per the product monographLU Authorization Period: Indefinite18651.34mg/mLInj Sol-Pref Pen 3mL PkOzempicNOO227.94002019-09-30227.9400For the treatment of adult patients with type 2 diabetes when adequate glycemic control is not achieved on the maximum tolerated dose of metformin or where metformin is contraindicated or inappropriate. Semaglutide is not funded in combination with another glucagon-like peptide-1 receptor agonist (GLP-1 RA) or dipeptidyl peptidase-4 (DPP-4) inhibitor. Injectable semaglutide is not funded in combination with oral semaglutide. Coverage is only provided for one dosage format. Reimbursed dose: As per the product monographLU Authorization Period: Indefinite18661.5mgTabRybelsusNOO7.53032026-03-317.5303For the treatment of adult patients with type 2 diabetes when adequate glycemic control is not achieved on the maximum tolerated dose of metformin or where metformin is contraindicated or inappropriate. Semaglutide is not funded in combination with another glucagon like peptide-1 receptor agonist (GLP-1 RA) or dipeptidyl peptidase-4 (DPP-4) inhibitor. Oral semaglutide is not funded in combination with injectable semaglutide. Coverage is only provided for one dosage format. Maximum reimbursed dose: 1.5mg once daily.LU Authorization Period: Indefinite18673mgTabRybelsusNOO7.53032023-12-297.5303For the treatment of adult patients with type 2 diabetes when adequate glycemic control is not achieved on the maximum tolerated dose of metformin or where metformin is contraindicated or inappropriate. Semaglutide is not funded in combination with another glucagon like peptide-1 receptor agonist (GLP-1 RA) or dipeptidyl peptidase-4 (DPP-4) inhibitor. Oral semaglutide is not funded in combination with injectable semaglutide. Coverage is only provided for one dosage format. Maximum reimbursed dose: 3mg once daily.LU Authorization Period: Indefinite18684mgTabRybelsusNOO7.53032026-03-317.5303For the treatment of adult patients with type 2 diabetes when adequate glycemic control is not achieved on the maximum tolerated dose of metformin or where metformin is contraindicated or inappropriate. Semaglutide is not funded in combination with another glucagon like peptide-1 receptor agonist (GLP-1 RA) or dipeptidyl peptidase-4 (DPP-4) inhibitor. Oral semaglutide is not funded in combination with injectable semaglutide. Coverage is only provided for one dosage format. Maximum reimbursed dose: 4mg once daily.LU Authorization Period: Indefinite18697mgTabRybelsusNOO7.53032023-12-297.5303For the treatment of adult patients with type 2 diabetes when adequate glycemic control is not achieved on the maximum tolerated dose of metformin or where metformin is contraindicated or inappropriate. Semaglutide is not funded in combination with another glucagon like peptide-1 receptor agonist (GLP-1 RA) or dipeptidyl peptidase-4 (DPP-4) inhibitor. Oral semaglutide is not funded in combination with injectable semaglutide. Coverage is only provided for one dosage format. Maximum reimbursed dose: 7mg once daily.LU Authorization Period: Indefinite18709mgTabRybelsusNOO7.53032026-03-317.5303For the treatment of adult patients with type 2 diabetes when adequate glycemic control is not achieved on the maximum tolerated dose of metformin or where metformin is contraindicated or inappropriate. Semaglutide is not funded in combination with another glucagon like peptide-1 receptor agonist (GLP-1 RA) or dipeptidyl peptidase-4 (DPP-4) inhibitor. Oral semaglutide is not funded in combination with injectable semaglutide. Coverage is only provided for one dosage format. Maximum reimbursed dose: 9mg once daily.LU Authorization Period: Indefinite187114mgTabRybelsusNOO7.53032023-12-297.5303For the treatment of adult patients with type 2 diabetes when adequate glycemic control is not achieved on the maximum tolerated dose of metformin or where metformin is contraindicated or inappropriate. Semaglutide is not funded in combination with another glucagon like peptide-1 receptor agonist (GLP-1 RA) or dipeptidyl peptidase-4 (DPP-4) inhibitor. Oral semaglutide is not funded in combination with injectable semaglutide. Coverage is only provided for one dosage format. Maximum reimbursed dose: 14mg once daily.LU Authorization Period: IndefiniteANTI-DIABETIC AGENTS INSULINS (RAPID ACTING)INSULIN (ZINC CRYSTALLINE) HUMAN BIOSYNTHETIC (RDNA ORIGIN)18721000U/10mLInj Sol-10mL PkHumulin RegularLIL29.98001996-10-0129.98001873100U/mLInj Sol-5x3mL PkHumulin RLIL60.00001998-12-1560.0000INSULIN ASPART1874100U/mLInj Sol-10mL PkNovoRapidNOO32.62002003-09-0432.6200Patient uses an insulin pump that has not been declared compatible with a funded biosimilar version by the insulin pump manufacturer's product labeling.LU Authorization Period: 1 year1875100U/mLInj Sol-10mL Vial PkTrurapiSAC22.64302023-11-3022.64301876100U/mLInj Sol-5x3mL Cart PkTrurapiSAC45.00002021-09-3045.00001877100U/mLInj Sol-5X3mL Pref Pen PkKirstyBSB42.71252023-01-3142.71251878100U/mLInj Sol-5x3mL SoloSTAR Pref Pen PkTrurapiSAC45.00002021-09-3045.0000INSULIN GLULISINE (DNA ORIGIN)1879100U/mLInj 5x3mL Cart ClickStar PenFor the treatment of patients with Type 1 diabetes mellitus. For the treatment of patients with Type 2 diabetes mellitus using insulin in an intensive regimen with 3 or more injections per day or an insulin pump. For the treatment of patients with Type 2 diabetes mellitus who are either experiencing recurrent hypoglycemia OR are unable to achieve adequate post-prandial glucose control while on less intensive regimen of regular insulin (1-2 injections per day).ApidraSAV55.95002010-06-1455.95001880100U/mLInj Sol-10mL VialNote: For the treatment of patients with Type 1 diabetes mellitus. For the treatment of patients with Type 2 diabetes mellitus using insulin in an intensive regimen with 3 or more injections per day or an insulin pump. For the treatment of patients with Type 2 diabetes mellitus who are either experiencing recurrent hypoglycemia OR are unable to achieve adequate post-prandial glucose control while on less intensive regimen of regular insulin (1-2 injections per day). ApidraSAV28.24002009-08-1828.24001881100U/mLInj Sol-5x3mL SoloSTAR Pref PenFor the treatment of patients with Type 1 diabetes mellitus. For the treatment of patients with Type 2 diabetes mellitus using insulin in an intensive regimen with 3 or more injections per day or an insulin pump. For the treatment of patients with Type 2 diabetes mellitus who are either experiencing recurrent hypoglycemia OR are unable to achieve adequate post-prandial glucose control while on less intensive regimen of regular insulin (1-2 injections per day). ApidraSAV56.49002009-08-1856.4900INSULIN HUMAN BIOSYNTHETIC18821000U/10mLInj Sol-10mL PkNovolin ge TorontoNOO25.73001996-10-0125.73001883100U/mLInj Sol-5x3mL PkNovolin ge Toronto PenfillNOO50.55001998-12-1550.5500INSULIN INJECTION, HUMAN BIOSYNTHETIC1884500U/mLInj Sol-Pref Pen 2x3mL PkEntuzity KwikPenLIL116.50002022-04-29116.5000INSULIN LISPRO1885100U/mLInj Sol-10mL PkHumalogLIL37.15001998-12-3137.1500Patient uses an insulin pump that has not been declared compatible with a funded biosimilar version by the insulin pump manufacturer's product labeling.LU Authorization Period: 1 year1886100U/mLInj Sol-10mL Vial PkAdmelogSAC22.70002020-12-1822.70001887100U/mLInj Sol-5x3mL Cart PkAdmelogSAC45.00002020-12-1845.00001888100U/mLInj Sol-5x3mL SoloSTAR Pref Pen PkAdmelogSAC45.00002020-12-1845.00001889200U/mLInj Sol-Pref Pen 5x3mL PkNote: For the treatment of patients with Type 1 diabetes mellitus. For the treatment of patients with Type 2 diabetes mellitus using insulin in an intensive regimen with 3 or more injections per day. For the treatment of patients with Type 2 diabetes mellitus who are either experiencing recurrent hypoglycemia OR are unable to achieve adequate post-prandial glucose control while on less intensive regimen of regular insulin (1-2 injections per day).Humalog 200 units/mL KwikPenLIL136.44002016-07-28136.4400ANTI-DIABETIC AGENTS INSULINS (INTERMEDIATE ACTING)INSULIN (ISOPHANE) HUMAN BIOSYNTHETIC18901000U/10mLInj Susp-10mL PkNovolin ge NPHNOO26.32001996-10-0126.32001891100U/mLInj Susp-5x3mL PkNovolin ge NPH PenfillNOO51.75001998-12-1551.7500INSULIN (ISOPHANE) HUMAN BIOSYNTHETIC (RDNA ORIGIN)18921000U/10mLInj Susp-10mL PkHumulin NPHLIL29.98001996-10-0129.98001893100U/mLInj Susp-5x3mL PkHumulin NLIL60.00001998-12-1560.0000ANTI-DIABETIC AGENTS INSULINS (LONG ACTING)INSULIN DEGLUDEC1894100U/mLInj Sol-3X5mL Cart PkTresibaNOO116.56002023-07-31116.56001895200U/mLInj Sol-Flextouch Pref Pen 3x3mL PkTresibaNOO139.88002018-09-27139.88001896100U/mLInj Sol-Flextouch Pref Pen 5x3mL PkTresibaNOO116.56002018-09-27116.5600INSULIN DETEMIR1897100U/mLInj Sol-5x3mL PkLevemir PenfillNOO116.76002009-06-23116.76001898100U/mLInj Sol-Pref Disp Pen 5X3mL PkLevemir FlextouchNOO115.29002014-07-30115.2900INSULIN GLARGINE1899300U/mLInj Sol-1.5mL Pref PenTOUJEO SoloSTARSAC26.43332018-09-2726.43331900100U/mLInj Sol-10mL Vial PkLantus-(Vial)SAV61.69002008-12-0361.6900Patient requires insulin therapy and is unable to use the insulin pen.LU Authorization Period: 1 year1901100U/mLInj Sol-3mL Pref PenSemgleeBSB12.76682022-12-2112.76681902300U/mLInj Sol-3mL Pref PenToujeo DoubleSTARSAC52.86662020-09-3052.86661903100U/mLInj Sol-Cartridge 5x3mL PkBasaglarLIL84.70002017-08-3084.70001904100U/mLInj Sol-KwikPen (80U) Pref Pen 5x3mL PkBasaglarLIL84.70002019-03-2884.7000ANTI-DIABETIC AGENTS INSULINS (PRE-MIXED)INSULIN (30% NEUTRAL & 70% ISOPHANE) HUMAN BIOSYNTHETIC19051000U/10mLInj Susp-10mL PkNovolin ge 30/70NOO26.45001996-10-0126.45001906100U/mLInj Susp-5x3mL PkNovolin ge 30/70 PenfillNOO50.01001998-12-1550.0100INSULIN ASPART 30% & INSULIN ASPART PROTAMINE 70%1907100U/mLInj Susp-5x3mL PkNovoMix 30 PenfillNOO60.67002007-11-1060.6700INSULIN HUMAN BIOSYNTHETIC 30% & ISOPHANE 70%19081000U/10mLInj Susp-10mL PkHumulin 30/70LIL29.98001996-10-0129.98001909100U/mLInj Susp-5x3mL PkHumulin 30/70LIL60.00001998-12-1560.0000INSULIN LISPRO & INSULIN LISPRO PROTAMINE191025% & 75%Inj Susp-5x3mL PkHumalog Mix25LIL74.69002000-04-1774.6900191125% & 75%Inj Susp-5x3mL PkHumalog Mix25 KwikpenLIL74.14002014-01-0374.1400191250% & 50%Inj Susp-5x3mL PkHumalog Mix50LIL73.55002008-08-2873.5500191350% & 50%Inj Susp-5x3mL PkHumalog Mix50 KwikpenLIL72.90002014-04-3072.9000PARATHYROID AGENTSCALCITONIN (SALMON SYNTHETIC)1914100IU/mLInj Sol-1mL PkCaltine 100FEI7.82001996-10-017.82001915400IU/2mLInj Sol-2mL PkCalcimarSAV65.44001996-10-0165.4400TERIPARATIDE1916250mcg/mLInj Sol-2.4mL Pref PenTeva-Teriparatide InjectionTEV535.47002020-07-31535.4700Apo-Teriparatide InjectionAPX535.47002025-01-31535.4700ForteoLIL1238.84002020-07-31535.4700For the treatment of osteoporosis in patients at a high risk of fragility fractures who meet ALL the following criteria: - 65 years of age or older; AND - Has a documented bone mineral density [BMD] T-score of less than or equal to -3; AND - Has a history of prior fragility fracture(s); AND - Has used an anti-resorptive agent for osteoporosis which resulted in osteonecrosis of the jaw and/or an atypical femur fracture. Note: The maximum lifetime exposure to teriparatide for an individual patient is 24 monthsLU Authorization Period: 2 years1917250mcg/mLInj Sol-3mL Cart PkOsnuvoAVP565.26002022-09-29565.2600For the treatment of osteoporosis in patients at a high risk of fragility fractures who meet ALL the following criteria: - 65 years of age or older; AND - Has a documented bone mineral density [BMD] T-score of less than or equal to -3; AND - Has a history of prior fragility fracture(s); AND - Has used an anti-resorptive agent for osteoporosis which resulted in osteonecrosis of the jaw and/or an atypical femur fracture. Note: The maximum lifetime exposure to teriparatide for an individual patient is 24 monthsLU Authorization Period: 2 yearsPITUITARY AGENTSDESMOPRESSIN ACETATE19184mcg/mLInj Sol-1mL Amp PkDDAVPRIP2021-12-17BipazenKVR9.00002021-12-179.000019190.1mg/mLNas Sol-2.5mL PkDDAVPFEI52.03751996-10-0152.0375192010mcg/Metered DoseNas Sp-2.5mL PkDDAVPFEI1996-10-01Desmopressin SprayAAP42.16612002-07-2942.16611921240mcgOrally Disintegrating TabDDAVP MeltFEI3.93822010-06-143.9382192260mcgOrally Disintegrating TabDDAVP MeltFEI1.49902007-06-061.49901923120mcgOrally Disintegrating TabDDAVP MeltFEI2.99902007-06-062.999019240.1mgTabDDAVPFEI1.32171997-08-28.6609Apo-DesmopressinAPX.66092007-04-02.6609PMS-DesmopressinPMS.66092010-04-23.660919250.2mgTabDDAVPFEI2.64341997-08-281.3217Apo-DesmopressinAPX1.32172007-04-021.3217PMS-DesmopressinPMS1.32172010-04-231.3217THYROTROPIN ALFA19260.9mg/mLInj Pd-2x1.1mg Vial PkThyrogenGZM1887.42002003-04-161887.4200PROGESTOGENS AND ORAL CONTRACEPTIVESCYPROTERONE ACETATE & ETHINYL ESTRADIOL19272mg & 0.035mgTab-21 PkDiane-35BAY2007-12-19Cyestra-35PAL23.33942007-12-19Teva-Cyproterone/Ethinyl EstradiolTEV23.34002008-12-03Ran-Cyproterone/Ethinyl EstradiolRAN23.33942015-05-28Cleo-35ALH23.33942024-10-31DESOGESTREL & ETHINYL ESTRADIOL19280.15mg & 0.03mgTab-21 PkMarvelon 21ORG22.16001996-10-015.2773Apri 21BAR5.27732009-04-015.2773Freya 21FAM5.27732013-05-315.2773Mirvala 21APX5.27732014-01-305.2773Miley 21AMB5.27732025-10-315.277319290.15mg & 0.03mgTab-28 PkMarvelon 28ORG22.16001996-10-015.2780Apri 28BAR5.27802009-04-015.2780Freya 28FAM5.27802013-05-315.2780Mirvala 28APX5.27802014-01-305.2780Miley 28AMB5.27802025-10-315.278019303 PhaseTabs-21 PkLinessa 21ASN20.25002012-12-2120.250019313 PhaseTabs-28 PkLinessa 28ASN20.25002012-12-2120.2500DIENOGEST19322mgTabVisanneBAH2.18762012-07-27.5115Aspen-DienogestASI.51152020-06-30.5115Jamp DienogestJPC.51152021-02-26.5115M-DienogestMAT.51152024-06-28.5115Mar-DienogestMAR.51152025-08-29.5115For the management of pelvic pain associated with endometriosis in patients for whom one or more less costly options are either ineffective or cannot be used. Note: For example for patients who are refractory to 6 months of continuous combined oral contraceptives and/or medroxyprogesterone therapy OR have contraindications to these therapies.LU Authorization Period: 1 yearDROSPIRENONE19334mgTab-28 Tab PkSlyndDUI12.66002024-11-2912.6600DROSPIRENONE & ETHINYL ESTRADIOL19343.0mg & 0.03mgTab-21 PkYasmin 21BAH12.44002007-06-066.2181Zamine 21APX6.21812013-10-316.2181Drospirenone&Ethinyl Estradiol USP 21GLP6.21812022-08-316.218119353.0mg & 0.02mgTab-28 PkYazBAH16.52002009-09-308.2600MYAAPX8.26002014-08-288.2600Drospirenone&Ethinyl Estradiol USPGLP8.26002022-09-298.260019363.0mg & 0.03mgTab-28 PkYasmin 28BAH12.44002007-06-066.2188Zamine 28APX6.21882013-10-316.2188Drospirenone&Ethinyl Estradiol USP 28GLP6.21882022-08-316.2188ETHINYL ESTRADIOL & LEVONORGESTREL193720mcg & 100mcgTab-21 PkAlesse 21PFI15.77001998-12-313.9425Aviane 21TEV3.94252008-01-153.9425Alysena 21APX3.94252012-11-273.9425Laylaa 21LUP3.94252025-11-283.9425Audrina 21JPC3.94252023-08-313.942519380.03mg & 0.15mgTab-21 PkMin-Ovral 21PFI19.29001996-10-017.2800Portia 21BAR10.66002007-10-037.2800Ovima 21APX7.28002014-01-037.280019393 PhaseTab-21 PkTriquilar 21BAY15.75001996-10-0115.7500194020mcg & 100mcgTab-28 PkAlesse 28PFI15.77001998-12-313.9425Aviane 28TEV3.94252008-01-153.9425Alysena 28APX3.94252012-11-273.9425Laylaa 28LUP3.94252025-11-283.9425Audrina 28JPC3.94252023-08-313.942519410.03mg & 0.15mgTab-28 PkMin-Ovral 28PFI19.29001996-10-017.2800Portia 28BAR10.66002007-10-037.2800Ovima 28APX7.28002014-01-037.280019423 PhaseTab-28 PkTriquilar 28BAY15.75001996-10-0115.750019430.03mg & 0.15mgTab-91 PkSeasonaleTEW2016-11-30IndayoMYL45.95502016-11-30ETHINYL ESTRADIOL & NORETHINDRONE19440.035mg & 0.5mgTab-21 PkBreviconPFI16.45001996-10-0116.450019450.035mg & 1mgTab-21 PkBrevicon 1/35PFI16.45001996-10-0116.450019463 PhaseTab-21 PkSynphasicPFI13.64001996-10-0113.640019470.035mg & 0.5mgTab-28 PkBreviconPFI16.45001996-10-0116.450019480.035mg & 1mgTab-28 PkBrevicon 1/35PFI16.45001996-10-0116.450019493 PhaseTab-28 PkSynphasicPFI13.64001996-10-0113.6400ETHINYL ESTRADIOL & NORETHINDRONE ACETATE19500.02mg & 1mgTab-21 PkMinestrin 1/20WAR16.99151996-10-0116.991519510.03mg & 1.5mgTab-21 PkLoestrin 1.5/30WAR16.99151996-10-0116.991519520.02mg & 1mgTab-28 PkMinestrin 1/20WAR16.99151996-10-0116.991519530.03mg & 1.5mgTab-28 PkLoestrin 1.5/30WAR16.99151996-10-0116.9915LEVONORGESTREL19541.5mgTab-1 Tab PkPlan BTBP17.20002016-09-294.3000Contingency OneMYL4.30002017-02-284.3000Backup Plan OnestepAPX4.30002017-06-294.3000MyStepJPC4.30002025-08-294.3000MEDROXYPROGESTERONE ACETATE1955150mg/mLInj Sol-1mL Pref SyrDepo-ProveraPFI31.69002021-05-3131.69001956150mg/mLInj Sol-1mL Pref SyrDepo-ProveraPFI34.14002022-08-3134.140019572.5mgTabProveraPFI.25671996-10-01.1301AA-MedroxyAAP.13012003-01-30.130119585mgTabProveraPFI.52741996-10-01.2602AA-MedroxyAAP.26022003-01-30.2602195910mgTabProveraPFI1.02711996-10-01.5649AA-MedroxyAAP.56492007-03-09.56491960100mgTabProveraPFI1996-10-01AA-MedroxyAAP1.20572005-10-061.2057NORETHINDRONE19610.35mgTab-28 PkMicronorJAN1996-10-01MovisseMYL10.99002016-03-3010.9900JencyclaLUP10.99002016-05-3110.9900NORGESTIMATE & ETHINYL ESTRADIOL19623 PhaseTab-21 PkTri-CyclenJAN1996-10-01Tri-Jordyna 21GLP14.39002020-10-3014.3900Tri-Cira 21APX14.39002021-04-3014.390019633 PhaseTab-21 PkTri-Cyclen LoJAN2008-02-12Tricira Lo (21 Day)APX13.39002014-07-3013.390019643 PhaseTab-28 PkTri-CyclenJAN1996-10-01Tri-Jordyna 28GLP14.39002020-05-2914.3900Tri-Cira 28APX14.39002021-04-3014.390019653 PhaseTab-28 PkTri-Cyclen LoJAN2008-02-12Tricira Lo (28 Day)APX13.39002014-07-3013.3900PROGESTERONE1966100mgCapPrometriumOCI2015-07-29Teva-ProgesteroneTEV1.43582015-07-291.4358Reddy-ProgesteroneDRR1.43582018-04-301.4358PMS-ProgesteronePMS1.43582018-11-291.4358Auro-ProgesteroneAUR1.43582020-05-291.4358ProgesteroneSAI1.43582021-11-301.4358M-ProgesteroneMAT1.43582025-09-291.4358THYROIDSLEVOTHYROXINE (SODIUM)19670.137mgTabSynthroidBGP2025-04-30Apo-LevothyroxineAPX.19062025-04-3019680.025mgTabSynthroidABB.11531996-10-01.0597Apo-LevothyroxineAPX.05972025-04-30.059719690.05mgTabSynthroidABB.07921996-10-01.0373EltroxinASN.03731997-07-12.0373Apo-LevothyroxineAPX.03732025-04-30.037319700.075mgTabSynthroidABB.12471996-10-01.0646Apo-LevothyroxineAPX.06462025-04-30.064619710.088mgTabSynthroidABB.12471996-12-19.0646Apo-LevothyroxineAPX.06462025-04-30.064619720.1mgTabSynthroidABB.09771996-10-01.0460EltroxinASN.04601997-07-12.0460Apo-LevothyroxineAPX.04602025-04-30.046019730.112mgTabSynthroidABB.13171996-10-01.0682Apo-LevothyroxineAPX.06822025-04-30.068219740.125mgTabSynthroidABB.13331996-10-01.0690Apo-LevothyroxineAPX.06902025-04-30.069019750.15mgTabSynthroidABB.10511996-10-01.0495EltroxinASN.04951997-01-20.0495Apo-LevothyroxineAPX.04952025-04-30.049519760.175mgTabSynthroidABB.14291996-10-01.0740Apo-LevothyroxineAPX.07402025-04-30.074019770.2mgTabSynthroidABB.11161996-10-01.0526EltroxinASN.05261997-01-20.0526Apo-LevothyroxineAPX.05262025-04-30.052619780.3mgTabSynthroidABB.15391996-10-01.0797Apo-LevothyroxineAPX.07972025-04-30.0797LIOTHYRONINE (SODIUM)19795mcgTabCytomelSKB2020-09-30Teva-LiothyronineTEV1.15872020-09-301.1587Auro-LiothyronineAUR1.15872025-11-281.1587ZDS-LiothyronineZDS1.15872026-01-301.1587198025mcgTabCytomelSKB2020-09-30Teva-LiothyronineTEV1.25952020-09-301.2595Auro-LiothyronineAUR1.25952025-11-281.2595ZDS-LiothyronineZDS1.25952026-01-301.2595PROPYLTHIOURACIL198150mgTabPTUPHB.50002020-07-31.5000198250mgTabPropylthiouracilACP.50002021-07-30.5000198350mgTabHalycilHAL.50002022-06-30.5000198450mgTabPropylthiouracil TabletsPHB.50002022-12-21.5000ANTI-THYROIDSMETHIMAZOLE19855mgTabTapazolePAL.36961996-10-01.1531Mar-MethimazoleMAR.15312018-12-21.1531Jamp MethimazoleJPC.15312020-10-30.1531198610mgTabTapazolePAL2018-12-21Mar-MethimazoleMAR.51812018-12-21Jamp MethimazoleJPC.51812020-10-30SKIN AND MUCOUS MEMBRANE PREPARATIONSANTI-INFECTIVES ANTIBIOTICSCLINDAMYCIN19871%Top SolDalacin T 1%PFI2017-03-28Taro-ClindamycinTAR.50722017-03-28CLINDAMYCIN PHOSPHATE & ADAPALENE & BENZOYL PEROXIDE19881.2% w/w & 0.15% w/w & 3.1% w/wTop Gel PumpCabtreoBHC3.00742025-06-303.0074For the treatment of acne vulgaris in patients 12 years of age and older.LU Authorization Period: 1 yearCLINDAMYCIN PHOSPHATE & BENZOYL PEROXIDE19891% & 5%GelClindoxylSTI.75002003-04-16.6857Taro-Clindamycin/Benzoyl Peroxide GelTAR.68572016-02-25.685719901% & 5%Top GelBenzaClin Topical GelVAL1.31692006-01-12.7422Taro-Benzoyl Peroxide / Clindamycin KitTAR.74222017-09-28.7422FUSIDIC ACID19912%CrFucidinLEO1.12021996-10-01.5676Taro-Fusidic AcidTAR.56762024-07-31.5676MUPIROCIN19922%OintBactrobanGCH1996-10-01Taro-MupirocinTAR.50692007-01-02.5069MUPIROCIN CALCIUM19932% w/wCrStramucinGLP1.60002020-09-301.6000SODIUM FUSIDATE19942%OintFucidinLEO1.12021996-10-011.1202ANTI-INFECTIVES ANTIVIRALSACYCLOVIR19955%Top OintZoviraxVAL1996-10-01Apo-Acyclovir OintmentAPX12.31142019-05-31Taro-AcyclovirTAR12.31142022-04-29ANTI-INFECTIVES FUNGICIDESDue to its efficacy and significantly lower cost, clotrimazole should be the first line of treatment for Tinea corporis and cruris. In Tinea pedis, topical terbinafine should be considered the first line of treatment due to its efficacy and lower rate of relapse.CICLOPIROX19968% W/WTop SolPenlacVAL2017-01-31Apo-CiclopiroxAPX7.74332017-01-31Taro-CiclopiroxTAR7.74332017-03-28CLOTRIMAZOLE199710mg/gCrClotrimadermTAR.22331996-10-01.2233Canesten 1% Topical CreamBAY1996-10-011998500mg & 1%Tab & CrCanesten 1 Comfortab Combi-PakBAY12.08002007-01-0212.0800199910mg/gVag Cr-AppClotrimaderm Vaginal CreamTAR.18121996-10-01.1812Canesten 6 CreamBAY.22121996-10-01.1812200020mg/gVag Cr-AppClotrimaderm Vaginal CreamTAR.36241996-10-01.3624Canesten 3 CreamBAY.44241996-10-01.3624CLOTRIMAZOLE & BETAMETHASONE DIPROPIONATE20011% w/w & 0.05% w/wTop CrLotriderm CreamMEK2020-06-30TaroClotrimazole/BetamethasoneDipropionaTAR1.08322020-06-30FLUCONAZOLE2002150mgCapDiflucan-150PFI15.76971998-12-313.9424Apo-Fluconazole-150APX3.94242001-03-073.9424Riva-FluconazoleRIA3.94242024-04-303.9424Mar-Fluconazole-150MAR3.94242017-01-313.9424Jamp-FluconazoleJPC3.94242015-03-313.9424Priva-FluconazolePHP3.94242021-06-303.9424Fluconazole-150SAI3.94242022-07-293.9424Jamp Fluconazole 150mgJPC3.94242025-04-303.9424For the treatment of vaginal candidiasis. Dose: 150mg orally once daily for 1 day.Repeats within a 25 day period will not be reimbursed.LU Authorization Period: 1 yearKETOCONAZOLE20032%CrNizoralJAN1996-10-01KetodermTAR.40432004-04-06.4043MICONAZOLE NITRATE20042%CrMicatinWEL.29701996-10-01.2970NYSTATIN2005100000U/gCrMycostatinBQUNystatin is not effective in the treatment of Dermatophyte infections or Tinea versicolor. 1996-10-01NyadermTAR.2037Nystatin is not effective in the treatment of Dermatophyte infections or Tinea versicolor. 1996-10-01.20372006100000U/gOintMycostatinBQUNystatin is not effective in the treatment of Dermatophyte infections or Tinea versicolor.1996-10-01Ratio-NystatinRPH.1277Nystatin is not effective in the treatment of Dermatophyte infections or Tinea versicolor. 1997-10-31.1277200725000U/gVag CrMycostatinBQU1996-10-01NyadermTAR.08341996-10-01.08342008100000U/gVag CrRatio-NystatinRPH.31911997-10-31.3191TERBINAFINE HCL20091%CrLamisilNOV.65961996-10-01.6596TERCONAZOLE20100.4%Vag CrTerazol 7JAN1996-10-01Taro-TerconazoleTAR.63542005-06-13.6354ANTI-INFECTIVES PARASITICIDESDIMETHICONE.201150% w/wTop Sol-50mL PkNYDAGPB22.42002013-10-3122.4200ISOPROPYL MYRISTATE201250%Top Sol-120mL PkResultzMEF12.65002008-02-1212.6500201350%Top Sol-240mL PkResultzARZ24.66002008-02-1224.6600PERMETHRIN20145%CrNix Dermal CreamHLN.49771998-10-21.497720151%Cr RinseNix Creme RinseIPL.17011996-10-01.170120161%Cr RinseKwellada-P Creme RinseMEP.17492000-01-17.174920175%LotKwellada-P LotionMEP.50531998-12-31.5053PYRETHRINS & PIPERONYL BUTOXIDE20180.33% & 3%Topical ShampooR & C Shampoo with ConditionerMEP.11101997-04-10.1110ANTI-INFECTIVES OTHER ANTI-INFECTIVESMETRONIDAZOLE20191%Top CrNoritateVAL.81491997-04-10.814920201%Top GelMetrogelGAC.72352010-03-02.7235202110%Vag Cr-AppFlagylSAV.27401996-10-01.2740METRONIDAZOLE & NYSTATIN2022500mg & 100000U/gVag Cr-AppFlagystatinSAV.60761996-10-01.60762023500mg & 100000UVag SupFlagystatinSAV3.69801996-10-013.6980POVIDONE - IODINE202410%Top SolBetadinePFP1996-10-01ProviodineROG1996-10-01SILVER SULFADIAZINE20251%CrFlamazineSNE.1320The listing of Flamazine 1% Cr (DIN 00323098) is for the 500g jar package format.1996-10-01.132020261%Cr-50g PkFlamazineSNE10.96001999-09-1510.9600ANTI-INFLAMMATORYAMCINONIDE20270.1%CrCyclocortSTI1998-03-17Taro-AmcinonideTAR.45222004-04-06.4522BECLOMETHASONE DIPROPIONATE20280.025%CrPropadermVAL.60881998-11-17.608820290.025%OintPropadermGLA.40381996-10-01.4038BETAMETHASONE DIPROPIONATE20300.05%CrDiprosoneOCI.21741996-10-01.2048Taro-SoneTAR.20481996-10-01.204820310.05%LotDiprosoneOCI.21001996-10-01.1980Ratio-TopisoneRPH.19801996-10-01.198020320.05%OintDiprosoneOCI.22841996-10-01.2152Ratio-TopisoneRPH.21521996-10-01.2152BETAMETHASONE DIPROPIONATE IN A BASE CONTAINING PROPYLENE GLYCOL20330.05%OintDiproleneOCI.51861996-10-01.5186Ratio-TopileneRPH.5186No more than 50 grams per week of ultrapotent steroids for a maximum of 2 weeks is recommended.1996-10-01.5186BETAMETHASONE DIPROPIONATE IN PROPYLENE GLYCOL BASE20340.05%CrDiprolene GlycolSCH.5186No more than 50 grams per week of ultrapotent steroids for a maximum of 2 weeks is recommended.1996-10-01.5186Ratio-TopileneRPH.5186No more than 50 grams per week of ultrapotent steroids for a maximum of 2 weeks is recommended. 1996-10-01.5186BETAMETHASONE VALERATE20350.05%CrBetnovate-1/2GLA1996-10-01Ratio-Ectosone MildRPH.06111996-10-01.0596BetadermTAR.05961996-10-01.059620360.1%CrBetnovateGLA1996-10-01Ratio-Ectosone RegularRPH.09111996-10-01.0889BetadermTAR.08891996-10-01.0889Celestoderm-VVAE.08892012-04-24.088920370.05%LotRatio-Ectosone MildRPH.28471996-10-01.2847Betnovate-1/2RBT1996-10-0120380.1%LotRatio-Ectosone RegularRPH.31251996-10-01.3125BetnovateSHI1996-10-0120390.05%OintBetnovate-1/2GLA1996-10-01BetadermTAR.05961996-10-01.0596Celestoderm-V/2VAE.05962012-04-24.059620400.1%OintBetnovateGLA1996-10-01BetadermTAR.08891996-10-01.0889Celestoderm-VVAE.08892012-04-24.088920410.1%Scalp LotValisoneVAE1996-10-01BetadermTAR.12711996-10-01.1271CALCIPOTRIOL & BETAMETHASONE DIPROPIONATE204250mcg/g & 0.5mg/gOintNote: For use in patients with psoriasis who have failed 1st line topical steroids and Dovonex (calcipotriol) therapy.DovobetLEO2.19182008-05-161.2545Teva-Betamethasone/CalcipotriolTEV1.25452021-04-301.2545204350mcg/g & 0.5mg/gTop Aero FoamFor the treatment of moderate to severe scalp psoriasis in patients who have failed first-line topical corticosteroid therapy. For the treatment of mild to moderate body psoriasis in patients who have failed first-line topical corticosteroid therapy and Dovonex (calcipotriol) therapy.EnstilarLEO1.64122018-10-311.6412204450mcg/g & 0.5mg/gTop GelNotes: For the treatment of moderate to severe scalp psoriasis in patients who have failed first-line topical corticosteroid therapy. For the treatment of mild to moderate body psoriasis in patients who have failed first-line topical corticosteroid therapy and Dovonex (calcipotriol) therapy. Dovobet GelLEO2.18672011-05-191.3142Taro-Calcipotriol / Betamethasone GelTAR1.31422022-06-301.3142CLOBETASOL PROPIONATENo more than 50 grams per week of ultrapotent steroids for a maximum of 2 weeks is recommended.20450.05%CrTeva-ClobetasolTEV.22791996-10-01.2279Mylan-ClobetasolMYL.22791996-10-01.2279DermovateTPH1.02031998-05-21.2279Taro-Clobetasol Cream USPTAR.22792003-01-30.227920460.05%OintTeva-ClobetasolTEV.22791996-10-01.2279Mylan-ClobetasolMYL.22791996-10-01.2279DermovateTPH1.02031998-05-02.2279Taro-Clobetasol Ointment USPTAR.22792003-01-30.227920470.05%Scalp LotDermovateTPH.81842003-01-30.3996Mylan-Clobetasol Scalp ApplicationMYL.39961996-10-01.3996Taro-Clobetasol Topical Solution USPTAR.39962003-01-30.399620480.05% w/wTop ShampooClobex ShampooGAC2020-12-18Taro-Clobetasol ShampooTAR1.08382020-12-18Reddy-Clobetasol ShampooDRR1.08382021-11-3020490.05% w/wTop Sol SpClobex SprayGAC2018-09-27Apo-Clobetasol SprayAPX1.92592018-09-27Taro-Clobetasol SprayTAR1.92592019-11-29Odan ClobetasolODN1.92602019-11-29Sandoz ClobetasolSDZ1.92592020-07-31Jamp Clobetasol SprayJPC1.92592024-01-31DESONIDE20500.05%CrTridesilonCPL1996-10-01PDP-DesonidePEN.28571997-04-10.285720510.05%OintTridesilonCPL1996-10-01PDP-DesonidePEN.28531997-04-10.2853FLUOCINONIDE20520.05%CrLydermTAR.25501996-10-01.2550LidexVAE1999-01-2020530.05%Emol CrTiamolTAR.19801996-10-01.1980LidemolVAE1996-10-0120540.05%GelLidexVAE1996-10-01LydermTAR.35171999-04-15.351720550.05%OintLidexVAE1996-10-01LydermTAR.33702000-04-17.3370HALOBETASOL PROPIONATE20560.01% w/wLotNo more than 50 grams per week is recommended.BryhaliBHC.98162023-04-28.9816HYDROCORTISONE20570.5%OintCortateSCH1996-10-01CortodermTAR.14001996-10-01.140020581%OintCortateSCH1996-10-01CortodermTAR.03901996-10-01.0390HYDROCORTISONE ACETATE20591%CrCorticremeROG1996-10-01HydermTAR.20561996-10-01.2056HYDROCORTISONE VALERATE20600.2%CrWestcortBQU1996-10-01HydrovalTPH.16672001-10-11.166720610.2%OintWestcortBQU1996-10-01HydrovalTPH.16672001-10-11.1667MOMETASONE FUROATE20620.1%CrElocomOCI.73931996-10-01.5542Taro-MometasoneTAR.55422012-02-29.554220630.1%LotElocomOCI.52551996-10-01.3627Taro-MometasoneTAR.36272014-07-30.362720640.1%OintElocomOCI.73421996-10-01.2252Ratio-MometasoneRPH.22522004-07-20.2252TRIAMCINOLONE ACETONIDE20650.1%CrKenalogWSQ1996-10-01TriadermTAR.05331996-10-01.0533Aristocort RVAL1998-03-1720660.1%OintKenalogWSQ1996-10-01Aristocort RVAE.18561998-03-17.1856TRIAMCINOLONE ACETONIDE 0.1% IN ORABASE2067Oral Top OintOracortTAR1.56071996-10-011.5607Kenalog-OrabaseBQU1996-10-01KERATOLYTIC AGENTSADAPALENE & BENZOYL PEROXIDE20680.1%w/w & 2.5%w/wTop GelTactuPumpGAC2019-11-29Taro-Adapalene/Benzoyl PeroxideTAR1.27192019-11-29Sandoz Adapalene/ Benzoyl PeroxideSDZ1.27182019-11-29TRETINOIN20690.01%CrStieva-ASTI.32121996-10-01.321220700.025%CrStieva-ASTI.32121996-10-01.321220710.05%CrStieva-ASTI.21441996-10-01.2144Vitamin A AcidSAV1996-10-0120720.01%GelVitamin A AcidVAL.42661996-10-01.426620730.05%GelVitamin A AcidVAL.42661996-10-01.4266For the treatment of acne vulgaris.LU Authorization Period: 1 yearMISCELLANEOUS SKIN AND MUCOUS MEMBRANE AGENTSACITRETINThis drug should be used with extreme caution in females of childbearing potential due to its teratogenicity. Effective contraception must be practised for at least 2 years following discontinuation.207410mgCapSoriataneALL3.44131996-10-011.2965Taro-AcitretinTAR1.29652018-03-291.2965Mint-AcitretinMIN1.29652018-04-301.2965207525mgCapSoriataneALL6.04331996-10-012.2770Taro-AcitretinTAR2.27702018-05-312.2770Mint-AcitretinMIN2.27702018-04-302.2770ADAPALENE & BENZOYL PEROXIDE20760.3% w/w & 2.5% w/wTop GelTactuPump ForteGAC2022-01-31Taro-Adapalene/Benzoyl Peroxide ForteTAR2.15772022-02-28Sandoz Adapalene/Benzoyl PeroxideSDZ2.15762022-01-31ALITRETINOINAlitretinoin should only be prescribed by physicians knowledgeable in the use of retinoids systemically, who understand the risk of teratogenicity in females of child bearing potential. Alitretinoin is contraindicated in pregnancy and females must not become pregnant while taking alitretinoin and for at least one month after its discontinuation. Please refer to the Toctino product monograph for details on use in women of child bearing potential.207710mgCapToctinoGSK2013-04-30HanzemaDRR16.98682021-07-3016.9868207830mgCapToctinoGSK2013-04-30HanzemaDRR16.98682021-07-3016.9868For adult patients with severe (see note 1 below) chronic (see note 2 below) hand eczema AND unresponsive to an 8 week course of high potency topical corticosteroids. 1. Severe defined based on the Physician Global Assessment (PGA), including: - At least one of the following cardinal features present at baseline as moderate or severe: erythema, scaling, hyperkeratosis/lichenification; and - one of the following features present as severe: vesiculation, edema, fissures, pruritus/pain; and - with an area of greater than 30% of affected hand surface 2. Chronic defined as: - persists for greater than 3 months; OR - reoccurs greater than or equal to 2 times within 12 monthsLU Authorization Period: 1 yearAZELAIC ACID207915%Top GelFinaceaLEO.87632011-09-15.8763BRODALUMAB2080210mg/1.5mLInj Sol-Pref SyrSiliqVAL645.00002019-04-30645.0000For the treatment of severe (see Note 1 below) plaque psoriasis in patients 18 years of age or older who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies (see Note 2 below). Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. Approvals will only allow for standard dosing for Siliq 210mg subcutaneously at weeks 0, 1 and 2, and then every 2 weeks. If the patient has not responded adequately after 12 weeks of treatment at the Health Canada approved dose, higher doses are not recommended and the physician should consider switching to an alternative biologic agent. Note 1: Definition of severe plaque psoriasis: - Body Surface Area (BSA) involvement of at least 10%, or involvement of the face, hands, feet or genital regions, AND - Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND - Dermatology Life Quality Index (DLQI) score of at least 10. Note 2: Definition of failure, intolerance or contraindication to adequate trials of standard therapies: - 6 month trial of at least 3 topical agents including vitamin D analogues and steroids, AND - 12 week trial of phototherapy (unless not accessible), AND - 6 month trial of at least 2 systemic, oral agents used alone or in combination - Methotrexate 15-30mg per week - Acitretin (could have been used with phototherapy) - Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: - at least 50% reduction in PASI, AND - at least 50% reduction in BSA involvement, AND - at least a 5 point reduction in DLQI score LU Authorization Period: 1 yearCALCIPOTRIOL208150mcg/gOintDovonexLEO1.24891997-04-101.2489For the treatment of psoriasis in patients who have failed topical corticosteroids alone, or are intolerant to topical corticosteroids.LU Authorization Period: IndefiniteCALCITRIOL20823mcg/gOintSilkisGAC1.36252011-08-041.3625For the treatment of psoriasis in patients who have failed topical corticosteroids alone, or are intolerant to topical corticosteroids.LU Authorization Period: IndefiniteCOLLAGENASE2083250Unit/g30g PkSantyl OintmentSNE87.50001998-12-3187.50002084250Unit/gOint-30g PkSantylSNE87.50002024-05-3187.5000FLUOROURACIL20855%CrEfudexVAL1.15691996-10-011.1569IMIQUIMOD20865%Top CrTaro-Imiquimod PumpTAR54.21472019-03-28Aldara PVAL2019-03-28ISOTRETINOIN208710mgCapIsotretinoin is indicated for the treatment of severe nodular and/or inflammatory acne, acne conglobata and recalcitrant acne that are unresponsive to conventional therapy including systemic antibiotics. Females of childbearing potential should have a negative pregnancy test within 2 weeks prior to starting treatment. Isotretinoin should be started the second or third day of the next normal menstrual period. Effective contraception should be used for at least 1 month prior to starting isotretinoin, during treatment and for at least 1 month following discontinuation of treatment.AccutaneHLR.97381996-10-01.9313ClarusMYL.93132006-07-19.9313208810mgCapIsotretinoin is indicated for the treatment of severe nodular and/or inflammatory acne, acne conglobata and recalcitrant acne that are unresponsive to conventional therapy including systemic antibiotics. Females of childbearing potential should have a negative pregnancy test within 2 weeks prior to starting treatment. Isotretinoin should be started the second or third day of the next normal menstrual period. Effective contraception should be used for at least 1 month prior to starting isotretinoin, during treatment and for at least 1 month following discontinuation of treatment.EpurisCIP1.51342014-02-271.5134208920mgCapIsotretinoin is indicated for the treatment of severe nodular and/or inflammatory acne, acne conglobata and recalcitrant acne that are unresponsive to conventional therapy including systemic antibiotics. Females of childbearing potential should have a negative pregnancy test within 2 weeks prior to starting treatment. Isotretinoin should be started the second or third day of the next normal menstrual period. Effective contraception should be used for at least 1 month prior to starting isotretinoin, during treatment and for at least 1 month following discontinuation of treatment.EpurisCIP2.09412014-02-272.0941209030mgCapIsotretinoin is indicated for the treatment of severe nodular and/or inflammatory acne, acne conglobata and recalcitrant acne that are unresponsive to conventional therapy including systemic antibiotics. Females of childbearing potential should have a negative pregnancy test within 2 weeks prior to starting treatment. Isotretinoin should be started the second or third day of the next normal menstrual period. Effective contraception should be used for at least 1 month prior to starting isotretinoin, during treatment and for at least 1 month following discontinuation of treatment.EpurisCIP2.63372014-02-272.6337209140mgCapIsotretinoin is indicated for the treatment of severe nodular and/or inflammatory acne, acne conglobata and recalcitrant acne that are unresponsive to conventional therapy including systemic antibiotics. Females of childbearing potential should have a negative pregnancy test within 2 weeks prior to starting treatment. Isotretinoin should be started the second or third day of the next normal menstrual period. Effective contraception should be used for at least 1 month prior to starting isotretinoin, during treatment and for at least 1 month following discontinuation of treatment.AccutaneHLR1.98701996-10-011.9003ClarusMYL1.90032006-07-191.9003209240mgCapIsotretinoin is indicated for the treatment of severe nodular and/or inflammatory acne, acne conglobata and recalcitrant acne that are unresponsive to conventional therapy including systemic antibiotics. Females of childbearing potential should have a negative pregnancy test within 2 weeks prior to starting treatment. Isotretinoin should be started the second or third day of the next normal menstrual period. Effective contraception should be used for at least 1 month prior to starting isotretinoin, during treatment and for at least 1 month following discontinuation of treatment.EpurisCIP3.08772014-02-273.0877IXEKIZUMAB209380mg/mLInj Sol-Pref AutoinjTaltzLIL1976.64002018-03-291976.6400209480mg/mLInj Sol-Pref SyrTaltzLIL1990.11002018-03-291990.1100For the treatment of severe (see Note 1 below) plaque psoriasis in patients 18 years of age or older who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies (see Note 2 below). Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. Approvals will only allow for standard dosing for Taltz 160mg at week 0, followed by 80mg subcutaneously at weeks 2, 4, 6, 8, 10, and 12, and then 80mg every 4 weeks. If the patient has not responded adequately after 12 weeks of treatment at the Health Canada approved dose, higher doses are not recommended and the physician should consider switching to an alternative biologic agent. Note 1: Definiton of severe plaque psoriasis: - Body Surface Area (BSA) involvement of at least 10%, or involvement of the face, hands, feet or genital regions, AND - Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND - Dermatology Life Quality Index (DLQI) score of at least 10. Note 2: Definition of failure, intolerance or contraindication to adequate trials of standard therapies: - 6 month trial of at least 3 topical agents including vitamin D analogues and steroids, AND - 12 week trial of phototherapy (unless not accessible), AND - 6 month trial of at least 2 systemic, oral agents used alone or in combination - Methotrexate 15-30mg per week - Acitretin (could have been used with phototherapy) - Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: - at least 50% reduction in PASI, AND - at least 50% reduction in BSA involvement, AND - at least a 5 point reduction in DLQI scoreLU Authorization Period: 1 yearPIMECROLIMUS20951%CrElidelVAL3.03142004-04-063.0314For use in combination with moisturizers or oral antihistamines in patients with atopic dermatitis who have failed or are intolerant to an 8 week trial of an intermediate potency topical steroid.Therapy should be reassessed at 6 months.LU Authorization Period: 1 yearRISANKIZUMAB209675mg/0.83mLInj Sol-0.83mL Pref Syr (Preservative-Free)SkyriziABV2467.50002020-01-312467.50002097150mg/mLInj Sol-Pref Pen (Preservative-Free)SkyriziABV4935.00002022-10-314935.00002098150mg/mLInj Sol-Pref Syr (Preservative-Free)SkyriziABV4935.00002022-10-314935.0000For the treatment of severe plaque psoriasis (see Note 1 below) in patients 18 years of age or older who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies (see Note 2 below). Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. Approvals will only allow for standard dosing for Skyrizi 150mg subcutaneously at weeks 0 and 4, and then every 12 weeks. If the patient has not responded adequately after 12 weeks of treatment at the Health Canada approved dose, higher doses are not recommended, and the physician should consider switching to an alternative biologic agent. Note 1: Definition of severe plaque psoriasis: - Body Surface Area (BSA) involvement of at least 10%, or involvement of the face, hands, feet or genital regions, AND - Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND - Dermatology Life Quality Index (DLQI) score of at least 10. Note 2: Definition of failure, intolerance or contraindication to adequate trials of standard therapies: - 6 month trial of at least 3 topical agents including vitamin D analogues and steroids, AND - 12 week trial of phototherapy (unless not accessible), AND - 6 month trial of at least 2 systemic, oral agents used alone or in combination - Methotrexate 15-30mg per week - Acitretin (could have been used with phototherapy) - Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: - at least 50% reduction in PASI, AND - at least 50% reduction in BSA involvement, AND - at least a 5 point reduction in DLQI score. LU Authorization Period: 1 yearSECUKINUMAB2099150mg/mLInj Sol-Pref PenCosentyxNOV952.72002016-08-30952.72002100150mg/mLInj Sol-Pref SyrCosentyxNOV952.72002016-08-30952.72002101150mg/mLInj Sol-Pref SyrCosentyxNOV952.72002025-04-30952.7200For the treatment of severe (see Note 1 below) plaque psoriasis in patients 18 years of age or older who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies (see Note 2 below). Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. The recommended dose for Cosentyx is 300mg subcutaneously at weeks 0, 1, 2 and 3, and then monthly starting at week 4. A maintenance dose of 300mg every 2 weeks may be considered for adult patients with a body weight of 90kg or higher. If the patient has not responded adequately after 12 weeks of treatment at the Health Canada approved doses, higher doses are not recommended and the physician should consider switching to an alternative biologic agent. Note 1: Definition of severe plaque psoriasis: - Body Surface Area (BSA) involvement of at least 10%, or involvement of the face, hands, feet or genital regions, AND - Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND - Dermatology Life Quality Index (DLQI) score of at least 10. Note 2: Definition of failure, intolerance or contraindication to adequate trials of standard therapies: - 6 month trial of at least 3 topical agents including vitamin D analogues and steroids, AND - 12 week trial of phototherapy (unless not accessible), AND - 6 month trial of at least 2 systemic, oral agents used alone or in combination - Methotrexate 15-30mg per week - Acitretin (could have been used with phototherapy) - Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: - At least a 50% reduction in PASI, AND - at least a 50% reduction in BSA involvement, AND - at least a 5 point reduction in DLQI scoreLU Authorization Period: 1 yearZINC SULFATE21020.5%OintAnusol OintmentCDC.21871996-10-01.2187210310mgSupAnuzincSDZ.35421996-10-01.3542MISCELLANEOUS SKIN AND MUCOUS MEMBRANE AGENTSBIMEKIZUMAB2104160mg/mLInj Sol-1mL Pref Autoinj (Preservative-Free)BimzelxUCB1625.00002023-03-311625.00002105160mg/mLInj Sol-1mL Pref Syr (Preservative-Free)BimzelxUCB1625.00002023-03-311625.00002106320mg/2mLInj Sol-2mL Pref Autoinj (Preservative-Free)BimzelxUCB3250.00002025-08-293250.00002107320mg/2mLInj Sol-2mL Pref Syr (Preservative-Free)BimzelxUCB3250.00002025-08-293250.0000For the treatment of severe (see Note 1 below) plaque psoriasis in patients 18 years of age or older who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies (see Note 2 below). Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. Note 1: Definition of severe plaque psoriasis: - Body Surface Area (BSA) involvement of at least 10%, or involvement of the face, hands, feet or genital regions, AND - Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND - Dermatology Life Quality Index (DLQI) score of at least 10. Note 2: Definition of failure, intolerance or contraindication to adequate trials of standard therapies: - 6 month trial of at least 3 topical agents including vitamin D analogues and steroids, AND - 12 week trial of phototherapy (unless not accessible), AND - 6 month trial of at least 2 systemic, oral agents used alone or in combination - Methotrexate 15-30mg per week - Acitretin (could have been used with phototherapy) - Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: - at least a 50% reduction in PASI, AND - at least a 50% reduction in BSA involvement, AND - at least a 5 point reduction in DLQI score Approvals will allow for standard dosing for Bimzelx, which is 320mg subcutaneously every 4 weeks for the first 16 weeks, and every 8 weeks thereafter. A dose of 320mg every 4 weeks after the first 16 weeks may be considered in patients with a body weight of 120kg or more who did not achieve a complete skin response. For patients with no improvement after 16 weeks of treatment at the Health Canada approved dose, higher or more frequent doses are not recommended and the physician should consider switching to an alternative biologic agent.LU Authorization Period: 1 yearGUSELKUMAB2108100mg/mLInj Sol-1mL Autoinj (Preservative-Free)Tremfya One-PressJAN3059.74002024-01-313059.74002109100mg/mLInj Sol-1mL Pref Syr (Preservative-Free)TremfyaJAN3059.74002023-11-303059.7400For the treatment of severe* plaque psoriasis in patients 18 years of age or older who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies**. Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 16 weeks is appropriate. Patients not responding adequately at 16 weeks should have treatment discontinued. *Definition of severe plaque psoriasis: Body Surface Area (BSA) involvement of at least 10 percent, or involvement of the face, hands, feet or genital regions, AND Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND Dermatology Life Quality Index (DLQI) score of at least 10. **Definition of failure, intolerance or contraindication to adequate trials of standard therapies: 6 month trial of at least 3 topical agents including vitamin D analogues and steroids, AND 12 week trial of phototherapy (unless not accessible), AND 6 month trial of at least 2 systemic, oral agents used alone or in combination - Methotrexate 15-30mg per week - Acitretin (could have been used with phototherapy) - Cyclosporine Maintenance/Renewal: After 16 weeks of therapy, patients who respond to therapy should have: - at least a 50% reduction in PASI, AND - at least a 50% reduction in BSA involvement, AND - at least a 5 point reduction in DLQI score Approvals will only allow for standard dosing for guselkumab. The recommended dosing regimen is 100mg administered subcutaneously at week 0 and week 4, followed by maintenance dosing every 8 weeks thereafter, as approved by Health Canada. If the patient has not responded adequately after 16 weeks of treatment at the Health Canada approved dose, higher doses are not recommended, and the physician should consider switching to an alternative biologic agent.LU Authorization Period: 1 yearHALOBETASOL PROPIONATE & TAZAROTENE21100.01% & 0.045%LotDuobriiBHC1.93002022-01-311.9300TAZAROTENE21110.045% w/wLotArazloBHC1.40512022-10-311.4051For the treatment of acne vulgaris.LU Authorization Period: 1 yearTILDRAKIZUMAB2112100mg/mLInj Sol-1mL Pref Syr (Preservative-Free)IlumyaSPC4935.00002022-02-284935.0000For the treatment of severe plaque psoriasis (see Note 1 below) in patients 18 years of age or older who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies (see Note 2 below). Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. Approvals will only allow for standard dosing for Ilumya 100mg subcutaneously at weeks 0 and 4, and then every 12 weeks. Ilumya should not be used in combination with other systemic or biologic treatments for severe plaque psoriasis. If the patient has not responded adequately after 12 weeks of treatment at the Health Canada approved dose, higher doses are not recommended, and the physician should consider switching to an alternative biologic agent. Note 1: Definition of severe plaque psoriasis: - Body Surface Area (BSA) involvement of at least 10%, or involvement of the face, hands, feet or genital regions, AND - Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND - Dermatology Life Quality Index (DLQI) score of at least 10. Note 2: Definition of failure, intolerance or contraindication to adequate trials of standard therapies: - 6 month trial of at least 3 topical agents including vitamin D analogues and steroids, AND - 12 week trial of phototherapy (unless not accessible), AND - 6 month trial of at least 2 systemic, oral agents used alone or in combination - Methotrexate 15-30mg per week - Acitretin (could have been used with phototherapy) - Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: - at least 75% reduction in PASI, AND - at least 50% reduction in BSA involvement, AND - at least a 5 point reduction in DLQI score. LU Authorization Period: 1 yearSPASMOLYTICSFESOTERODINE FUMARATE21134mgTabToviazPFI1.55002013-04-301.1250Sandoz Fesoterodine FumarateSDZ1.12502022-06-301.125021148mgTabToviazPFI1.55002013-04-301.1250Sandoz Fesoterodine FumarateSDZ1.12502022-06-301.1250For patients with urinary frequency, urgency or urge incontinence who have: Failed to respond to behavioral techniques AND an adequate trial of oxybutynin with gradual dose escalation has shown to be either ineffective or resulted in unacceptable side effects. NOTE: If after a trial of 2 weeks patients continue to experience similar side effects and no greater efficacy than oxybutynin, continued therapy with this more costly agent should be reassessed. Antimuscarinic agents should be used with caution in the elderly due to potentially serious adverse effects (e.g. confusion, psychosis, acute urinary retention, constipation). Antimuscarinic agents should be avoided in older adults with pre-existing cognitive impairment (e.g. dementia) and those who are already using other drugs with significant anticholinergic effects (e.g. tricyclic antidepressants) in order to avoid a high overall anticholinergic drug burden.LU Authorization Period: IndefiniteMIRABEGRON211525mgER TabMyrbetriqASE1.46002015-05-281.4600211650mgER TabMyrbetriqASE1.46002015-05-281.4600For patients with urinary frequency, urgency or urge incontinence who have: Failed to respond to behavioral techniques AND an adequate trial of oxybutynin with gradual dose escalation has shown to be either ineffective or resulted in unacceptable side effects. NOTE: If after a trial of 2 weeks patients continue to experience similar side effects and no greater efficacy than oxybutynin, continued therapy with this more costly agent should be reassessed. Antimuscarinic agents should be used with caution in the elderly due to potentially serious adverse effects (e.g. confusion, psychosis, acute urinary retention, constipation). Antimuscarinic agents should be avoided in older adults with pre-existing cognitive impairment (e.g. dementia) and those who are already using other drugs with significant anticholinergic effects (e.g. tricyclic antidepressants) in order to avoid a high overall anticholinergic drug burden.LU Authorization Period: IndefiniteOXTRIPHYLLINE211720mg/mLO/LCholedylSLP.03981996-10-01.0398THEOPHYLLINE ANHYDROUS2118400mgSR TabUniphylELV1996-10-01Theo ERAAP.37352014-01-03.37342119600mgSR TabUniphylELV1996-10-01Theo ERAAP.45242014-01-03.4524GENITOURINARY SMOOTH MUSCLE RELAXANTS ANTIMUSCARINICSPROPIVERINE HYDROCHLORIDE21205mgTabMictoryl PediatricDUI.38892018-05-31.3889For the symptomatic treatment of urinary incontinence and/or increased urinary frequency and urgency in pediatric patients with overactive bladder.LU Authorization Period: 1 yearVITAMINSVITAMIN BCYANOCOBALAMIN21211mg/mLInj Sol-10mL PkRubraminBQU1996-10-01Vitamin B12-1000mcg/mLSDZ3.06002003-01-303.0600CyanocobalaminSTE3.06001997-04-103.0600Cyanocobalamin Injection USPMYL3.06002015-08-263.0600Jamp-CyanocobalaminJPC3.06002015-08-263.0600FOLIC ACID21225mgTabFolviteLED1996-10-01Folic AcidAAP.04041996-10-01.0404LEUCOVORIN CALCIUM21235mgTabLeucovorin CalciumWAY7.35521999-01-071.8388Riva LeucovorinRIA1.83882020-11-301.8388Mint-LeucovorinMIN1.83882021-03-291.8388Jamp LeucovorinJPC1.83882025-03-311.8388NICOTINIC ACIDNicotinic acid is the most cost-effective therapy for hyperlipidemia and is tolerated in approximately 80% of patients with adequate warning about expected flushing which disappears after 5 days in most cases, and is significantly reduced with regular use of ASA.212450mgTabNiacin-ICNVAL1996-10-01Novo-NiacinNOP1996-10-01THIAMINE HCL212550mgTabVitamin B1-ICNVAL1996-10-01Vitamin B1LEA1996-10-01VITAMIN CASCORBIC ACID2126500mgTabNovo-CNOP1996-10-01Vitamin CRPR1996-10-01Apo-CAPX1996-10-01VITAMIN DALFACALCIDOL21270.25mcgCapOne-AlphaLEO.64151996-10-01.4313Sandoz AlfacalcidolSDZ.43132023-05-31.431321281mcgCapOne-AlphaLEO1.92041996-10-011.2911Sandoz AlfacalcidolSDZ1.29112023-05-311.291121292mcg/mLOral DropsOne-Alpha DropsLEO7.70372019-10-317.7037CALCITRIOL21300.25mcgCapRocaltrolHLR.70711996-10-01.2341Calcitriol-OdanODN.23412016-03-30.2341Taro-CalcitriolTAR.23412019-12-20.2341PMS-CalcitriolPMS.23412020-11-30.234121310.5mcgCapRocaltrolHLR1.12461996-10-01.3723Calcitriol-OdanODN.37232016-06-29.3723Taro-CalcitriolTAR.37232019-12-20.3723PMS-CalcitriolPMS.37232020-11-30.372321321mcg/mLInj Sol Amp-1mL PkCalcijexABV2016-06-29Calcitriol Injection USPSTE9.51322016-06-299.5132ERGOCALCIFEROL21338288IU/mLO/LDrisdolSAV1996-10-01ErdolODN.60552012-03-26.6055VITAMIN KPHYTONADIONE21341mg/0.5mLInj-0.5mL Amp Pk (Preservative Free)Vitamin K1 Inj 1mg/0.5mL USPSDZ5.29502019-04-305.2950213510mg/mLInj-1mL Amp Pk (Preservative Free)Vitamin K1 Inj 10mg/mL USPSDZ6.00002019-04-306.0000MULTIVITAMINSHEXAVITAMINS USP2136TabHexavitaminsNOP1996-10-01Apo-HexaAPX1996-10-01MULTIVITAMINS2137TabPregvitDUI2025-02-28Pregnancy MultivitaminJPC.31252025-02-282138TabPregvit Folic 5DUI2025-02-28Pregnancy Multivitamin Folic 5JPC.50252025-02-28MULTIVITAMINS FOR INFUSION2139Inj-2x5mL Vial PkMulti-12SDZ23.00002019-04-3023.00002140Inj-4mL+1mL Vial PkMulti 12/K1 PediatricSDZ41.80002019-04-3041.8000UNCLASSIFIED THERAPEUTIC AGENTSALENDRONATE21415mgTabFosamaxMFC2007-10-03Teva-AlendronateTEV1.03702007-10-03Apo-AlendronateAPX1.03702007-10-03Alendronate Sodium TabletsACH1.03702012-08-27214210mgTabFosamaxMFC2000-11-30Teva-AlendronateTEV.49872003-09-04.4987Apo-AlendronateAPX.49872004-07-20.4987Sandoz AlendronateSDZ.49872007-03-09.4987Alendronate Sodium TabletsACH.49872012-06-26.4987Ran-AlendronateRAN.49872012-07-27.4987Auro-AlendronateAUR.49872012-09-28.4987Mint-AlendronateMIN.49872013-03-20.4987214370mgTabFosamaxOCI12.62502003-01-301.7804Apo-AlendronateAPX1.78042005-07-141.7804Teva-AlendronateTEV1.78042005-08-191.7804Riva-AlendronateRIA1.78042021-08-311.7804PMS-Alendronate-FCPMS1.78042007-03-091.7804Sandoz AlendronateSDZ1.78042007-03-091.7804AlendronateSIV1.78042009-11-191.7804AlendronateSAI1.78042011-08-041.7804Alendronate Sodium TabletsACH1.78042012-06-261.7804Jamp-AlendronateJPC1.78042012-09-281.7804Auro-AlendronateAUR1.78042012-09-281.7804Mint-AlendronateMIN1.78042013-03-201.7804AG-AlendronateANG1.78042020-11-301.7804Jamp Alendronate SodiumJPC1.78042022-09-291.7804NRA-AlendronateNRA1.78042022-11-301.7804M-AlendronateMAT1.78042023-06-301.7804ALENDRONATE & CHOLECALCIFEROL214470mg & 70mcgTabFosavanceOCI5.5335Note: The recommended dose of Vitamin D for osteoporosis prevention and treatment in adults over 50 years old is at least 800 IU/day, in conjunction with calcium. This product does not provide the total recommended daily intake of Vitamin D; supplemental Vitamin D may be required. The appropriate dosage of ALENDRONATE & CHOLECALCIFEROL must be determined by the physician based on the patient's vitamin D requirement.2007-01-022.4348Apo-Alendronate/Vitamin D3APX2.4348Note: The recommended dose of Vitamin D for osteoporosis prevention and treatment in adults over 50 years old is at least 800 IU/day, in conjunction with calcium. This product does not provide the total recommended daily intake of Vitamin D; supplemental Vitamin D may be required. The appropriate dosage of ALENDRONATE & CHOLECALCIFEROL must be determined by the physician based on the patient's vitamin D requirement.2016-09-292.4348Jamp Alendronate/Vitamin D3JPC2.43482023-07-312.4348214570mg & 140mcgTabFosavanceOCI5.42502009-06-232.4348Apo-Alendronate/Vitamin D3APX2.43482016-09-292.4348Jamp Alendronate/Vitamin D3JPC2.43482023-05-312.4348ALFUZOSIN HYDROCHLORIDE214610mgProlong-Rel TabXatralSAV1.09002003-01-30.2601Sandoz AlfuzosinSDZ.26012008-11-04.2601Apo-AlfuzosinAPX.26012008-11-04.2601Auro-AlfuzosinAUR.26012016-02-25.2601AlfuzosinSIV.26012020-06-30.2601AlfuzosinSAI.26012022-04-29.2601For the management of benign prostatic hyperplasia where six weeks of treatment with other formulary alpha blockers (e.g. doxazosin, terazosin, tamsulosin) have been ineffective.LU Authorization Period: IndefiniteFor the management of benign prostatic hyperplasia where other formulary alpha blockers (e.g. doxazosin, terazosin, tamsulosin) have produced intolerable side effects.LU Authorization Period: IndefiniteALLOPURINOLReduce dose of mercaptopurine or azathioprine if used concomitantly. Adjust dose of allopurinol in patients with renal impairment. Allopurinol should not be used to treat patients with hyperuricemia when decreased uricosuria is the cause.2147100mgTabApo-Allopurinol TabletsAPX.07801996-10-01.0780Mar-AllopurinolMAR.07802013-02-28.0780Apo-AllopurinolAPX2013-07-302148200mgTabApo-Allopurinol TabletsAPX.13001996-10-01.1300Mar-AllopurinolMAR.13002013-02-28.1300Apo-AllopurinolAPX2013-07-302149300mgTabZyloprimBWE1996-10-01Apo-Allopurinol TabletsAPX.21251996-10-01.2125Mar-AllopurinolMAR.21252013-02-28.2125Apo-AllopurinolAPX2013-07-30AMANTADINE HCLAmantadine increases central and peripheral effects of anticholinergic drugs.2150100mgCapSymmetrelBQU1996-10-01PDP-Amantadine Hydrochloride CapsulesPEN.56621999-04-15.5662215110mg/mLO/LSymmetrelBQU1996-10-01PDP-Amantadine Hydrochloride SyrupPEN.09881997-08-28.0988Odan-Amantadine SyrupODN.09882023-10-31.0988ANAGRELIDE HCL21520.5mgCapAgrylinTAK2020-02-28PMS-AnagrelidePMS4.69972020-02-284.6997For the treatment of essential thrombocytosis in patients who are intolerant of or who have failed hydroxyurea therapy.LU Authorization Period: 5 years.21530.5mgCapAnagrideSET5.96962025-06-305.9696AZATHIOPRINE215450mgTabImuranASN1.4511Decrease dose of azathioprine to 25 -33% of initial dose if allopurinol used concomitantly.1996-10-01.5185Teva-AzathioprineTEV.5185Decrease dose of azathioprine to 25 -33% of initial dose if allopurinol used concomitantly.1999-04-15.5185Apo-AzathioprineAPX.5185Decrease dose of azathioprine to 25 -33% of initial dose if allopurinol used concomitantly.2001-10-11.5185BOTULINUM TOXIN TYPE A2155100U/VialPd Inj-100U Vial PkBotoxABV389.84401996-10-01389.84402156200U/VialPd Inj-200U Vial PkBotoxABV779.68802011-08-04779.68802157200U/VialPd Inj-200U Vial PkBotoxABV779.68802023-10-31779.6880215850U/VialPd Inj-50U Vial PkBotoxABV194.92202011-08-04194.9220215950U/VialPd Inj-50U Vial PkBotoxABV194.92202023-06-30194.9220For the treatment of strabismus and blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders in patients 12 years of age or older.LU Authorization Period: 1 yearTo reduce the subjective symptoms and objective signs of cervical dystonia (spasmodic torticollis) in adults.LU Authorization Period: 1 yearFor the management of focal spasticity, due to stroke or spinal cord injury in adults.LU Authorization Period: 1 yearFor the treatment of focal spasticity secondary to cerebral palsy in patients two years of age or older.LU Authorization Period: 1 yearFor adult patients with urinary incontinence due to neurogenic detrusor overactivity resulting from neurogenic bladder associated with multiple sclerosis or subcervical spinal cord injury who fail to respond to behavioural medication and anticholinergics and/or are intolerant to anticholinergics. The recommended dose is 200U injected into the detrusor muscle. Subsequent injections should be provided at intervals of no less than every 36 weeks and patients who fail to respond to initial treatment with Botulinum Toxin Type A should not be retreated. LU Authorization Period: 1 yearFor adult patients with urinary frequency, urgency or urge incontinence due to overactive bladder who have: Failed to respond to behavioral techniques AND had an inadequate response or intolerance to adequate trials (i.e., at least 2 weeks at the maximum tolerated dose) of at least two medications for overactive bladder (e.g. anticholinergics, mirabegron). The recommended dose is 100U injected into the detrusor muscle. NOTES: -Patients who fail to achieve a reduction of greater than 50 percent in the frequency of urinary incontinence episodes with 1 dose should not be retreated. -Maximum 3 doses per year in responders, at a frequency of no more than once every 12 weeks. -Patients must have a post-void residual (PVR) urine volume of less than 150mL.LU Authorization Period: 1 yearNote: Botox should be administered personally by a urologist, pediatrician, neurologist, physical medicine specialist or a physician with equivalent post-graduate training and experience with neuromuscular or urological disorders as appropriate.BROMOCRIPTINE21605mgCapParlodelNOV1996-10-01BromocriptineAAP1.70971997-08-281.709721612.5mgTabParlodelNOV1996-10-01BromocriptineAAP1.08001996-10-011.0800BUPROPION HCL2162150mgSR TabZybanVAL1.35412011-08-041.3541For smoking-cessation treatment in adults, in conjunction with smoking-cessation counseling. Network Note: Limited to 12 weeks (168 tablets) of reimbursement per 365 days per patient.LU Authorization Period: 12 Weeks.CABERGOLINE21630.5mgTabDostinexPMJ23.51992008-06-277.2907Apo-CabergolineAPX7.29072017-05-317.2907Jamp CabergolineJPC7.29072025-03-317.2907For the treatment of hyperprolactinemia.LU Authorization Period: IndefiniteCASPOFUNGIN216470mg/VialInj Pd-Vial PkCancidasFRS2017-08-30Caspofungin for InjectionJUN222.00002017-08-30222.0000Caspofungin for InjectionFKC222.50002020-05-29222.5000CINACALCET216530mgTabSensiparAMG2016-05-31Mylan-CinacalcetMYL10.19472016-08-3010.1947Teva-CinacalcetTEV10.19472017-01-3110.1947Apo-CinacalcetAPX10.19472016-05-3110.1947Auro-CinacalcetAUR10.19472019-04-3010.1947Mar-CinacalcetMAR10.19472019-01-3110.1947M-CinacalcetMAT10.19472021-09-3010.1947Jamp Cinacalcet TabletsJPC10.19472021-04-3010.1947PMS-CinacalcetPMS10.19472022-09-2910.1947CinacalcetSAI10.19472022-07-2910.1947216660mgTabSensiparAMG2016-05-31Mylan-CinacalcetMYL18.59002017-02-2818.5900Teva-CinacalcetTEV18.59002017-01-3118.5900Apo-CinacalcetAPX18.59002016-05-3118.5900Auro-CinacalcetAUR18.59002019-04-3018.5900Mar-CinacalcetMAR18.59002019-01-3118.5900M-CinacalcetMAT18.59002021-09-3018.5900Jamp Cinacalcet TabletsJPC18.59002021-04-3018.5900PMS-CinacalcetPMS18.59002022-09-2918.5900216790mgTabSensiparAMG2016-05-31Mylan-CinacalcetMYL27.05172017-02-2827.0517Teva-CinacalcetTEV27.05172017-01-3127.0517Apo-CinacalcetAPX27.05172016-05-3127.0517Auro-CinacalcetAUR27.05172019-04-3027.0517Mar-CinacalcetMAR27.05172019-01-3127.0517M-CinacalcetMAT27.05172021-09-3027.0517Jamp Cinacalcet TabletsJPC27.05172021-04-3027.0517PMS-CinacalcetPMS27.05172022-09-2927.0517CLODRONATE DISODIUM2168400mgCapOstacHLR1996-10-01ClasteonSUO1.20832004-10-141.2083For the control and prophylaxis of hypercalcemia of malignancy.LU Authorization Period: IndefiniteFor the treatment of bony metastases in patients with breast cancer.LU Authorization Period: IndefiniteFor the prevention and treatment of osteolytic lesions in patients with multiple myeloma.LU Authorization Period: IndefiniteCLOPIDOGREL BISULFATE216975mgTabPlavixSAV2.81802003-09-04.2631Apo-ClopidogrelAPX.26312012-01-19.2631Teva-ClopidogrelTEV.26312012-02-29.2631Co ClopidogrelCOB.26312012-01-19.2631PMS-ClopidogrelPMS.26312012-02-29.2631Sandoz ClopidogrelSDZ.26312012-02-29.2631Ran-ClopidogrelRAN.26312012-06-26.2631ClopidogrelSIV.26312020-06-30.2631ClopidogrelSAI.26312020-06-30.2631Mint-ClopidogrelMIN.26312013-09-27.2631Jamp-ClopidogrelJPC.26312014-07-30.2631Auro-ClopidogrelAUR.26312014-04-30.2631Mar-ClopidogrelMAR.26312014-06-26.2631NRA-ClopidogrelNRA.26312020-06-30.2631M-ClopidogrelMAT.26312021-11-30.26312170300mgTabPlavixSAV2012-08-27Teva-ClopidogrelTEV9.54472012-08-27Apo-ClopidogrelAPX9.54472013-06-27CYCLOSPORINE217110mgCapNeoralNOV.76762000-01-17.7676217225mgCapNeoralNOV1.78501996-12-19.8657Sandoz CyclosporineSDZ.86572006-01-24.8657217350mgCapNeoralNOV3.48161996-12-191.6885Sandoz CyclosporineSDZ1.68852007-01-021.68852174100mgCapNeoralNOV6.96801996-12-193.3792Sandoz CyclosporineSDZ3.37922003-01-303.37922175100mg/mLO/LNeoralNOV6.19521996-12-196.1952DARIFENACIN21767.5mgER TabEnablexSLP1.61162011-12-15.8058Apo-DarifenacinAPX.80582021-08-31.8058Jamp DarifenacinJPC.80582022-02-28.8058217715mgER TabEnablexSLP1.61162011-12-15.8058Apo-DarifenacinAPX.80582021-08-31.8058Jamp DarifenacinJPC.80582022-02-28.8058For patients with urinary frequency, urgency or urge incontinence who have: Failed to respond to behavioral techniques AND an adequate trial of oxybutynin with gradual dose escalation has shown to be either ineffective or resulted in unacceptable side effects. NOTE: If after a trial of 2 weeks patients continue to experience similar side effects and no greater efficacy than oxybutynin, continued therapy with this more costly agent should be reassessed. Antimuscarinic agents should be used with caution in the elderly due to potentially serious adverse effects (e.g. confusion, psychosis, acute urinary retention, constipation). Antimuscarinic agents should be avoided in older adults with pre-existing cognitive impairment (e.g. dementia) and those who are already using other drugs with significant anticholinergic effects (e.g. tricyclic antidepressants) in order to avoid a high overall anticholinergic drug burden.LU Authorization Period: IndefiniteDENOSUMAB217860mg/mLInj Sol-1.0mL Pref Syr Pk (Preservative-Free)StobocloCEI194.70002025-11-28194.7000To increase the bone mass in postmenopausal females with osteoporosis who are at high risk* for fracture who have failed, had intolerance to, or are unable to take a bisphosphonate therapy. *High risk of fracture based on a clinician's evaluation of the individual's risk of fractures that may include prior fragility fracture history and the Fracture Risk Assessment (FRAX) scores or another validated tool.LU Authorization Period: IndefiniteTo increase the bone mass in males with osteoporosis who are at high risk* of fractures who have failed, had intolerance to, or are unable to take a bisphosphonate therapy. *High risk of fracture based on a clinician's evaluation of the individual's risk of fractures that may include prior fragility fracture history and the Fracture Risk Assessment (FRAX) scores or another validated tool.LU Authorization Period: Indefinite217960mg/mLInj Sol-Pref SyrProlia (Preservative Free)AMG440.10002012-02-29440.1000Only for a patient who is established on Prolia (denosumab) therapy prior to November 29, 2024 and who is or becomes palliative requiring end-of-life care during the biosimilar transition period between November 29, 2024 to August 29, 2025. Patient must also meet the following criteria: - The patient is a postmenopausal female or male with osteoporosis and Prolia (denosumab) is being used to increase the bone mass in the patient; - The patient is at high risk* for fracture; and - One of the following applies to the patient: - The patient has failed other available osteoporosis therapy (i.e., fragility fracture or evidence of a decline in bone mineral density below pre-treatment baseline levels) despite adherence to the therapy for one year; or - bisphosphonates are contraindicated for the patient due to hypersensitivity, abnormalities of the esophagus (e.g., esophageal stricture or achalasia), or inability to stand or sit upright for at least 30 minutes. *High risk of fracture is defined as one of the following: - a prior fragility fracture AND a moderate 10-year fracture risk (10% to 20%) based on the Canadian Association of Radiologists and Osteoporosis Canada (CAROC) tool or the Fracture Risk Assessment (FRAX) tool; - a high 10-year fracture risk (greater than or equal to 20%) based on the CAROC or FRAX tool; or - where a patient's 10-year fracture risk based on the CAROC or FRAX tool is less than the thresholds defined above, a high fracture risk based on evaluation of clinical risk factors for fracture. Note: Use of the CAROC or FRAX tool may underestimate fracture risk in certain circumstances and may not include all risk factors. Funded duration: One period of up to 12 months beginning on the date of the first prescription with RFU code 690 is dispensed for the patient. Note: In all cases, patients receiving Prolia must not be receiving concomitant bisphosphonate therapy. The recommended dose of PROLIA (denosumab) is a single SC injection of 60mg, once every 6 months. LU Authorization Period: 1 year218060mg/mLInj Sol-Pref SyrJubbonti (Preservative Free)SDZ194.70002024-08-30194.7000To increase the bone mass in postmenopausal females with osteoporosis who are at high risk* for fracture who have failed, had intolerance to, or are unable to take a bisphosphonate therapy. *High risk of fracture based on a clinician's evaluation of the individual's risk of fractures that may include prior fragility fracture history and the Fracture Risk Assessment (FRAX) scores or another validated tool.LU Authorization Period: IndefiniteTo increase the bone mass in males with osteoporosis who are at high risk* of fractures who have failed, had intolerance to, or are unable to take a bisphosphonate therapy. *High risk of fracture based on a clinician's evaluation of the individual's risk of fractures that may include prior fragility fracture history and the Fracture Risk Assessment (FRAX) scores or another validated tool.LU Authorization Period: Indefinite2181120mg/1.7mLInj Sol-Vial PkWyost (Preservative Free)SDZ312.00002024-08-30312.00002182120mg/1.7mLInj Sol-Vial Pk (Preservative-Free)OsenveltCEI312.00002025-11-28312.0000For the treatment of bony metastases for patients with hormone refractory prostate cancer as determined by an elevated PSA level, or evidence of progressive bony disease, despite castrate serum testosterone levels (less than 1.7nmol/L or less than 50ng/dL) or having undergone orchidectomy. Dose: 120mg SC every 4 weeks LU Authorization Period: 1 yearDUTASTERIDE21830.5mgCapAvodartGSK2.22932005-09-27.2565Apo-DutasterideAPX.25652014-09-25.2565Teva-DutasterideTEV.25652014-09-25.2565Med-DutasterideGMP.25652014-12-18.2565Sandoz DutasterideSDZ.25652014-09-25.2565Mint-DutasterideMIN.25652014-11-27.2565DutasterideSIV.25652020-06-30.2565DutasterideSAI.25652020-06-30.2565Auro-DutasterideAUR.25652018-07-31.2565Jamp DutasterideJPC.25652020-01-31.2565Priva-DutasteridePHP.25652021-05-31.2565Jamp Dutasteride CapsulesJPC.25652025-05-30.2565For use in combination with an alpha blocker for the treatment of men with symptomatic* Benign Prostatic Hyperplasia.LU Authorization Period: IndefiniteFor monotherapy, as a second line agent in patients with symptomatic* Benign Prostatic Hyperplasia following treatment failure or intolerance to an alpha blocker.* Symptomatic is defined as having moderate (about half the time) to severe (almost always) symptoms related to the prostate in at least 4 of the following domains: 1. feeling of incomplete emptying of the bladder after voiding 2. needing to urinate again less than 2 hours after previous void 3. stopping and starting urine several times while voiding 4. difficulty postponing urination 5. weak urinary stream 6. pushing or straining to begin voiding 7. the need to get up to void at least 3 times in the night.LU Authorization Period: IndefiniteETIDRONATE DISODIUM2184200mgTabDidronelPGP1996-10-01Co EtidronateCOB.35692005-01-25.3569For the treatment of Paget's disease;LU Authorization Period: IndefiniteFor the management of hypercalcemia of malignancy.LU Authorization Period: IndefiniteFEBUXOSTAT218580mgTabUloricTAK2019-07-31Teva-FebuxostatTEV1.35152019-12-201.3515Mar-FebuxostatMAR1.35152019-07-311.3515Jamp-FebuxostatJPC1.35152020-05-291.3515Auro-FebuxostatAUR1.35152023-05-311.3515FebuxostatSAI1.35152024-01-311.3515FINASTERIDE21861mgTabPropeciaOCI2010-07-20PMS-FinasteridePMS1.14532010-07-20Sandoz Finasteride ASDZ1.14532010-07-20Auro-Finasteride 1mgAUR1.14552015-02-26FinasterideSAI1.14532020-06-30FinasterideSIV1.14552020-06-30Mint-FinasterideMIN1.14532024-02-29Jamp Finasteride TabletsJPC1.14532025-11-2821875mgTabProscarOCI2.68912004-07-20.3506Ratio-FinasterideRPH.35062010-06-14.3506PMS-FinasteridePMS.35062010-06-14.3506Sandoz FinasterideSDZ.35062010-04-23.3506Novo-FinasterideTEV.35062010-06-14.3506Finasteride Tablets USPACH.35062010-12-14.3506Jamp-FinasterideJPC.35062011-03-15.3506Apo-FinasterideAPX.35062011-09-15.3506Mint-FinasterideMIN.35062012-09-28.3506Auro-FinasterideAUR.35062013-07-30.3506FinasterideSAI.35062020-06-30.3506FinasterideSIV.35062020-06-30.3506Riva-FinasterideRIA.35062021-08-31.3506M-FinasterideMAT.35062022-11-30.3506For use in combination with an alpha blocker for the treatment of men with symptomatic* Benign Prostatic Hyperplasia.LU Authorization Period: IndefiniteFor monotherapy, as a second line agent in patients with symptomatic* Benign Prostatic Hyperplasia following treatment failure or intolerance to an alpha blocker.* Symptomatic is defined as having moderate (about half the time) to severe (almost always) symptoms related to the prostate in at least 4 of the following domains: 1. feeling of incomplete emptying of the bladder after voiding 2. needing to urinate again less than 2 hours after previous void 3. stopping and starting urine several times while voiding 4. difficulty postponing urination 5. weak urinary stream 6. pushing or straining to begin voiding 7. the need to get up to void at least 3 times in the night.LU Authorization Period: IndefiniteFINGOLIMOD21880.5mgCapGilenyaNOV86.95252019-10-3173.9100Teva-FingolimodTEV73.90962019-12-2073.9096Taro-FingolimodTAR73.90962019-12-2073.9096Mylan-FingolimodMYL73.90962019-11-2973.9096PMS-FingolimodPMS73.90962019-10-3173.9096Apo-FingolimodAPX73.90962019-12-2073.9096Mar-FingolimodMAR73.90962019-12-2073.9096Ach-FingolimodACH73.91002019-11-2973.9100Sandoz FingolimodSDZ73.90962019-12-2073.9096Jamp FingolimodJPC73.90962020-01-3173.9096FLUNARIZINE HCL21895mgCapSibeliumPMS1996-10-01FlunarizineAAP.85032003-01-30.8503For patients with migraine headaches who have not responded to propranolol.LU Authorization Period: 1 yearFor patients who have tried propranolol and experienced significant adverse effects.LU Authorization Period: 1 yearFor patients in whom propranolol is contraindicated.Contraindicated in patients with clinical depression and in patients with extrapyramidal disorders.LU Authorization Period: 1 yearGLATIRAMER ACETATE219020mg/mLInj Sol Pref Syr-1mL PkCopaxoneTEI50.65222024-05-3127.8587Glatiramer Acetate InjectionMYL27.85872024-05-3127.8587As monotherapy for the treatment of patients with relapsing remitting multiple sclerosis (RRMS) meeting ALL the following criteria: -Recent neurological examination consistent with the diagnosis of RRMS; AND -Lesions typical of multiple sclerosis on brain magnetic resonance imaging (MRI); AND -Experienced at least 2 clinical attacks in their lifetime with one attack occurring within the prior year; AND -EDSS score less than or equal to 6.0 prior to start of treatment; AND -Prescribed by a neurologist who is experienced in the treatment of Multiple Sclerosis. Note: Transition from another Disease Modifying therapy (DMT) is permitted in those who are deemed to have met the above criteria prior to initiation of the other DMT and if glatiramer acetate is used as monotherapy.LU Authorization Period: 1 yearAs monotherapy for the treatment of patients who have experienced a single demyelinating event/ Clinically Isolated Syndrome (CIS) meeting ALL the following criteria: - CIS occurred within the prior 12 months; AND - Recent neurological examination; AND - Lesions typical of CIS confirmed on brain magnetic resonance imaging (MRI); AND - EDSS score less than or equal to 6.0 prior to start of treatment; AND - Prescribed by a neurologist who is experienced in the treatment of Multiple Sclerosis Note: Transition from another Disease Modifying therapy (DMT) is permitted in those who are deemed to have met the above criteria prior to initiation of the other DMT and if glatiramer acetate is used as monotherapy.LU Authorization Period: 1 yearRenewal of therapy for patients diagnosed with relapsing remitting multiple sclerosis (RRMS) or a single demyelinating event /Clinically Isolated Syndrome (CIS) who meet ALL the following criteria: - Used as monotherapy for the treatment of RRMS or CIS; AND - EDSS score less than or equal to 6.0; AND - Disease activity is stabilized as determined by a neurological exam and the number of clinical relapses experienced while on treatment; AND - Prescribed by a neurologist experienced in the treatment of Multiple Sclerosis (MS) OR a prescriber in consultation with a neurologist overseeing the patient's MS.LU Authorization Period: 1 yearGLUCAGON21911mg/VialInj Pd-1mL Vial Pk (Kit)Glucagon Injection KitAMP280.00002023-09-28280.000021923mgNas Pd DeviceBaqsimiAMP160.52002022-01-31160.5200For the treatment of severe hypoglycemia (SH) reactions in patients with diabetes mellitus who are receiving insulin therapy and are at high risk for SH, when impaired consciousness precludes oral carbohydrate.LU Authorization Period: 1 yearGLUCAGON RDNA ORIGIN21931mg/VialInj Pd-Syr PkGlucaGen HypoKitNOO112.67002011-12-15112.670021941mg/VialInj Pd-Vial PkGlucaGenNOO108.33002011-12-15108.3300GRASS POLLEN ALLERGEN EXTRACT2195100IRSL TabOralairSTL1.38922014-03-271.38922196300IRSL TabOralairSTL4.18952014-03-274.1895For the seasonal treatment of grass pollen allergic rhinitis in patients that have not adequately responded to, or tolerated, conventional pharmacotherapy. Notes: - Treatment with grass pollen allergen extract must be initiated by physicians with adequate training and experience in the treatment of respiratory allergic diseases. - Treatment should be initiated four (4) months before the onset of pollen season and should only be continued until the end of the season. - Treatment should not be taken for more than three (3) consecutive years.LU Authorization Period: 1 yearICATIBANT219730mg/3mLInj Sol-Pref Syr 3mL PkFirazyrTAK2700.00002024-08-301485.0000Icatibant InjectionJPC1485.00002024-12-301485.0000INCOBOTULINUMTOXINA219850 LD50 UnitsPd for Inj-Vial PkXeominMEZ169.45502013-10-31169.45502199100 LD50 UnitsPd for Inj-Vial PkXeominMEZ338.91002011-05-19338.91002200200 Units/VialPd for Inj-Vial Pk (Preservative-Free)XeominMEZ677.82002026-02-27677.8200To reduce the subjective symptoms and objective signs of cervical dystonia (spasmodic torticollis) in adults.LU Authorization Period: 1 yearFor the management of focal spasticity, due to stroke or spinal cord injury in adults.LU Authorization Period: 1 yearFor the treatment of blepharospasm associated with dystonia, including benign essential blepharospasm or VII nerve disorders in adults.LU Authorization Period: 1 yearXeomin should be administered personally by a neurologist or a physician with equivalent post-graduate training and experience with neuromuscular disorders.LANREOTIDE ACETATE220160mg/0.3mLER Pref Syr-0.3mL PkSomatuline AutogelIPS1450.91982008-11-041450.9198220290mg/0.3mLER Pref Syr-0.3mL PkSomatuline AutogelIPS1935.42912008-11-041935.42912203120mg/0.5mLER Pref Syr-0.5mL PkSomatuline AutogelIPS2422.58322008-11-042422.5832LEFLUNOMIDE220410mgTabAravaSAV11.44402001-03-072.0000Apo-LeflunomideAPX2.64332004-11-162.0000Teva-LeflunomideTEV2.64332005-01-252.0000Sandoz LeflunomideSDZ2.64332007-01-022.0000LeflunomideSAI2.64332011-08-042.0000Accel-LeflunomideACC2.00002019-12-202.0000LeflunomideSIV2.64332024-07-312.0000Mar-LeflunomideMAR2.64332025-01-312.0000220520mgTabAravaSAV11.44432001-03-072.0000Apo-LeflunomideAPX2.64332004-11-162.0000Teva-LeflunomideTEV2.64332005-01-252.0000Sandoz LeflunomideSDZ2.64332007-01-022.0000LeflunomideSAI2.64332011-08-042.0000Accel-LeflunomideACC2.00002019-12-202.0000LeflunomideSIV2.64332024-07-312.0000Mar-LeflunomideMAR2.64332025-01-312.0000LENALIDOMIDE22062.5mgCapRevlimidBQU329.50002021-10-2982.3750Reddy-LenalidomideDRR82.37502021-10-2982.3750Nat-LenalidomideNAT82.37502021-10-2982.3750Jamp LenalidomideJPC82.37502022-03-3182.3750Taro-LenalidomideTAR82.37502022-07-2982.3750Apo-LenalidomideAPX82.37502021-10-2982.3750Sandoz LenalidomideSDZ82.37502021-10-2982.3750220715mgCapRevlimidBQU382.00002021-10-2995.5000Reddy-LenalidomideDRR95.50002021-10-2995.5000Nat-LenalidomideNAT95.50002021-10-2995.5000Jamp LenalidomideJPC95.50002022-03-3195.5000Taro-LenalidomideTAR95.50002022-07-2995.5000Apo-LenalidomideAPX95.50002021-10-2995.5000Sandoz LenalidomideSDZ95.50002021-10-2995.5000220820mgCapRevlimidBQU403.00002021-10-29100.7500Reddy-LenalidomideDRR100.75002021-10-29100.7500Nat-LenalidomideNAT100.75002021-10-29100.7500Jamp LenalidomideJPC100.75002022-03-31100.7500Taro-LenalidomideTAR100.75002022-07-29100.7500Apo-LenalidomideAPX100.75002021-10-29100.7500Sandoz LenalidomideSDZ100.75002021-10-29100.7500220925mgCapRevlimidBQU424.00002021-10-29106.0000Reddy-LenalidomideDRR106.00002021-10-29106.0000Nat-LenalidomideNAT106.00002021-10-29106.0000Jamp LenalidomideJPC106.00002022-03-31106.0000Taro-LenalidomideTAR106.00002022-07-29106.0000Apo-LenalidomideAPX106.00002021-10-29106.0000Sandoz LenalidomideSDZ106.00002021-10-29106.000022105mgCapRevlimidBQU340.00002021-10-2985.0000Reddy-LenalidomideDRR85.00002021-10-2985.0000Nat-LenalidomideNAT85.00002021-10-2985.0000Jamp LenalidomideJPC85.00002022-03-3185.0000Taro-LenalidomideTAR85.00002022-07-2985.0000Apo-LenalidomideAPX85.00002021-10-2985.0000Sandoz LenalidomideSDZ85.00002021-10-2985.0000221110mgCapRevlimidBQU361.00002021-10-2990.2500Reddy-LenalidomideDRR90.25002021-10-2990.2500Nat-LenalidomideNAT90.25002021-10-2990.2500Jamp LenalidomideJPC90.25002022-03-3190.2500Taro-LenalidomideTAR90.25002022-07-2990.2500Apo-LenalidomideAPX90.25002021-10-2990.2500Sandoz LenalidomideSDZ90.25002021-10-2990.2500Myelodysplastic Syndrome Initial criteria: For the treatment of patients with anemia due to myelodysplastic syndrome (MDS) who meet all of the following clinical criteria: 1. Demonstrated diagnosis of myelodysplastic syndrome (MDS) on bone marrow aspiration 2. Presence of deletion 5q cytogenetic abnormality documented by standard cytogenetic, fluorescence in situ hybridization, or genomic testing 3. International Prognostic Scoring System (IPSS) risk category low or intermediate-1 4. Symptomatic anemia (transfusion dependent or non-transfusion dependent) LU Authorization Period: 6 months Renewal criteria: There is at least a fifty percent (50%) reduction in transfusion requirements and/or evidence of hematologic response. Renewal Duration: 1 year Recommended dose: 10mg daily adjusted based on clinical and laboratory findings.Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of this criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria governs for the purpose of funding under the Ontario Drug Benefit Program.Multiple Myeloma (maintenance treatment following stem cell transplant) Initial criteria: For the maintenance treatment of patients with newly diagnosed multiple myeloma, following autologous stem-cell transplantation (ASCT) who have stable disease or better, with no evidence of disease progression. LU Authorization Period: 1 year Renewal criteria: Lenalidomide may be continued until evidence of disease progression or development of unacceptable toxicity requiring discontinuation of lenalidomide Renewal Duration: 1 year Recommended Dosage: Initial dose of 10mg daily Dose adjustments (5-15mg) may be necessary based on individual patient characteristics/responses. Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of this criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria governs for the purpose of funding under the Ontario Drug Benefit Program.Multiple Myeloma Initial criteria For the treatment of patients with multiple myeloma who meet ALL the following criteria: 1. Patient is deemed to be lenalidomide sensitive, defined as disease that has not been refractory to a lenalidomide-based regimen, and/or has not experienced progression while on a lenalidomide-based regimen in a treatment or maintenance setting (Note 1); AND 2. Patient has good performance status; AND 3. Lenalidomide is being used in ONE of the following situations: a) In a transplant ineligible patient with previously untreated multiple myeloma, as first line therapy within a dual regimen in combination with dexamethasone OR as part of a triplet regimen in combination with dexamethasone and bortezomib (Note 2); OR as part of a triplet regimen in combination with dexamethasone and daratumumab (Note 3) OR b) In a transplant ineligible patient with relapsed or refractory multiple myeloma as second or third line treatment within a dual regimen in combination with dexamethasone; OR as part of a triplet regimen in combination with dexamethasone and carfilzomib; OR as part of a triplet regimen in combination with dexamethasone and daratumumab (Note 3); OR c) In a patient with relapsed or refractory multiple myeloma who received a stem-cell transplant as first line treatment and is using a lenalidomide based regimen as second or third line treatment within a dual regimen in combination with dexamethasone; OR as part of a triplet regimen in combination with dexamethasone and carfilzomib; OR as part of a triplet regimen in combination with dexamethasone and daratumumab (Note 3). LU Authorization Period: 1 year Renewal criteria: Lenalidomide may be continued for the treatment of multiple myeloma in those who continue to respond to therapy and have not experienced refractory disease or progressive disease while on the lenalidomide-based regimen. Renewal Duration: 1 year Exclusion Criteria: Patients meeting the following are not eligible for funding: 1. Patients with multiple myeloma who have experienced disease that has been refractory to treatment with a lenalidomide-based treatment. 2. Patients with multiple myeloma who have experienced disease progression while on a lenalidomide-based treatment used for multiple myeloma in any setting including in maintenance treatment. 3. Patients requesting lenalidomide as fourth line treatment for multiple myeloma. 4. Patients with monoclonal gammopathy of uncertain significance (MGUS), smoldering myeloma, or primary amyloidosis. Recommended Dose: 25mg daily as a single 25mg capsule Patients should be dispensed the most appropriate strength of lenalidomide to achieve the dose recommendation and with the fewest number of tablets per day.Notes (Multiple Myeloma): 1. Refractory disease is defined as disease progression within 60 days after stopping treatment or progression on any dose of lenalidomide or bortezomib including while on maintenance therapy or non-responsive disease during therapy (either failure to achieve minimal response or disease progression). Relapsed/Progressive disease is defined as having one or more of the following: i) An increase of 25% from lowest response value in serum M-component (absolute increase must be greater than or equal to 0.5g/dL), and/or urine M-component (absolute increase must be greater than or equal to 200mg/24 hours). ii) An absolute increase of greater than 10mg/dL in the difference between involved and uninvolved FLC levels (if no measurable serum and urine M-protein levels). iii) Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. iv) Development of hypercalcemia (corrected serum calcium greater than 11.5mg/dL or 2.5mmol/L) that can be attributed solely to the plasma cell proliferative disorder. 2. Patients with multiple myeloma who experience disease progression on a lenalidomide-bortezomib-dexamethasone triplet will not be eligible for further bortezomib-based regimens subsequent to disease progression, in any multiple myeloma settings. Patients with multiple myeloma who experience disease progression on a lenalidomide-daratumumab-dexamethasone triplet will not be eligible for further daratumumab-based regimens subsequent to disease progression, in any multiple myeloma setting. 3. Patients using combination regimens must meet the eligibility requirements for bortezomib, carfilzomib and daratumumab through the New Drug Funding Program (NDFP). 4. Patients using lenalidomide in regimens that are not specified in the LU criteria may apply for case-by-case consideration through the EAP.Note: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of this criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria governs for the purpose of funding under the Ontario Drug Benefit Program.Multiple Myeloma - Induction Therapy for Transplant Eligible, Newly Diagnosed Multiple Myeloma Lenalidomide in combination with bortezomib and dexamethasone (RVd) as induction therapy before an autologous stem cell transplantation in patients with previously untreated, transplant-eligible, newly diagnosed multiple myeloma. Funding is for a total of 4 cycles. Recommended Dose: 15mg or 25mg daily depending on the treatment regimen as a single 15mg capsule or 25mg capsule Patients should be dispensed the most appropriate strength of lenalidomide to achieve the dose recommendation and with the fewest number of capsules per day.LU Authorization Period: 1 yearNote: Pharmacists and prescribers should be informed of a drug product's official indications and recommended dosage as set out in Health Canada's approved product monograph. Some aspects of this criteria may differ from the official indications and recommended dosage as described in the product monographs for lenalidomide or other products that may be used as part of combination therapy with lenalidomide. The Executive Officer's funding of drug products is informed by advice from expert committees that consider evidence regarding the safety, clinical efficacy, and cost-effectiveness of the drug products. Where there is a difference between a product monograph and the LU criteria described above, the LU criteria governs for the purpose of funding under the Ontario Drug Benefit Program.LEVOCARNITINE2212100mg/mLOral Sol (with preservative)CarnitorLBI.38092020-01-31.3809Odan LevocarnitineODN.38092020-01-31.3809LEVODOPA & BENSERAZIDE221350mg & 12.5mgCapProlopa 50-12.5HLR.35081996-10-01.35082214100mg & 25mgCapProlopa 100-25HLR.57771996-10-01.57772215200mg & 50mgCapProlopa 200-50HLR.96991996-10-01.9699LEVODOPA & CARBIDOPA2216100mg & 25mgCR TabSinemet CRMFC1996-10-01AA-Levocarb CRAAP.79742009-08-18.79742217200mg & 50mgCR TabSinemet CRMFC1996-10-01AA-Levocarb CRAAP1.42822004-07-201.4282For patients with Parkinson's disease who have been treated with conventional therapy (Prolopa or conventional Sinemet), and experienced adverse effects related to drug level fluctuations, such as ON/OFF or wearing off phenomena.LU Authorization Period: IndefiniteFor patients presently requiring anti-parkinsonian drug administration (levodopa/carbidopa) more than three times daily.LU Authorization Period: Indefinite2218100mg & 10mgTabSinemetMFC1996-10-01Apo-LevocarbAPX.14791996-12-19.1479Teva-LevocarbidopaTEV.14792003-01-30.1479Mint-LevocarbMIN.14792017-02-28.1479Auro-LevocarbAUR.14792023-06-30.1479Jamp LevocarbJPC.14792025-01-31.1479PMS-Levodopa-CarbidopaPMS.14792025-04-30.14792219100mg & 25mgTabSinemetOCI1996-10-01Apo-LevocarbAPX.22091996-12-19.2209Teva-LevocarbidopaTEV.22092003-01-30.2209Mint-LevocarbMIN.22092017-02-28.2209Auro-LevocarbAUR.22092023-06-30.2209Jamp LevocarbJPC.22092025-01-31.2209PMS-Levodopa-CarbidopaPMS.22092025-04-30.22092220250mg & 25mgTabSinemetOCI1996-10-01Apo-LevocarbAPX.24661996-12-19.2466Teva-LevocarbidopaTEV.24662002-07-29.2466Mint-LevocarbMIN.24662017-02-28.2466Auro-LevocarbAUR.24662023-06-30.2466Jamp LevocarbJPC.24662025-01-31.2466PMS-Levodopa-CarbidopaPMS.24662025-04-30.2466LEVODOPA & CARBIDOPA & ENTACAPONE222175 & 18.75 & 200mgTabStalevoSDZ1.74712010-10-281.74712222125 & 31.25 & 200mgTabStalevoSDZ1.74712010-10-281.7471222350 & 12.5 & 200mgTabStalevoSDZ1.74712009-03-021.74712224100 & 25 & 200mgTabStalevoSDZ1.74712009-03-021.74712225150 & 37.5 & 200mgTabStalevoSDZ1.74712009-03-021.7471For the treatment of patients with Parkinson's disease with 25% of the waking day in the off state despite maximally tolerated doses of levodopa.LU Authorization Period: IndefiniteMIGLUSTAT2226100mgCapZavescaACT128.96002020-06-3081.4125Sandoz MiglustatSDZ81.41252020-06-3081.4125MONTELUKAST SODIUM22274mgChew TabSingulairOCI1.85032004-04-06.2758Sandoz MontelukastSDZ.27582012-01-19.2758PMS-MontelukastPMS.27582012-01-19.2758Teva-MontelukastTEV.27582012-01-19.2758Apo-MontelukastAPX.27582012-02-29.2758MontelukastSIV.27582020-06-30.2758Mar-MontelukastMAR.27582013-04-30.2758Mint-MontelukastMIN.27582014-01-03.2758Auro-Montelukast Chewable TabletAUR.27582014-05-29.2758Jamp-MontelukastJPC.27582018-12-21.2758Jamp Montelukast Chewable TabletsJPC.27582022-10-31.2758Nat-MontelukastNAT.27582023-01-31.2758For the treatment of asthma in patients aged 2-5 years old.LU Authorization Period: 1 year22285mgChew TabSingulairOCI2012-01-19Sandoz MontelukastSDZ1.20752012-01-191.2075PMS-MontelukastPMS1.20752012-01-191.2075Teva-MontelukastTEV1.20772012-01-191.2077Apo-MontelukastAPX1.20752012-02-291.2075MontelukastSAI1.20752022-08-311.2075MontelukastSIV1.20752020-06-301.2075Mar-MontelukastMAR1.20752013-04-301.2075Ran-MontelukastRAN1.20752013-09-271.2075Mint-MontelukastMIN1.20752014-01-031.2075Auro-Montelukast Chewable TabletAUR1.20772016-02-251.2077Jamp-MontelukastJPC1.20752018-12-211.2075Jamp Montelukast Chewable TabletsJPC1.20752022-03-311.2075Nat-MontelukastNAT1.20772023-01-311.207722294mgGran PkSingulairOCI2012-01-19Sandoz MontelukastSDZ1.34402012-01-19223010mgTabSingulairOCI2012-01-19Sandoz MontelukastSDZ1.77352012-01-191.7735Teva-MontelukastTEV1.77372012-01-191.7737PMS-Montelukast FCPMS1.77352012-01-191.7735Apo-MontelukastAPX1.77352012-01-191.7735Ach-MontelukastACH1.77352012-12-211.7735MontelukastSAI1.77352020-06-301.7735MontelukastSIV1.77352020-06-301.7735Ran-MontelukastRAN1.77352013-07-301.7735Jamp-MontelukastJPC1.77352012-11-271.7735Mar-MontelukastMAR1.77352013-03-201.7735Auro-MontelukastAUR1.77352013-04-301.7735Mint-MontelukastMIN1.77352014-01-031.7735M-MontelukastMAT1.77352021-10-291.7735NRA-MontelukastNRA1.77352020-06-301.7735Nat-MontelukastNAT1.77372023-01-311.7737MYCOPHENOLATE MOFETIL2231250mgCapCellCeptHLR2.28331997-04-10.3712Sandoz Mycophenolate MofetilSDZ.37122012-01-19.3712Apo-MycophenolateAPX.37122012-01-19.3712Teva-MycophenolateTEV.37122012-01-19.3712Mycophenolate Mofetil CapsulesACH.37122012-06-26.3712Jamp-Mycophenolate CapsulesJPC.37122012-08-27.3712Mycophenolate MofetilSAI.37122020-08-28.37122232200mg/mLPd for Oral Susp-175mL PkCellCeptHLR358.06002005-02-22244.7025Mar-Mycophenolate MofetilMAR244.70252022-03-31244.7025For patients who are unable to swallow or tolerate solid oral dosage forms.LU Authorization Period: Indefinite2233500mgTabCellCeptHLR4.56662000-04-17.7423Sandoz Mycophenolate MofetilSDZ.74232012-01-19.7423Teva-MycophenolateTEV.74232012-01-19.7423Apo-MycophenolateAPX.74232012-01-19.7423Ach-MycophenolateACH.74232012-06-26.7423Jamp-MycophenolateJPC.74232012-08-27.7423Mycophenolate MofetilSAI.74232020-08-28.7423MYCOPHENOLATE SODIUM2234180mgEnt TabMyforticNOV1.99772006-01-12.4994Apo-Mycophenolic AcidAPX.49942014-07-30.4994Mar-Mycophenolic AcidMAR.49942021-05-31.4994Jamp Mycophenolic AcidJPC.49942025-04-30.49942235360mgEnt TabMyforticNOV3.99532006-01-12.9988Apo-Mycophenolic AcidAPX.99882014-07-30.9988Mar-Mycophenolic AcidMAR.99882021-05-31.9988Jamp Mycophenolic AcidJPC.99882025-04-30.9988OCTREOTIDE223610mgInj Kit PkSandostatin LARNOV1320.93002007-01-02990.6975Octreotide for Injectable SuspensionTEV990.69752021-11-30990.6975223720mgInj Kit PkSandostatin LARNOV1706.58002007-01-021279.9350Octreotide for Injectable SuspensionTEV1279.93502021-11-301279.9350223830mgInj Kit PkSandostatin LARNOV2189.52002007-01-021642.1400Octreotide for Injectable SuspensionTEV1642.14002021-11-301642.14002239100mcg/mLInj SolSandostatinNOV10.08802007-01-025.0440Octreotide Acetate OmegaOMG5.04402008-03-255.0440Octreotide InjectionSTE5.04402026-02-275.04402240500mcg/mLInj SolSandostatinNOV2007-01-02Octreotide Acetate OmegaOMG23.70702008-03-2523.7070Octreotide InjectionSTE23.70702026-02-2723.7070224150mcg/mLInj Sol - 1mL Amp PkSandostatinNOV5.34402007-01-024.0080Octreotide Acetate OmegaOMG4.00802008-03-254.00802242200mcg/mLInj Sol - 5mL Vial PkSandostatinNOV97.03002007-01-0248.5150Octreotide Acetate OmegaOMG48.51502008-03-2548.5150Octreotide InjectionSTE48.51502026-02-2748.5150OMALIZUMAB224375mg/0.5mLInj Sol-0.5mL Pref Syr PkOmlycloCEI168.74402025-08-29168.74402244150mg/mLInj Sol-1mL Pref Syr PkOmlycloCEI384.96002025-08-29384.9600For the treatment of adults with severe uncontrolled asthma who meet the following criteria: 1. Patient is 12 years of age or older; AND 2. Diagnosed with severe asthma that is not controlled despite treatment with a high-dose inhaled corticosteroid, defined as greater than or equal to 500mcg of fluticasone propionate or equivalent daily*, in addition to a long-acting inhaled beta 2-agonist; *Note: Check dose comparison tables for high-dose inhaled corticosteroid equivalency comparisons for various inhaled corticosteroids. Omalizumab will not be funded as a first line treatment for uncontrolled asthma and patients must try other conventional therapies for asthma that include a corticosteroid inhaler before being prescribed a biologic treatment. Proper inhaler technique (with a spacer if required/appropriate) and adherence to prescribed treatment should be confirmed. Patients may also be on other concomitant therapies. AND 3. In the past 12 months, inadequately controlled asthma has resulted in at least one of the following: - Hospitalization for asthma - Two or more urgent care visits to a physician/nurse practitioner or emergency department for asthma exacerbations. - Use of two or more courses of high-dose oral corticosteroids (e.g. prednisone) or increase in the dose of chronic prednisone treatment to manage asthma exacerbations; AND 4. Patient has demonstrated a positive skin test or in vitro reactivity to a perennial aeroallergen (e.g. positive allergy testing by skin prick test or IgE RAST); Note: Removal or reduction of allergic and environmental triggers of asthma to the fullest extent possible should be attempted. AND 5. Has a baseline Immunoglobulin E (IgE) level between 30IU/mL and 700IU/mL inclusive prior to start of omalizumab; Note: Serum total IgE levels increase following administration of omalizumab due to formation of omalizumab:IgE complexes. Elevated serum total IgE levels may persist for up to 1 year following discontinuation of omalizumab. Serum total IgE levels obtained less than 1 year following discontinuation may not reflect steady state free IgE levels and should not be used to reassess the dosing regimen in asthma patients. AND 6. Has an actual body weight between 20 to 150kg inclusive (Refer to Omlyclo product monograph for dosing in individuals 12 years of age and older by IgE level and weight); AND 7. Prescribed by or in consultation with a specialist in respirology or allergy/clinical immunology. 8. Omalizumab is not being used in combination with another biologic drug used for the treatment of asthma. Renewal of omalizumab is provided for patients who have responded to treatment by improving asthma control compared to baseline before omalizumab was initiated. Depending on the baseline parameters, this may be evidenced by clinical improvements of one or more of the following; - Decreased utilization of rescue medications [as determined by reduction in nighttime awakenings or reduction in average number of puffs/day of short-acting beta-agonists (SABA)]; OR - Decreased frequency of asthma exacerbations (as determined by reduction in exacerbations that require hospitalization and/or urgent care visits to a hospital emergency department or physician/nurse practitioner clinic.); OR - Reduction in asthma exacerbations that require adding or increasing doses of corticosteroids; OR - Increase in percent predicted FEV-1 from pre-treatment baselines. Recommended dose: Omalizumab 75 to 375mg administered SC every 2 to 4 weeks.LU Authorization Period: 1 yearFor the treatment of moderate to severe chronic idiopathic urticaria (CIU) in patients who meet all the following criteria: 1. Patient is 12 years of age or older; AND 2. Diagnosed with moderate to severe CIU [Weekly urticaria activity score (UAS7) of 16 or greater]; AND 3. Remains symptomatic despite management with optimal doses of standard oral therapies for CIU (e.g. histamine H1 receptor antagonists [e.g. cetirizine, desloratadine, loratadine, fexofenadine]); AND 4. Omalizumab is not being used in combination with another biologic drug used for the treatment of CIU; AND 5. Prescribed by a specialist (e.g. allergist, immunologist, dermatologist, etc.). Recommended dose: 300mg SC every 4 weeks Note the following guidance: Severe urticaria - UAS7 of 28 to 42 Moderate urticaria - UAS7 of 16 to 27 Mild urticaria - UAS7 of 7 to 15 Well-controlled urticaria - UAS7 of 1 to 6 Urticaria-free - UAS7 of 0 (zero) Patients who achieve symptom control for at least 12 weeks while on therapy should have a trial of stopping treatment.LU Authorization Period: 6 MonthsAll patients new to the Ontario Drug Benefit (ODB) Program should meet the RFU Code for initiation. Renewal of funding of omalizumab will be provided for the treatment of chronic idiopathic urticaria (CIU) in patients who meet the following criteria: 1. Patient is 12 years of age or older; AND 2. Omalizumab is prescribed by a specialist (e.g. allergist, immunologist, dermatologist, etc.); AND 3. Omalizumab is not being used in combination with another biologic drug used for the treatment of CIU; AND 4. Patient's response to omalizumab previously funded under the ODB program meets at least ONE of the following criteria: - Has achieved symptom control on omalizumab and tried stopping therapy but experienced symptom relapse of their urticaria while off treatment. - Has experienced a partial improvement in response with omalizumab treatment by demonstrating a reduction of the weekly urticaria activity score (UAS7) by 9.5 points or more but patient has not been able to achieve complete symptom control for more than 12 consecutive weeks. - Has responded to omalizumab in the past but has been rediagnosed with moderate to severe CIU with UAS7 of 16 or higher. Notes: 1. Patients who achieve complete symptom control for at least 12 weeks while on therapy should have a trial of stopping treatment to establish whether the condition has gone into spontaneous remission. 2. Patients must demonstrate a minimum response to omalizumab for CIU by reducing the UAS7 score by at least 9.5 points from baseline before initiation of omalizumab for CIU. Note the following guidance: Urticaria-free - UAS7 of 0 (zero) Well-controlled urticaria - UAS7 of 1 to 6 Mild urticaria - UAS7 of 7 to 15 Moderate urticaria - UAS7 of 16 to 27 Severe urticaria - UAS7 of 28 to 42 Recommended dose: 300mg every 4 weeksLU Authorization Period: 1 yearPAMIDRONATE DISODIUM22453mg/mLInj Sol-10mL VialArediaNOV2007-07-12Pamidronate Disodium for InjectionFKC86.78002019-08-3086.7800Pamidronate Disodium OmegaOMG86.78002011-12-1586.780022466mg/mLInj Sol-10mL VialArediaNOV2007-07-12Pamidronate Disodium for InjectionFKC176.70002019-08-30176.7000Pamidronate Disodium OmegaOMG176.70002011-12-15176.700022479mg/mLInj Sol-10mL VialArediaNOV2007-07-12Pamidronate Disodium for InjectionFKC260.33002019-08-30260.3300Pamidronate Disodium OmegaOMG260.33002011-12-15260.3300PINAVERIUM BROMIDE224850mgTabDicetelBGP2018-10-31PinaveriumAAP.31002018-10-31.31002249100mgTabDicetelBGP2018-10-31PinaveriumAAP.54052018-10-31.5405PIRFENIDONE2250267mgCapEsbrietINT2021-07-30Sandoz Pirfenidone CapsulesSDZ6.71202021-11-306.7120Jamp PirfenidoneJPC6.71202021-07-306.7120QUINAGOLIDE HCL22510.15mgTabNorprolacFEI1.72942006-10-231.7294For the treatment of hyperprolactinemia in patients who have: * Failed to respond to a greater than or equal to 3 month trial of bromocriptine; or * Failed to tolerate bromocriptine; or * Failed to shrink a prolactinoma by greater than 1 cm after 12 months of bromocriptine therapyLU Authorization Period: 5 years.RALOXIFENE HCL225260mgTabEvistaLIL2.37572000-11-30.5134Apo-RaloxifeneAPX.51342009-05-20.5134Co RaloxifeneCOB.51342012-10-30.5134Jamp RaloxifeneJPC.51342024-08-30.5134For the treatment of osteoporosis in postmenopausal women who have:Failed or, experienced intractable side effects, or have a contraindication to, alendronate OR risedronate.Failure is defined as: continued loss of bone mineral density (loss of more than 3%) after two years of therapy; or a new osteoporosis related fracture after one year of therapy.LU Authorization Period: IndefiniteRILUZOLE225350mgTabRilutekSAC10.55002012-11-277.3630Apo-RiluzoleAPX7.36302012-11-277.3630Mylan-RiluzoleMYL7.36302012-12-217.3630RISEDRONATE SODIUM225435mgDR TabActonel DRWAR11.86532012-02-292.9663AA-Risedronate DRAAP2.96632021-07-302.966322555mgTabActonelWAR2001-03-07Teva-RisedronateTEV1.84452010-04-231.8445225630mgTabActonelWAR2000-04-17Teva-RisedronateTEV11.38072010-04-2311.3807225735mgTabActonelWAR2003-04-16Teva-RisedronateTEV1.67642010-04-231.6764PMS-RisedronatePMS1.67642010-10-281.6764Ratio-RisedronateRPH1.67642010-10-281.6764Sandoz RisedronateSDZ1.67642010-10-281.6764Riva-RisedronateRIA1.67642021-08-311.6764Apo-RisedronateAPX1.67642010-10-281.6764Jamp-RisedronateJPC1.67642012-08-271.6764RisedronateSAI1.67642020-06-301.6764Auro-RisedronateAUR1.67642013-09-271.6764RisedronateSIV1.67642020-05-291.67642258150mgTabActonelWAR47.33702009-06-2311.1875Apo-RisedronateAPX11.18752012-06-2611.1875Teva-RisedronateTEV11.18752014-01-0311.1875PMS-RisedronatePMS11.18752014-07-3011.1875Auro-RisedronateAUR11.18752018-04-3011.1875RisedronateSAI11.18752022-11-3011.1875ROPINIROLE22590.25mgTabReQuipGSK2000-04-17Ran-RopiniroleRAN.14412009-09-30.1441Teva-RopiniroleTEV.14412009-09-30.144122601mgTabReQuipGSK2000-04-17Ran-RopiniroleRAN.57622009-09-30.5762Teva-RopiniroleTEV.57622009-09-30.576222612mgTabReQuipGSK2000-04-17Ran-RopiniroleRAN.63382009-09-30.6338Teva-RopiniroleTEV.63382009-09-30.633822625mgTabReQuipGSK2000-04-17Ran-RopiniroleRAN1.74502009-09-301.7450Teva-RopiniroleTEV1.74502009-09-301.7450SAPROPTERIN DIHYDROCHLORIDE2263100mgPd for Sol (Sachet Pk)KuvanBIM2024-01-31Reddy-SapropterinDRR24.75002024-01-312264500mgPd for Sol (Sachet Pk)KuvanBIM2024-01-31Reddy-SapropterinDRR123.75002024-01-31SELEGILINE HCL22655mgTabEldeprylBJH1996-10-01SelegilineAAP1.70721997-08-281.7072SILDENAFIL226620mgTabRevatioUJC13.53142010-09-097.2940Teva-Sildenafil RTEV7.29402010-09-097.2940PMS-Sildenafil RPMS7.29402015-01-287.2940Apo-Sildenafil RAPX7.29402014-02-277.2940Jamp-Sildenafil RJPC7.29402021-03-297.2940226725mgTabViagraUJC2013-01-29Apo-SildenafilAPX8.28942013-01-298.2894Teva-SildenafilTEV8.29002013-01-298.2894SildenafilPMS8.28942013-09-278.2894Co SildenafilCOB8.28942013-01-298.2894Mint-SildenafilMIN8.29002013-08-298.2894SildenafilSIV8.29002024-06-288.2894Jamp-SildenafilJPC8.29002014-05-298.2894Auro-SildenafilAUR8.28942016-02-258.2894Accel-SildenafilACC3.18502019-11-293.1850PRZ-SildenafilPRZ8.28942022-01-318.2894SildenafilSAI8.28942024-07-318.2894226850mgTabViagraUJC2013-01-29Apo-SildenafilAPX8.84812013-01-298.8481Teva-SildenafilTEV8.84812013-01-298.8481SildenafilPMS8.84812013-09-278.8481Co SildenafilCOB8.84812013-01-298.8481Mint-SildenafilMIN8.84752013-08-298.8475SildenafilSIV8.84812024-06-288.8481Jamp-SildenafilJPC8.84752014-05-298.8475SildenafilSAI8.84752016-10-278.8475Auro-SildenafilAUR8.84752016-02-258.8475Accel-SildenafilACC3.40002019-11-293.4000PRZ-SildenafilPRZ8.84752022-01-318.84752269100mgTabViagraUJC2013-01-29Apo-SildenafilAPX9.20062013-01-299.2006Teva-SildenafilTEV9.20062013-01-299.2006SildenafilPMS9.20062013-09-279.2006Co SildenafilCOB9.20162013-01-299.2016Mint-SildenafilMIN9.20002013-08-299.2000SildenafilSIV9.20062024-06-289.2006Mar-SildenafilMAR9.20062017-03-289.2006Jamp-SildenafilJPC9.20002014-05-299.2000SildenafilSAI9.20062016-10-279.2006Auro-SildenafilAUR9.20002016-02-259.2000M-SildenafilMAT9.20002016-10-279.2000Riva-SildenafilRIA9.20062021-08-319.2006PRZ-SildenafilPRZ9.20062019-03-289.2006NRA-SildenafilNRA9.20062020-07-319.2006Accel-SildenafilACC3.53502019-11-293.5350Jamp Sildenafil TabletsJPC9.20002021-03-299.2000SILODOSIN22704mgCapRapafloWAT2013-02-28Sandoz SilodosinSDZ.47422021-03-29.4742Auro-SilodosinAUR.47422022-04-29.4742PMS-SilodosinPMS.47422021-11-30.4742Jamp SilodosinJPC.47422024-06-28.474222718mgCapRapafloWAT2013-02-28Sandoz SilodosinSDZ.47422021-03-29.4742Auro-SilodosinAUR.47422022-04-29.4742PMS-SilodosinPMS.47422021-11-30.4742Jamp SilodosinJPC.47422024-06-28.4742For the management of benign prostatic hyperplasia where six weeks of treatment with other formulary alpha blockers (e.g. doxazosin, terazosin, tamsulosin) have been ineffective.LU Authorization Period: IndefiniteFor the management of benign prostatic hyperplasia where other formulary alpha blockers (e.g. doxazosin, terazosin, tamsulosin) have produced intolerable side effects.LU Authorization Period: IndefiniteSIROLIMUS22721mg/mLO/LRapamuneWAY9.68552005-02-229.685522731mgTabRapamuneWAY9.68552005-02-229.6855For the prophylaxis of organ rejection in patients receiving allogeneic renal transplants.LU Authorization Period: IndefiniteSOLIFENACIN SUCCINATE22745mgTabVesicareASE1.68922011-12-15.3041Teva-SolifenacinTEV.30412015-09-30.3041Sandoz SolifenacinSDZ.30412015-11-26.3041PMS-SolifenacinPMS.30412016-01-28.3041Act SolifenacinACV.30412015-11-26.3041Apo-SolifenacinAPX.30412018-09-27.3041Jamp-SolifenacinJPC.30412016-02-25.3041Jamp Solifenacin SuccinateJPC.30412016-07-28.3041Ran-SolifenacinRAN.30412016-02-25.3041Ach-Solifenacin SuccinateACH.30412023-05-31.3041Auro-SolifenacinAUR.30412016-06-29.3041Solifenacin Succinate TabletsMDI.30412017-11-30.3041SolifenacinSAI.30412020-10-30.3041PRZ-SolifenacinPRZ.30412021-02-26.3041M-Solifenacin SuccinateMAT.30412023-10-31.3041227510mgTabVesicareASE1.68922011-12-15.3041Teva-SolifenacinTEV.30412015-09-30.3041Sandoz SolifenacinSDZ.30412015-11-26.3041PMS-SolifenacinPMS.30412016-01-28.3041Act SolifenacinACV.30412015-11-26.3041Apo-SolifenacinAPX.30412018-09-27.3041Jamp-SolifenacinJPC.30412016-02-25.3041Jamp Solifenacin SuccinateJPC.30412016-07-28.3041Ran-SolifenacinRAN.30412016-02-25.3041Ach-Solifenacin SuccinateACH.30412023-05-31.3041Auro-SolifenacinAUR.30412016-06-29.3041Solifenacin Succinate TabletsMDI.30412017-11-30.3041SolifenacinSAI.30412020-10-30.3041PRZ-SolifenacinPRZ.30412021-02-26.3041M-Solifenacin SuccinateMAT.30412023-10-31.3041For patients with urinary frequency, urgency or urge incontinence who have: Failed to respond to behavioral techniques AND an adequate trial of oxybutynin with gradual dose escalation has shown to be either ineffective or resulted in unacceptable side effects. NOTE: If after a trial of 2 weeks patients continue to experience similar side effects and no greater efficacy than oxybutynin, continued therapy with this more costly agent should be reassessed. Antimuscarinic agents should be used with caution in the elderly due to potentially serious adverse effects (e.g. confusion, psychosis, acute urinary retention, constipation). Antimuscarinic agents should be avoided in older adults with pre-existing cognitive impairment (e.g. dementia) and those who are already using other drugs with significant anticholinergic effects (e.g. tricyclic antidepressants) in order to avoid a high overall anticholinergic drug burden.LU Authorization Period: IndefiniteSTANDARDIZED SHORT RAGWEED POLLEN ALLERGENIC EXTRACT227612USL TabRagwitekALK5.11862015-04-305.1186For the seasonal treatment of short ragweed pollen induced allergic rhinitis in patients that have not adequately responded to, or tolerated, conventional pharmacotherapy. Notes: Treatment with short ragweed pollen allergen extract must be initiated by physicians with adequate training and experience in the treatment of respiratory allergic diseases. Treatment should be initiated at least twelve (12) weeks before the onset of ragweed pollen season and should only be continued until the end of the season.LU Authorization Period: 1 yearSUNITINIB MALATE227712.5mgCapSutentPFI65.12402022-09-2955.3553Taro-SunitinibTAR55.35532022-09-2955.3553Teva-SunitinibTEV55.35532023-11-3055.3553Auro-SunitinibAUR55.35532023-08-3155.3553Sandoz SunitinibSDZ55.35532023-03-3155.3553Nat-SunitinibNAT55.35532025-11-2855.3553227825mgCapSutentPFI130.24702022-09-29110.7100Taro-SunitinibTAR110.71002022-09-29110.7100Teva-SunitinibTEV110.71002023-11-30110.7100Auro-SunitinibAUR110.71002023-08-31110.7100Sandoz SunitinibSDZ110.71002023-03-31110.7100Nat-SunitinibNAT110.71002025-11-28110.7100227950mgCapSutentPFI260.49502022-09-29221.4208Taro-SunitinibTAR221.42082022-09-29221.4208Teva-SunitinibTEV221.42082023-11-30221.4208Auro-SunitinibAUR221.42082023-08-31221.4208Sandoz SunitinibSDZ221.42082023-03-31221.4208Nat-SunitinibNAT221.42082025-11-28221.4208TACROLIMUS22805mg/mLAmpPrografASE128.23501996-12-19128.235022810.5mgCapPrografASE2.02912009-04-011.0146Sandoz TacrolimusSDZ1.01462015-01-281.0146Ach-TacrolimusACH1.01462023-11-301.014622821mgCapPrografASE2.59561996-12-191.2978Sandoz TacrolimusSDZ1.29782014-01-301.2978Ach-TacrolimusACH1.29782023-11-301.297822835mgCapPrografASE12.99861996-12-196.4993Sandoz TacrolimusSDZ6.49932014-01-306.4993Ach-TacrolimusACH6.49932023-11-306.4993For solid organ transplant and bone marrow transplant.LU Authorization Period: Indefinite22840.5mgER CapAdvagrafASE2.21992009-04-012.219922851mgER CapAdvagrafASE2.83962009-04-011.5618Sandoz Tacrolimus XRSDZ1.56182025-12-301.561822863mgER CapAdvagrafASE8.51882011-03-154.6853Sandoz Tacrolimus XRSDZ4.68532025-12-304.685322875mgER CapAdvagrafASE14.22052009-04-017.8213Sandoz Tacrolimus XRSDZ7.82132025-12-307.8213For prophylaxis of organ rejection in adult patients receiving allogeneic kidney transplants LU Authorization Period: Indefinite22880.03%OintProtopicLEO3.43012004-04-063.430122890.1%OintProtopicLEO3.66912004-04-063.6691For use in combination with moisturizers or oral antihistamines in patients with atopic dermatitis who have failed or are intolerant to an 8 week trial of an intermediate potency topical steroid.Therapy should be reassessed at 6 months.LU Authorization Period: 1 yearTAMSULOSIN HCL22900.4mgFlomax CR TabBOE.6700Note: Randomized controlled trials have shown no significant differences in efficacy between daily doses of 0.4mg and 0.8mg of tamsulosin. Therefore, the daily tamsulosin dose should not exceed 0.4mg.2006-06-15.1500Sandoz Tamsulosin CR TabSDZ.1500Note: Randomized controlled trials have shown no significant differences in efficacy between daily doses of 0.4mg and 0.8mg of tamsulosin. Therefore, the daily tamsulosin dose should not exceed 0.4mg.2011-05-19.1500Apo-Tamsulosin CR TabAPX.1500Note: Randomized controlled trials have shown no significant differences in efficacy between daily doses of 0.4mg and 0.8mg of tamsulosin. Therefore, the daily tamsulosin dose should not exceed 0.4mg.2011-12-15.1500Teva-Tamsulosin CR TabTEV.1500Note: Randomized controlled trials have shown no significant differences in efficacy between daily doses of 0.4mg and 0.8mg of tamsulosin. Therefore, the daily tamsulosin dose should not exceed 0.4mg.2011-09-15.1500Tamsulosin CR TabSAI.1500Note: Randomized controlled trials have shown no significant differences in efficacy between daily doses of 0.4mg and 0.8mg of tamsulosin. Therefore, the daily tamsulosin dose should not exceed 0.4mg.2020-06-30.1500Tamsulosin CR TabSIV.1500Note: Randomized controlled trials have shown no significant differences in efficacy between daily doses of 0.4mg and 0.8mg of tamsulosin. Therefore, the daily tamsulosin dose should not exceed 0.4mg.2020-04-30.1500Auro-Tamsulosin CR TabAUR.15002024-10-31.150022910.4mgER CapFlomaxBOENote: Randomized controlled trials have shown no significant differences in efficacy between daily doses of 0.4mg and 0.8mg of tamsulosin. Therefore, the daily tamsulosin dose should not exceed 0.4mg.2002-04-04Sandoz TamsulosinSDZ.4750Note: Randomized controlled trials have shown no significant differences in efficacy between daily doses of 0.4mg and 0.8mg of tamsulosin. Therefore, the daily tamsulosin dose should not exceed 0.4mg.2014-05-29.4750Jamp TamsulosinJPC.4750Note: Randomized controlled trials have shown no significant differences in efficacy between daily doses of 0.4mg and 0.8mg of tamsulosin. Therefore, the daily tamsulosin dose should not exceed 0.4mg.2010-10-28.4750TERIFLUNOMIDE229214mgTabAubagioSAG2022-07-29Nat-TeriflunomideNAT14.93002022-07-2914.9300PMS-TeriflunomidePMS14.93002022-07-2914.9300Mar-TeriflunomideMAR14.93002022-07-2914.9300Apo-TeriflunomideAPX14.93002022-07-2914.9300Teva-TeriflunomideTEV14.93002022-07-2914.9300Ach-TeriflunomideACH14.93002022-07-2914.9300Jamp TeriflunomideJPC14.93002022-07-2914.9300Sandoz TeriflunomideSDZ14.93002022-07-2914.9300M-TeriflunomideMAT14.93002022-07-2914.9300For the treatment of Relapsing Remitting Multiple Sclerosis (RRMS) in adult patients with active disease meeting ALL the following criteria: 1. 18 years of age or older; AND 2. Diagnosis of RRMS is in accordance with the McDonald 2017 criteria demonstrating dissemination of lesions in the central nervous system in space and time meeting the following: - 2 or more attacks (Note 1) and clinical evidence of 2 or more lesions (Note 2); OR - 2 or more attacks and clinical evidence of 1 lesion with clear historical evidence of a prior attack involving a lesion in a different location; Note 1: If the patient has experienced only one attack, the patient must meet ONE of the additional criteria of dissemination in time in the list below: - Additional clinical attack - Simultaneous presence of both enhancing and non-enhancing, symptomatic or asymptomatic MS-typical MRI lesions; OR a new T2 or enhancing MRI lesion compared to a baseline scan (without regard to timing of baseline scan) - Presence of cerebrospinal fluid (CSF)-specific oligoclonal bands Note 2: If the patient has evidence of only one lesion the patient must meet ONE of the additional criteria of dissemination in space in the list below: - additional clinical attack implicating different CNS site - 1 or more MS-typical T2 lesions in 2 or more areas of the Central Nervous System (CNS): periventricular, cortical, juxtacortical, infratentorial or spinal cord AND 3. Patient has experienced a clinical relapse and/or new MS lesions in the last 2 years; AND 4. Patient has an Expanded Disability Status Scale (EDSS) score less than 6.0 before start of therapy; AND 5. Teriflunomide is used as monotherapy; AND 6. The drug request is from a neurologist experienced in the management of RRMS. Exclusion Criteria: 1. Combination therapy with another disease modifying therapy for RRMS will not be reimbursed. 2. Patients with an EDSS score equal to or greater than 7.0. LU Authorization Period: 1 year Renewal Criteria: Teriflunomide may be continued for the treatment of RRMS for patients who have not experienced a suboptimal response with teriflunomide monotherapy and who have an EDSS score less than 7.0. Patients who continue to experience clinical attacks or increased lesions or worsening EDSS should be evaluated for appropriateness of therapy and consideration of other treatment options available on the ODB formulary or through the Exceptional Access Program. Renewal duration: 1 year Recommended Dose: 14mg once daily Refer to the product monograph for prescribing information.TETRABENAZINE229325mgTabNitomanVAL2013-04-30PMS-TetrabenazinePMS4.85512013-04-304.8551Apo-TetrabenazineAPX4.85512013-11-284.8551Tetrabenazine TabletsSTE4.85512014-01-034.8551TICLOPIDINE HCL2294250mgTabTiclidHLR1996-10-01TiclopidineAAP1.06791999-04-151.0679Ticlopidine is restricted to patients with transient cerebral ischemia. Ticlopidine may be somewhat more effective than ASA in preventing fatal and non-fatal strokes. However, it is associated with neutropenia in 0.8-2.4% of patients, a serious side-effect which may be fatal. Patients on ticlopidine require blood tests every two weeks for the first three months of therapy. There have been more than 60 cases of ticlopidine associated thrombotic thrombocytopenic purpura (TTP) with 33% mortality rate. As well, there are other side-effects such as diarrhea that occurs in 12.5% of patients. Ticlopidine should be used only after careful consideration. The appropriate use of ticlopidine in the management of patients with cerebral ischemic events (TIA or stroke) is based on the following: (a) Determining that the symptoms are due to focal cerebral ischemia, and differentiating the symptoms of dizziness due to vestibular dysfunction, lightheadedness, or syncope from antihypertensive drugs or cardiac dysfunction, and from symptoms due to migraine, epilepsy, hypoglycemia, or other causes, such as tumor. (b) If investigation demonstrates that the events are caused by emboli from the heart, the patient should be treated with anticoagulants, such as warfarin. (c) If the events are due to artery-to-artery emboli from the carotid bifurcation with a severe stenosis, the patient should probably be treated with ASA and offered carotid endarterectomy if medically suitable (70% to 99% stenosis). (d) ASA should be the first line of defense for patients with TIA and threatened stroke, and after an initial stroke of any severity. (e) The only drugs other than ASA that are available as platelet inhibitors and which have been shown to be of value for such patients are ticlopidine and clopidogrel. (f) Before abandoning ASA in favour of ticlopidine, efforts should be made to improve the tolerability of ASA by reducing the dose, taking it with food, and using enteric coated ASA. Ticlopidine will be reimbursed for patients:Who are known to be, or become, intolerant of ASA;LU Authorization Period: IndefiniteWhere ASA is contraindicated;LU Authorization Period: IndefiniteWho continue to have TIA or stroke symptoms while being treated with ASA.LU Authorization Period: IndefiniteTOLTERODINE L-TARTRATE22952mgSR CapDetrol LAUJC2.36982004-04-06.9822Teva-Tolterodine LATEV.98222016-02-25.9822Sandoz Tolterodine LASDZ.98222016-02-25.982222964mgSR CapDetrol LAUJC2.36982004-04-06.9822Teva-Tolterodine LATEV.98222016-02-25.9822Sandoz Tolterodine LASDZ.98222016-02-25.982222971mgTabDetrolUJC1.18471999-09-15.4910Mint-TolterodineMIN.49102016-02-25.4910Jamp TolterodineJPC.49102022-09-29.491022982mgTabDetrolUJC1.18471999-09-15.4910Mint-TolterodineMIN.49102016-02-25.4910Jamp TolterodineJPC.49102022-09-29.4910For patients with urinary frequency, urgency or urge incontinence who have: Failed to respond to behavioral techniques AND an adequate trial of oxybutynin with gradual dose escalation has shown to be either ineffective or resulted in unacceptable side effects. NOTE: If after a trial of 2 weeks patients continue to experience similar side effects and no greater efficacy than oxybutynin, continued therapy with this more costly agent should be reassessed. Antimuscarinic agents should be used with caution in the elderly due to potentially serious adverse effects (e.g. confusion, psychosis, acute urinary retention, constipation). Antimuscarinic agents should be avoided in older adults with pre-existing cognitive impairment (e.g. dementia) and those who are already using other drugs with significant anticholinergic effects (e.g. tricyclic antidepressants) in order to avoid a high overall anticholinergic drug burden.LU Authorization Period: IndefiniteTRETINOIN229910mgCapVesanoidHLR2023-11-30Jamp TretinoinJPC13.92842023-11-3013.9284TROSPIUM CHLORIDE230020mgTabTrosecSUO2011-12-15Mar-TrospiumMAR.40722019-08-30.4072Jamp TrospiumJPC.40722023-12-29.4072For patients with urinary frequency, urgency or urge incontinence who have: Failed to respond to behavioral techniques AND an adequate trial of oxybutynin with gradual dose escalation has shown to be either ineffective or resulted in unacceptable side effects. NOTE: If after a trial of 2 weeks patients continue to experience similar side effects and no greater efficacy than oxybutynin, continued therapy with this more costly agent should be reassessed. Antimuscarinic agents should be used with caution in the elderly due to potentially serious adverse effects (e.g. confusion, psychosis, acute urinary retention, constipation). Antimuscarinic agents should be avoided in older adults with pre-existing cognitive impairment (e.g. dementia) and those who are already using other drugs with significant anticholinergic effects (e.g. tricyclic antidepressants) in order to avoid a high overall anticholinergic drug burden.LU Authorization Period: IndefiniteURSODIOL2301250mgTabUrsoBFI2000-01-17PMS-Ursodiol CPMS.38182007-04-02.3818GLN-UrsodiolGLP.38182016-06-29.3818Jamp-UrsodiolJPC.38182018-11-29.3818AG-UrsodiolANG.38182021-06-30.3818Ursodiol CSAI.38182021-12-17.3818NRA-UrsodiolNRA.38182024-10-31.3818For the treatment of primary biliary cirrhosis.LU Authorization Period: IndefiniteFor the treatment of primary sclerosing cholangitis.LU Authorization Period: Indefinite2302500mgTabUrso DSBFI3.17512004-04-06.7242PMS-Ursodiol CPMS.72422007-04-02.7242GLN-UrsodiolGLP.72422016-06-29.7242Jamp-UrsodiolJPC.72422018-11-29.7242AG-UrsodiolANG.72422021-06-30.7242Ursodiol CSAI.72422021-12-17.7242NRA-UrsodiolNRA.72422024-10-31.7242For the treatment of primary biliary cirrhosis.LU Authorization Period: IndefiniteFor the treatment of primary sclerosing cholangitis.LU Authorization Period: IndefiniteUSTEKINUMAB230345mg/0.5mLInj Sol-0.5mL Pref Autoinj (Preservative-Free)WezlanaAMG2755.88402025-06-302755.8840For the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite: i) treatment with methotrexate (20mg/week) for at least 3 months; AND ii) one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months. If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months is required. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must have objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 45mg administered subcutaneously at weeks 0 and 4, then every 12 weeks thereafter. Alternatively, 90mg may be used in patients with a body weight greater than 100kg. Ustekinumab may be used alone or in combination with methotrexate (MTX).LU Authorization Period: 1 yearFor the treatment of severe* plaque psoriasis in patients who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies**. Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. * Definition of severe plaque psoriasis: Body Surface Area (BSA) involvement of at least 10%, or involvement of the face, hands, feet or genital regions, AND Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND Dermatology Life Quality Index (DLQI) score of at least 10. ** Definition of failure, intolerance or contraindication to adequate trials of standard therapies: 6 month trial of at least 3 topical agents including vitamin D analogues and steroids; AND 12 week trial of phototherapy (unless not accessible); AND 6 month trial of at least 2 systemic, oral agents used alone or in combination -Methotrexate 15-30mg per week -Acitretin (could have been used with phototherapy) -Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: -At least a 50% reduction in PASI, AND -at least a 50% reduction in BSA involvement, AND -at least a 5 point reduction in DLQI score Recommended dose: The recommended dose of ustekinumab for adult patients is 45mg administered subcutaneously at weeks 0 and 4, then every 12 weeks thereafter. Alternatively, 90mg may be used in patients with a body weight of over 100kg. In patients weighing over 100kg, both the 45mg and 90mg doses were shown to be efficacious. However, 90mg was efficacious in a higher percentage of these patients. Refer to the appropriate product monograph for dosing in pediatric patients weighing less than 60kg. For patients who inadequately respond to dosing every 12 weeks, consideration may be given to treating as often as every 8 weeks. If the patient has not responded after 12 weeks of treatment, the prescriber should consider switching to an alternative biologic agent.LU Authorization Period: 1 yearFor the treatment of moderate to severe ulcerative colitis in patients who meet the following criteria: A. Mayo score greater than or equal to 6 with an endoscopic subscore* of at least 2 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Ustekinumab is being used to induce remission or as a steroid-sparing maintenance therapy. *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. The recommended induction dosing is a single intravenous (IV) dose based on body weight (for patients less than or equal to 55kg a dose of ustekinumab IV 260mg, for patients greater than 55kg to less than or equal to 85kg a dose of ustekinumab IV 390mg, and for patients greater than 85kg a dose of ustekinumab IV 520mg). The recommended maintenance dosing regimen is 90mg administered subcutaneously at week 8 following the IV induction dose, followed by subsequent doses every 8 weeks thereafter. Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit 16 weeks after the IV induction dose. Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., Mayo score less than 6), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory disease will not be funded. Patients with mild ulcerative colitis (e.g., Mayo score less than 6) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of moderate to severe (luminal) Crohn's disease in patients who meet the following criteria: A. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe luminal Crohn's disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine, methotrexate); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Ustekinumab is being used to induce remission or as a steroid-sparing maintenance therapy. The recommended induction dosing is a single intravenous (IV) dose based on body weight (for patients less than or equal to 55kg a dose of ustekinumab IV 260mg, for patients greater than 55kg to less than or equal to 85kg a dose of ustekinumab IV 390mg, and for patients greater than 85kg a dose of ustekinumab IV 520mg). The recommended maintenance dosing regimen is 90mg administered subcutaneously at week 8 following the IV induction dose, followed by subsequent doses every 8 weeks thereafter. Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit 16 weeks after the IV induction dose. Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., HBI score decrease greater than or equal to 50% from pre-treatment measurement), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. Patients with mild Crohn's disease (e.g., HBI less than 7) may be considered on a case-by-case basis through the Exceptional Access Program. Patients with fistulising Crohn's disease may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 year230445mg/0.5mLInj Sol-0.5mL Pref Syr PkJamtekiJPC2755.88402024-04-302755.8840For the treatment of severe* plaque psoriasis in patients who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies**. Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. * Definition of severe plaque psoriasis: Body Surface Area (BSA) involvement of at least 10%, or involvement of the face, hands, feet or genital regions, AND Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND Dermatology Life Quality Index (DLQI) score of at least 10. ** Definition of failure, intolerance or contraindication to adequate trials of standard therapies: 6 month trial of at least 3 topical agents including vitamin D analogues and steroids; AND 12 week trial of phototherapy (unless not accessible); AND 6 month trial of at least 2 systemic, oral agents used alone or in combination -Methotrexate 15-30mg per week -Acitretin (could have been used with phototherapy) -Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: -At least a 50% reduction in PASI, AND -at least a 50% reduction in BSA involvement, AND -at least a 5 point reduction in DLQI score Recommended dose: The recommended dose of ustekinumab is 45mg administered subcutaneously at weeks 0 and 4, then every 12 weeks thereafter. Alternatively, 90mg may be used in patients with a body weight of over 100kg. In patients weighing over 100kg, both the 45mg and 90mg doses were shown to be efficacious. However, 90mg was efficacious in a higher percentage of these patients. Refer to the appropriate product monograph for dosing in pediatric patients weighing less than 60kg. For patients who inadequately respond to dosing every 12 weeks, consideration may be given to treating as often as every 8 weeks. If the patient has not responded after 12 weeks of treatment, the prescriber should consider switching to an alternative biologic agent.LU Authorization Period: 1 yearFor the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite: i) treatment with methotrexate (20mg/week) for at least 3 months; AND ii) one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months. If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months is required. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must have objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 45mg administered subcutaneously at weeks 0 and 4, then every 12 weeks thereafter. Alternatively, 90mg may be used in patients with a body weight greater than 100kg. Ustekinumab may be used alone or in combination with methotrexate (MTX).LU Authorization Period: 1 yearFor the treatment of moderate to severe ulcerative colitis in patients who meet the following criteria: A. Mayo score greater than or equal to 6 with an endoscopic subscore* of at least 2 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Ustekinumab is being used to induce remission or as a steroid-sparing maintenance therapy. *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. The recommended induction dosing is a single intravenous (IV) dose based on body weight (for patients less than or equal to 55kg a dose of ustekinumab IV 260mg, for patients greater than 55kg to less than or equal to 85kg a dose of ustekinumab IV 390mg, and for patients greater than 85kg a dose of ustekinumab IV 520mg). The recommended maintenance dosing regimen is 90mg administered subcutaneously at week 8 following the IV induction dose, followed by subsequent doses every 8 weeks thereafter. Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit 16 weeks after the IV induction dose. Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., Mayo score less than 6), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory disease will not be funded. Patients with mild ulcerative colitis (e.g., Mayo score less than 6) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of moderate to severe (luminal) Crohn's disease in patients who meet the following criteria: A. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe luminal Crohn's disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine, methotrexate); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Ustekinumab is being used to induce remission or as a steroid-sparing maintenance therapy. The recommended induction dosing is a single intravenous (IV) dose based on body weight (for patients less than or equal to 55kg a dose of ustekinumab IV 260mg, for patients greater than 55kg to less than or equal to 85kg a dose of ustekinumab IV 390mg, and for patients greater than 85kg a dose of ustekinumab IV 520mg). The recommended maintenance dosing regimen is 90mg administered subcutaneously at week 8 following the IV induction dose, followed by subsequent doses every 8 weeks thereafter. Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit 16 weeks after the IV induction dose. Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., HBI score decrease greater than or equal to 50% from pre-treatment measurement), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. Patients with mild Crohn's disease (e.g., HBI less than 7) may be considered on a case-by-case basis through the Exceptional Access Program. Patients with fistulising Crohn's disease may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 year230545mg/0.5mLInj Sol-0.5mL Pref Syr PkWezlanaAMG2755.88402024-04-302755.8840For the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite: i) treatment with methotrexate (20mg/week) for at least 3 months; AND ii) one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months. If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months is required. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must have objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 45mg administered subcutaneously at weeks 0 and 4, then every 12 weeks thereafter. Alternatively, 90mg may be used in patients with a body weight greater than 100kg. Ustekinumab may be used alone or in combination with methotrexate (MTX).LU Authorization Period: 1 yearFor the treatment of severe* plaque psoriasis in patients who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies**. Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. * Definition of severe plaque psoriasis: Body Surface Area (BSA) involvement of at least 10%, or involvement of the face, hands, feet or genital regions, AND Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND Dermatology Life Quality Index (DLQI) score of at least 10. ** Definition of failure, intolerance or contraindication to adequate trials of standard therapies: 6 month trial of at least 3 topical agents including vitamin D analogues and steroids; AND 12 week trial of phototherapy (unless not accessible); AND 6 month trial of at least 2 systemic, oral agents used alone or in combination -Methotrexate 15-30mg per week -Acitretin (could have been used with phototherapy) -Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: -At least a 50% reduction in PASI, AND -at least a 50% reduction in BSA involvement, AND -at least a 5 point reduction in DLQI score Recommended dose: The recommended dose of ustekinumab for adult patients is 45mg administered subcutaneously at weeks 0 and 4, then every 12 weeks thereafter. Alternatively, 90mg may be used in patients with a body weight of over 100kg. In patients weighing over 100kg, both the 45mg and 90mg doses were shown to be efficacious. However, 90mg was efficacious in a higher percentage of these patients. Refer to the appropriate product monograph for dosing in pediatric patients weighing less than 60kg. For patients who inadequately respond to dosing every 12 weeks, consideration may be given to treating as often as every 8 weeks. If the patient has not responded after 12 weeks of treatment, the prescriber should consider switching to an alternative biologic agent.LU Authorization Period: 1 yearFor the treatment of moderate to severe ulcerative colitis in patients who meet the following criteria: A. Mayo score greater than or equal to 6 with an endoscopic subscore* of at least 2 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Ustekinumab is being used to induce remission or as a steroid-sparing maintenance therapy. *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. The recommended induction dosing is a single intravenous (IV) dose based on body weight (for patients less than or equal to 55kg a dose of ustekinumab IV 260mg, for patients greater than 55kg to less than or equal to 85kg a dose of ustekinumab IV 390mg, and for patients greater than 85kg a dose of ustekinumab IV 520mg). The recommended maintenance dosing regimen is 90mg administered subcutaneously at week 8 following the IV induction dose, followed by subsequent doses every 8 weeks thereafter. Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit 16 weeks after the IV induction dose. Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., Mayo score less than 6), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory disease will not be funded. Patients with mild ulcerative colitis (e.g., Mayo score less than 6) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of moderate to severe (luminal) Crohn's disease in patients who meet the following criteria: A. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe luminal Crohn's disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine, methotrexate); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Ustekinumab is being used to induce remission or as a steroid-sparing maintenance therapy. The recommended induction dosing is a single intravenous (IV) dose based on body weight (for patients less than or equal to 55kg a dose of ustekinumab IV 260mg, for patients greater than 55kg to less than or equal to 85kg a dose of ustekinumab IV 390mg, and for patients greater than 85kg a dose of ustekinumab IV 520mg). The recommended maintenance dosing regimen is 90mg administered subcutaneously at week 8 following the IV induction dose, followed by subsequent doses every 8 weeks thereafter. Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit 16 weeks after the IV induction dose. Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., HBI score decrease greater than or equal to 50% from pre-treatment measurement), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. Patients with mild Crohn's disease (e.g., HBI less than 7) may be considered on a case-by-case basis through the Exceptional Access Program. Patients with fistulising Crohn's disease may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 year230645mg/0.5mLInj Sol-0.5mL Pref Syr Pk (Preservative-Free)OtulfiFKC2755.88402025-11-282755.8840For the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite: i) treatment with methotrexate (20mg/week) for at least 3 months; AND ii) one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months. If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months is required. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must have objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 45mg administered subcutaneously at weeks 0 and 4, then every 12 weeks thereafter. Alternatively, 90mg may be used in patients with a body weight greater than 100kg. Ustekinumab may be used alone or in combination with methotrexate (MTX).LU Authorization Period: 1 yearFor the treatment of moderate to severe ulcerative colitis in patients who meet the following criteria: A. Mayo score greater than or equal to 6 with an endoscopic subscore* of at least 2 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Ustekinumab is being used to induce remission or as a steroid-sparing maintenance therapy. *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. The recommended induction dosing is a single intravenous (IV) dose based on body weight (for patients less than or equal to 55kg a dose of ustekinumab IV 260mg, for patients greater than 55kg to less than or equal to 85kg a dose of ustekinumab IV 390mg, and for patients greater than 85kg a dose of ustekinumab IV 520mg). The recommended maintenance dosing regimen is 90mg administered subcutaneously at week 8 following the IV induction dose, followed by subsequent doses every 8 weeks thereafter. Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit 16 weeks after the IV induction dose. Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., Mayo score less than 6), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory disease will not be funded. Patients with mild ulcerative colitis (e.g., Mayo score less than 6) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of moderate to severe (luminal) Crohn's disease in patients who meet the following criteria: A. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe luminal Crohn's disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine, methotrexate); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Ustekinumab is being used to induce remission or as a steroid-sparing maintenance therapy. The recommended induction dosing is a single intravenous (IV) dose based on body weight (for patients less than or equal to 55kg a dose of ustekinumab IV 260mg, for patients greater than 55kg to less than or equal to 85kg a dose of ustekinumab IV 390mg, and for patients greater than 85kg a dose of ustekinumab IV 520mg). The recommended maintenance dosing regimen is 90mg administered subcutaneously at week 8 following the IV induction dose, followed by subsequent doses every 8 weeks thereafter. Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit 16 weeks after the IV induction dose. Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., HBI score decrease greater than or equal to 50% from pre-treatment measurement), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. Patients with mild Crohn's disease (e.g., HBI less than 7) may be considered on a case-by-case basis through the Exceptional Access Program. Patients with fistulising Crohn's disease may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of severe* plaque psoriasis in patients who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies**. Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. * Definition of severe plaque psoriasis: Body Surface Area (BSA) involvement of at least 10%, or involvement of the face, hands, feet or genital regions, AND Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND Dermatology Life Quality Index (DLQI) score of at least 10. ** Definition of failure, intolerance or contraindication to adequate trials of standard therapies: 6 month trial of at least 3 topical agents including vitamin D analogues and steroids; AND 12 week trial of phototherapy (unless not accessible); AND 6 month trial of at least 2 systemic, oral agents used alone or in combination -Methotrexate 15-30mg per week -Acitretin (could have been used with phototherapy) -Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: -At least a 50% reduction in PASI, AND -at least a 50% reduction in BSA involvement, AND -at least a 5 point reduction in DLQI score Recommended dose: The recommended dose of ustekinumab is 45mg administered subcutaneously at weeks 0 and 4, then every 12 weeks thereafter. Alternatively, 90mg may be used in patients with a body weight of over 100kg. In patients weighing over 100kg, both the 45mg and 90mg doses were shown to be efficacious. However, 90mg was efficacious in a higher percentage of these patients. For patients who inadequately respond to dosing every 12 weeks, consideration may be given to treating as often as every 8 weeks. If the patient has not responded after 12 weeks of treatment, the prescriber should consider switching to an alternative biologic agent.LU Authorization Period: 1 year230745mg/0.5mLInj Sol-0.5mL Vial PkWezlanaAMG2755.88402024-04-302755.8840For the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite: i) treatment with methotrexate (20mg/week) for at least 3 months; AND ii) one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months. If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months is required. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must have objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 45mg administered subcutaneously at weeks 0 and 4, then every 12 weeks thereafter. Alternatively, 90mg may be used in patients with a body weight greater than 100kg. Ustekinumab may be used alone or in combination with methotrexate (MTX).LU Authorization Period: 1 yearFor the treatment of severe* plaque psoriasis in patients who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies**. Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. * Definition of severe plaque psoriasis: Body Surface Area (BSA) involvement of at least 10%, or involvement of the face, hands, feet or genital regions, AND Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND Dermatology Life Quality Index (DLQI) score of at least 10. ** Definition of failure, intolerance or contraindication to adequate trials of standard therapies: 6 month trial of at least 3 topical agents including vitamin D analogues and steroids; AND 12 week trial of phototherapy (unless not accessible); AND 6 month trial of at least 2 systemic, oral agents used alone or in combination -Methotrexate 15-30mg per week -Acitretin (could have been used with phototherapy) -Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: -At least a 50% reduction in PASI, AND -at least a 50% reduction in BSA involvement, AND -at least a 5 point reduction in DLQI score Recommended dose: The recommended dose of ustekinumab for adult patients is 45mg administered subcutaneously at weeks 0 and 4, then every 12 weeks thereafter. Alternatively, 90mg may be used in patients with a body weight of over 100kg. In patients weighing over 100kg, both the 45mg and 90mg doses were shown to be efficacious. However, 90mg was efficacious in a higher percentage of these patients. Refer to the appropriate product monograph for dosing in pediatric patients weighing less than 60kg. For patients who inadequately respond to dosing every 12 weeks, consideration may be given to treating as often as every 8 weeks. If the patient has not responded after 12 weeks of treatment, the prescriber should consider switching to an alternative biologic agent.LU Authorization Period: 1 yearFor the treatment of moderate to severe ulcerative colitis in patients who meet the following criteria: A. Mayo score greater than or equal to 6 with an endoscopic subscore* of at least 2 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Ustekinumab is being used to induce remission or as a steroid-sparing maintenance therapy. *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. The recommended induction dosing is a single intravenous (IV) dose based on body weight (for patients less than or equal to 55kg a dose of ustekinumab IV 260mg, for patients greater than 55kg to less than or equal to 85kg a dose of ustekinumab IV 390mg, and for patients greater than 85kg a dose of ustekinumab IV 520mg). The recommended maintenance dosing regimen is 90mg administered subcutaneously at week 8 following the IV induction dose, followed by subsequent doses every 8 weeks thereafter. Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit 16 weeks after the IV induction dose. Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., Mayo score less than 6), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory disease will not be funded. Patients with mild ulcerative colitis (e.g., Mayo score less than 6) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of moderate to severe (luminal) Crohn's disease in patients who meet the following criteria: A. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe luminal Crohn's disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine, methotrexate); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Ustekinumab is being used to induce remission or as a steroid-sparing maintenance therapy. The recommended induction dosing is a single intravenous (IV) dose based on body weight (for patients less than or equal to 55kg a dose of ustekinumab IV 260mg, for patients greater than 55kg to less than or equal to 85kg a dose of ustekinumab IV 390mg, and for patients greater than 85kg a dose of ustekinumab IV 520mg). The recommended maintenance dosing regimen is 90mg administered subcutaneously at week 8 following the IV induction dose, followed by subsequent doses every 8 weeks thereafter. Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit 16 weeks after the IV induction dose. Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., HBI score decrease greater than or equal to 50% from pre-treatment measurement), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. Patients with mild Crohn's disease (e.g., HBI less than 7) may be considered on a case-by-case basis through the Exceptional Access Program. Patients with fistulising Crohn's disease may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 year230890mg/mLInj Sol-1.0mL Pref Syr Pk (Preservative-Free)OtulfiFKC2755.88402025-11-282755.8840For the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite: i) treatment with methotrexate (20mg/week) for at least 3 months; AND ii) one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months. If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months is required. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must have objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 45mg administered subcutaneously at weeks 0 and 4, then every 12 weeks thereafter. Alternatively, 90mg may be used in patients with a body weight greater than 100kg. Ustekinumab may be used alone or in combination with methotrexate (MTX).LU Authorization Period: 1 yearFor the treatment of moderate to severe ulcerative colitis in patients who meet the following criteria: A. Mayo score greater than or equal to 6 with an endoscopic subscore* of at least 2 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Ustekinumab is being used to induce remission or as a steroid-sparing maintenance therapy. *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. The recommended induction dosing is a single intravenous (IV) dose based on body weight (for patients less than or equal to 55kg a dose of ustekinumab IV 260mg, for patients greater than 55kg to less than or equal to 85kg a dose of ustekinumab IV 390mg, and for patients greater than 85kg a dose of ustekinumab IV 520mg). The recommended maintenance dosing regimen is 90mg administered subcutaneously at week 8 following the IV induction dose, followed by subsequent doses every 8 weeks thereafter. Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit 16 weeks after the IV induction dose. Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., Mayo score less than 6), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory disease will not be funded. Patients with mild ulcerative colitis (e.g., Mayo score less than 6) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of moderate to severe (luminal) Crohn's disease in patients who meet the following criteria: A. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe luminal Crohn's disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine, methotrexate); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Ustekinumab is being used to induce remission or as a steroid-sparing maintenance therapy. The recommended induction dosing is a single intravenous (IV) dose based on body weight (for patients less than or equal to 55kg a dose of ustekinumab IV 260mg, for patients greater than 55kg to less than or equal to 85kg a dose of ustekinumab IV 390mg, and for patients greater than 85kg a dose of ustekinumab IV 520mg). The recommended maintenance dosing regimen is 90mg administered subcutaneously at week 8 following the IV induction dose, followed by subsequent doses every 8 weeks thereafter. Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit 16 weeks after the IV induction dose. Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., HBI score decrease greater than or equal to 50% from pre-treatment measurement), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. Patients with mild Crohn's disease (e.g., HBI less than 7) may be considered on a case-by-case basis through the Exceptional Access Program. Patients with fistulising Crohn's disease may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of severe* plaque psoriasis in patients who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies**. Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. * Definition of severe plaque psoriasis: Body Surface Area (BSA) involvement of at least 10%, or involvement of the face, hands, feet or genital regions, AND Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND Dermatology Life Quality Index (DLQI) score of at least 10. ** Definition of failure, intolerance or contraindication to adequate trials of standard therapies: 6 month trial of at least 3 topical agents including vitamin D analogues and steroids; AND 12 week trial of phototherapy (unless not accessible); AND 6 month trial of at least 2 systemic, oral agents used alone or in combination -Methotrexate 15-30mg per week -Acitretin (could have been used with phototherapy) -Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: -At least a 50% reduction in PASI, AND -at least a 50% reduction in BSA involvement, AND -at least a 5 point reduction in DLQI score Recommended dose: The recommended dose of ustekinumab is 45mg administered subcutaneously at weeks 0 and 4, then every 12 weeks thereafter. Alternatively, 90mg may be used in patients with a body weight of over 100kg. In patients weighing over 100kg, both the 45mg and 90mg doses were shown to be efficacious. However, 90mg was efficacious in a higher percentage of these patients. For patients who inadequately respond to dosing every 12 weeks, consideration may be given to treating as often as every 8 weeks. If the patient has not responded after 12 weeks of treatment, the prescriber should consider switching to an alternative biologic agent.LU Authorization Period: 1 year230990mg/mLInj Sol-1mL Pref Autoinj (Preservative-Free)WezlanaAMG2755.88402025-06-302755.8840For the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite: i) treatment with methotrexate (20mg/week) for at least 3 months; AND ii) one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months. If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months is required. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must have objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 45mg administered subcutaneously at weeks 0 and 4, then every 12 weeks thereafter. Alternatively, 90mg may be used in patients with a body weight greater than 100kg. Ustekinumab may be used alone or in combination with methotrexate (MTX).LU Authorization Period: 1 yearFor the treatment of severe* plaque psoriasis in patients who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies**. Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. * Definition of severe plaque psoriasis: Body Surface Area (BSA) involvement of at least 10%, or involvement of the face, hands, feet or genital regions, AND Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND Dermatology Life Quality Index (DLQI) score of at least 10. ** Definition of failure, intolerance or contraindication to adequate trials of standard therapies: 6 month trial of at least 3 topical agents including vitamin D analogues and steroids; AND 12 week trial of phototherapy (unless not accessible); AND 6 month trial of at least 2 systemic, oral agents used alone or in combination -Methotrexate 15-30mg per week -Acitretin (could have been used with phototherapy) -Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: -At least a 50% reduction in PASI, AND -at least a 50% reduction in BSA involvement, AND -at least a 5 point reduction in DLQI score Recommended dose: The recommended dose of ustekinumab for adult patients is 45mg administered subcutaneously at weeks 0 and 4, then every 12 weeks thereafter. Alternatively, 90mg may be used in patients with a body weight of over 100kg. In patients weighing over 100kg, both the 45mg and 90mg doses were shown to be efficacious. However, 90mg was efficacious in a higher percentage of these patients. Refer to the appropriate product monograph for dosing in pediatric patients weighing less than 60kg. For patients who inadequately respond to dosing every 12 weeks, consideration may be given to treating as often as every 8 weeks. If the patient has not responded after 12 weeks of treatment, the prescriber should consider switching to an alternative biologic agent.LU Authorization Period: 1 yearFor the treatment of moderate to severe ulcerative colitis in patients who meet the following criteria: A. Mayo score greater than or equal to 6 with an endoscopic subscore* of at least 2 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Ustekinumab is being used to induce remission or as a steroid-sparing maintenance therapy. *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. The recommended induction dosing is a single intravenous (IV) dose based on body weight (for patients less than or equal to 55kg a dose of ustekinumab IV 260mg, for patients greater than 55kg to less than or equal to 85kg a dose of ustekinumab IV 390mg, and for patients greater than 85kg a dose of ustekinumab IV 520mg). The recommended maintenance dosing regimen is 90mg administered subcutaneously at week 8 following the IV induction dose, followed by subsequent doses every 8 weeks thereafter. Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit 16 weeks after the IV induction dose. Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., Mayo score less than 6), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory disease will not be funded. Patients with mild ulcerative colitis (e.g., Mayo score less than 6) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of moderate to severe (luminal) Crohn's disease in patients who meet the following criteria: A. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe luminal Crohn's disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine, methotrexate); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Ustekinumab is being used to induce remission or as a steroid-sparing maintenance therapy. The recommended induction dosing is a single intravenous (IV) dose based on body weight (for patients less than or equal to 55kg a dose of ustekinumab IV 260mg, for patients greater than 55kg to less than or equal to 85kg a dose of ustekinumab IV 390mg, and for patients greater than 85kg a dose of ustekinumab IV 520mg). The recommended maintenance dosing regimen is 90mg administered subcutaneously at week 8 following the IV induction dose, followed by subsequent doses every 8 weeks thereafter. Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit 16 weeks after the IV induction dose. Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., HBI score decrease greater than or equal to 50% from pre-treatment measurement), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. Patients with mild Crohn's disease (e.g., HBI less than 7) may be considered on a case-by-case basis through the Exceptional Access Program. Patients with fistulising Crohn's disease may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 year231090mg/mLInj Sol-1mL Pref Syr PkJamtekiJPC2755.88402024-04-302755.8840For the treatment of severe* plaque psoriasis in patients who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies**. Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. * Definition of severe plaque psoriasis: Body Surface Area (BSA) involvement of at least 10%, or involvement of the face, hands, feet or genital regions, AND Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND Dermatology Life Quality Index (DLQI) score of at least 10. ** Definition of failure, intolerance or contraindication to adequate trials of standard therapies: 6 month trial of at least 3 topical agents including vitamin D analogues and steroids; AND 12 week trial of phototherapy (unless not accessible); AND 6 month trial of at least 2 systemic, oral agents used alone or in combination -Methotrexate 15-30mg per week -Acitretin (could have been used with phototherapy) -Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: -At least a 50% reduction in PASI, AND -at least a 50% reduction in BSA involvement, AND -at least a 5 point reduction in DLQI score Recommended dose: The recommended dose of ustekinumab is 45mg administered subcutaneously at weeks 0 and 4, then every 12 weeks thereafter. Alternatively, 90mg may be used in patients with a body weight of over 100kg. In patients weighing over 100kg, both the 45mg and 90mg doses were shown to be efficacious. However, 90mg was efficacious in a higher percentage of these patients. Refer to the appropriate product monograph for dosing in pediatric patients weighing less than 60kg. For patients who inadequately respond to dosing every 12 weeks, consideration may be given to treating as often as every 8 weeks. If the patient has not responded after 12 weeks of treatment, the prescriber should consider switching to an alternative biologic agent.LU Authorization Period: 1 yearFor the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite: i) treatment with methotrexate (20mg/week) for at least 3 months; AND ii) one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months. If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months is required. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must have objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 45mg administered subcutaneously at weeks 0 and 4, then every 12 weeks thereafter. Alternatively, 90mg may be used in patients with a body weight greater than 100kg. Ustekinumab may be used alone or in combination with methotrexate (MTX).LU Authorization Period: 1 yearFor the treatment of moderate to severe ulcerative colitis in patients who meet the following criteria: A. Mayo score greater than or equal to 6 with an endoscopic subscore* of at least 2 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Ustekinumab is being used to induce remission or as a steroid-sparing maintenance therapy. *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. The recommended induction dosing is a single intravenous (IV) dose based on body weight (for patients less than or equal to 55kg a dose of ustekinumab IV 260mg, for patients greater than 55kg to less than or equal to 85kg a dose of ustekinumab IV 390mg, and for patients greater than 85kg a dose of ustekinumab IV 520mg). The recommended maintenance dosing regimen is 90mg administered subcutaneously at week 8 following the IV induction dose, followed by subsequent doses every 8 weeks thereafter. Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit 16 weeks after the IV induction dose. Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., Mayo score less than 6), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory disease will not be funded. Patients with mild ulcerative colitis (e.g., Mayo score less than 6) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of moderate to severe (luminal) Crohn's disease in patients who meet the following criteria: A. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe luminal Crohn's disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine, methotrexate); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Ustekinumab is being used to induce remission or as a steroid-sparing maintenance therapy. The recommended induction dosing is a single intravenous (IV) dose based on body weight (for patients less than or equal to 55kg a dose of ustekinumab IV 260mg, for patients greater than 55kg to less than or equal to 85kg a dose of ustekinumab IV 390mg, and for patients greater than 85kg a dose of ustekinumab IV 520mg). The recommended maintenance dosing regimen is 90mg administered subcutaneously at week 8 following the IV induction dose, followed by subsequent doses every 8 weeks thereafter. Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit 16 weeks after the IV induction dose. Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., HBI score decrease greater than or equal to 50% from pre-treatment measurement), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. Patients with mild Crohn's disease (e.g., HBI less than 7) may be considered on a case-by-case basis through the Exceptional Access Program. Patients with fistulising Crohn's disease may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 year231190mg/mLInj Sol-1mL Pref Syr PkWezlanaAMG2755.88402024-04-302755.8840For the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite: i) treatment with methotrexate (20mg/week) for at least 3 months; AND ii) one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months. If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months is required. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must have objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 45mg administered subcutaneously at weeks 0 and 4, then every 12 weeks thereafter. Alternatively, 90mg may be used in patients with a body weight greater than 100kg. Ustekinumab may be used alone or in combination with methotrexate (MTX).LU Authorization Period: 1 yearFor the treatment of severe* plaque psoriasis in patients who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies**. Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. * Definition of severe plaque psoriasis: Body Surface Area (BSA) involvement of at least 10%, or involvement of the face, hands, feet or genital regions, AND Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND Dermatology Life Quality Index (DLQI) score of at least 10. ** Definition of failure, intolerance or contraindication to adequate trials of standard therapies: 6 month trial of at least 3 topical agents including vitamin D analogues and steroids; AND 12 week trial of phototherapy (unless not accessible); AND 6 month trial of at least 2 systemic, oral agents used alone or in combination -Methotrexate 15-30mg per week -Acitretin (could have been used with phototherapy) -Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: -At least a 50% reduction in PASI, AND -at least a 50% reduction in BSA involvement, AND -at least a 5 point reduction in DLQI score Recommended dose: The recommended dose of ustekinumab for adult patients is 45mg administered subcutaneously at weeks 0 and 4, then every 12 weeks thereafter. Alternatively, 90mg may be used in patients with a body weight of over 100kg. In patients weighing over 100kg, both the 45mg and 90mg doses were shown to be efficacious. However, 90mg was efficacious in a higher percentage of these patients. Refer to the appropriate product monograph for dosing in pediatric patients weighing less than 60kg. For patients who inadequately respond to dosing every 12 weeks, consideration may be given to treating as often as every 8 weeks. If the patient has not responded after 12 weeks of treatment, the prescriber should consider switching to an alternative biologic agent.LU Authorization Period: 1 yearFor the treatment of moderate to severe ulcerative colitis in patients who meet the following criteria: A. Mayo score greater than or equal to 6 with an endoscopic subscore* of at least 2 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Ustekinumab is being used to induce remission or as a steroid-sparing maintenance therapy. *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. The recommended induction dosing is a single intravenous (IV) dose based on body weight (for patients less than or equal to 55kg a dose of ustekinumab IV 260mg, for patients greater than 55kg to less than or equal to 85kg a dose of ustekinumab IV 390mg, and for patients greater than 85kg a dose of ustekinumab IV 520mg). The recommended maintenance dosing regimen is 90mg administered subcutaneously at week 8 following the IV induction dose, followed by subsequent doses every 8 weeks thereafter. Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit 16 weeks after the IV induction dose. Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., Mayo score less than 6), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory disease will not be funded. Patients with mild ulcerative colitis (e.g., Mayo score less than 6) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of moderate to severe (luminal) Crohn's disease in patients who meet the following criteria: A. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe luminal Crohn's disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine, methotrexate); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Ustekinumab is being used to induce remission or as a steroid-sparing maintenance therapy. The recommended induction dosing is a single intravenous (IV) dose based on body weight (for patients less than or equal to 55kg a dose of ustekinumab IV 260mg, for patients greater than 55kg to less than or equal to 85kg a dose of ustekinumab IV 390mg, and for patients greater than 85kg a dose of ustekinumab IV 520mg). The recommended maintenance dosing regimen is 90mg administered subcutaneously at week 8 following the IV induction dose, followed by subsequent doses every 8 weeks thereafter. Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit 16 weeks after the IV induction dose. Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., HBI score decrease greater than or equal to 50% from pre-treatment measurement), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. Patients with mild Crohn's disease (e.g., HBI less than 7) may be considered on a case-by-case basis through the Exceptional Access Program. Patients with fistulising Crohn's disease may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 year2312130mg/26mLInj Sol-26mL Vial PkWezlana I.V.AMG1248.00002024-04-301248.0000For the treatment of moderate to severe ulcerative colitis in patients who meet the following criteria: A. Mayo score greater than or equal to 6 with an endoscopic subscore* of at least 2 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Ustekinumab is being used to induce remission or as a steroid-sparing maintenance therapy. *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. The recommended induction dosing is a single intravenous (IV) dose based on body weight (for patients less than or equal to 55kg a dose of ustekinumab IV 260mg, for patients greater than 55kg to less than or equal to 85kg a dose of ustekinumab IV 390mg, and for patients greater than 85kg a dose of ustekinumab IV 520mg). The recommended maintenance dosing regimen is 90mg administered subcutaneously at week 8 following the IV induction dose, followed by subsequent doses every 8 weeks thereafter. Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit 16 weeks after the IV induction dose. Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., Mayo score less than 6), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory disease will not be funded. Patients with mild ulcerative colitis (e.g., Mayo score less than 6) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of moderate to severe (luminal) Crohn's disease in patients who meet the following criteria: A. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe luminal Crohn's disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine, methotrexate); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Ustekinumab is being used to induce remission or as a steroid-sparing maintenance therapy. The recommended induction dosing is a single intravenous (IV) dose based on body weight (for patients less than or equal to 55kg a dose of ustekinumab IV 260mg, for patients greater than 55kg to less than or equal to 85kg a dose of ustekinumab IV 390mg, and for patients greater than 85kg a dose of ustekinumab IV 520mg). The recommended maintenance dosing regimen is 90mg administered subcutaneously at week 8 following the IV induction dose, followed by subsequent doses every 8 weeks thereafter. Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit 16 weeks after the IV induction dose. Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., HBI score decrease greater than or equal to 50% from pre-treatment measurement), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. Patients with mild Crohn's disease (e.g., HBI less than 7) may be considered on a case-by-case basis through the Exceptional Access Program. Patients with fistulising Crohn's disease may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 year23135mg/mLInj Sol-Vial Pk (Preservative-Free)OtulfiFKC1248.00002025-11-281248.0000For the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite: i) treatment with methotrexate (20mg/week) for at least 3 months; AND ii) one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months. If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months is required. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must have objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 45mg administered subcutaneously at weeks 0 and 4, then every 12 weeks thereafter. Alternatively, 90mg may be used in patients with a body weight greater than 100kg. Ustekinumab may be used alone or in combination with methotrexate (MTX).LU Authorization Period: 1 yearFor the treatment of moderate to severe ulcerative colitis in patients who meet the following criteria: A. Mayo score greater than or equal to 6 with an endoscopic subscore* of at least 2 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Ustekinumab is being used to induce remission or as a steroid-sparing maintenance therapy. *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. The recommended induction dosing is a single intravenous (IV) dose based on body weight (for patients less than or equal to 55kg a dose of ustekinumab IV 260mg, for patients greater than 55kg to less than or equal to 85kg a dose of ustekinumab IV 390mg, and for patients greater than 85kg a dose of ustekinumab IV 520mg). The recommended maintenance dosing regimen is 90mg administered subcutaneously at week 8 following the IV induction dose, followed by subsequent doses every 8 weeks thereafter. Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit 16 weeks after the IV induction dose. Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., Mayo score less than 6), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory disease will not be funded. Patients with mild ulcerative colitis (e.g., Mayo score less than 6) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of moderate to severe (luminal) Crohn's disease in patients who meet the following criteria: A. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe luminal Crohn's disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine, methotrexate); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Ustekinumab is being used to induce remission or as a steroid-sparing maintenance therapy. The recommended induction dosing is a single intravenous (IV) dose based on body weight (for patients less than or equal to 55kg a dose of ustekinumab IV 260mg, for patients greater than 55kg to less than or equal to 85kg a dose of ustekinumab IV 390mg, and for patients greater than 85kg a dose of ustekinumab IV 520mg). The recommended maintenance dosing regimen is 90mg administered subcutaneously at week 8 following the IV induction dose, followed by subsequent doses every 8 weeks thereafter. Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit 16 weeks after the IV induction dose. Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., HBI score decrease greater than or equal to 50% from pre-treatment measurement), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. Patients with mild Crohn's disease (e.g., HBI less than 7) may be considered on a case-by-case basis through the Exceptional Access Program. Patients with fistulising Crohn's disease may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of severe* plaque psoriasis in patients who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies**. Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. * Definition of severe plaque psoriasis: Body Surface Area (BSA) involvement of at least 10%, or involvement of the face, hands, feet or genital regions, AND Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND Dermatology Life Quality Index (DLQI) score of at least 10. ** Definition of failure, intolerance or contraindication to adequate trials of standard therapies: 6 month trial of at least 3 topical agents including vitamin D analogues and steroids; AND 12 week trial of phototherapy (unless not accessible); AND 6 month trial of at least 2 systemic, oral agents used alone or in combination -Methotrexate 15-30mg per week -Acitretin (could have been used with phototherapy) -Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: -At least a 50% reduction in PASI, AND -at least a 50% reduction in BSA involvement, AND -at least a 5 point reduction in DLQI score Recommended dose: The recommended dose of ustekinumab is 45mg administered subcutaneously at weeks 0 and 4, then every 12 weeks thereafter. Alternatively, 90mg may be used in patients with a body weight of over 100kg. In patients weighing over 100kg, both the 45mg and 90mg doses were shown to be efficacious. However, 90mg was efficacious in a higher percentage of these patients. For patients who inadequately respond to dosing every 12 weeks, consideration may be given to treating as often as every 8 weeks. If the patient has not responded after 12 weeks of treatment, the prescriber should consider switching to an alternative biologic agent.LU Authorization Period: 1 yearVARENICLINE TARTRATE23140.5mgTabChampixPFI2011-08-04Apo-VareniclineAPX.46182018-10-31.4618Teva-VareniclineTEV.46182019-07-31.4618NRA-VareniclineNRA.46182024-08-30.4618Mint-VareniclineMIN.46182024-12-30.4618Auro-VareniclineAUR.46182026-02-27.461823151.0mgTabChampixPFI2011-08-04Apo-VareniclineAPX.46182018-10-31.4618Teva-VareniclineTEV.46182019-06-28.4618NRA-VareniclineNRA.46182024-08-30.4618Mint-VareniclineMIN.46182024-12-30.4618Auro-VareniclineAUR.46182026-02-27.461823160.5mg & 1.0mgTab (Starter Pack-53 Tabs)Apo-VareniclineAPX24.38532018-10-3124.3853NRA-VareniclineNRA24.38532024-08-3024.3853Mint-VareniclineMIN24.38532025-07-3124.3853ChampixPFI2015-01-28Teva-VareniclineTEV24.3853PIN 09857631 includes 25 tablets (0.5mg & 1.0mg) from the Teva-Varenicline Starter Pack (DIN 02426781) and 28 tablets of Teva-Varenicline 1.0mg tablets (DIN 02426234). Dispensers need to ensure that only 1 claim is submitted by using the assigned PIN 09857631 when dispensing a total of 53 tablets from the combination of 28 tablets of Teva-Varenicline 1.0mg (DIN 02426234) with 25 tablets of the Teva-Varenicline Starter Pack (DIN 02426781).2019-08-3024.3853For smoking-cessation treatment in adults, in conjunction with smoking-cessation counseling. Network Note: Limited to 12 weeks (168 tablets) of reimbursement per 365 days per patient.LU Authorization Period: 12 Weeks.ZOLEDRONIC ACID23175mg/100mLInj Sol-100mL Pk (Preservative-Free)AclastaSDZ882.09002006-10-23356.0100Taro-Zoledronic AcidTAR356.01002014-05-29356.0100Zoledronic Acid InjectionDRR356.01002014-09-25356.0100For the treatment of Paget's disease.LU Authorization Period: IndefiniteFor the treatment of osteoporosis in postmenopausal females who meet the following criteria: - High risk* for fracture; and - For whom oral bisphosphonates are contraindicated due to abnormalities of the esophagus (e.g. esophageal stricture or achalasia) OR inability to stand or sit upright for at least 30 minutes. *High fracture risk is defined as either: - a prior fragility fracture AND a moderate 10-year fracture risk (10% to 20%) based on the Canadian Association of Radiologists and Osteoporosis Canada (CAROC) tool or the Fracture Risk Assessment (FRAX) tool; OR - a high 10-year fracture risk (greater than or equal to 20%) based on the CAROC or FRAX tool; OR - where a patient's 10-year fracture risk based on the CAROC or FRAX tool, is less than the thresholds defined above, a high fracture risk based on evaluation of clinical risk factors for fracture Note: Use of the CAROC or FRAX tool may underestimate fracture risk in certain circumstances and may not include all risk factors.LU Authorization Period: IndefiniteFor the treatment of osteoporosis in males who meet the following criteria: - High risk* for fracture; and - For whom oral bisphosphonates are contraindicated due to abnormalities of the esophagus (e.g. esophageal stricture or achalasia) OR inability to stand or sit upright for at least 30 minutes. *High fracture risk is defined as either: - a moderate 10-year fracture risk (10% to 20%) with a prior fragility fracture based on the Canadian Association of Radiologists and Osteoporosis Canada (CAROC) tool or the Fracture Risk Assessment (FRAX) tool; OR - a high 10-year fracture risk (greater than or equal to 20%) based on the CAROC or FRAX tool; OR - where the patient's 10-year fracture risk is below 10% based on the CAROC or FRAX tool, a high fracture risk based on evaluation of clinical risk factors for fracture Note: Use of the CAROC or FRAX tool may underestimate fracture risk in certain circumstances and may not include all risk factors.LU Authorization Period: IndefiniteIn all cases, patients receiving Aclasta should not be receiving concomitant bisphosphonate therapy. The recommended dose of Aclasta (zoledronic acid) is a single IV injection of 5mg, once yearly.23184mg/5mLInj Sol-5mL Pk (Preservative-Free)Zometa ConcentrateNOV2014-04-30Zoledronic Acid-ZSDZ415.56002014-04-30415.5600Zoledronic Acid for InjectionTEV415.56002014-05-29415.5600Zoledronic Acid for Inj. ConcentrateOMG415.00002014-10-29415.0000Taro-Zoledronic Acid ConcentrateTAR415.56002014-05-29415.5600Zoledronic Acid for Inj. ConcentrateDRR415.56002014-09-25415.5600Zoledronic Acid for InjectionFKC415.56002018-12-21415.5600Zoledronic Acid for InjectionMDI415.56002016-12-22415.5600Zoledronic Acid for InjectionMAR415.56002019-04-30415.5600Jamp-Zoledronic AcidJPC415.56002019-10-31415.5600BIOLOGIC RESPONSE MODIFIERSGLATIRAMER ACETATE231920mg/mLInj Sol-Pref Syr 1mL PkGlatectPMS35.84002018-09-2735.8400As monotherapy for the treatment of patients with relapsing remitting multiple sclerosis (RRMS) meeting ALL the following criteria: -Recent neurological examination consistent with the diagnosis of RRMS; AND -Lesions typical of multiple sclerosis on brain magnetic resonance imaging (MRI); AND -Experienced at least 2 clinical attacks in their lifetime with one attack occurring within the prior year; AND -EDSS score less than or equal to 6.0 prior to start of treatment; AND -Prescribed by a neurologist who is experienced in the treatment of Multiple Sclerosis. Note: Transition from another Disease Modifying therapy (DMT) is permitted in those who are deemed to have met the above criteria prior to initiation of the other DMT and if glatiramer acetate is used as monotherapy.LU Authorization Period: 1 yearAs monotherapy for the treatment of patients who have experienced a single demyelinating event/ Clinically Isolated Syndrome (CIS) meeting ALL the following criteria: - CIS occurred within the prior 12 months; AND - Recent neurological examination; AND - Lesions typical of CIS confirmed on brain magnetic resonance imaging (MRI); AND - EDSS score less than or equal to 6.0 prior to start of treatment; AND - Prescribed by a neurologist who is experienced in the treatment of Multiple Sclerosis Note: Transition from another Disease Modifying therapy (DMT) is permitted in those who are deemed to have met the above criteria prior to initiation of the other DMT and if glatiramer acetate is used as monotherapy.LU Authorization Period: 1 yearRenewal of therapy for patients diagnosed with relapsing remitting multiple sclerosis (RRMS) or a single demyelinating event /Clinically Isolated Syndrome (CIS) who meet ALL the following criteria: - Used as monotherapy for the treatment of RRMS or CIS; AND - EDSS score less than or equal to 6.0; AND - Disease activity is stabilized as determined by a neurological exam and the number of clinical relapses experienced while on treatment; AND - Prescribed by a neurologist experienced in the treatment of Multiple Sclerosis (MS) OR a prescriber in consultation with a neurologist overseeing the patient's MS.LU Authorization Period: 1 yearUSTEKINUMAB232045mg/0.5mLInj Sol-0.5mL Pref Syr Pk (Preservative-Free)SteqeymaCEH2755.88402024-09-272755.8840For the treatment of severe* plaque psoriasis in patients who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies**. Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. * Definition of severe plaque psoriasis: Body Surface Area (BSA) involvement of at least 10%, or involvement of the face, hands, feet or genital regions, AND Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND Dermatology Life Quality Index (DLQI) score of at least 10. ** Definition of failure, intolerance or contraindication to adequate trials of standard therapies: 6 month trial of at least 3 topical agents including vitamin D analogues and steroids; AND 12 week trial of phototherapy (unless not accessible); AND 6 month trial of at least 2 systemic, oral agents used alone or in combination -Methotrexate 15-30mg per week -Acitretin (could have been used with phototherapy) -Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: -At least a 50% reduction in PASI, AND -at least a 50% reduction in BSA involvement, AND -at least a 5 point reduction in DLQI score Recommended dose: The recommended dose of ustekinumab is 45mg administered subcutaneously at weeks 0 and 4, then every 12 weeks thereafter. Alternatively, 90mg may be used in patients with a body weight of over 100kg. In patients weighing over 100kg, both the 45mg and 90mg doses were shown to be efficacious. However, 90mg was efficacious in a higher percentage of these patients. Refer to the appropriate product monograph for dosing in pediatric patients weighing less than 60kg. For patients who inadequately respond to dosing every 12 weeks, consideration may be given to treating as often as every 8 weeks. If the patient has not responded after 12 weeks of treatment, the prescriber should consider switching to an alternative biologic agent.LU Authorization Period: 1 yearFor the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite: i) treatment with methotrexate (20mg/week) for at least 3 months; AND ii) one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months. If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months is required. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must have objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 45mg administered subcutaneously at weeks 0 and 4, then every 12 weeks thereafter. Alternatively, 90mg may be used in patients with a body weight greater than 100kg. Ustekinumab may be used alone or in combination with methotrexate (MTX).LU Authorization Period: 1 yearFor the treatment of moderate to severe ulcerative colitis in patients who meet the following criteria: A. Mayo score greater than or equal to 6 with an endoscopic subscore* of at least 2 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Ustekinumab is being used to induce remission or as a steroid-sparing maintenance therapy. *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. The recommended induction dosing is a single intravenous (IV) dose based on body weight (for patients less than or equal to 55kg a dose of ustekinumab IV 260mg, for patients greater than 55kg to less than or equal to 85kg a dose of ustekinumab IV 390mg, and for patients greater than 85kg a dose of ustekinumab IV 520mg). The recommended maintenance dosing regimen is 90mg administered subcutaneously at week 8 following the IV induction dose, followed by subsequent doses every 8 weeks thereafter. Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit 16 weeks after the IV induction dose. Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., Mayo score less than 6), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory disease will not be funded. Patients with mild ulcerative colitis (e.g., Mayo score less than 6) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of moderate to severe (luminal) Crohn's disease in patients who meet the following criteria: A. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe luminal Crohn's disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine, methotrexate); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Ustekinumab is being used to induce remission or as a steroid-sparing maintenance therapy. The recommended induction dosing is a single intravenous (IV) dose based on body weight (for patients less than or equal to 55kg a dose of ustekinumab IV 260mg, for patients greater than 55kg to less than or equal to 85kg a dose of ustekinumab IV 390mg, and for patients greater than 85kg a dose of ustekinumab IV 520mg). The recommended maintenance dosing regimen is 90mg administered subcutaneously at week 8 following the IV induction dose, followed by subsequent doses every 8 weeks thereafter. Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit 16 weeks after the IV induction dose. Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., HBI score decrease greater than or equal to 50% from pre-treatment measurement), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. Patients with mild Crohn's disease (e.g., HBI less than 7) may be considered on a case-by-case basis through the Exceptional Access Program. Patients with fistulising Crohn's disease may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 year232145mg/0.5mLInj Sol-0.5mL Vial Pk (Preservative-Free)JamtekiJPC2755.88402025-07-312755.8840For the treatment of severe* plaque psoriasis in patients who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies**. Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. * Definition of severe plaque psoriasis: Body Surface Area (BSA) involvement of at least 10%, or involvement of the face, hands, feet or genital regions, AND Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND Dermatology Life Quality Index (DLQI) score of at least 10. ** Definition of failure, intolerance or contraindication to adequate trials of standard therapies: 6 month trial of at least 3 topical agents including vitamin D analogues and steroids; AND 12 week trial of phototherapy (unless not accessible); AND 6 month trial of at least 2 systemic, oral agents used alone or in combination -Methotrexate 15-30mg per week -Acitretin (could have been used with phototherapy) -Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: -At least a 50% reduction in PASI, AND -at least a 50% reduction in BSA involvement, AND -at least a 5 point reduction in DLQI score Recommended dose: The recommended dose of ustekinumab is 45mg administered subcutaneously at weeks 0 and 4, then every 12 weeks thereafter. Alternatively, 90mg may be used in patients with a body weight of over 100kg. In patients weighing over 100kg, both the 45mg and 90mg doses were shown to be efficacious. However, 90mg was efficacious in a higher percentage of these patients. Refer to the appropriate product monograph for dosing in pediatric patients weighing less than 60kg. For patients who inadequately respond to dosing every 12 weeks, consideration may be given to treating as often as every 8 weeks. If the patient has not responded after 12 weeks of treatment, the prescriber should consider switching to an alternative biologic agent.LU Authorization Period: 1 yearFor the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite: i) treatment with methotrexate (20mg/week) for at least 3 months; AND ii) one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months. If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months is required. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must have objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 45mg administered subcutaneously at weeks 0 and 4, then every 12 weeks thereafter. Alternatively, 90mg may be used in patients with a body weight greater than 100kg. Ustekinumab may be used alone or in combination with methotrexate (MTX).LU Authorization Period: 1 yearFor the treatment of moderate to severe ulcerative colitis in patients who meet the following criteria: A. Mayo score greater than or equal to 6 with an endoscopic subscore* of at least 2 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Ustekinumab is being used to induce remission or as a steroid-sparing maintenance therapy. *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. The recommended induction dosing is a single intravenous (IV) dose based on body weight (for patients less than or equal to 55kg a dose of ustekinumab IV 260mg, for patients greater than 55kg to less than or equal to 85kg a dose of ustekinumab IV 390mg, and for patients greater than 85kg a dose of ustekinumab IV 520mg). The recommended maintenance dosing regimen is 90mg administered subcutaneously at week 8 following the IV induction dose, followed by subsequent doses every 8 weeks thereafter. Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit 16 weeks after the IV induction dose. Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., Mayo score less than 6), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory disease will not be funded. Patients with mild ulcerative colitis (e.g., Mayo score less than 6) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of moderate to severe (luminal) Crohn's disease in patients who meet the following criteria: A. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe luminal Crohn's disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine, methotrexate); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Ustekinumab is being used to induce remission or as a steroid-sparing maintenance therapy. The recommended induction dosing is a single intravenous (IV) dose based on body weight (for patients less than or equal to 55kg a dose of ustekinumab IV 260mg, for patients greater than 55kg to less than or equal to 85kg a dose of ustekinumab IV 390mg, and for patients greater than 85kg a dose of ustekinumab IV 520mg). The recommended maintenance dosing regimen is 90mg administered subcutaneously at week 8 following the IV induction dose, followed by subsequent doses every 8 weeks thereafter. Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit 16 weeks after the IV induction dose. Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., HBI score decrease greater than or equal to 50% from pre-treatment measurement), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. Patients with mild Crohn's disease (e.g., HBI less than 7) may be considered on a case-by-case basis through the Exceptional Access Program. Patients with fistulising Crohn's disease may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 year232245mg/0.5mLInj Sol-0.5mL Vial Pk (Preservative-Free)SteqeymaCEH2755.88402025-08-292755.8840232390mg/1.0mLInj Sol-1.0mL Pref Syr Pk (Preservative-Free)SteqeymaCEH2755.88402024-09-272755.8840For the treatment of severe* plaque psoriasis in patients who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies**. Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. * Definition of severe plaque psoriasis: Body Surface Area (BSA) involvement of at least 10%, or involvement of the face, hands, feet or genital regions, AND Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND Dermatology Life Quality Index (DLQI) score of at least 10. ** Definition of failure, intolerance or contraindication to adequate trials of standard therapies: 6 month trial of at least 3 topical agents including vitamin D analogues and steroids; AND 12 week trial of phototherapy (unless not accessible); AND 6 month trial of at least 2 systemic, oral agents used alone or in combination -Methotrexate 15-30mg per week -Acitretin (could have been used with phototherapy) -Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: -At least a 50% reduction in PASI, AND -at least a 50% reduction in BSA involvement, AND -at least a 5 point reduction in DLQI score Recommended dose: The recommended dose of ustekinumab is 45mg administered subcutaneously at weeks 0 and 4, then every 12 weeks thereafter. Alternatively, 90mg may be used in patients with a body weight of over 100kg. In patients weighing over 100kg, both the 45mg and 90mg doses were shown to be efficacious. However, 90mg was efficacious in a higher percentage of these patients. Refer to the appropriate product monograph for dosing in pediatric patients weighing less than 60kg. For patients who inadequately respond to dosing every 12 weeks, consideration may be given to treating as often as every 8 weeks. If the patient has not responded after 12 weeks of treatment, the prescriber should consider switching to an alternative biologic agent.LU Authorization Period: 1 yearFor the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite: i) treatment with methotrexate (20mg/week) for at least 3 months; AND ii) one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months. If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months is required. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must have objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 45mg administered subcutaneously at weeks 0 and 4, then every 12 weeks thereafter. Alternatively, 90mg may be used in patients with a body weight greater than 100kg. Ustekinumab may be used alone or in combination with methotrexate (MTX).LU Authorization Period: 1 yearFor the treatment of moderate to severe ulcerative colitis in patients who meet the following criteria: A. Mayo score greater than or equal to 6 with an endoscopic subscore* of at least 2 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Ustekinumab is being used to induce remission or as a steroid-sparing maintenance therapy. *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. The recommended induction dosing is a single intravenous (IV) dose based on body weight (for patients less than or equal to 55kg a dose of ustekinumab IV 260mg, for patients greater than 55kg to less than or equal to 85kg a dose of ustekinumab IV 390mg, and for patients greater than 85kg a dose of ustekinumab IV 520mg). The recommended maintenance dosing regimen is 90mg administered subcutaneously at week 8 following the IV induction dose, followed by subsequent doses every 8 weeks thereafter. Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit 16 weeks after the IV induction dose. Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., Mayo score less than 6), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory disease will not be funded. Patients with mild ulcerative colitis (e.g., Mayo score less than 6) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of moderate to severe (luminal) Crohn's disease in patients who meet the following criteria: A. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe luminal Crohn's disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine, methotrexate); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Ustekinumab is being used to induce remission or as a steroid-sparing maintenance therapy. The recommended induction dosing is a single intravenous (IV) dose based on body weight (for patients less than or equal to 55kg a dose of ustekinumab IV 260mg, for patients greater than 55kg to less than or equal to 85kg a dose of ustekinumab IV 390mg, and for patients greater than 85kg a dose of ustekinumab IV 520mg). The recommended maintenance dosing regimen is 90mg administered subcutaneously at week 8 following the IV induction dose, followed by subsequent doses every 8 weeks thereafter. Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit 16 weeks after the IV induction dose. Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., HBI score decrease greater than or equal to 50% from pre-treatment measurement), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. Patients with mild Crohn's disease (e.g., HBI less than 7) may be considered on a case-by-case basis through the Exceptional Access Program. Patients with fistulising Crohn's disease may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 year23245mg/mLInj Sol-26mL Vial Pk (Preservative-Free)Steqeyma I.V.CEH1248.00002024-09-271248.0000For the treatment of moderate to severe ulcerative colitis in patients who meet the following criteria: A. Mayo score greater than or equal to 6 with an endoscopic subscore* of at least 2 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Ustekinumab is being used to induce remission or as a steroid-sparing maintenance therapy. *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. The recommended induction dosing is a single intravenous (IV) dose based on body weight (for patients less than or equal to 55kg a dose of ustekinumab IV 260mg, for patients greater than 55kg to less than or equal to 85kg a dose of ustekinumab IV 390mg, and for patients greater than 85kg a dose of ustekinumab IV 520mg). The recommended maintenance dosing regimen is 90mg administered subcutaneously at week 8 following the IV induction dose, followed by subsequent doses every 8 weeks thereafter. Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit 16 weeks after the IV induction dose. Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., Mayo score less than 6), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory disease will not be funded. Patients with mild ulcerative colitis (e.g., Mayo score less than 6) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of moderate to severe (luminal) Crohn's disease in patients who meet the following criteria: A. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe luminal Crohn's disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine, methotrexate); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Ustekinumab is being used to induce remission or as a steroid-sparing maintenance therapy. The recommended induction dosing is a single intravenous (IV) dose based on body weight (for patients less than or equal to 55kg a dose of ustekinumab IV 260mg, for patients greater than 55kg to less than or equal to 85kg a dose of ustekinumab IV 390mg, and for patients greater than 85kg a dose of ustekinumab IV 520mg). The recommended maintenance dosing regimen is 90mg administered subcutaneously at week 8 following the IV induction dose, followed by subsequent doses every 8 weeks thereafter. Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit 16 weeks after the IV induction dose. Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., HBI score decrease greater than or equal to 50% from pre-treatment measurement), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. Patients with mild Crohn's disease (e.g., HBI less than 7) may be considered on a case-by-case basis through the Exceptional Access Program. Patients with fistulising Crohn's disease may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 year23255mg/mLInj Sol-26mL Vial Pk (Preservative-Free)Jamteki I.V.JPC1248.00002025-07-311248.0000For the treatment of moderate to severe ulcerative colitis in patients who meet the following criteria: A. Mayo score greater than or equal to 6 with an endoscopic subscore* of at least 2 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Ustekinumab is being used to induce remission or as a steroid-sparing maintenance therapy. *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. The recommended induction dosing is a single intravenous (IV) dose based on body weight (for patients less than or equal to 55kg a dose of ustekinumab IV 260mg, for patients greater than 55kg to less than or equal to 85kg a dose of ustekinumab IV 390mg, and for patients greater than 85kg a dose of ustekinumab IV 520mg). The recommended maintenance dosing regimen is 90mg administered subcutaneously at week 8 following the IV induction dose, followed by subsequent doses every 8 weeks thereafter. Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit 16 weeks after the IV induction dose. Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., Mayo score less than 6), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory disease will not be funded. Patients with mild ulcerative colitis (e.g., Mayo score less than 6) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of moderate to severe (luminal) Crohn's disease in patients who meet the following criteria: A. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe luminal Crohn's disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine, methotrexate); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Ustekinumab is being used to induce remission or as a steroid-sparing maintenance therapy. The recommended induction dosing is a single intravenous (IV) dose based on body weight (for patients less than or equal to 55kg a dose of ustekinumab IV 260mg, for patients greater than 55kg to less than or equal to 85kg a dose of ustekinumab IV 390mg, and for patients greater than 85kg a dose of ustekinumab IV 520mg). The recommended maintenance dosing regimen is 90mg administered subcutaneously at week 8 following the IV induction dose, followed by subsequent doses every 8 weeks thereafter. Consideration should be given to discontinuing treatment in patients who show no evidence of therapeutic benefit 16 weeks after the IV induction dose. Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., HBI score decrease greater than or equal to 50% from pre-treatment measurement), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. Patients with mild Crohn's disease (e.g., HBI less than 7) may be considered on a case-by-case basis through the Exceptional Access Program. Patients with fistulising Crohn's disease may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearDISEASE-MODIFYING ANTIRHEUMATIC AGENTSADALIMUMAB232620mg/0.2mLInj Sol-0.2mL Pref Syr (Preservative-Free)HyrimozSDZ235.63502024-04-30235.6350For the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or, anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments: A. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide (20mg/day) for at least 3 months, in addition to iii) an adequate trial of at least one combination of DMARDs for 3 months; OR B. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide in combination with methotrexate for at least 3 months; OR C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.) Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For renewals beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. Approvals will only allow for standard dosing for adalimumab. The recommended dosing regimen is 40mg every two weeks.LU Authorization Period: 1 yearFor the treatment of polyarticular juvenile idiopathic arthritis (pJIA) in patients who have active disease (greater than or equal to 3 swollen joints and greater than or equal to 5 active joints) despite a trial of optimal doses of subcutaneously administered methotrexate (i.e. 15mg/m2 per week) for at least 3 months. If the patient is unable to tolerate or has a contraindication to subcutaneous methotrexate, the nature of the intolerance or contraindication should be documented. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. The recommended dosing regimen is for pediatric patients 2 years of age and older: - 10kg to less than 30kg: 20mg every other week* - 30kg and greater: 40mg every other week *a dose of 10mg every other week can be considered for patients weighing 10kg to less than 15kg It should be noted that some adalimumab products may not be available as 20mg injectables. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.LU Authorization Period: 1 yearFor the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite: i) treatment with methotrexate (20mg/week) for at least 3 months; AND ii) one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months. If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months is required. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must have objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 40mg every 2 weeks. Higher doses may be considered case-by-case through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of ankylosing spondylitis (AS) in patients who have severe active disease confirmed by radiographic evidence (see note below) with: - Age of disease onset equal to or younger than 50; AND - Low back pain and stiffness for greater than 3 months that improves with exercise and not relieved by rest; AND - Failure to respond to or documented intolerance to adequate trials of 2 non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks each; AND - Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of greater than or equal to 4 for at least 4 weeks while on standard therapy. Note: Radiographic evidence demonstrating the presence of "SI joint fusion" or "SI joint erosion" on x-ray or CT scan, or MRI demonstrating the presence of "inflammation" or "edema" of the SI joint. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 50 percent reduction in BASDAI score or greater than or equal to 2 absolute point reduction in BASDAI score. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 40mg every 2 weeks. Higher doses may be considered case-by-case through the Exceptional Access Program.LU Authorization Period: 1 yearLuminal Crohn's disease For the treatment of moderate to severe (luminal) Crohn's disease in patients who meet the following criteria: A. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine, methotrexate); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Adalimumab is being used to induce remission or as a steroid-sparing maintenance therapy. The recommended induction dosing regimen is 160mg at week 0, followed by 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., HBI score decrease greater than or equal to 50% from pre-treatment measurement), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. Patients with mild Crohn's disease (e.g., HBI less than 7) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFistulising Crohn's disease For the treatment of fistulising Crohn's disease with concomitant luminal disease in patients who meet the following criteria: A. Patient has actively draining perianal or enterocutaneous fistula(e) that have recurred OR persist despite a course of appropriate antibiotic therapy (e.g., ciprofloxacin and/or metronidazole); AND B. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease) The recommended induction dosing regimen is 160mg at week 0, followed by 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and achieve and maintain response to therapy (e.g., partial or complete resolution of fistulae and symptom improvement). Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded.LU Authorization Period: 1 yearUlcerative Colitis For the treatment of moderate to severe ulcerative colitis in patients who meet the following criteria: A. Mayo score greater than or equal to 6 with an endoscopic subscore* of at least 2 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Adalimumab is being used to induce remission or as a steroid-sparing maintenance therapy. *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. The recommended induction dosing regimen is up to 160mg at week 0, followed by up to 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., Mayo score less than 6), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory disease will not be funded. Patients with mild ulcerative colitis (e.g., Mayo score less than 6) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of patients with active moderate to severe hidradenitis suppurativa (HS) who have not responded to conventional therapy (including systemic antibiotics) and who meet all of the following: A. A total abscess and nodule count of 3 or greater; AND B. Lesions in at least two distinct anatomic areas, one of which must be Hurley Stage II or III; AND C. Experienced an inadequate response to a 90-day trial of oral antibiotics. Therapy must be prescribed by a practitioner with expertise in the management of patients with HS. The recommended adult dosing regimen is 160mg at week 0, followed by 80mg at week 2, then 40mg at week 4, and 40mg weekly thereafter. The recommended adolescent dosing regimen is 80mg at week 0, followed by 40mg every other week starting at week 1 up to 40mg weekly in those with inadequate response. If there is no improvement after 12 weeks of treatment with adalimumab at the Health Canada approved dose, higher doses are not recommended and the prescriber should discontinue treatment. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Maintenance/Renewal: Maintenance therapy is funded for patients beyond the first 12 weeks in those who meet the Ministry initiation criteria and who have responded to treatment defined as at least a 50% reduction in abscesses and inflammatory nodule count with no increase in abscess count or draining fistula count relative to baseline. Maintenance therapy beyond the second year is funded for patients using adalimumab for HS, where there is objective evidence of the preservation of treatment effect (i.e. the current abscess and inflammatory nodule count should be compared to the count prior to initiating treatment with adalimumab). The recommended maintenance dose is 40mg weekly. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.LU Authorization Period: 1 yearFor the treatment of severe* plaque psoriasis in patients 18 years of age or older who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies**. Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. *Definition of severe plaque psoriasis: Body Surface Area (BSA) involvement of at least 10 percent, or involvement of the face, hands, feet or genital regions, AND Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND Dermatology Life Quality Index (DLQI) score of at least 10. **Definition of failure, intolerance or contraindication to adequate trials of standard therapies: 6 month trial of at least 3 topical agents including vitamin D analogues and steroids 12 week trial of phototherapy (unless not accessible) 6 month trial of at least 2 systemic, oral agents used alone or in combination - Methotrexate 15-30mg per week - Acitretin (could have been used with phototherapy) - Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: - at least a 50% reduction in PASI, AND - at least a 50% reduction in BSA involvement, AND - at least a 5 point reduction in DLQI score Approvals will only allow for standard dosing for adalimumab. The recommended dose is an initial 80mg administered subcutaneously at week 0, followed by 40mg subcutaneously given every other week starting at week 1, as approved by Health Canada. If the patient has not responded adequately after 12 weeks of treatment at the Health Canada approved dose, higher doses are not recommended, and the physician should consider switching to an alternative biologic agent.LU Authorization Period: 1 yearFor the treatment of severe uveitis in patients meeting the following criteria: A. Has experienced failure or intolerance to an oral corticosteroid (or topical corticosteroid for anterior uveitis) or where the use of corticosteroids is contraindicated, and has experienced failure or intolerance to at least one immunosuppressive therapy; AND B. Treatment must be prescribed by an opthalmologist specialized in uveitis or retinal disease, a uveitis specialist, or a retina specialist familiar with ocular inflammatory diseases. Requests not meeting the above criteria may be considered on a case-by-case basis through the Exceptional Access Program. The recommended adult dose is an initial 80mg administered subcutaneously at week 0, followed by 40mg subsubcutaneously given every other week starting at week 1, as approved by Health Canada. Note: Higher doses up to 40mg weekly may be considered in patients who have failed to respond to lower doses. The recommended dose for pediatric patients (2 years of age and older) with anterior uveitis is: Less than 30kg: 20mg every other week in combination with methotrexate 30kg or greater: 40mg every other week in combination with methotrexate For patients 6 years of age or older and less than 30kg, an optional loading dose of 40mg at week 0 may be administered before starting maintenance therapy. For patients 6 years of age or older and weighing 30kg or greater, an optional loading dose of 80mg at week 0 may be administered before starting maintenance therapy. It should be noted that some adalimumab products may not be available as 20mg injectables. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Maintenance/Renewals: Maintenance therapy is funded for patients who meet the Ministry initiation criteria and who have experienced improvement and/or stability of vision and other treatment goals (e.g. reduction or control of ocular inflammation).LU Authorization Period: 1 year232740mg/0.4mLInj Sol-0.4mL Autoinj (Preservative-Free)Hadlima PushTouchSAM471.27002023-11-30471.2700For the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or, anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments: A. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide (20mg/day) for at least 3 months, in addition to iii) an adequate trial of at least one combination of DMARDs for 3 months; OR B. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide in combination with methotrexate for at least 3 months; OR C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.) Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For renewals beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. Approvals will only allow for standard dosing for adalimumab. The recommended dosing regimen is 40mg every two weeks.LU Authorization Period: 1 yearFor the treatment of polyarticular juvenile idiopathic arthritis (pJIA) in patients who have active disease (greater than or equal to 3 swollen joints and greater than or equal to 5 active joints) despite a trial of optimal doses of subcutaneously administered methotrexate (i.e. 15mg/m2 per week) for at least 3 months. If the patient is unable to tolerate or has a contraindication to subcutaneous methotrexate, the nature of the intolerance or contraindication should be documented. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. The recommended dosing regimen is for pediatric patients 2 years of age and older: - 10kg to less than 30kg: 20mg every other week* - 30kg and greater: 40mg every other week *a dose of 10mg every other week can be considered for patients weighing 10kg to less than 15kg It should be noted that some adalimumab products may not be available as 20mg injectables. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.LU Authorization Period: 1 yearFor the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite: i) treatment with methotrexate (20mg/week) for at least 3 months; AND ii) one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months. If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months is required. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must have objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 40mg every 2 weeks. Higher doses may be considered case-by-case through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of ankylosing spondylitis (AS) in patients who have severe active disease confirmed by radiographic evidence (see note below) with: - Age of disease onset equal to or younger than 50; AND - Low back pain and stiffness for greater than 3 months that improves with exercise and not relieved by rest; AND - Failure to respond to or documented intolerance to adequate trials of 2 non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks each; AND - Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of greater than or equal to 4 for at least 4 weeks while on standard therapy. Note: Radiographic evidence demonstrating the presence of "SI joint fusion" or "SI joint erosion" on x-ray or CT scan, or MRI demonstrating the presence of "inflammation" or "edema" of the SI joint. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 50 percent reduction in BASDAI score or greater than or equal to 2 absolute point reduction in BASDAI score. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 40mg every 2 weeks. Higher doses may be considered case-by-case through the Exceptional Access Program.LU Authorization Period: 1 yearLuminal Crohn's disease For the treatment of moderate to severe (luminal) Crohn's disease in patients who meet the following criteria: A. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine, methotrexate); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Adalimumab is being used to induce remission or as a steroid-sparing maintenance therapy. The recommended induction dosing regimen is 160mg at week 0, followed by 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., HBI score decrease greater than or equal to 50% from pre-treatment measurement), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. Patients with mild Crohn's disease (e.g., HBI less than 7) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFistulising Crohn's disease For the treatment of fistulising Crohn's disease with concomitant luminal disease in patients who meet the following criteria: A. Patient has actively draining perianal or enterocutaneous fistula(e) that have recurred OR persist despite a course of appropriate antibiotic therapy (e.g., ciprofloxacin and/or metronidazole); AND B. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease) The recommended induction dosing regimen is 160mg at week 0, followed by 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and achieve and maintain response to therapy (e.g., partial or complete resolution of fistulae and symptom improvement). Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded.LU Authorization Period: 1 yearUlcerative Colitis For the treatment of moderate to severe ulcerative colitis in patients who meet the following criteria: A. Mayo score greater than or equal to 6 with an endoscopic subscore* of at least 2 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Adalimumab is being used to induce remission or as a steroid-sparing maintenance therapy. *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. The recommended induction dosing regimen is up to 160mg at week 0, followed by up to 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., Mayo score less than 6), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory disease will not be funded. Patients with mild ulcerative colitis (e.g., Mayo score less than 6) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of patients with active moderate to severe hidradenitis suppurativa (HS) who have not responded to conventional therapy (including systemic antibiotics) and who meet all of the following: A. A total abscess and nodule count of 3 or greater; AND B. Lesions in at least two distinct anatomic areas, one of which must be Hurley Stage II or III; AND C. Experienced an inadequate response to a 90-day trial of oral antibiotics. Therapy must be prescribed by a practitioner with expertise in the management of patients with HS. The recommended adult dosing regimen is 160mg at week 0, followed by 80mg at week 2, then 40mg at week 4, and 40mg weekly thereafter. The recommended adolescent dosing regimen is 80mg at week 0, followed by 40mg every other week starting at week 1 up to 40mg weekly in those with inadequate response. If there is no improvement after 12 weeks of treatment with adalimumab at the Health Canada approved dose, higher doses are not recommended and the prescriber should discontinue treatment. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Maintenance/Renewal: Maintenance therapy is funded for patients beyond the first 12 weeks in those who meet the Ministry initiation criteria and who have responded to treatment defined as at least a 50% reduction in abscesses and inflammatory nodule count with no increase in abscess count or draining fistula count relative to baseline. Maintenance therapy beyond the second year is funded for patients using adalimumab for HS, where there is objective evidence of the preservation of treatment effect (i.e. the current abscess and inflammatory nodule count should be compared to the count prior to initiating treatment with adalimumab). The recommended maintenance dose is 40mg weekly. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.LU Authorization Period: 1 yearFor the treatment of severe* plaque psoriasis in patients 18 years of age or older who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies**. Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. *Definition of severe plaque psoriasis: Body Surface Area (BSA) involvement of at least 10 percent, or involvement of the face, hands, feet or genital regions, AND Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND Dermatology Life Quality Index (DLQI) score of at least 10. **Definition of failure, intolerance or contraindication to adequate trials of standard therapies: 6 month trial of at least 3 topical agents including vitamin D analogues and steroids 12 week trial of phototherapy (unless not accessible) 6 month trial of at least 2 systemic, oral agents used alone or in combination - Methotrexate 15-30mg per week - Acitretin (could have been used with phototherapy) - Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: - at least a 50% reduction in PASI, AND - at least a 50% reduction in BSA involvement, AND - at least a 5 point reduction in DLQI score Approvals will only allow for standard dosing for adalimumab. The recommended dose is an initial 80mg administered subcutaneously at week 0, followed by 40mg subcutaneously given every other week starting at week 1, as approved by Health Canada. If the patient has not responded adequately after 12 weeks of treatment at the Health Canada approved dose, higher doses are not recommended, and the physician should consider switching to an alternative biologic agent.LU Authorization Period: 1 yearFor the treatment of severe uveitis in patients meeting the following criteria: A. Has experienced failure or intolerance to an oral corticosteroid (or topical corticosteroid for anterior uveitis) or where the use of corticosteroids is contraindicated, and has experienced failure or intolerance to at least one immunosuppressive therapy; AND B. Treatment must be prescribed by an opthalmologist specialized in uveitis or retinal disease, a uveitis specialist, or a retina specialist familiar with ocular inflammatory diseases. Requests not meeting the above criteria may be considered on a case-by-case basis through the Exceptional Access Program. The recommended adult dose is an initial 80mg administered subcutaneously at week 0, followed by 40mg subsubcutaneously given every other week starting at week 1, as approved by Health Canada. Note: Higher doses up to 40mg weekly may be considered in patients who have failed to respond to lower doses. The recommended dose for pediatric patients (2 years of age and older) with anterior uveitis is: Less than 30kg: 20mg every other week in combination with methotrexate 30kg or greater: 40mg every other week in combination with methotrexate For patients 6 years of age or older and less than 30kg, an optional loading dose of 40mg at week 0 may be administered before starting maintenance therapy. For patients 6 years of age or older and weighing 30kg or greater, an optional loading dose of 80mg at week 0 may be administered before starting maintenance therapy. It should be noted that some adalimumab products may not be available as 20mg injectables. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Maintenance/Renewals: Maintenance therapy is funded for patients who meet the Ministry initiation criteria and who have experienced improvement and/or stability of vision and other treatment goals (e.g. reduction or control of ocular inflammation).LU Authorization Period: 1 year232840mg/0.4mLInj Sol-0.4mL Pref Autoinj Pen (Preservative-Free)YuflymaCEH471.27002022-05-31471.2700232940mg/0.4mLInj Sol-0.4mL Pref Autoinj Syr (Preservative-Free)SimlandiJPC471.27002022-05-31471.2700For the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or, anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments: A. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide (20mg/day) for at least 3 months, in addition to iii) an adequate trial of at least one combination of DMARDs for 3 months; OR B. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide in combination with methotrexate for at least 3 months; OR C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.) Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For renewals beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. Approvals will only allow for standard dosing for adalimumab. The recommended dosing regimen is 40mg every two weeks.LU Authorization Period: 1 yearFor the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite: i) treatment with methotrexate (20mg/week) for at least 3 months; AND ii) one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months. If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months is required. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must have objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 40mg every 2 weeks. Higher doses may be considered case-by-case through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of ankylosing spondylitis (AS) in patients who have severe active disease confirmed by radiographic evidence (see note below) with: - Age of disease onset equal to or younger than 50; AND - Low back pain and stiffness for greater than 3 months that improves with exercise and not relieved by rest; AND - Failure to respond to or documented intolerance to adequate trials of 2 non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks each; AND - Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of greater than or equal to 4 for at least 4 weeks while on standard therapy. Note: Radiographic evidence demonstrating the presence of "SI joint fusion" or "SI joint erosion" on x-ray or CT scan, or MRI demonstrating the presence of "inflammation" or "edema" of the SI joint. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 50 percent reduction in BASDAI score or greater than or equal to 2 absolute point reduction in BASDAI score. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 40mg every 2 weeks. Higher doses may be considered case-by-case through the Exceptional Access Program.LU Authorization Period: 1 yearLuminal Crohn's disease For the treatment of moderate to severe (luminal) Crohn's disease in patients who meet the following criteria: A. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine, methotrexate); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Adalimumab is being used to induce remission or as a steroid-sparing maintenance therapy. The recommended induction dosing regimen is 160mg at week 0, followed by 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., HBI score decrease greater than or equal to 50% from pre-treatment measurement), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. Patients with mild Crohn's disease (e.g., HBI less than 7) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFistulising Crohn's disease For the treatment of fistulising Crohn's disease with concomitant luminal disease in patients who meet the following criteria: A. Patient has actively draining perianal or enterocutaneous fistula(e) that have recurred OR persist despite a course of appropriate antibiotic therapy (e.g., ciprofloxacin and/or metronidazole); AND B. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease) The recommended induction dosing regimen is 160mg at week 0, followed by 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and achieve and maintain response to therapy (e.g., partial or complete resolution of fistulae and symptom improvement). Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded.LU Authorization Period: 1 yearUlcerative Colitis For the treatment of moderate to severe ulcerative colitis in patients who meet the following criteria: A. Mayo score greater than or equal to 6 with an endoscopic subscore* of at least 2 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Adalimumab is being used to induce remission or as a steroid-sparing maintenance therapy. *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. The recommended induction dosing regimen is up to 160mg at week 0, followed by up to 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., Mayo score less than 6), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory disease will not be funded. Patients with mild ulcerative colitis (e.g., Mayo score less than 6) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of patients with active moderate to severe hidradenitis suppurativa (HS) who have not responded to conventional therapy (including systemic antibiotics) and who meet all of the following: A. A total abscess and nodule count of 3 or greater; AND B. Lesions in at least two distinct anatomic areas, one of which must be Hurley Stage II or III; AND C. Experienced an inadequate response to a 90-day trial of oral antibiotics. Therapy must be prescribed by a practitioner with expertise in the management of patients with HS. The recommended adult dosing regimen is 160mg at week 0, followed by 80mg at week 2, then 40mg at week 4, and 40mg weekly thereafter. The recommended adolescent dosing regimen is 80mg at week 0, followed by 40mg every other week starting at week 1 up to 40mg weekly in those with inadequate response. If there is no improvement after 12 weeks of treatment with adalimumab at the Health Canada approved dose, higher doses are not recommended and the prescriber should discontinue treatment. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Maintenance/Renewal: Maintenance therapy is funded for patients beyond the first 12 weeks in those who meet the Ministry initiation criteria and who have responded to treatment defined as at least a 50% reduction in abscesses and inflammatory nodule count with no increase in abscess count or draining fistula count relative to baseline. Maintenance therapy beyond the second year is funded for patients using adalimumab for HS, where there is objective evidence of the preservation of treatment effect (i.e. the current abscess and inflammatory nodule count should be compared to the count prior to initiating treatment with adalimumab). The recommended maintenance dose is 40mg weekly. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.LU Authorization Period: 1 yearFor the treatment of severe* plaque psoriasis in patients 18 years of age or older who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies**. Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. *Definition of severe plaque psoriasis: Body Surface Area (BSA) involvement of at least 10 percent, or involvement of the face, hands, feet or genital regions, AND Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND Dermatology Life Quality Index (DLQI) score of at least 10. **Definition of failure, intolerance or contraindication to adequate trials of standard therapies: 6 month trial of at least 3 topical agents including vitamin D analogues and steroids 12 week trial of phototherapy (unless not accessible) 6 month trial of at least 2 systemic, oral agents used alone or in combination - Methotrexate 15-30mg per week - Acitretin (could have been used with phototherapy) - Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: - at least a 50% reduction in PASI, AND - at least a 50% reduction in BSA involvement, AND - at least a 5 point reduction in DLQI score Approvals will only allow for standard dosing for adalimumab. The recommended dose is an initial 80mg administered subcutaneously at week 0, followed by 40mg subcutaneously given every other week starting at week 1, as approved by Health Canada. If the patient has not responded adequately after 12 weeks of treatment at the Health Canada approved dose, higher doses are not recommended, and the physician should consider switching to an alternative biologic agent.LU Authorization Period: 1 yearPolyarticular Juvenile Idiopathic Arthritis For the treatment of polyarticular juvenile idiopathic arthritis (pJIA) in patients who have active disease (greater than or equal to 3 swollen joints and greater than or equal to 5 active joints) despite a trial of optimal doses of subcutaneously administered methotrexate (i.e. 15mg/m2 per week) for at least 3 months. If the patient is unable to tolerate or has a contraindication to subcutaneous methotrexate, the nature of the intolerance or contraindication should be documented. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. The recommended dosing regimen is for pediatric patients 2 years of age and older: - 30kg and greater: 40mg every other week Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. LU Authorization Period: 1 yearFor the treatment of severe uveitis in patients meeting the following criteria: A. Has experienced failure or intolerance to an oral corticosteroid (or topical corticosteroid for anterior uveitis) or where the use of corticosteroids is contraindicated, and has experienced failure or intolerance to at least one immunosuppressive therapy; AND B. Treatment must be prescribed by an ophthalmologist specialized in uveitis or retinal disease, a uveitis specialist, or a retina specialist familiar with ocular inflammatory diseases. Requests not meeting the above criteria may be considered on a case-by-case basis through the Exceptional Access Program. The recommended adult dose is an initial 80mg administered subcutaneously at week 0, followed by 40mg subcutaneously given every other week starting at week 1, as approved by Health Canada. Note: Higher doses up to 40mg weekly may be considered in patients who have failed to respond to lower doses. The recommended dose for pediatric patients (2 years or older) with anterior uveitis is: 30kg or greater: 40mg every other week in combination with methotrexate For patients 6 years of age or older and weighing 30kg or greater, an optional loading dose of 80mg at week 0 may be administered before starting maintenance therapy. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Maintenance/Renewals: Maintenance therapy is funded for patients who meet the Ministry initiation criteria and who have experienced improvement and/or stability of vision and other treatment goals (e.g. reduction or control of ocular inflammation).LU Authorization Period: 1 year233040mg/0.4mLInj Sol-0.4mL Pref Pen (Preservative-Free)HyrimozSDZ471.27002024-04-30471.2700For the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or, anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments: A. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide (20mg/day) for at least 3 months, in addition to iii) an adequate trial of at least one combination of DMARDs for 3 months; OR B. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide in combination with methotrexate for at least 3 months; OR C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.) Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For renewals beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. Approvals will only allow for standard dosing for adalimumab. The recommended dosing regimen is 40mg every two weeks.LU Authorization Period: 1 yearFor the treatment of polyarticular juvenile idiopathic arthritis (pJIA) in patients who have active disease (greater than or equal to 3 swollen joints and greater than or equal to 5 active joints) despite a trial of optimal doses of subcutaneously administered methotrexate (i.e. 15mg/m2 per week) for at least 3 months. If the patient is unable to tolerate or has a contraindication to subcutaneous methotrexate, the nature of the intolerance or contraindication should be documented. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. The recommended dosing regimen is for pediatric patients 2 years of age and older: - 10kg to less than 30kg: 20mg every other week* - 30kg and greater: 40mg every other week *a dose of 10mg every other week can be considered for patients weighing 10kg to less than 15kg It should be noted that some adalimumab products may not be available as 20mg injectables. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.LU Authorization Period: 1 yearFor the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite: i) treatment with methotrexate (20mg/week) for at least 3 months; AND ii) one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months. If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months is required. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must have objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 40mg every 2 weeks. Higher doses may be considered case-by-case through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of ankylosing spondylitis (AS) in patients who have severe active disease confirmed by radiographic evidence (see note below) with: - Age of disease onset equal to or younger than 50; AND - Low back pain and stiffness for greater than 3 months that improves with exercise and not relieved by rest; AND - Failure to respond to or documented intolerance to adequate trials of 2 non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks each; AND - Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of greater than or equal to 4 for at least 4 weeks while on standard therapy. Note: Radiographic evidence demonstrating the presence of "SI joint fusion" or "SI joint erosion" on x-ray or CT scan, or MRI demonstrating the presence of "inflammation" or "edema" of the SI joint. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 50 percent reduction in BASDAI score or greater than or equal to 2 absolute point reduction in BASDAI score. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 40mg every 2 weeks. Higher doses may be considered case-by-case through the Exceptional Access Program.LU Authorization Period: 1 yearLuminal Crohn's disease For the treatment of moderate to severe (luminal) Crohn's disease in patients who meet the following criteria: A. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine, methotrexate); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Adalimumab is being used to induce remission or as a steroid-sparing maintenance therapy. The recommended induction dosing regimen is 160mg at week 0, followed by 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., HBI score decrease greater than or equal to 50% from pre-treatment measurement), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. Patients with mild Crohn's disease (e.g., HBI less than 7) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFistulising Crohn's disease For the treatment of fistulising Crohn's disease with concomitant luminal disease in patients who meet the following criteria: A. Patient has actively draining perianal or enterocutaneous fistula(e) that have recurred OR persist despite a course of appropriate antibiotic therapy (e.g., ciprofloxacin and/or metronidazole); AND B. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease) The recommended induction dosing regimen is 160mg at week 0, followed by 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and achieve and maintain response to therapy (e.g., partial or complete resolution of fistulae and symptom improvement). Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded.LU Authorization Period: 1 yearUlcerative Colitis For the treatment of moderate to severe ulcerative colitis in patients who meet the following criteria: A. Mayo score greater than or equal to 6 with an endoscopic subscore* of at least 2 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Adalimumab is being used to induce remission or as a steroid-sparing maintenance therapy. *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. The recommended induction dosing regimen is up to 160mg at week 0, followed by up to 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., Mayo score less than 6), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory disease will not be funded. Patients with mild ulcerative colitis (e.g., Mayo score less than 6) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of patients with active moderate to severe hidradenitis suppurativa (HS) who have not responded to conventional therapy (including systemic antibiotics) and who meet all of the following: A. A total abscess and nodule count of 3 or greater; AND B. Lesions in at least two distinct anatomic areas, one of which must be Hurley Stage II or III; AND C. Experienced an inadequate response to a 90-day trial of oral antibiotics. Therapy must be prescribed by a practitioner with expertise in the management of patients with HS. The recommended adult dosing regimen is 160mg at week 0, followed by 80mg at week 2, then 40mg at week 4, and 40mg weekly thereafter. The recommended adolescent dosing regimen is 80mg at week 0, followed by 40mg every other week starting at week 1 up to 40mg weekly in those with inadequate response. If there is no improvement after 12 weeks of treatment with adalimumab at the Health Canada approved dose, higher doses are not recommended and the prescriber should discontinue treatment. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Maintenance/Renewal: Maintenance therapy is funded for patients beyond the first 12 weeks in those who meet the Ministry initiation criteria and who have responded to treatment defined as at least a 50% reduction in abscesses and inflammatory nodule count with no increase in abscess count or draining fistula count relative to baseline. Maintenance therapy beyond the second year is funded for patients using adalimumab for HS, where there is objective evidence of the preservation of treatment effect (i.e. the current abscess and inflammatory nodule count should be compared to the count prior to initiating treatment with adalimumab). The recommended maintenance dose is 40mg weekly. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.LU Authorization Period: 1 yearFor the treatment of severe* plaque psoriasis in patients 18 years of age or older who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies**. Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. *Definition of severe plaque psoriasis: Body Surface Area (BSA) involvement of at least 10 percent, or involvement of the face, hands, feet or genital regions, AND Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND Dermatology Life Quality Index (DLQI) score of at least 10. **Definition of failure, intolerance or contraindication to adequate trials of standard therapies: 6 month trial of at least 3 topical agents including vitamin D analogues and steroids 12 week trial of phototherapy (unless not accessible) 6 month trial of at least 2 systemic, oral agents used alone or in combination - Methotrexate 15-30mg per week - Acitretin (could have been used with phototherapy) - Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: - at least a 50% reduction in PASI, AND - at least a 50% reduction in BSA involvement, AND - at least a 5 point reduction in DLQI score Approvals will only allow for standard dosing for adalimumab. The recommended dose is an initial 80mg administered subcutaneously at week 0, followed by 40mg subcutaneously given every other week starting at week 1, as approved by Health Canada. If the patient has not responded adequately after 12 weeks of treatment at the Health Canada approved dose, higher doses are not recommended, and the physician should consider switching to an alternative biologic agent.LU Authorization Period: 1 yearFor the treatment of severe uveitis in patients meeting the following criteria: A. Has experienced failure or intolerance to an oral corticosteroid (or topical corticosteroid for anterior uveitis) or where the use of corticosteroids is contraindicated, and has experienced failure or intolerance to at least one immunosuppressive therapy; AND B. Treatment must be prescribed by an opthalmologist specialized in uveitis or retinal disease, a uveitis specialist, or a retina specialist familiar with ocular inflammatory diseases. Requests not meeting the above criteria may be considered on a case-by-case basis through the Exceptional Access Program. The recommended adult dose is an initial 80mg administered subcutaneously at week 0, followed by 40mg subsubcutaneously given every other week starting at week 1, as approved by Health Canada. Note: Higher doses up to 40mg weekly may be considered in patients who have failed to respond to lower doses. The recommended dose for pediatric patients (2 years of age and older) with anterior uveitis is: Less than 30kg: 20mg every other week in combination with methotrexate 30kg or greater: 40mg every other week in combination with methotrexate For patients 6 years of age or older and less than 30kg, an optional loading dose of 40mg at week 0 may be administered before starting maintenance therapy. For patients 6 years of age or older and weighing 30kg or greater, an optional loading dose of 80mg at week 0 may be administered before starting maintenance therapy. It should be noted that some adalimumab products may not be available as 20mg injectables. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Maintenance/Renewals: Maintenance therapy is funded for patients who meet the Ministry initiation criteria and who have experienced improvement and/or stability of vision and other treatment goals (e.g. reduction or control of ocular inflammation).LU Authorization Period: 1 year233120mg/0.4mLInj Sol-0.4mL Pref Syr (Preservative-Free)AmgevitaAMG235.64002021-03-29235.6400For the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or, anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments: A. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide (20mg/day) for at least 3 months, in addition to iii) an adequate trial of at least one combination of DMARDs for 3 months; OR B. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide in combination with methotrexate for at least 3 months; OR C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.) Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For renewals beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. Approvals will only allow for standard dosing for adalimumab. The recommended dosing regimen is 40mg every two weeks.LU Authorization Period: 1 yearFor the treatment of polyarticular juvenile idiopathic arthritis (pJIA) in patients who have active disease (greater than or equal to 3 swollen joints and greater than or equal to 5 active joints) despite a trial of optimal doses of subcutaneously administered methotrexate (i.e. 15mg/m2 per week) for at least 3 months. If the patient is unable to tolerate or has a contraindication to subcutaneous methotrexate, the nature of the intolerance or contraindication should be documented. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. The recommended dosing regimen is for pediatric patients 2 years of age and older: - 10kg to less than 30kg: 20mg every other week* - 30kg and greater: 40mg every other week *a dose of 10mg every other week can be considered for patients weighing 10kg to less than 15kg It should be noted that some adalimumab products may not be available as 20mg injectables. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.LU Authorization Period: 1 yearFor the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite: i) treatment with methotrexate (20mg/week) for at least 3 months; AND ii) one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months. If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months is required. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must have objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 40mg every 2 weeks. Higher doses may be considered case-by-case through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of ankylosing spondylitis (AS) in patients who have severe active disease confirmed by radiographic evidence (see note below) with: - Age of disease onset equal to or younger than 50; AND - Low back pain and stiffness for greater than 3 months that improves with exercise and not relieved by rest; AND - Failure to respond to or documented intolerance to adequate trials of 2 non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks each; AND - Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of greater than or equal to 4 for at least 4 weeks while on standard therapy. Note: Radiographic evidence demonstrating the presence of "SI joint fusion" or "SI joint erosion" on x-ray or CT scan, or MRI demonstrating the presence of "inflammation" or "edema" of the SI joint. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 50 percent reduction in BASDAI score or greater than or equal to 2 absolute point reduction in BASDAI score. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 40mg every 2 weeks. Higher doses may be considered case-by-case through the Exceptional Access Program.LU Authorization Period: 1 yearLuminal Crohn's disease For the treatment of moderate to severe (luminal) Crohn's disease in patients who meet the following criteria: A. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine, methotrexate); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Adalimumab is being used to induce remission or as a steroid-sparing maintenance therapy. The recommended induction dosing regimen is 160mg at week 0, followed by 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., HBI score decrease greater than or equal to 50% from pre-treatment measurement), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. Patients with mild Crohn's disease (e.g., HBI less than 7) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFistulising Crohn's disease For the treatment of fistulising Crohn's disease with concomitant luminal disease in patients who meet the following criteria: A. Patient has actively draining perianal or enterocutaneous fistula(e) that have recurred OR persist despite a course of appropriate antibiotic therapy (e.g., ciprofloxacin and/or metronidazole); AND B. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease) The recommended induction dosing regimen is 160mg at week 0, followed by 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and achieve and maintain response to therapy (e.g., partial or complete resolution of fistulae and symptom improvement). Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded.LU Authorization Period: 1 yearUlcerative Colitis For the treatment of moderate to severe ulcerative colitis in patients who meet the following criteria: A. Mayo score greater than or equal to 6 with an endoscopic subscore* of at least 2 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Adalimumab is being used to induce remission or as a steroid-sparing maintenance therapy. *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. The recommended induction dosing regimen is up to 160mg at week 0, followed by up to 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., Mayo score less than 6), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory disease will not be funded. Patients with mild ulcerative colitis (e.g., Mayo score less than 6) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of patients with active moderate to severe hidradenitis suppurativa (HS) who have not responded to conventional therapy (including systemic antibiotics) and who meet all of the following: A. A total abscess and nodule count of 3 or greater; AND B. Lesions in at least two distinct anatomic areas, one of which must be Hurley Stage II or III; AND C. Experienced an inadequate response to a 90-day trial of oral antibiotics. Therapy must be prescribed by a practitioner with expertise in the management of patients with HS. The recommended adult dosing regimen is 160mg at week 0, followed by 80mg at week 2, then 40mg at week 4, and 40mg weekly thereafter. The recommended adolescent dosing regimen is 80mg at week 0, followed by 40mg every other week starting at week 1 up to 40mg weekly in those with inadequate response. If there is no improvement after 12 weeks of treatment with adalimumab at the Health Canada approved dose, higher doses are not recommended and the prescriber should discontinue treatment. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Maintenance/Renewal: Maintenance therapy is funded for patients beyond the first 12 weeks in those who meet the Ministry initiation criteria and who have responded to treatment defined as at least a 50% reduction in abscesses and inflammatory nodule count with no increase in abscess count or draining fistula count relative to baseline. Maintenance therapy beyond the second year is funded for patients using adalimumab for HS, where there is objective evidence of the preservation of treatment effect (i.e. the current abscess and inflammatory nodule count should be compared to the count prior to initiating treatment with adalimumab). The recommended maintenance dose is 40mg weekly. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.LU Authorization Period: 1 yearFor the treatment of severe* plaque psoriasis in patients 18 years of age or older who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies**. Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. *Definition of severe plaque psoriasis: Body Surface Area (BSA) involvement of at least 10 percent, or involvement of the face, hands, feet or genital regions, AND Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND Dermatology Life Quality Index (DLQI) score of at least 10. **Definition of failure, intolerance or contraindication to adequate trials of standard therapies: 6 month trial of at least 3 topical agents including vitamin D analogues and steroids 12 week trial of phototherapy (unless not accessible) 6 month trial of at least 2 systemic, oral agents used alone or in combination - Methotrexate 15-30mg per week - Acitretin (could have been used with phototherapy) - Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: - at least a 50% reduction in PASI, AND - at least a 50% reduction in BSA involvement, AND - at least a 5 point reduction in DLQI score Approvals will only allow for standard dosing for adalimumab. The recommended dose is an initial 80mg administered subcutaneously at week 0, followed by 40mg subcutaneously given every other week starting at week 1, as approved by Health Canada. If the patient has not responded adequately after 12 weeks of treatment at the Health Canada approved dose, higher doses are not recommended, and the physician should consider switching to an alternative biologic agent.LU Authorization Period: 1 yearFor the treatment of severe uveitis in patients meeting the following criteria: A. Has experienced failure or intolerance to an oral corticosteroid (or topical corticosteroid for anterior uveitis) or where the use of corticosteroids is contraindicated, and has experienced failure or intolerance to at least one immunosuppressive therapy; AND B. Treatment must be prescribed by an opthalmologist specialized in uveitis or retinal disease, a uveitis specialist, or a retina specialist familiar with ocular inflammatory diseases. Requests not meeting the above criteria may be considered on a case-by-case basis through the Exceptional Access Program. The recommended adult dose is an initial 80mg administered subcutaneously at week 0, followed by 40mg subsubcutaneously given every other week starting at week 1, as approved by Health Canada. Note: Higher doses up to 40mg weekly may be considered in patients who have failed to respond to lower doses. The recommended dose for pediatric patients (2 years of age and older) with anterior uveitis is: Less than 30kg: 20mg every other week in combination with methotrexate 30kg or greater: 40mg every other week in combination with methotrexate For patients 6 years of age or older and less than 30kg, an optional loading dose of 40mg at week 0 may be administered before starting maintenance therapy. For patients 6 years of age or older and weighing 30kg or greater, an optional loading dose of 80mg at week 0 may be administered before starting maintenance therapy. It should be noted that some adalimumab products may not be available as 20mg injectables. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Maintenance/Renewals: Maintenance therapy is funded for patients who meet the Ministry initiation criteria and who have experienced improvement and/or stability of vision and other treatment goals (e.g. reduction or control of ocular inflammation).LU Authorization Period: 1 year233220mg/0.4mLInj Sol-0.4mL Pref Syr (Preservative-Free)HyrimozSDZ235.63502021-03-29235.6350For the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or, anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments: A. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide (20mg/day) for at least 3 months, in addition to iii) an adequate trial of at least one combination of DMARDs for 3 months; OR B. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide in combination with methotrexate for at least 3 months; OR C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.) Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For renewals beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. Approvals will only allow for standard dosing for adalimumab. The recommended dosing regimen is 40mg every two weeks.LU Authorization Period: 1 yearFor the treatment of polyarticular juvenile idiopathic arthritis (pJIA) in patients who have active disease (greater than or equal to 3 swollen joints and greater than or equal to 5 active joints) despite a trial of optimal doses of subcutaneously administered methotrexate (i.e. 15mg/m2 per week) for at least 3 months. If the patient is unable to tolerate or has a contraindication to subcutaneous methotrexate, the nature of the intolerance or contraindication should be documented. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. The recommended dosing regimen is for pediatric patients 2 years of age and older: - 10kg to less than 30kg: 20mg every other week* - 30kg and greater: 40mg every other week *a dose of 10mg every other week can be considered for patients weighing 10kg to less than 15kg It should be noted that some adalimumab products may not be available as 20mg injectables. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.LU Authorization Period: 1 yearFor the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite: i) treatment with methotrexate (20mg/week) for at least 3 months; AND ii) one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months. If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months is required. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must have objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 40mg every 2 weeks. Higher doses may be considered case-by-case through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of ankylosing spondylitis (AS) in patients who have severe active disease confirmed by radiographic evidence (see note below) with: - Age of disease onset equal to or younger than 50; AND - Low back pain and stiffness for greater than 3 months that improves with exercise and not relieved by rest; AND - Failure to respond to or documented intolerance to adequate trials of 2 non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks each; AND - Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of greater than or equal to 4 for at least 4 weeks while on standard therapy. Note: Radiographic evidence demonstrating the presence of "SI joint fusion" or "SI joint erosion" on x-ray or CT scan, or MRI demonstrating the presence of "inflammation" or "edema" of the SI joint. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 50 percent reduction in BASDAI score or greater than or equal to 2 absolute point reduction in BASDAI score. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 40mg every 2 weeks. Higher doses may be considered case-by-case through the Exceptional Access Program.LU Authorization Period: 1 yearLuminal Crohn's disease For the treatment of moderate to severe (luminal) Crohn's disease in patients who meet the following criteria: A. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine, methotrexate); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Adalimumab is being used to induce remission or as a steroid-sparing maintenance therapy. The recommended induction dosing regimen is 160mg at week 0, followed by 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., HBI score decrease greater than or equal to 50% from pre-treatment measurement), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. Patients with mild Crohn's disease (e.g., HBI less than 7) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFistulising Crohn's disease For the treatment of fistulising Crohn's disease with concomitant luminal disease in patients who meet the following criteria: A. Patient has actively draining perianal or enterocutaneous fistula(e) that have recurred OR persist despite a course of appropriate antibiotic therapy (e.g., ciprofloxacin and/or metronidazole); AND B. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease) The recommended induction dosing regimen is 160mg at week 0, followed by 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and achieve and maintain response to therapy (e.g., partial or complete resolution of fistulae and symptom improvement). Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded.LU Authorization Period: 1 yearUlcerative Colitis For the treatment of moderate to severe ulcerative colitis in patients who meet the following criteria: A. Mayo score greater than or equal to 6 with an endoscopic subscore* of at least 2 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Adalimumab is being used to induce remission or as a steroid-sparing maintenance therapy. *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. The recommended induction dosing regimen is up to 160mg at week 0, followed by up to 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., Mayo score less than 6), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory disease will not be funded. Patients with mild ulcerative colitis (e.g., Mayo score less than 6) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of patients with active moderate to severe hidradenitis suppurativa (HS) who have not responded to conventional therapy (including systemic antibiotics) and who meet all of the following: A. A total abscess and nodule count of 3 or greater; AND B. Lesions in at least two distinct anatomic areas, one of which must be Hurley Stage II or III; AND C. Experienced an inadequate response to a 90-day trial of oral antibiotics. Therapy must be prescribed by a practitioner with expertise in the management of patients with HS. The recommended adult dosing regimen is 160mg at week 0, followed by 80mg at week 2, then 40mg at week 4, and 40mg weekly thereafter. The recommended adolescent dosing regimen is 80mg at week 0, followed by 40mg every other week starting at week 1 up to 40mg weekly in those with inadequate response. If there is no improvement after 12 weeks of treatment with adalimumab at the Health Canada approved dose, higher doses are not recommended and the prescriber should discontinue treatment. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Maintenance/Renewal: Maintenance therapy is funded for patients beyond the first 12 weeks in those who meet the Ministry initiation criteria and who have responded to treatment defined as at least a 50% reduction in abscesses and inflammatory nodule count with no increase in abscess count or draining fistula count relative to baseline. Maintenance therapy beyond the second year is funded for patients using adalimumab for HS, where there is objective evidence of the preservation of treatment effect (i.e. the current abscess and inflammatory nodule count should be compared to the count prior to initiating treatment with adalimumab). The recommended maintenance dose is 40mg weekly. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.LU Authorization Period: 1 yearFor the treatment of severe* plaque psoriasis in patients 18 years of age or older who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies**. Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. *Definition of severe plaque psoriasis: Body Surface Area (BSA) involvement of at least 10 percent, or involvement of the face, hands, feet or genital regions, AND Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND Dermatology Life Quality Index (DLQI) score of at least 10. **Definition of failure, intolerance or contraindication to adequate trials of standard therapies: 6 month trial of at least 3 topical agents including vitamin D analogues and steroids 12 week trial of phototherapy (unless not accessible) 6 month trial of at least 2 systemic, oral agents used alone or in combination - Methotrexate 15-30mg per week - Acitretin (could have been used with phototherapy) - Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: - at least a 50% reduction in PASI, AND - at least a 50% reduction in BSA involvement, AND - at least a 5 point reduction in DLQI score Approvals will only allow for standard dosing for adalimumab. The recommended dose is an initial 80mg administered subcutaneously at week 0, followed by 40mg subcutaneously given every other week starting at week 1, as approved by Health Canada. If the patient has not responded adequately after 12 weeks of treatment at the Health Canada approved dose, higher doses are not recommended, and the physician should consider switching to an alternative biologic agent.LU Authorization Period: 1 yearFor the treatment of severe uveitis in patients meeting the following criteria: A. Has experienced failure or intolerance to an oral corticosteroid (or topical corticosteroid for anterior uveitis) or where the use of corticosteroids is contraindicated, and has experienced failure or intolerance to at least one immunosuppressive therapy; AND B. Treatment must be prescribed by an opthalmologist specialized in uveitis or retinal disease, a uveitis specialist, or a retina specialist familiar with ocular inflammatory diseases. Requests not meeting the above criteria may be considered on a case-by-case basis through the Exceptional Access Program. The recommended adult dose is an initial 80mg administered subcutaneously at week 0, followed by 40mg subsubcutaneously given every other week starting at week 1, as approved by Health Canada. Note: Higher doses up to 40mg weekly may be considered in patients who have failed to respond to lower doses. The recommended dose for pediatric patients (2 years of age and older) with anterior uveitis is: Less than 30kg: 20mg every other week in combination with methotrexate 30kg or greater: 40mg every other week in combination with methotrexate For patients 6 years of age or older and less than 30kg, an optional loading dose of 40mg at week 0 may be administered before starting maintenance therapy. For patients 6 years of age or older and weighing 30kg or greater, an optional loading dose of 80mg at week 0 may be administered before starting maintenance therapy. It should be noted that some adalimumab products may not be available as 20mg injectables. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Maintenance/Renewals: Maintenance therapy is funded for patients who meet the Ministry initiation criteria and who have experienced improvement and/or stability of vision and other treatment goals (e.g. reduction or control of ocular inflammation).LU Authorization Period: 1 year233320mg/0.4mLInj Sol-0.4mL Pref Syr (Preservative-Free)HulioBGP235.63502022-05-31235.6350233420mg/0.4mLInj Sol-0.4mL Pref Syr (Preservative-Free)AbriladaPFI235.63002025-06-30235.6300For the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or, anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments: A. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide (20mg/day) for at least 3 months, in addition to iii) an adequate trial of at least one combination of DMARDs for 3 months; OR B. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide in combination with methotrexate for at least 3 months; OR C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.) Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For renewals beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. Approvals will only allow for standard dosing for adalimumab. The recommended dosing regimen is 40mg every two weeks.LU Authorization Period: 1 yearFor the treatment of polyarticular juvenile idiopathic arthritis (pJIA) in patients who have active disease (greater than or equal to 3 swollen joints and greater than or equal to 5 active joints) despite a trial of optimal doses of subcutaneously administered methotrexate (i.e. 15mg/m2 per week) for at least 3 months. If the patient is unable to tolerate or has a contraindication to subcutaneous methotrexate, the nature of the intolerance or contraindication should be documented. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. The recommended dosing regimen is for pediatric patients 2 years of age and older: - 10kg to less than 30kg: 20mg every other week* - 30kg and greater: 40mg every other week *a dose of 10mg every other week can be considered for patients weighing 10kg to less than 15kg It should be noted that some adalimumab products may not be available as 20mg injectables. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.LU Authorization Period: 1 yearFor the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite: i) treatment with methotrexate (20mg/week) for at least 3 months; AND ii) one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months. If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months is required. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must have objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 40mg every 2 weeks. Higher doses may be considered case-by-case through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of ankylosing spondylitis (AS) in patients who have severe active disease confirmed by radiographic evidence (see note below) with: - Age of disease onset equal to or younger than 50; AND - Low back pain and stiffness for greater than 3 months that improves with exercise and not relieved by rest; AND - Failure to respond to or documented intolerance to adequate trials of 2 non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks each; AND - Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of greater than or equal to 4 for at least 4 weeks while on standard therapy. Note: Radiographic evidence demonstrating the presence of "SI joint fusion" or "SI joint erosion" on x-ray or CT scan, or MRI demonstrating the presence of "inflammation" or "edema" of the SI joint. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 50 percent reduction in BASDAI score or greater than or equal to 2 absolute point reduction in BASDAI score. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 40mg every 2 weeks. Higher doses may be considered case-by-case through the Exceptional Access Program.LU Authorization Period: 1 yearLuminal Crohn's disease For the treatment of moderate to severe (luminal) Crohn's disease in patients who meet the following criteria: A. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine, methotrexate); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Adalimumab is being used to induce remission or as a steroid-sparing maintenance therapy. The recommended induction dosing regimen is 160mg at week 0, followed by 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., HBI score decrease greater than or equal to 50% from pre-treatment measurement), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. Patients with mild Crohn's disease (e.g., HBI less than 7) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFistulising Crohn's disease For the treatment of fistulising Crohn's disease with concomitant luminal disease in patients who meet the following criteria: A. Patient has actively draining perianal or enterocutaneous fistula(e) that have recurred OR persist despite a course of appropriate antibiotic therapy (e.g., ciprofloxacin and/or metronidazole); AND B. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease) The recommended induction dosing regimen is 160mg at week 0, followed by 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and achieve and maintain response to therapy (e.g., partial or complete resolution of fistulae and symptom improvement). Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded.LU Authorization Period: 1 yearUlcerative Colitis For the treatment of moderate to severe ulcerative colitis in patients who meet the following criteria: A. Mayo score greater than or equal to 6 with an endoscopic subscore* of at least 2 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Adalimumab is being used to induce remission or as a steroid-sparing maintenance therapy. *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. The recommended induction dosing regimen is up to 160mg at week 0, followed by up to 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., Mayo score less than 6), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory disease will not be funded. Patients with mild ulcerative colitis (e.g., Mayo score less than 6) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of patients with active moderate to severe hidradenitis suppurativa (HS) who have not responded to conventional therapy (including systemic antibiotics) and who meet all of the following: A. A total abscess and nodule count of 3 or greater; AND B. Lesions in at least two distinct anatomic areas, one of which must be Hurley Stage II or III; AND C. Experienced an inadequate response to a 90-day trial of oral antibiotics. Therapy must be prescribed by a practitioner with expertise in the management of patients with HS. The recommended adult dosing regimen is 160mg at week 0, followed by 80mg at week 2, then 40mg at week 4, and 40mg weekly thereafter. The recommended adolescent dosing regimen is 80mg at week 0, followed by 40mg every other week starting at week 1 up to 40mg weekly in those with inadequate response. If there is no improvement after 12 weeks of treatment with adalimumab at the Health Canada approved dose, higher doses are not recommended and the prescriber should discontinue treatment. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Maintenance/Renewal: Maintenance therapy is funded for patients beyond the first 12 weeks in those who meet the Ministry initiation criteria and who have responded to treatment defined as at least a 50% reduction in abscesses and inflammatory nodule count with no increase in abscess count or draining fistula count relative to baseline. Maintenance therapy beyond the second year is funded for patients using adalimumab for HS, where there is objective evidence of the preservation of treatment effect (i.e. the current abscess and inflammatory nodule count should be compared to the count prior to initiating treatment with adalimumab). The recommended maintenance dose is 40mg weekly. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.LU Authorization Period: 1 yearFor the treatment of severe* plaque psoriasis in patients 18 years of age or older who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies**. Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. *Definition of severe plaque psoriasis: Body Surface Area (BSA) involvement of at least 10 percent, or involvement of the face, hands, feet or genital regions, AND Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND Dermatology Life Quality Index (DLQI) score of at least 10. **Definition of failure, intolerance or contraindication to adequate trials of standard therapies: 6 month trial of at least 3 topical agents including vitamin D analogues and steroids 12 week trial of phototherapy (unless not accessible) 6 month trial of at least 2 systemic, oral agents used alone or in combination - Methotrexate 15-30mg per week - Acitretin (could have been used with phototherapy) - Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: - at least a 50% reduction in PASI, AND - at least a 50% reduction in BSA involvement, AND - at least a 5 point reduction in DLQI score Approvals will only allow for standard dosing for adalimumab. The recommended dose is an initial 80mg administered subcutaneously at week 0, followed by 40mg subcutaneously given every other week starting at week 1, as approved by Health Canada. If the patient has not responded adequately after 12 weeks of treatment at the Health Canada approved dose, higher doses are not recommended, and the physician should consider switching to an alternative biologic agent.LU Authorization Period: 1 yearFor the treatment of severe uveitis in patients meeting the following criteria: A. Has experienced failure or intolerance to an oral corticosteroid (or topical corticosteroid for anterior uveitis) or where the use of corticosteroids is contraindicated, and has experienced failure or intolerance to at least one immunosuppressive therapy; AND B. Treatment must be prescribed by an opthalmologist specialized in uveitis or retinal disease, a uveitis specialist, or a retina specialist familiar with ocular inflammatory diseases. Requests not meeting the above criteria may be considered on a case-by-case basis through the Exceptional Access Program. The recommended adult dose is an initial 80mg administered subcutaneously at week 0, followed by 40mg subsubcutaneously given every other week starting at week 1, as approved by Health Canada. Note: Higher doses up to 40mg weekly may be considered in patients who have failed to respond to lower doses. The recommended dose for pediatric patients (2 years of age and older) with anterior uveitis is: Less than 30kg: 20mg every other week in combination with methotrexate 30kg or greater: 40mg every other week in combination with methotrexate For patients 6 years of age or older and less than 30kg, an optional loading dose of 40mg at week 0 may be administered before starting maintenance therapy. For patients 6 years of age or older and weighing 30kg or greater, an optional loading dose of 80mg at week 0 may be administered before starting maintenance therapy. It should be noted that some adalimumab products may not be available as 20mg injectables. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Maintenance/Renewals: Maintenance therapy is funded for patients who meet the Ministry initiation criteria and who have experienced improvement and/or stability of vision and other treatment goals (e.g. reduction or control of ocular inflammation).LU Authorization Period: 1 year233540mg/0.4mLInj Sol-0.4mL Pref Syr (Preservative-Free)YuflymaCEH471.27002022-05-31471.2700233640mg/0.4mLInj Sol-0.4mL Pref Syr (Preservative-Free)SimlandiJPC471.27002022-05-31471.2700For the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or, anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments: A. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide (20mg/day) for at least 3 months, in addition to iii) an adequate trial of at least one combination of DMARDs for 3 months; OR B. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide in combination with methotrexate for at least 3 months; OR C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.) Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For renewals beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. Approvals will only allow for standard dosing for adalimumab. The recommended dosing regimen is 40mg every two weeks.LU Authorization Period: 1 yearFor the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite: i) treatment with methotrexate (20mg/week) for at least 3 months; AND ii) one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months. If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months is required. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must have objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 40mg every 2 weeks. Higher doses may be considered case-by-case through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of ankylosing spondylitis (AS) in patients who have severe active disease confirmed by radiographic evidence (see note below) with: - Age of disease onset equal to or younger than 50; AND - Low back pain and stiffness for greater than 3 months that improves with exercise and not relieved by rest; AND - Failure to respond to or documented intolerance to adequate trials of 2 non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks each; AND - Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of greater than or equal to 4 for at least 4 weeks while on standard therapy. Note: Radiographic evidence demonstrating the presence of "SI joint fusion" or "SI joint erosion" on x-ray or CT scan, or MRI demonstrating the presence of "inflammation" or "edema" of the SI joint. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 50 percent reduction in BASDAI score or greater than or equal to 2 absolute point reduction in BASDAI score. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 40mg every 2 weeks. Higher doses may be considered case-by-case through the Exceptional Access Program.LU Authorization Period: 1 yearLuminal Crohn's disease For the treatment of moderate to severe (luminal) Crohn's disease in patients who meet the following criteria: A. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine, methotrexate); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Adalimumab is being used to induce remission or as a steroid-sparing maintenance therapy. The recommended induction dosing regimen is 160mg at week 0, followed by 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., HBI score decrease greater than or equal to 50% from pre-treatment measurement), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. Patients with mild Crohn's disease (e.g., HBI less than 7) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFistulising Crohn's disease For the treatment of fistulising Crohn's disease with concomitant luminal disease in patients who meet the following criteria: A. Patient has actively draining perianal or enterocutaneous fistula(e) that have recurred OR persist despite a course of appropriate antibiotic therapy (e.g., ciprofloxacin and/or metronidazole); AND B. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease) The recommended induction dosing regimen is 160mg at week 0, followed by 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and achieve and maintain response to therapy (e.g., partial or complete resolution of fistulae and symptom improvement). Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded.LU Authorization Period: 1 yearUlcerative Colitis For the treatment of moderate to severe ulcerative colitis in patients who meet the following criteria: A. Mayo score greater than or equal to 6 with an endoscopic subscore* of at least 2 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Adalimumab is being used to induce remission or as a steroid-sparing maintenance therapy. *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. The recommended induction dosing regimen is up to 160mg at week 0, followed by up to 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., Mayo score less than 6), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory disease will not be funded. Patients with mild ulcerative colitis (e.g., Mayo score less than 6) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of patients with active moderate to severe hidradenitis suppurativa (HS) who have not responded to conventional therapy (including systemic antibiotics) and who meet all of the following: A. A total abscess and nodule count of 3 or greater; AND B. Lesions in at least two distinct anatomic areas, one of which must be Hurley Stage II or III; AND C. Experienced an inadequate response to a 90-day trial of oral antibiotics. Therapy must be prescribed by a practitioner with expertise in the management of patients with HS. The recommended adult dosing regimen is 160mg at week 0, followed by 80mg at week 2, then 40mg at week 4, and 40mg weekly thereafter. The recommended adolescent dosing regimen is 80mg at week 0, followed by 40mg every other week starting at week 1 up to 40mg weekly in those with inadequate response. If there is no improvement after 12 weeks of treatment with adalimumab at the Health Canada approved dose, higher doses are not recommended and the prescriber should discontinue treatment. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Maintenance/Renewal: Maintenance therapy is funded for patients beyond the first 12 weeks in those who meet the Ministry initiation criteria and who have responded to treatment defined as at least a 50% reduction in abscesses and inflammatory nodule count with no increase in abscess count or draining fistula count relative to baseline. Maintenance therapy beyond the second year is funded for patients using adalimumab for HS, where there is objective evidence of the preservation of treatment effect (i.e. the current abscess and inflammatory nodule count should be compared to the count prior to initiating treatment with adalimumab). The recommended maintenance dose is 40mg weekly. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.LU Authorization Period: 1 yearFor the treatment of severe* plaque psoriasis in patients 18 years of age or older who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies**. Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. *Definition of severe plaque psoriasis: Body Surface Area (BSA) involvement of at least 10 percent, or involvement of the face, hands, feet or genital regions, AND Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND Dermatology Life Quality Index (DLQI) score of at least 10. **Definition of failure, intolerance or contraindication to adequate trials of standard therapies: 6 month trial of at least 3 topical agents including vitamin D analogues and steroids 12 week trial of phototherapy (unless not accessible) 6 month trial of at least 2 systemic, oral agents used alone or in combination - Methotrexate 15-30mg per week - Acitretin (could have been used with phototherapy) - Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: - at least a 50% reduction in PASI, AND - at least a 50% reduction in BSA involvement, AND - at least a 5 point reduction in DLQI score Approvals will only allow for standard dosing for adalimumab. The recommended dose is an initial 80mg administered subcutaneously at week 0, followed by 40mg subcutaneously given every other week starting at week 1, as approved by Health Canada. If the patient has not responded adequately after 12 weeks of treatment at the Health Canada approved dose, higher doses are not recommended, and the physician should consider switching to an alternative biologic agent.LU Authorization Period: 1 yearPolyarticular Juvenile Idiopathic Arthritis For the treatment of polyarticular juvenile idiopathic arthritis (pJIA) in patients who have active disease (greater than or equal to 3 swollen joints and greater than or equal to 5 active joints) despite a trial of optimal doses of subcutaneously administered methotrexate (i.e. 15mg/m2 per week) for at least 3 months. If the patient is unable to tolerate or has a contraindication to subcutaneous methotrexate, the nature of the intolerance or contraindication should be documented. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. The recommended dosing regimen is for pediatric patients 2 years of age and older: - 30kg and greater: 40mg every other week Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. LU Authorization Period: 1 yearFor the treatment of severe uveitis in patients meeting the following criteria: A. Has experienced failure or intolerance to an oral corticosteroid (or topical corticosteroid for anterior uveitis) or where the use of corticosteroids is contraindicated, and has experienced failure or intolerance to at least one immunosuppressive therapy; AND B. Treatment must be prescribed by an ophthalmologist specialized in uveitis or retinal disease, a uveitis specialist, or a retina specialist familiar with ocular inflammatory diseases. Requests not meeting the above criteria may be considered on a case-by-case basis through the Exceptional Access Program. The recommended adult dose is an initial 80mg administered subcutaneously at week 0, followed by 40mg subcutaneously given every other week starting at week 1, as approved by Health Canada. Note: Higher doses up to 40mg weekly may be considered in patients who have failed to respond to lower doses. The recommended dose for pediatric patients (2 years or older) with anterior uveitis is: 30kg or greater: 40mg every other week in combination with methotrexate For patients 6 years of age or older and weighing 30kg or greater, an optional loading dose of 80mg at week 0 may be administered before starting maintenance therapy. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Maintenance/Renewals: Maintenance therapy is funded for patients who meet the Ministry initiation criteria and who have experienced improvement and/or stability of vision and other treatment goals (e.g. reduction or control of ocular inflammation).LU Authorization Period: 1 year233740mg/0.4mLInj Sol-0.4mL Pref Syr (Preservative-Free)HadlimaSAM471.27002023-11-30471.2700For the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or, anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments: A. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide (20mg/day) for at least 3 months, in addition to iii) an adequate trial of at least one combination of DMARDs for 3 months; OR B. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide in combination with methotrexate for at least 3 months; OR C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.) Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For renewals beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. Approvals will only allow for standard dosing for adalimumab. The recommended dosing regimen is 40mg every two weeks.LU Authorization Period: 1 yearFor the treatment of polyarticular juvenile idiopathic arthritis (pJIA) in patients who have active disease (greater than or equal to 3 swollen joints and greater than or equal to 5 active joints) despite a trial of optimal doses of subcutaneously administered methotrexate (i.e. 15mg/m2 per week) for at least 3 months. If the patient is unable to tolerate or has a contraindication to subcutaneous methotrexate, the nature of the intolerance or contraindication should be documented. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. The recommended dosing regimen is for pediatric patients 2 years of age and older: - 10kg to less than 30kg: 20mg every other week* - 30kg and greater: 40mg every other week *a dose of 10mg every other week can be considered for patients weighing 10kg to less than 15kg It should be noted that some adalimumab products may not be available as 20mg injectables. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.LU Authorization Period: 1 yearFor the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite: i) treatment with methotrexate (20mg/week) for at least 3 months; AND ii) one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months. If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months is required. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must have objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 40mg every 2 weeks. Higher doses may be considered case-by-case through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of ankylosing spondylitis (AS) in patients who have severe active disease confirmed by radiographic evidence (see note below) with: - Age of disease onset equal to or younger than 50; AND - Low back pain and stiffness for greater than 3 months that improves with exercise and not relieved by rest; AND - Failure to respond to or documented intolerance to adequate trials of 2 non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks each; AND - Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of greater than or equal to 4 for at least 4 weeks while on standard therapy. Note: Radiographic evidence demonstrating the presence of "SI joint fusion" or "SI joint erosion" on x-ray or CT scan, or MRI demonstrating the presence of "inflammation" or "edema" of the SI joint. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 50 percent reduction in BASDAI score or greater than or equal to 2 absolute point reduction in BASDAI score. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 40mg every 2 weeks. Higher doses may be considered case-by-case through the Exceptional Access Program.LU Authorization Period: 1 yearLuminal Crohn's disease For the treatment of moderate to severe (luminal) Crohn's disease in patients who meet the following criteria: A. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine, methotrexate); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Adalimumab is being used to induce remission or as a steroid-sparing maintenance therapy. The recommended induction dosing regimen is 160mg at week 0, followed by 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., HBI score decrease greater than or equal to 50% from pre-treatment measurement), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. Patients with mild Crohn's disease (e.g., HBI less than 7) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFistulising Crohn's disease For the treatment of fistulising Crohn's disease with concomitant luminal disease in patients who meet the following criteria: A. Patient has actively draining perianal or enterocutaneous fistula(e) that have recurred OR persist despite a course of appropriate antibiotic therapy (e.g., ciprofloxacin and/or metronidazole); AND B. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease) The recommended induction dosing regimen is 160mg at week 0, followed by 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and achieve and maintain response to therapy (e.g., partial or complete resolution of fistulae and symptom improvement). Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded.LU Authorization Period: 1 yearUlcerative Colitis For the treatment of moderate to severe ulcerative colitis in patients who meet the following criteria: A. Mayo score greater than or equal to 6 with an endoscopic subscore* of at least 2 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Adalimumab is being used to induce remission or as a steroid-sparing maintenance therapy. *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. The recommended induction dosing regimen is up to 160mg at week 0, followed by up to 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., Mayo score less than 6), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory disease will not be funded. Patients with mild ulcerative colitis (e.g., Mayo score less than 6) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of patients with active moderate to severe hidradenitis suppurativa (HS) who have not responded to conventional therapy (including systemic antibiotics) and who meet all of the following: A. A total abscess and nodule count of 3 or greater; AND B. Lesions in at least two distinct anatomic areas, one of which must be Hurley Stage II or III; AND C. Experienced an inadequate response to a 90-day trial of oral antibiotics. Therapy must be prescribed by a practitioner with expertise in the management of patients with HS. The recommended adult dosing regimen is 160mg at week 0, followed by 80mg at week 2, then 40mg at week 4, and 40mg weekly thereafter. The recommended adolescent dosing regimen is 80mg at week 0, followed by 40mg every other week starting at week 1 up to 40mg weekly in those with inadequate response. If there is no improvement after 12 weeks of treatment with adalimumab at the Health Canada approved dose, higher doses are not recommended and the prescriber should discontinue treatment. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Maintenance/Renewal: Maintenance therapy is funded for patients beyond the first 12 weeks in those who meet the Ministry initiation criteria and who have responded to treatment defined as at least a 50% reduction in abscesses and inflammatory nodule count with no increase in abscess count or draining fistula count relative to baseline. Maintenance therapy beyond the second year is funded for patients using adalimumab for HS, where there is objective evidence of the preservation of treatment effect (i.e. the current abscess and inflammatory nodule count should be compared to the count prior to initiating treatment with adalimumab). The recommended maintenance dose is 40mg weekly. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.LU Authorization Period: 1 yearFor the treatment of severe* plaque psoriasis in patients 18 years of age or older who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies**. Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. *Definition of severe plaque psoriasis: Body Surface Area (BSA) involvement of at least 10 percent, or involvement of the face, hands, feet or genital regions, AND Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND Dermatology Life Quality Index (DLQI) score of at least 10. **Definition of failure, intolerance or contraindication to adequate trials of standard therapies: 6 month trial of at least 3 topical agents including vitamin D analogues and steroids 12 week trial of phototherapy (unless not accessible) 6 month trial of at least 2 systemic, oral agents used alone or in combination - Methotrexate 15-30mg per week - Acitretin (could have been used with phototherapy) - Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: - at least a 50% reduction in PASI, AND - at least a 50% reduction in BSA involvement, AND - at least a 5 point reduction in DLQI score Approvals will only allow for standard dosing for adalimumab. The recommended dose is an initial 80mg administered subcutaneously at week 0, followed by 40mg subcutaneously given every other week starting at week 1, as approved by Health Canada. If the patient has not responded adequately after 12 weeks of treatment at the Health Canada approved dose, higher doses are not recommended, and the physician should consider switching to an alternative biologic agent.LU Authorization Period: 1 yearFor the treatment of severe uveitis in patients meeting the following criteria: A. Has experienced failure or intolerance to an oral corticosteroid (or topical corticosteroid for anterior uveitis) or where the use of corticosteroids is contraindicated, and has experienced failure or intolerance to at least one immunosuppressive therapy; AND B. Treatment must be prescribed by an opthalmologist specialized in uveitis or retinal disease, a uveitis specialist, or a retina specialist familiar with ocular inflammatory diseases. Requests not meeting the above criteria may be considered on a case-by-case basis through the Exceptional Access Program. The recommended adult dose is an initial 80mg administered subcutaneously at week 0, followed by 40mg subsubcutaneously given every other week starting at week 1, as approved by Health Canada. Note: Higher doses up to 40mg weekly may be considered in patients who have failed to respond to lower doses. The recommended dose for pediatric patients (2 years of age and older) with anterior uveitis is: Less than 30kg: 20mg every other week in combination with methotrexate 30kg or greater: 40mg every other week in combination with methotrexate For patients 6 years of age or older and less than 30kg, an optional loading dose of 40mg at week 0 may be administered before starting maintenance therapy. For patients 6 years of age or older and weighing 30kg or greater, an optional loading dose of 80mg at week 0 may be administered before starting maintenance therapy. It should be noted that some adalimumab products may not be available as 20mg injectables. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Maintenance/Renewals: Maintenance therapy is funded for patients who meet the Ministry initiation criteria and who have experienced improvement and/or stability of vision and other treatment goals (e.g. reduction or control of ocular inflammation).LU Authorization Period: 1 year233840mg/0.4mLInj Sol-0.4mL Pref Syr (Preservative-Free)HyrimozSDZ471.27002024-04-30471.2700For the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or, anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments: A. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide (20mg/day) for at least 3 months, in addition to iii) an adequate trial of at least one combination of DMARDs for 3 months; OR B. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide in combination with methotrexate for at least 3 months; OR C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.) Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For renewals beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. Approvals will only allow for standard dosing for adalimumab. The recommended dosing regimen is 40mg every two weeks.LU Authorization Period: 1 yearFor the treatment of polyarticular juvenile idiopathic arthritis (pJIA) in patients who have active disease (greater than or equal to 3 swollen joints and greater than or equal to 5 active joints) despite a trial of optimal doses of subcutaneously administered methotrexate (i.e. 15mg/m2 per week) for at least 3 months. If the patient is unable to tolerate or has a contraindication to subcutaneous methotrexate, the nature of the intolerance or contraindication should be documented. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. The recommended dosing regimen is for pediatric patients 2 years of age and older: - 10kg to less than 30kg: 20mg every other week* - 30kg and greater: 40mg every other week *a dose of 10mg every other week can be considered for patients weighing 10kg to less than 15kg It should be noted that some adalimumab products may not be available as 20mg injectables. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.LU Authorization Period: 1 yearFor the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite: i) treatment with methotrexate (20mg/week) for at least 3 months; AND ii) one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months. If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months is required. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must have objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 40mg every 2 weeks. Higher doses may be considered case-by-case through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of ankylosing spondylitis (AS) in patients who have severe active disease confirmed by radiographic evidence (see note below) with: - Age of disease onset equal to or younger than 50; AND - Low back pain and stiffness for greater than 3 months that improves with exercise and not relieved by rest; AND - Failure to respond to or documented intolerance to adequate trials of 2 non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks each; AND - Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of greater than or equal to 4 for at least 4 weeks while on standard therapy. Note: Radiographic evidence demonstrating the presence of "SI joint fusion" or "SI joint erosion" on x-ray or CT scan, or MRI demonstrating the presence of "inflammation" or "edema" of the SI joint. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 50 percent reduction in BASDAI score or greater than or equal to 2 absolute point reduction in BASDAI score. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 40mg every 2 weeks. Higher doses may be considered case-by-case through the Exceptional Access Program.LU Authorization Period: 1 yearLuminal Crohn's disease For the treatment of moderate to severe (luminal) Crohn's disease in patients who meet the following criteria: A. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine, methotrexate); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Adalimumab is being used to induce remission or as a steroid-sparing maintenance therapy. The recommended induction dosing regimen is 160mg at week 0, followed by 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., HBI score decrease greater than or equal to 50% from pre-treatment measurement), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. Patients with mild Crohn's disease (e.g., HBI less than 7) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFistulising Crohn's disease For the treatment of fistulising Crohn's disease with concomitant luminal disease in patients who meet the following criteria: A. Patient has actively draining perianal or enterocutaneous fistula(e) that have recurred OR persist despite a course of appropriate antibiotic therapy (e.g., ciprofloxacin and/or metronidazole); AND B. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease) The recommended induction dosing regimen is 160mg at week 0, followed by 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and achieve and maintain response to therapy (e.g., partial or complete resolution of fistulae and symptom improvement). Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded.LU Authorization Period: 1 yearUlcerative Colitis For the treatment of moderate to severe ulcerative colitis in patients who meet the following criteria: A. Mayo score greater than or equal to 6 with an endoscopic subscore* of at least 2 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Adalimumab is being used to induce remission or as a steroid-sparing maintenance therapy. *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. The recommended induction dosing regimen is up to 160mg at week 0, followed by up to 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., Mayo score less than 6), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory disease will not be funded. Patients with mild ulcerative colitis (e.g., Mayo score less than 6) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of patients with active moderate to severe hidradenitis suppurativa (HS) who have not responded to conventional therapy (including systemic antibiotics) and who meet all of the following: A. A total abscess and nodule count of 3 or greater; AND B. Lesions in at least two distinct anatomic areas, one of which must be Hurley Stage II or III; AND C. Experienced an inadequate response to a 90-day trial of oral antibiotics. Therapy must be prescribed by a practitioner with expertise in the management of patients with HS. The recommended adult dosing regimen is 160mg at week 0, followed by 80mg at week 2, then 40mg at week 4, and 40mg weekly thereafter. The recommended adolescent dosing regimen is 80mg at week 0, followed by 40mg every other week starting at week 1 up to 40mg weekly in those with inadequate response. If there is no improvement after 12 weeks of treatment with adalimumab at the Health Canada approved dose, higher doses are not recommended and the prescriber should discontinue treatment. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Maintenance/Renewal: Maintenance therapy is funded for patients beyond the first 12 weeks in those who meet the Ministry initiation criteria and who have responded to treatment defined as at least a 50% reduction in abscesses and inflammatory nodule count with no increase in abscess count or draining fistula count relative to baseline. Maintenance therapy beyond the second year is funded for patients using adalimumab for HS, where there is objective evidence of the preservation of treatment effect (i.e. the current abscess and inflammatory nodule count should be compared to the count prior to initiating treatment with adalimumab). The recommended maintenance dose is 40mg weekly. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.LU Authorization Period: 1 yearFor the treatment of severe* plaque psoriasis in patients 18 years of age or older who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies**. Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. *Definition of severe plaque psoriasis: Body Surface Area (BSA) involvement of at least 10 percent, or involvement of the face, hands, feet or genital regions, AND Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND Dermatology Life Quality Index (DLQI) score of at least 10. **Definition of failure, intolerance or contraindication to adequate trials of standard therapies: 6 month trial of at least 3 topical agents including vitamin D analogues and steroids 12 week trial of phototherapy (unless not accessible) 6 month trial of at least 2 systemic, oral agents used alone or in combination - Methotrexate 15-30mg per week - Acitretin (could have been used with phototherapy) - Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: - at least a 50% reduction in PASI, AND - at least a 50% reduction in BSA involvement, AND - at least a 5 point reduction in DLQI score Approvals will only allow for standard dosing for adalimumab. The recommended dose is an initial 80mg administered subcutaneously at week 0, followed by 40mg subcutaneously given every other week starting at week 1, as approved by Health Canada. If the patient has not responded adequately after 12 weeks of treatment at the Health Canada approved dose, higher doses are not recommended, and the physician should consider switching to an alternative biologic agent.LU Authorization Period: 1 yearFor the treatment of severe uveitis in patients meeting the following criteria: A. Has experienced failure or intolerance to an oral corticosteroid (or topical corticosteroid for anterior uveitis) or where the use of corticosteroids is contraindicated, and has experienced failure or intolerance to at least one immunosuppressive therapy; AND B. Treatment must be prescribed by an opthalmologist specialized in uveitis or retinal disease, a uveitis specialist, or a retina specialist familiar with ocular inflammatory diseases. Requests not meeting the above criteria may be considered on a case-by-case basis through the Exceptional Access Program. The recommended adult dose is an initial 80mg administered subcutaneously at week 0, followed by 40mg subsubcutaneously given every other week starting at week 1, as approved by Health Canada. Note: Higher doses up to 40mg weekly may be considered in patients who have failed to respond to lower doses. The recommended dose for pediatric patients (2 years of age and older) with anterior uveitis is: Less than 30kg: 20mg every other week in combination with methotrexate 30kg or greater: 40mg every other week in combination with methotrexate For patients 6 years of age or older and less than 30kg, an optional loading dose of 40mg at week 0 may be administered before starting maintenance therapy. For patients 6 years of age or older and weighing 30kg or greater, an optional loading dose of 80mg at week 0 may be administered before starting maintenance therapy. It should be noted that some adalimumab products may not be available as 20mg injectables. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Maintenance/Renewals: Maintenance therapy is funded for patients who meet the Ministry initiation criteria and who have experienced improvement and/or stability of vision and other treatment goals (e.g. reduction or control of ocular inflammation).LU Authorization Period: 1 year233940mg/0.8mLInj Sol-0.8mL Pref Autoinj (Preservative-Free)AmgevitaAMG471.27002021-03-29471.2700234040mg/0.8mLInj Sol-0.8mL Pref Autoinj (Preservative-Free)Hadlima PushTouchSAM471.27002021-03-29471.2700For the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or, anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments: A. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide (20mg/day) for at least 3 months, in addition to iii) an adequate trial of at least one combination of DMARDs for 3 months; OR B. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide in combination with methotrexate for at least 3 months; OR C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.) Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For renewals beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. Approvals will only allow for standard dosing for adalimumab. The recommended dosing regimen is 40mg every two weeks.LU Authorization Period: 1 yearFor the treatment of polyarticular juvenile idiopathic arthritis (pJIA) in patients who have active disease (greater than or equal to 3 swollen joints and greater than or equal to 5 active joints) despite a trial of optimal doses of subcutaneously administered methotrexate (i.e. 15mg/m2 per week) for at least 3 months. If the patient is unable to tolerate or has a contraindication to subcutaneous methotrexate, the nature of the intolerance or contraindication should be documented. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. The recommended dosing regimen is for pediatric patients 2 years of age and older: - 10kg to less than 30kg: 20mg every other week* - 30kg and greater: 40mg every other week *a dose of 10mg every other week can be considered for patients weighing 10kg to less than 15kg It should be noted that some adalimumab products may not be available as 20mg injectables. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.LU Authorization Period: 1 yearFor the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite: i) treatment with methotrexate (20mg/week) for at least 3 months; AND ii) one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months. If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months is required. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must have objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 40mg every 2 weeks. Higher doses may be considered case-by-case through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of ankylosing spondylitis (AS) in patients who have severe active disease confirmed by radiographic evidence (see note below) with: - Age of disease onset equal to or younger than 50; AND - Low back pain and stiffness for greater than 3 months that improves with exercise and not relieved by rest; AND - Failure to respond to or documented intolerance to adequate trials of 2 non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks each; AND - Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of greater than or equal to 4 for at least 4 weeks while on standard therapy. Note: Radiographic evidence demonstrating the presence of "SI joint fusion" or "SI joint erosion" on x-ray or CT scan, or MRI demonstrating the presence of "inflammation" or "edema" of the SI joint. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 50 percent reduction in BASDAI score or greater than or equal to 2 absolute point reduction in BASDAI score. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 40mg every 2 weeks. Higher doses may be considered case-by-case through the Exceptional Access Program.LU Authorization Period: 1 yearLuminal Crohn's disease For the treatment of moderate to severe (luminal) Crohn's disease in patients who meet the following criteria: A. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine, methotrexate); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Adalimumab is being used to induce remission or as a steroid-sparing maintenance therapy. The recommended induction dosing regimen is 160mg at week 0, followed by 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., HBI score decrease greater than or equal to 50% from pre-treatment measurement), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. Patients with mild Crohn's disease (e.g., HBI less than 7) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFistulising Crohn's disease For the treatment of fistulising Crohn's disease with concomitant luminal disease in patients who meet the following criteria: A. Patient has actively draining perianal or enterocutaneous fistula(e) that have recurred OR persist despite a course of appropriate antibiotic therapy (e.g., ciprofloxacin and/or metronidazole); AND B. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease) The recommended induction dosing regimen is 160mg at week 0, followed by 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and achieve and maintain response to therapy (e.g., partial or complete resolution of fistulae and symptom improvement). Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded.LU Authorization Period: 1 yearUlcerative Colitis For the treatment of moderate to severe ulcerative colitis in patients who meet the following criteria: A. Mayo score greater than or equal to 6 with an endoscopic subscore* of at least 2 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Adalimumab is being used to induce remission or as a steroid-sparing maintenance therapy. *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. The recommended induction dosing regimen is up to 160mg at week 0, followed by up to 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., Mayo score less than 6), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory disease will not be funded. Patients with mild ulcerative colitis (e.g., Mayo score less than 6) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of patients with active moderate to severe hidradenitis suppurativa (HS) who have not responded to conventional therapy (including systemic antibiotics) and who meet all of the following: A. A total abscess and nodule count of 3 or greater; AND B. Lesions in at least two distinct anatomic areas, one of which must be Hurley Stage II or III; AND C. Experienced an inadequate response to a 90-day trial of oral antibiotics. Therapy must be prescribed by a practitioner with expertise in the management of patients with HS. The recommended adult dosing regimen is 160mg at week 0, followed by 80mg at week 2, then 40mg at week 4, and 40mg weekly thereafter. The recommended adolescent dosing regimen is 80mg at week 0, followed by 40mg every other week starting at week 1 up to 40mg weekly in those with inadequate response. If there is no improvement after 12 weeks of treatment with adalimumab at the Health Canada approved dose, higher doses are not recommended and the prescriber should discontinue treatment. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Maintenance/Renewal: Maintenance therapy is funded for patients beyond the first 12 weeks in those who meet the Ministry initiation criteria and who have responded to treatment defined as at least a 50% reduction in abscesses and inflammatory nodule count with no increase in abscess count or draining fistula count relative to baseline. Maintenance therapy beyond the second year is funded for patients using adalimumab for HS, where there is objective evidence of the preservation of treatment effect (i.e. the current abscess and inflammatory nodule count should be compared to the count prior to initiating treatment with adalimumab). The recommended maintenance dose is 40mg weekly. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.LU Authorization Period: 1 yearFor the treatment of severe* plaque psoriasis in patients 18 years of age or older who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies**. Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. *Definition of severe plaque psoriasis: Body Surface Area (BSA) involvement of at least 10 percent, or involvement of the face, hands, feet or genital regions, AND Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND Dermatology Life Quality Index (DLQI) score of at least 10. **Definition of failure, intolerance or contraindication to adequate trials of standard therapies: 6 month trial of at least 3 topical agents including vitamin D analogues and steroids 12 week trial of phototherapy (unless not accessible) 6 month trial of at least 2 systemic, oral agents used alone or in combination - Methotrexate 15-30mg per week - Acitretin (could have been used with phototherapy) - Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: - at least a 50% reduction in PASI, AND - at least a 50% reduction in BSA involvement, AND - at least a 5 point reduction in DLQI score Approvals will only allow for standard dosing for adalimumab. The recommended dose is an initial 80mg administered subcutaneously at week 0, followed by 40mg subcutaneously given every other week starting at week 1, as approved by Health Canada. If the patient has not responded adequately after 12 weeks of treatment at the Health Canada approved dose, higher doses are not recommended, and the physician should consider switching to an alternative biologic agent.LU Authorization Period: 1 yearFor the treatment of severe uveitis in patients meeting the following criteria: A. Has experienced failure or intolerance to an oral corticosteroid (or topical corticosteroid for anterior uveitis) or where the use of corticosteroids is contraindicated, and has experienced failure or intolerance to at least one immunosuppressive therapy; AND B. Treatment must be prescribed by an opthalmologist specialized in uveitis or retinal disease, a uveitis specialist, or a retina specialist familiar with ocular inflammatory diseases. Requests not meeting the above criteria may be considered on a case-by-case basis through the Exceptional Access Program. The recommended adult dose is an initial 80mg administered subcutaneously at week 0, followed by 40mg subsubcutaneously given every other week starting at week 1, as approved by Health Canada. Note: Higher doses up to 40mg weekly may be considered in patients who have failed to respond to lower doses. The recommended dose for pediatric patients (2 years of age and older) with anterior uveitis is: Less than 30kg: 20mg every other week in combination with methotrexate 30kg or greater: 40mg every other week in combination with methotrexate For patients 6 years of age or older and less than 30kg, an optional loading dose of 40mg at week 0 may be administered before starting maintenance therapy. For patients 6 years of age or older and weighing 30kg or greater, an optional loading dose of 80mg at week 0 may be administered before starting maintenance therapy. It should be noted that some adalimumab products may not be available as 20mg injectables. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Maintenance/Renewals: Maintenance therapy is funded for patients who meet the Ministry initiation criteria and who have experienced improvement and/or stability of vision and other treatment goals (e.g. reduction or control of ocular inflammation).LU Authorization Period: 1 year234140mg/0.8mLInj Sol-0.8mL Pref Autoinj (Preservative-Free)HyrimozSDZ471.27002021-03-29471.2700For the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or, anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments: A. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide (20mg/day) for at least 3 months, in addition to iii) an adequate trial of at least one combination of DMARDs for 3 months; OR B. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide in combination with methotrexate for at least 3 months; OR C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.) Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For renewals beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. Approvals will only allow for standard dosing for adalimumab. The recommended dosing regimen is 40mg every two weeks.LU Authorization Period: 1 yearFor the treatment of polyarticular juvenile idiopathic arthritis (pJIA) in patients who have active disease (greater than or equal to 3 swollen joints and greater than or equal to 5 active joints) despite a trial of optimal doses of subcutaneously administered methotrexate (i.e. 15mg/m2 per week) for at least 3 months. If the patient is unable to tolerate or has a contraindication to subcutaneous methotrexate, the nature of the intolerance or contraindication should be documented. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. The recommended dosing regimen is for pediatric patients 2 years of age and older: - 10kg to less than 30kg: 20mg every other week* - 30kg and greater: 40mg every other week *a dose of 10mg every other week can be considered for patients weighing 10kg to less than 15kg It should be noted that some adalimumab products may not be available as 20mg injectables. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.LU Authorization Period: 1 yearFor the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite: i) treatment with methotrexate (20mg/week) for at least 3 months; AND ii) one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months. If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months is required. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must have objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 40mg every 2 weeks. Higher doses may be considered case-by-case through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of ankylosing spondylitis (AS) in patients who have severe active disease confirmed by radiographic evidence (see note below) with: - Age of disease onset equal to or younger than 50; AND - Low back pain and stiffness for greater than 3 months that improves with exercise and not relieved by rest; AND - Failure to respond to or documented intolerance to adequate trials of 2 non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks each; AND - Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of greater than or equal to 4 for at least 4 weeks while on standard therapy. Note: Radiographic evidence demonstrating the presence of "SI joint fusion" or "SI joint erosion" on x-ray or CT scan, or MRI demonstrating the presence of "inflammation" or "edema" of the SI joint. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 50 percent reduction in BASDAI score or greater than or equal to 2 absolute point reduction in BASDAI score. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 40mg every 2 weeks. Higher doses may be considered case-by-case through the Exceptional Access Program.LU Authorization Period: 1 yearLuminal Crohn's disease For the treatment of moderate to severe (luminal) Crohn's disease in patients who meet the following criteria: A. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine, methotrexate); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Adalimumab is being used to induce remission or as a steroid-sparing maintenance therapy. The recommended induction dosing regimen is 160mg at week 0, followed by 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., HBI score decrease greater than or equal to 50% from pre-treatment measurement), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. Patients with mild Crohn's disease (e.g., HBI less than 7) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFistulising Crohn's disease For the treatment of fistulising Crohn's disease with concomitant luminal disease in patients who meet the following criteria: A. Patient has actively draining perianal or enterocutaneous fistula(e) that have recurred OR persist despite a course of appropriate antibiotic therapy (e.g., ciprofloxacin and/or metronidazole); AND B. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease) The recommended induction dosing regimen is 160mg at week 0, followed by 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and achieve and maintain response to therapy (e.g., partial or complete resolution of fistulae and symptom improvement). Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded.LU Authorization Period: 1 yearUlcerative Colitis For the treatment of moderate to severe ulcerative colitis in patients who meet the following criteria: A. Mayo score greater than or equal to 6 with an endoscopic subscore* of at least 2 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Adalimumab is being used to induce remission or as a steroid-sparing maintenance therapy. *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. The recommended induction dosing regimen is up to 160mg at week 0, followed by up to 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., Mayo score less than 6), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory disease will not be funded. Patients with mild ulcerative colitis (e.g., Mayo score less than 6) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of patients with active moderate to severe hidradenitis suppurativa (HS) who have not responded to conventional therapy (including systemic antibiotics) and who meet all of the following: A. A total abscess and nodule count of 3 or greater; AND B. Lesions in at least two distinct anatomic areas, one of which must be Hurley Stage II or III; AND C. Experienced an inadequate response to a 90-day trial of oral antibiotics. Therapy must be prescribed by a practitioner with expertise in the management of patients with HS. The recommended adult dosing regimen is 160mg at week 0, followed by 80mg at week 2, then 40mg at week 4, and 40mg weekly thereafter. The recommended adolescent dosing regimen is 80mg at week 0, followed by 40mg every other week starting at week 1 up to 40mg weekly in those with inadequate response. If there is no improvement after 12 weeks of treatment with adalimumab at the Health Canada approved dose, higher doses are not recommended and the prescriber should discontinue treatment. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Maintenance/Renewal: Maintenance therapy is funded for patients beyond the first 12 weeks in those who meet the Ministry initiation criteria and who have responded to treatment defined as at least a 50% reduction in abscesses and inflammatory nodule count with no increase in abscess count or draining fistula count relative to baseline. Maintenance therapy beyond the second year is funded for patients using adalimumab for HS, where there is objective evidence of the preservation of treatment effect (i.e. the current abscess and inflammatory nodule count should be compared to the count prior to initiating treatment with adalimumab). The recommended maintenance dose is 40mg weekly. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.LU Authorization Period: 1 yearFor the treatment of severe* plaque psoriasis in patients 18 years of age or older who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies**. Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. *Definition of severe plaque psoriasis: Body Surface Area (BSA) involvement of at least 10 percent, or involvement of the face, hands, feet or genital regions, AND Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND Dermatology Life Quality Index (DLQI) score of at least 10. **Definition of failure, intolerance or contraindication to adequate trials of standard therapies: 6 month trial of at least 3 topical agents including vitamin D analogues and steroids 12 week trial of phototherapy (unless not accessible) 6 month trial of at least 2 systemic, oral agents used alone or in combination - Methotrexate 15-30mg per week - Acitretin (could have been used with phototherapy) - Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: - at least a 50% reduction in PASI, AND - at least a 50% reduction in BSA involvement, AND - at least a 5 point reduction in DLQI score Approvals will only allow for standard dosing for adalimumab. The recommended dose is an initial 80mg administered subcutaneously at week 0, followed by 40mg subcutaneously given every other week starting at week 1, as approved by Health Canada. If the patient has not responded adequately after 12 weeks of treatment at the Health Canada approved dose, higher doses are not recommended, and the physician should consider switching to an alternative biologic agent.LU Authorization Period: 1 yearFor the treatment of severe uveitis in patients meeting the following criteria: A. Has experienced failure or intolerance to an oral corticosteroid (or topical corticosteroid for anterior uveitis) or where the use of corticosteroids is contraindicated, and has experienced failure or intolerance to at least one immunosuppressive therapy; AND B. Treatment must be prescribed by an opthalmologist specialized in uveitis or retinal disease, a uveitis specialist, or a retina specialist familiar with ocular inflammatory diseases. Requests not meeting the above criteria may be considered on a case-by-case basis through the Exceptional Access Program. The recommended adult dose is an initial 80mg administered subcutaneously at week 0, followed by 40mg subsubcutaneously given every other week starting at week 1, as approved by Health Canada. Note: Higher doses up to 40mg weekly may be considered in patients who have failed to respond to lower doses. The recommended dose for pediatric patients (2 years of age and older) with anterior uveitis is: Less than 30kg: 20mg every other week in combination with methotrexate 30kg or greater: 40mg every other week in combination with methotrexate For patients 6 years of age or older and less than 30kg, an optional loading dose of 40mg at week 0 may be administered before starting maintenance therapy. For patients 6 years of age or older and weighing 30kg or greater, an optional loading dose of 80mg at week 0 may be administered before starting maintenance therapy. It should be noted that some adalimumab products may not be available as 20mg injectables. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Maintenance/Renewals: Maintenance therapy is funded for patients who meet the Ministry initiation criteria and who have experienced improvement and/or stability of vision and other treatment goals (e.g. reduction or control of ocular inflammation).LU Authorization Period: 1 year234240mg/0.8mLInj Sol-0.8mL Pref Pen (Preservative-Free)HulioBGP471.27002021-03-29471.2700234340mg/0.8mLInj Sol-0.8mL Pref Pen (Preservative-Free)IdacioFKC471.27002021-03-29471.2700For the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or, anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments: A. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide (20mg/day) for at least 3 months, in addition to iii) an adequate trial of at least one combination of DMARDs for 3 months; OR B. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide in combination with methotrexate for at least 3 months; OR C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.) Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For renewals beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. Approvals will only allow for standard dosing for adalimumab. The recommended dosing regimen is 40mg every two weeks.LU Authorization Period: 1 yearFor the treatment of polyarticular juvenile idiopathic arthritis (pJIA) in patients who have active disease (greater than or equal to 3 swollen joints and greater than or equal to 5 active joints) despite a trial of optimal doses of subcutaneously administered methotrexate (i.e. 15mg/m2 per week) for at least 3 months. If the patient is unable to tolerate or has a contraindication to subcutaneous methotrexate, the nature of the intolerance or contraindication should be documented. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. The recommended dosing regimen is for pediatric patients 2 years of age and older: - 10kg to less than 30kg: 20mg every other week* - 30kg and greater: 40mg every other week *a dose of 10mg every other week can be considered for patients weighing 10kg to less than 15kg It should be noted that some adalimumab products may not be available as 20mg injectables. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.LU Authorization Period: 1 yearFor the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite: i) treatment with methotrexate (20mg/week) for at least 3 months; AND ii) one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months. If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months is required. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must have objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 40mg every 2 weeks. Higher doses may be considered case-by-case through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of ankylosing spondylitis (AS) in patients who have severe active disease confirmed by radiographic evidence (see note below) with: - Age of disease onset equal to or younger than 50; AND - Low back pain and stiffness for greater than 3 months that improves with exercise and not relieved by rest; AND - Failure to respond to or documented intolerance to adequate trials of 2 non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks each; AND - Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of greater than or equal to 4 for at least 4 weeks while on standard therapy. Note: Radiographic evidence demonstrating the presence of "SI joint fusion" or "SI joint erosion" on x-ray or CT scan, or MRI demonstrating the presence of "inflammation" or "edema" of the SI joint. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 50 percent reduction in BASDAI score or greater than or equal to 2 absolute point reduction in BASDAI score. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 40mg every 2 weeks. Higher doses may be considered case-by-case through the Exceptional Access Program.LU Authorization Period: 1 yearLuminal Crohn's disease For the treatment of moderate to severe (luminal) Crohn's disease in patients who meet the following criteria: A. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine, methotrexate); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Adalimumab is being used to induce remission or as a steroid-sparing maintenance therapy. The recommended induction dosing regimen is 160mg at week 0, followed by 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., HBI score decrease greater than or equal to 50% from pre-treatment measurement), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. Patients with mild Crohn's disease (e.g., HBI less than 7) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFistulising Crohn's disease For the treatment of fistulising Crohn's disease with concomitant luminal disease in patients who meet the following criteria: A. Patient has actively draining perianal or enterocutaneous fistula(e) that have recurred OR persist despite a course of appropriate antibiotic therapy (e.g., ciprofloxacin and/or metronidazole); AND B. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease) The recommended induction dosing regimen is 160mg at week 0, followed by 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and achieve and maintain response to therapy (e.g., partial or complete resolution of fistulae and symptom improvement). Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded.LU Authorization Period: 1 yearUlcerative Colitis For the treatment of moderate to severe ulcerative colitis in patients who meet the following criteria: A. Mayo score greater than or equal to 6 with an endoscopic subscore* of at least 2 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Adalimumab is being used to induce remission or as a steroid-sparing maintenance therapy. *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. The recommended induction dosing regimen is up to 160mg at week 0, followed by up to 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., Mayo score less than 6), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory disease will not be funded. Patients with mild ulcerative colitis (e.g., Mayo score less than 6) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of patients with active moderate to severe hidradenitis suppurativa (HS) who have not responded to conventional therapy (including systemic antibiotics) and who meet all of the following: A. A total abscess and nodule count of 3 or greater; AND B. Lesions in at least two distinct anatomic areas, one of which must be Hurley Stage II or III; AND C. Experienced an inadequate response to a 90-day trial of oral antibiotics. Therapy must be prescribed by a practitioner with expertise in the management of patients with HS. The recommended adult dosing regimen is 160mg at week 0, followed by 80mg at week 2, then 40mg at week 4, and 40mg weekly thereafter. The recommended adolescent dosing regimen is 80mg at week 0, followed by 40mg every other week starting at week 1 up to 40mg weekly in those with inadequate response. If there is no improvement after 12 weeks of treatment with adalimumab at the Health Canada approved dose, higher doses are not recommended and the prescriber should discontinue treatment. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Maintenance/Renewal: Maintenance therapy is funded for patients beyond the first 12 weeks in those who meet the Ministry initiation criteria and who have responded to treatment defined as at least a 50% reduction in abscesses and inflammatory nodule count with no increase in abscess count or draining fistula count relative to baseline. Maintenance therapy beyond the second year is funded for patients using adalimumab for HS, where there is objective evidence of the preservation of treatment effect (i.e. the current abscess and inflammatory nodule count should be compared to the count prior to initiating treatment with adalimumab). The recommended maintenance dose is 40mg weekly. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.LU Authorization Period: 1 yearFor the treatment of severe* plaque psoriasis in patients 18 years of age or older who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies**. Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. *Definition of severe plaque psoriasis: Body Surface Area (BSA) involvement of at least 10 percent, or involvement of the face, hands, feet or genital regions, AND Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND Dermatology Life Quality Index (DLQI) score of at least 10. **Definition of failure, intolerance or contraindication to adequate trials of standard therapies: 6 month trial of at least 3 topical agents including vitamin D analogues and steroids 12 week trial of phototherapy (unless not accessible) 6 month trial of at least 2 systemic, oral agents used alone or in combination - Methotrexate 15-30mg per week - Acitretin (could have been used with phototherapy) - Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: - at least a 50% reduction in PASI, AND - at least a 50% reduction in BSA involvement, AND - at least a 5 point reduction in DLQI score Approvals will only allow for standard dosing for adalimumab. The recommended dose is an initial 80mg administered subcutaneously at week 0, followed by 40mg subcutaneously given every other week starting at week 1, as approved by Health Canada. If the patient has not responded adequately after 12 weeks of treatment at the Health Canada approved dose, higher doses are not recommended, and the physician should consider switching to an alternative biologic agent.LU Authorization Period: 1 yearFor the treatment of severe uveitis in patients meeting the following criteria: A. Has experienced failure or intolerance to an oral corticosteroid (or topical corticosteroid for anterior uveitis) or where the use of corticosteroids is contraindicated, and has experienced failure or intolerance to at least one immunosuppressive therapy; AND B. Treatment must be prescribed by an opthalmologist specialized in uveitis or retinal disease, a uveitis specialist, or a retina specialist familiar with ocular inflammatory diseases. Requests not meeting the above criteria may be considered on a case-by-case basis through the Exceptional Access Program. The recommended adult dose is an initial 80mg administered subcutaneously at week 0, followed by 40mg subsubcutaneously given every other week starting at week 1, as approved by Health Canada. Note: Higher doses up to 40mg weekly may be considered in patients who have failed to respond to lower doses. The recommended dose for pediatric patients (2 years of age and older) with anterior uveitis is: Less than 30kg: 20mg every other week in combination with methotrexate 30kg or greater: 40mg every other week in combination with methotrexate For patients 6 years of age or older and less than 30kg, an optional loading dose of 40mg at week 0 may be administered before starting maintenance therapy. For patients 6 years of age or older and weighing 30kg or greater, an optional loading dose of 80mg at week 0 may be administered before starting maintenance therapy. It should be noted that some adalimumab products may not be available as 20mg injectables. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Maintenance/Renewals: Maintenance therapy is funded for patients who meet the Ministry initiation criteria and who have experienced improvement and/or stability of vision and other treatment goals (e.g. reduction or control of ocular inflammation).LU Authorization Period: 1 year234440mg/0.8mLInj Sol-0.8mL Pref Pen (Preservative-Free)AbriladaPFI471.27002022-05-31471.2700For the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or, anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments: A. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide (20mg/day) for at least 3 months, in addition to iii) an adequate trial of at least one combination of DMARDs for 3 months; OR B. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide in combination with methotrexate for at least 3 months; OR C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.) Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For renewals beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. Approvals will only allow for standard dosing for adalimumab. The recommended dosing regimen is 40mg every two weeks.LU Authorization Period: 1 yearFor the treatment of polyarticular juvenile idiopathic arthritis (pJIA) in patients who have active disease (greater than or equal to 3 swollen joints and greater than or equal to 5 active joints) despite a trial of optimal doses of subcutaneously administered methotrexate (i.e. 15mg/m2 per week) for at least 3 months. If the patient is unable to tolerate or has a contraindication to subcutaneous methotrexate, the nature of the intolerance or contraindication should be documented. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. The recommended dosing regimen is for pediatric patients 2 years of age and older: - 10kg to less than 30kg: 20mg every other week* - 30kg and greater: 40mg every other week *a dose of 10mg every other week can be considered for patients weighing 10kg to less than 15kg It should be noted that some adalimumab products may not be available as 20mg injectables. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.LU Authorization Period: 1 yearFor the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite: i) treatment with methotrexate (20mg/week) for at least 3 months; AND ii) one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months. If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months is required. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must have objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 40mg every 2 weeks. Higher doses may be considered case-by-case through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of ankylosing spondylitis (AS) in patients who have severe active disease confirmed by radiographic evidence (see note below) with: - Age of disease onset equal to or younger than 50; AND - Low back pain and stiffness for greater than 3 months that improves with exercise and not relieved by rest; AND - Failure to respond to or documented intolerance to adequate trials of 2 non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks each; AND - Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of greater than or equal to 4 for at least 4 weeks while on standard therapy. Note: Radiographic evidence demonstrating the presence of "SI joint fusion" or "SI joint erosion" on x-ray or CT scan, or MRI demonstrating the presence of "inflammation" or "edema" of the SI joint. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 50 percent reduction in BASDAI score or greater than or equal to 2 absolute point reduction in BASDAI score. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 40mg every 2 weeks. Higher doses may be considered case-by-case through the Exceptional Access Program.LU Authorization Period: 1 yearLuminal Crohn's disease For the treatment of moderate to severe (luminal) Crohn's disease in patients who meet the following criteria: A. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine, methotrexate); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Adalimumab is being used to induce remission or as a steroid-sparing maintenance therapy. The recommended induction dosing regimen is 160mg at week 0, followed by 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., HBI score decrease greater than or equal to 50% from pre-treatment measurement), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. Patients with mild Crohn's disease (e.g., HBI less than 7) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFistulising Crohn's disease For the treatment of fistulising Crohn's disease with concomitant luminal disease in patients who meet the following criteria: A. Patient has actively draining perianal or enterocutaneous fistula(e) that have recurred OR persist despite a course of appropriate antibiotic therapy (e.g., ciprofloxacin and/or metronidazole); AND B. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease) The recommended induction dosing regimen is 160mg at week 0, followed by 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and achieve and maintain response to therapy (e.g., partial or complete resolution of fistulae and symptom improvement). Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded.LU Authorization Period: 1 yearUlcerative Colitis For the treatment of moderate to severe ulcerative colitis in patients who meet the following criteria: A. Mayo score greater than or equal to 6 with an endoscopic subscore* of at least 2 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Adalimumab is being used to induce remission or as a steroid-sparing maintenance therapy. *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. The recommended induction dosing regimen is up to 160mg at week 0, followed by up to 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., Mayo score less than 6), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory disease will not be funded. Patients with mild ulcerative colitis (e.g., Mayo score less than 6) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of patients with active moderate to severe hidradenitis suppurativa (HS) who have not responded to conventional therapy (including systemic antibiotics) and who meet all of the following: A. A total abscess and nodule count of 3 or greater; AND B. Lesions in at least two distinct anatomic areas, one of which must be Hurley Stage II or III; AND C. Experienced an inadequate response to a 90-day trial of oral antibiotics. Therapy must be prescribed by a practitioner with expertise in the management of patients with HS. The recommended adult dosing regimen is 160mg at week 0, followed by 80mg at week 2, then 40mg at week 4, and 40mg weekly thereafter. The recommended adolescent dosing regimen is 80mg at week 0, followed by 40mg every other week starting at week 1 up to 40mg weekly in those with inadequate response. If there is no improvement after 12 weeks of treatment with adalimumab at the Health Canada approved dose, higher doses are not recommended and the prescriber should discontinue treatment. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Maintenance/Renewal: Maintenance therapy is funded for patients beyond the first 12 weeks in those who meet the Ministry initiation criteria and who have responded to treatment defined as at least a 50% reduction in abscesses and inflammatory nodule count with no increase in abscess count or draining fistula count relative to baseline. Maintenance therapy beyond the second year is funded for patients using adalimumab for HS, where there is objective evidence of the preservation of treatment effect (i.e. the current abscess and inflammatory nodule count should be compared to the count prior to initiating treatment with adalimumab). The recommended maintenance dose is 40mg weekly. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.LU Authorization Period: 1 yearFor the treatment of severe* plaque psoriasis in patients 18 years of age or older who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies**. Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. *Definition of severe plaque psoriasis: Body Surface Area (BSA) involvement of at least 10 percent, or involvement of the face, hands, feet or genital regions, AND Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND Dermatology Life Quality Index (DLQI) score of at least 10. **Definition of failure, intolerance or contraindication to adequate trials of standard therapies: 6 month trial of at least 3 topical agents including vitamin D analogues and steroids 12 week trial of phototherapy (unless not accessible) 6 month trial of at least 2 systemic, oral agents used alone or in combination - Methotrexate 15-30mg per week - Acitretin (could have been used with phototherapy) - Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: - at least a 50% reduction in PASI, AND - at least a 50% reduction in BSA involvement, AND - at least a 5 point reduction in DLQI score Approvals will only allow for standard dosing for adalimumab. The recommended dose is an initial 80mg administered subcutaneously at week 0, followed by 40mg subcutaneously given every other week starting at week 1, as approved by Health Canada. If the patient has not responded adequately after 12 weeks of treatment at the Health Canada approved dose, higher doses are not recommended, and the physician should consider switching to an alternative biologic agent.LU Authorization Period: 1 yearFor the treatment of severe uveitis in patients meeting the following criteria: A. Has experienced failure or intolerance to an oral corticosteroid (or topical corticosteroid for anterior uveitis) or where the use of corticosteroids is contraindicated, and has experienced failure or intolerance to at least one immunosuppressive therapy; AND B. Treatment must be prescribed by an opthalmologist specialized in uveitis or retinal disease, a uveitis specialist, or a retina specialist familiar with ocular inflammatory diseases. Requests not meeting the above criteria may be considered on a case-by-case basis through the Exceptional Access Program. The recommended adult dose is an initial 80mg administered subcutaneously at week 0, followed by 40mg subsubcutaneously given every other week starting at week 1, as approved by Health Canada. Note: Higher doses up to 40mg weekly may be considered in patients who have failed to respond to lower doses. The recommended dose for pediatric patients (2 years of age and older) with anterior uveitis is: Less than 30kg: 20mg every other week in combination with methotrexate 30kg or greater: 40mg every other week in combination with methotrexate For patients 6 years of age or older and less than 30kg, an optional loading dose of 40mg at week 0 may be administered before starting maintenance therapy. For patients 6 years of age or older and weighing 30kg or greater, an optional loading dose of 80mg at week 0 may be administered before starting maintenance therapy. It should be noted that some adalimumab products may not be available as 20mg injectables. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Maintenance/Renewals: Maintenance therapy is funded for patients who meet the Ministry initiation criteria and who have experienced improvement and/or stability of vision and other treatment goals (e.g. reduction or control of ocular inflammation).LU Authorization Period: 1 year234580mg/0.8mLInj Sol-0.8mL Pref Pen (Preservative-Free)YuflymaCEH942.54002023-11-30942.5400For the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or, anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments: A. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide (20mg/day) for at least 3 months, in addition to iii) an adequate trial of at least one combination of DMARDs for 3 months; OR B. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide in combination with methotrexate for at least 3 months; OR C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.) Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For renewals beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. Approvals will only allow for standard dosing for adalimumab. The recommended dosing regimen is 40mg every two weeks.LU Authorization Period: 1 yearFor the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite: i) treatment with methotrexate (20mg/week) for at least 3 months; AND ii) one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months. If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months is required. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must have objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 40mg every 2 weeks. Higher doses may be considered case-by-case through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of ankylosing spondylitis (AS) in patients who have severe active disease confirmed by radiographic evidence (see note below) with: - Age of disease onset equal to or younger than 50; AND - Low back pain and stiffness for greater than 3 months that improves with exercise and not relieved by rest; AND - Failure to respond to or documented intolerance to adequate trials of 2 non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks each; AND - Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of greater than or equal to 4 for at least 4 weeks while on standard therapy. Note: Radiographic evidence demonstrating the presence of "SI joint fusion" or "SI joint erosion" on x-ray or CT scan, or MRI demonstrating the presence of "inflammation" or "edema" of the SI joint. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 50 percent reduction in BASDAI score or greater than or equal to 2 absolute point reduction in BASDAI score. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 40mg every 2 weeks. Higher doses may be considered case-by-case through the Exceptional Access Program.LU Authorization Period: 1 yearLuminal Crohn's disease For the treatment of moderate to severe (luminal) Crohn's disease in patients who meet the following criteria: A. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine, methotrexate); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Adalimumab is being used to induce remission or as a steroid-sparing maintenance therapy. The recommended induction dosing regimen is 160mg at week 0, followed by 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., HBI score decrease greater than or equal to 50% from pre-treatment measurement), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. Patients with mild Crohn's disease (e.g., HBI less than 7) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFistulising Crohn's disease For the treatment of fistulising Crohn's disease with concomitant luminal disease in patients who meet the following criteria: A. Patient has actively draining perianal or enterocutaneous fistula(e) that have recurred OR persist despite a course of appropriate antibiotic therapy (e.g., ciprofloxacin and/or metronidazole); AND B. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease) The recommended induction dosing regimen is 160mg at week 0, followed by 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and achieve and maintain response to therapy (e.g., partial or complete resolution of fistulae and symptom improvement). Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded.LU Authorization Period: 1 yearUlcerative Colitis For the treatment of moderate to severe ulcerative colitis in patients who meet the following criteria: A. Mayo score greater than or equal to 6 with an endoscopic subscore* of at least 2 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Adalimumab is being used to induce remission or as a steroid-sparing maintenance therapy. *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. The recommended induction dosing regimen is up to 160mg at week 0, followed by up to 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., Mayo score less than 6), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory disease will not be funded. Patients with mild ulcerative colitis (e.g., Mayo score less than 6) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of patients with active moderate to severe hidradenitis suppurativa (HS) who have not responded to conventional therapy (including systemic antibiotics) and who meet all of the following: A. A total abscess and nodule count of 3 or greater; AND B. Lesions in at least two distinct anatomic areas, one of which must be Hurley Stage II or III; AND C. Experienced an inadequate response to a 90-day trial of oral antibiotics. Therapy must be prescribed by a practitioner with expertise in the management of patients with HS. The recommended adult dosing regimen is 160mg at week 0, followed by 80mg at week 2, then 40mg at week 4, and 40mg weekly thereafter. The recommended adolescent dosing regimen is 80mg at week 0, followed by 40mg every other week starting at week 1 up to 40mg weekly in those with inadequate response. If there is no improvement after 12 weeks of treatment with adalimumab at the Health Canada approved dose, higher doses are not recommended and the prescriber should discontinue treatment. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Maintenance/Renewal: Maintenance therapy is funded for patients beyond the first 12 weeks in those who meet the Ministry initiation criteria and who have responded to treatment defined as at least a 50% reduction in abscesses and inflammatory nodule count with no increase in abscess count or draining fistula count relative to baseline. Maintenance therapy beyond the second year is funded for patients using adalimumab for HS, where there is objective evidence of the preservation of treatment effect (i.e. the current abscess and inflammatory nodule count should be compared to the count prior to initiating treatment with adalimumab). The recommended maintenance dose is 40mg weekly. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.LU Authorization Period: 1 yearFor the treatment of severe* plaque psoriasis in patients 18 years of age or older who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies**. Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. *Definition of severe plaque psoriasis: Body Surface Area (BSA) involvement of at least 10 percent, or involvement of the face, hands, feet or genital regions, AND Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND Dermatology Life Quality Index (DLQI) score of at least 10. **Definition of failure, intolerance or contraindication to adequate trials of standard therapies: 6 month trial of at least 3 topical agents including vitamin D analogues and steroids 12 week trial of phototherapy (unless not accessible) 6 month trial of at least 2 systemic, oral agents used alone or in combination - Methotrexate 15-30mg per week - Acitretin (could have been used with phototherapy) - Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: - at least a 50% reduction in PASI, AND - at least a 50% reduction in BSA involvement, AND - at least a 5 point reduction in DLQI score Approvals will only allow for standard dosing for adalimumab. The recommended dose is an initial 80mg administered subcutaneously at week 0, followed by 40mg subcutaneously given every other week starting at week 1, as approved by Health Canada. If the patient has not responded adequately after 12 weeks of treatment at the Health Canada approved dose, higher doses are not recommended, and the physician should consider switching to an alternative biologic agent.LU Authorization Period: 1 yearPolyarticular Juvenile Idiopathic Arthritis For the treatment of polyarticular juvenile idiopathic arthritis (pJIA) in patients who have active disease (greater than or equal to 3 swollen joints and greater than or equal to 5 active joints) despite a trial of optimal doses of subcutaneously administered methotrexate (i.e. 15mg/m2 per week) for at least 3 months. If the patient is unable to tolerate or has a contraindication to subcutaneous methotrexate, the nature of the intolerance or contraindication should be documented. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. The recommended dosing regimen is for pediatric patients 2 years of age and older: - 30kg and greater: 40mg every other week Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. LU Authorization Period: 1 yearFor the treatment of severe uveitis in patients meeting the following criteria: A. Has experienced failure or intolerance to an oral corticosteroid (or topical corticosteroid for anterior uveitis) or where the use of corticosteroids is contraindicated, and has experienced failure or intolerance to at least one immunosuppressive therapy; AND B. Treatment must be prescribed by an ophthalmologist specialized in uveitis or retinal disease, a uveitis specialist, or a retina specialist familiar with ocular inflammatory diseases. Requests not meeting the above criteria may be considered on a case-by-case basis through the Exceptional Access Program. The recommended adult dose is an initial 80mg administered subcutaneously at week 0, followed by 40mg subcutaneously given every other week starting at week 1, as approved by Health Canada. Note: Higher doses up to 40mg weekly may be considered in patients who have failed to respond to lower doses. The recommended dose for pediatric patients (2 years or older) with anterior uveitis is: 30kg or greater: 40mg every other week in combination with methotrexate For patients 6 years of age or older and weighing 30kg or greater, an optional loading dose of 80mg at week 0 may be administered before starting maintenance therapy. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Maintenance/Renewals: Maintenance therapy is funded for patients who meet the Ministry initiation criteria and who have experienced improvement and/or stability of vision and other treatment goals (e.g. reduction or control of ocular inflammation).LU Authorization Period: 1 year234680mg/0.8mLInj Sol-0.8mL Pref Pen (Preservative-Free)HyrimozSDZ942.54002024-04-30942.5400For the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or, anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments: A. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide (20mg/day) for at least 3 months, in addition to iii) an adequate trial of at least one combination of DMARDs for 3 months; OR B. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide in combination with methotrexate for at least 3 months; OR C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.) Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For renewals beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. Approvals will only allow for standard dosing for adalimumab. The recommended dosing regimen is 40mg every two weeks.LU Authorization Period: 1 yearFor the treatment of polyarticular juvenile idiopathic arthritis (pJIA) in patients who have active disease (greater than or equal to 3 swollen joints and greater than or equal to 5 active joints) despite a trial of optimal doses of subcutaneously administered methotrexate (i.e. 15mg/m2 per week) for at least 3 months. If the patient is unable to tolerate or has a contraindication to subcutaneous methotrexate, the nature of the intolerance or contraindication should be documented. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. The recommended dosing regimen is for pediatric patients 2 years of age and older: - 10kg to less than 30kg: 20mg every other week* - 30kg and greater: 40mg every other week *a dose of 10mg every other week can be considered for patients weighing 10kg to less than 15kg It should be noted that some adalimumab products may not be available as 20mg injectables. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.LU Authorization Period: 1 yearFor the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite: i) treatment with methotrexate (20mg/week) for at least 3 months; AND ii) one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months. If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months is required. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must have objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 40mg every 2 weeks. Higher doses may be considered case-by-case through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of ankylosing spondylitis (AS) in patients who have severe active disease confirmed by radiographic evidence (see note below) with: - Age of disease onset equal to or younger than 50; AND - Low back pain and stiffness for greater than 3 months that improves with exercise and not relieved by rest; AND - Failure to respond to or documented intolerance to adequate trials of 2 non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks each; AND - Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of greater than or equal to 4 for at least 4 weeks while on standard therapy. Note: Radiographic evidence demonstrating the presence of "SI joint fusion" or "SI joint erosion" on x-ray or CT scan, or MRI demonstrating the presence of "inflammation" or "edema" of the SI joint. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 50 percent reduction in BASDAI score or greater than or equal to 2 absolute point reduction in BASDAI score. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 40mg every 2 weeks. Higher doses may be considered case-by-case through the Exceptional Access Program.LU Authorization Period: 1 yearLuminal Crohn's disease For the treatment of moderate to severe (luminal) Crohn's disease in patients who meet the following criteria: A. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine, methotrexate); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Adalimumab is being used to induce remission or as a steroid-sparing maintenance therapy. The recommended induction dosing regimen is 160mg at week 0, followed by 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., HBI score decrease greater than or equal to 50% from pre-treatment measurement), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. Patients with mild Crohn's disease (e.g., HBI less than 7) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFistulising Crohn's disease For the treatment of fistulising Crohn's disease with concomitant luminal disease in patients who meet the following criteria: A. Patient has actively draining perianal or enterocutaneous fistula(e) that have recurred OR persist despite a course of appropriate antibiotic therapy (e.g., ciprofloxacin and/or metronidazole); AND B. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease) The recommended induction dosing regimen is 160mg at week 0, followed by 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and achieve and maintain response to therapy (e.g., partial or complete resolution of fistulae and symptom improvement). Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded.LU Authorization Period: 1 yearUlcerative Colitis For the treatment of moderate to severe ulcerative colitis in patients who meet the following criteria: A. Mayo score greater than or equal to 6 with an endoscopic subscore* of at least 2 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Adalimumab is being used to induce remission or as a steroid-sparing maintenance therapy. *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. The recommended induction dosing regimen is up to 160mg at week 0, followed by up to 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., Mayo score less than 6), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory disease will not be funded. Patients with mild ulcerative colitis (e.g., Mayo score less than 6) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of patients with active moderate to severe hidradenitis suppurativa (HS) who have not responded to conventional therapy (including systemic antibiotics) and who meet all of the following: A. A total abscess and nodule count of 3 or greater; AND B. Lesions in at least two distinct anatomic areas, one of which must be Hurley Stage II or III; AND C. Experienced an inadequate response to a 90-day trial of oral antibiotics. Therapy must be prescribed by a practitioner with expertise in the management of patients with HS. The recommended adult dosing regimen is 160mg at week 0, followed by 80mg at week 2, then 40mg at week 4, and 40mg weekly thereafter. The recommended adolescent dosing regimen is 80mg at week 0, followed by 40mg every other week starting at week 1 up to 40mg weekly in those with inadequate response. If there is no improvement after 12 weeks of treatment with adalimumab at the Health Canada approved dose, higher doses are not recommended and the prescriber should discontinue treatment. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Maintenance/Renewal: Maintenance therapy is funded for patients beyond the first 12 weeks in those who meet the Ministry initiation criteria and who have responded to treatment defined as at least a 50% reduction in abscesses and inflammatory nodule count with no increase in abscess count or draining fistula count relative to baseline. Maintenance therapy beyond the second year is funded for patients using adalimumab for HS, where there is objective evidence of the preservation of treatment effect (i.e. the current abscess and inflammatory nodule count should be compared to the count prior to initiating treatment with adalimumab). The recommended maintenance dose is 40mg weekly. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.LU Authorization Period: 1 yearFor the treatment of severe* plaque psoriasis in patients 18 years of age or older who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies**. Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. *Definition of severe plaque psoriasis: Body Surface Area (BSA) involvement of at least 10 percent, or involvement of the face, hands, feet or genital regions, AND Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND Dermatology Life Quality Index (DLQI) score of at least 10. **Definition of failure, intolerance or contraindication to adequate trials of standard therapies: 6 month trial of at least 3 topical agents including vitamin D analogues and steroids 12 week trial of phototherapy (unless not accessible) 6 month trial of at least 2 systemic, oral agents used alone or in combination - Methotrexate 15-30mg per week - Acitretin (could have been used with phototherapy) - Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: - at least a 50% reduction in PASI, AND - at least a 50% reduction in BSA involvement, AND - at least a 5 point reduction in DLQI score Approvals will only allow for standard dosing for adalimumab. The recommended dose is an initial 80mg administered subcutaneously at week 0, followed by 40mg subcutaneously given every other week starting at week 1, as approved by Health Canada. If the patient has not responded adequately after 12 weeks of treatment at the Health Canada approved dose, higher doses are not recommended, and the physician should consider switching to an alternative biologic agent.LU Authorization Period: 1 yearFor the treatment of severe uveitis in patients meeting the following criteria: A. Has experienced failure or intolerance to an oral corticosteroid (or topical corticosteroid for anterior uveitis) or where the use of corticosteroids is contraindicated, and has experienced failure or intolerance to at least one immunosuppressive therapy; AND B. Treatment must be prescribed by an opthalmologist specialized in uveitis or retinal disease, a uveitis specialist, or a retina specialist familiar with ocular inflammatory diseases. Requests not meeting the above criteria may be considered on a case-by-case basis through the Exceptional Access Program. The recommended adult dose is an initial 80mg administered subcutaneously at week 0, followed by 40mg subsubcutaneously given every other week starting at week 1, as approved by Health Canada. Note: Higher doses up to 40mg weekly may be considered in patients who have failed to respond to lower doses. The recommended dose for pediatric patients (2 years of age and older) with anterior uveitis is: Less than 30kg: 20mg every other week in combination with methotrexate 30kg or greater: 40mg every other week in combination with methotrexate For patients 6 years of age or older and less than 30kg, an optional loading dose of 40mg at week 0 may be administered before starting maintenance therapy. For patients 6 years of age or older and weighing 30kg or greater, an optional loading dose of 80mg at week 0 may be administered before starting maintenance therapy. It should be noted that some adalimumab products may not be available as 20mg injectables. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Maintenance/Renewals: Maintenance therapy is funded for patients who meet the Ministry initiation criteria and who have experienced improvement and/or stability of vision and other treatment goals (e.g. reduction or control of ocular inflammation).LU Authorization Period: 1 year234740mg/0.8mLInj Sol-0.8mL Pref Syr (Preservative-Free)AmgevitaAMG471.27002021-03-29471.2700234840mg/0.8mLInj Sol-0.8mL Pref Syr (Preservative-Free)HulioBGP471.27002021-03-29471.2700234940mg/0.8mLInj Sol-0.8mL Pref Syr (Preservative-Free)HadlimaSAM471.27002021-03-29471.2700For the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or, anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments: A. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide (20mg/day) for at least 3 months, in addition to iii) an adequate trial of at least one combination of DMARDs for 3 months; OR B. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide in combination with methotrexate for at least 3 months; OR C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.) Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For renewals beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. Approvals will only allow for standard dosing for adalimumab. The recommended dosing regimen is 40mg every two weeks.LU Authorization Period: 1 yearFor the treatment of polyarticular juvenile idiopathic arthritis (pJIA) in patients who have active disease (greater than or equal to 3 swollen joints and greater than or equal to 5 active joints) despite a trial of optimal doses of subcutaneously administered methotrexate (i.e. 15mg/m2 per week) for at least 3 months. If the patient is unable to tolerate or has a contraindication to subcutaneous methotrexate, the nature of the intolerance or contraindication should be documented. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. The recommended dosing regimen is for pediatric patients 2 years of age and older: - 10kg to less than 30kg: 20mg every other week* - 30kg and greater: 40mg every other week *a dose of 10mg every other week can be considered for patients weighing 10kg to less than 15kg It should be noted that some adalimumab products may not be available as 20mg injectables. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.LU Authorization Period: 1 yearFor the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite: i) treatment with methotrexate (20mg/week) for at least 3 months; AND ii) one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months. If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months is required. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must have objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 40mg every 2 weeks. Higher doses may be considered case-by-case through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of ankylosing spondylitis (AS) in patients who have severe active disease confirmed by radiographic evidence (see note below) with: - Age of disease onset equal to or younger than 50; AND - Low back pain and stiffness for greater than 3 months that improves with exercise and not relieved by rest; AND - Failure to respond to or documented intolerance to adequate trials of 2 non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks each; AND - Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of greater than or equal to 4 for at least 4 weeks while on standard therapy. Note: Radiographic evidence demonstrating the presence of "SI joint fusion" or "SI joint erosion" on x-ray or CT scan, or MRI demonstrating the presence of "inflammation" or "edema" of the SI joint. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 50 percent reduction in BASDAI score or greater than or equal to 2 absolute point reduction in BASDAI score. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 40mg every 2 weeks. Higher doses may be considered case-by-case through the Exceptional Access Program.LU Authorization Period: 1 yearLuminal Crohn's disease For the treatment of moderate to severe (luminal) Crohn's disease in patients who meet the following criteria: A. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine, methotrexate); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Adalimumab is being used to induce remission or as a steroid-sparing maintenance therapy. The recommended induction dosing regimen is 160mg at week 0, followed by 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., HBI score decrease greater than or equal to 50% from pre-treatment measurement), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. Patients with mild Crohn's disease (e.g., HBI less than 7) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFistulising Crohn's disease For the treatment of fistulising Crohn's disease with concomitant luminal disease in patients who meet the following criteria: A. Patient has actively draining perianal or enterocutaneous fistula(e) that have recurred OR persist despite a course of appropriate antibiotic therapy (e.g., ciprofloxacin and/or metronidazole); AND B. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease) The recommended induction dosing regimen is 160mg at week 0, followed by 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and achieve and maintain response to therapy (e.g., partial or complete resolution of fistulae and symptom improvement). Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded.LU Authorization Period: 1 yearUlcerative Colitis For the treatment of moderate to severe ulcerative colitis in patients who meet the following criteria: A. Mayo score greater than or equal to 6 with an endoscopic subscore* of at least 2 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Adalimumab is being used to induce remission or as a steroid-sparing maintenance therapy. *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. The recommended induction dosing regimen is up to 160mg at week 0, followed by up to 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., Mayo score less than 6), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory disease will not be funded. Patients with mild ulcerative colitis (e.g., Mayo score less than 6) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of patients with active moderate to severe hidradenitis suppurativa (HS) who have not responded to conventional therapy (including systemic antibiotics) and who meet all of the following: A. A total abscess and nodule count of 3 or greater; AND B. Lesions in at least two distinct anatomic areas, one of which must be Hurley Stage II or III; AND C. Experienced an inadequate response to a 90-day trial of oral antibiotics. Therapy must be prescribed by a practitioner with expertise in the management of patients with HS. The recommended adult dosing regimen is 160mg at week 0, followed by 80mg at week 2, then 40mg at week 4, and 40mg weekly thereafter. The recommended adolescent dosing regimen is 80mg at week 0, followed by 40mg every other week starting at week 1 up to 40mg weekly in those with inadequate response. If there is no improvement after 12 weeks of treatment with adalimumab at the Health Canada approved dose, higher doses are not recommended and the prescriber should discontinue treatment. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Maintenance/Renewal: Maintenance therapy is funded for patients beyond the first 12 weeks in those who meet the Ministry initiation criteria and who have responded to treatment defined as at least a 50% reduction in abscesses and inflammatory nodule count with no increase in abscess count or draining fistula count relative to baseline. Maintenance therapy beyond the second year is funded for patients using adalimumab for HS, where there is objective evidence of the preservation of treatment effect (i.e. the current abscess and inflammatory nodule count should be compared to the count prior to initiating treatment with adalimumab). The recommended maintenance dose is 40mg weekly. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.LU Authorization Period: 1 yearFor the treatment of severe* plaque psoriasis in patients 18 years of age or older who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies**. Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. *Definition of severe plaque psoriasis: Body Surface Area (BSA) involvement of at least 10 percent, or involvement of the face, hands, feet or genital regions, AND Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND Dermatology Life Quality Index (DLQI) score of at least 10. **Definition of failure, intolerance or contraindication to adequate trials of standard therapies: 6 month trial of at least 3 topical agents including vitamin D analogues and steroids 12 week trial of phototherapy (unless not accessible) 6 month trial of at least 2 systemic, oral agents used alone or in combination - Methotrexate 15-30mg per week - Acitretin (could have been used with phototherapy) - Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: - at least a 50% reduction in PASI, AND - at least a 50% reduction in BSA involvement, AND - at least a 5 point reduction in DLQI score Approvals will only allow for standard dosing for adalimumab. The recommended dose is an initial 80mg administered subcutaneously at week 0, followed by 40mg subcutaneously given every other week starting at week 1, as approved by Health Canada. If the patient has not responded adequately after 12 weeks of treatment at the Health Canada approved dose, higher doses are not recommended, and the physician should consider switching to an alternative biologic agent.LU Authorization Period: 1 yearFor the treatment of severe uveitis in patients meeting the following criteria: A. Has experienced failure or intolerance to an oral corticosteroid (or topical corticosteroid for anterior uveitis) or where the use of corticosteroids is contraindicated, and has experienced failure or intolerance to at least one immunosuppressive therapy; AND B. Treatment must be prescribed by an opthalmologist specialized in uveitis or retinal disease, a uveitis specialist, or a retina specialist familiar with ocular inflammatory diseases. Requests not meeting the above criteria may be considered on a case-by-case basis through the Exceptional Access Program. The recommended adult dose is an initial 80mg administered subcutaneously at week 0, followed by 40mg subsubcutaneously given every other week starting at week 1, as approved by Health Canada. Note: Higher doses up to 40mg weekly may be considered in patients who have failed to respond to lower doses. The recommended dose for pediatric patients (2 years of age and older) with anterior uveitis is: Less than 30kg: 20mg every other week in combination with methotrexate 30kg or greater: 40mg every other week in combination with methotrexate For patients 6 years of age or older and less than 30kg, an optional loading dose of 40mg at week 0 may be administered before starting maintenance therapy. For patients 6 years of age or older and weighing 30kg or greater, an optional loading dose of 80mg at week 0 may be administered before starting maintenance therapy. It should be noted that some adalimumab products may not be available as 20mg injectables. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Maintenance/Renewals: Maintenance therapy is funded for patients who meet the Ministry initiation criteria and who have experienced improvement and/or stability of vision and other treatment goals (e.g. reduction or control of ocular inflammation).LU Authorization Period: 1 year235040mg/0.8mLInj Sol-0.8mL Pref Syr (Preservative-Free)HyrimozSDZ471.27002021-03-29471.2700For the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or, anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments: A. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide (20mg/day) for at least 3 months, in addition to iii) an adequate trial of at least one combination of DMARDs for 3 months; OR B. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide in combination with methotrexate for at least 3 months; OR C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.) Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For renewals beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. Approvals will only allow for standard dosing for adalimumab. The recommended dosing regimen is 40mg every two weeks.LU Authorization Period: 1 yearFor the treatment of polyarticular juvenile idiopathic arthritis (pJIA) in patients who have active disease (greater than or equal to 3 swollen joints and greater than or equal to 5 active joints) despite a trial of optimal doses of subcutaneously administered methotrexate (i.e. 15mg/m2 per week) for at least 3 months. If the patient is unable to tolerate or has a contraindication to subcutaneous methotrexate, the nature of the intolerance or contraindication should be documented. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. The recommended dosing regimen is for pediatric patients 2 years of age and older: - 10kg to less than 30kg: 20mg every other week* - 30kg and greater: 40mg every other week *a dose of 10mg every other week can be considered for patients weighing 10kg to less than 15kg It should be noted that some adalimumab products may not be available as 20mg injectables. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.LU Authorization Period: 1 yearFor the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite: i) treatment with methotrexate (20mg/week) for at least 3 months; AND ii) one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months. If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months is required. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must have objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 40mg every 2 weeks. Higher doses may be considered case-by-case through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of ankylosing spondylitis (AS) in patients who have severe active disease confirmed by radiographic evidence (see note below) with: - Age of disease onset equal to or younger than 50; AND - Low back pain and stiffness for greater than 3 months that improves with exercise and not relieved by rest; AND - Failure to respond to or documented intolerance to adequate trials of 2 non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks each; AND - Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of greater than or equal to 4 for at least 4 weeks while on standard therapy. Note: Radiographic evidence demonstrating the presence of "SI joint fusion" or "SI joint erosion" on x-ray or CT scan, or MRI demonstrating the presence of "inflammation" or "edema" of the SI joint. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 50 percent reduction in BASDAI score or greater than or equal to 2 absolute point reduction in BASDAI score. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 40mg every 2 weeks. Higher doses may be considered case-by-case through the Exceptional Access Program.LU Authorization Period: 1 yearLuminal Crohn's disease For the treatment of moderate to severe (luminal) Crohn's disease in patients who meet the following criteria: A. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine, methotrexate); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Adalimumab is being used to induce remission or as a steroid-sparing maintenance therapy. The recommended induction dosing regimen is 160mg at week 0, followed by 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., HBI score decrease greater than or equal to 50% from pre-treatment measurement), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. Patients with mild Crohn's disease (e.g., HBI less than 7) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFistulising Crohn's disease For the treatment of fistulising Crohn's disease with concomitant luminal disease in patients who meet the following criteria: A. Patient has actively draining perianal or enterocutaneous fistula(e) that have recurred OR persist despite a course of appropriate antibiotic therapy (e.g., ciprofloxacin and/or metronidazole); AND B. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease) The recommended induction dosing regimen is 160mg at week 0, followed by 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and achieve and maintain response to therapy (e.g., partial or complete resolution of fistulae and symptom improvement). Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded.LU Authorization Period: 1 yearUlcerative Colitis For the treatment of moderate to severe ulcerative colitis in patients who meet the following criteria: A. Mayo score greater than or equal to 6 with an endoscopic subscore* of at least 2 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Adalimumab is being used to induce remission or as a steroid-sparing maintenance therapy. *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. The recommended induction dosing regimen is up to 160mg at week 0, followed by up to 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., Mayo score less than 6), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory disease will not be funded. Patients with mild ulcerative colitis (e.g., Mayo score less than 6) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of patients with active moderate to severe hidradenitis suppurativa (HS) who have not responded to conventional therapy (including systemic antibiotics) and who meet all of the following: A. A total abscess and nodule count of 3 or greater; AND B. Lesions in at least two distinct anatomic areas, one of which must be Hurley Stage II or III; AND C. Experienced an inadequate response to a 90-day trial of oral antibiotics. Therapy must be prescribed by a practitioner with expertise in the management of patients with HS. The recommended adult dosing regimen is 160mg at week 0, followed by 80mg at week 2, then 40mg at week 4, and 40mg weekly thereafter. The recommended adolescent dosing regimen is 80mg at week 0, followed by 40mg every other week starting at week 1 up to 40mg weekly in those with inadequate response. If there is no improvement after 12 weeks of treatment with adalimumab at the Health Canada approved dose, higher doses are not recommended and the prescriber should discontinue treatment. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Maintenance/Renewal: Maintenance therapy is funded for patients beyond the first 12 weeks in those who meet the Ministry initiation criteria and who have responded to treatment defined as at least a 50% reduction in abscesses and inflammatory nodule count with no increase in abscess count or draining fistula count relative to baseline. Maintenance therapy beyond the second year is funded for patients using adalimumab for HS, where there is objective evidence of the preservation of treatment effect (i.e. the current abscess and inflammatory nodule count should be compared to the count prior to initiating treatment with adalimumab). The recommended maintenance dose is 40mg weekly. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.LU Authorization Period: 1 yearFor the treatment of severe* plaque psoriasis in patients 18 years of age or older who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies**. Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. *Definition of severe plaque psoriasis: Body Surface Area (BSA) involvement of at least 10 percent, or involvement of the face, hands, feet or genital regions, AND Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND Dermatology Life Quality Index (DLQI) score of at least 10. **Definition of failure, intolerance or contraindication to adequate trials of standard therapies: 6 month trial of at least 3 topical agents including vitamin D analogues and steroids 12 week trial of phototherapy (unless not accessible) 6 month trial of at least 2 systemic, oral agents used alone or in combination - Methotrexate 15-30mg per week - Acitretin (could have been used with phototherapy) - Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: - at least a 50% reduction in PASI, AND - at least a 50% reduction in BSA involvement, AND - at least a 5 point reduction in DLQI score Approvals will only allow for standard dosing for adalimumab. The recommended dose is an initial 80mg administered subcutaneously at week 0, followed by 40mg subcutaneously given every other week starting at week 1, as approved by Health Canada. If the patient has not responded adequately after 12 weeks of treatment at the Health Canada approved dose, higher doses are not recommended, and the physician should consider switching to an alternative biologic agent.LU Authorization Period: 1 yearFor the treatment of severe uveitis in patients meeting the following criteria: A. Has experienced failure or intolerance to an oral corticosteroid (or topical corticosteroid for anterior uveitis) or where the use of corticosteroids is contraindicated, and has experienced failure or intolerance to at least one immunosuppressive therapy; AND B. Treatment must be prescribed by an opthalmologist specialized in uveitis or retinal disease, a uveitis specialist, or a retina specialist familiar with ocular inflammatory diseases. Requests not meeting the above criteria may be considered on a case-by-case basis through the Exceptional Access Program. The recommended adult dose is an initial 80mg administered subcutaneously at week 0, followed by 40mg subsubcutaneously given every other week starting at week 1, as approved by Health Canada. Note: Higher doses up to 40mg weekly may be considered in patients who have failed to respond to lower doses. The recommended dose for pediatric patients (2 years of age and older) with anterior uveitis is: Less than 30kg: 20mg every other week in combination with methotrexate 30kg or greater: 40mg every other week in combination with methotrexate For patients 6 years of age or older and less than 30kg, an optional loading dose of 40mg at week 0 may be administered before starting maintenance therapy. For patients 6 years of age or older and weighing 30kg or greater, an optional loading dose of 80mg at week 0 may be administered before starting maintenance therapy. It should be noted that some adalimumab products may not be available as 20mg injectables. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Maintenance/Renewals: Maintenance therapy is funded for patients who meet the Ministry initiation criteria and who have experienced improvement and/or stability of vision and other treatment goals (e.g. reduction or control of ocular inflammation).LU Authorization Period: 1 year235140mg/0.8mLInj Sol-0.8mL Pref Syr (Preservative-Free)IdacioFKC471.27002021-10-29471.2700For the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or, anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments: A. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide (20mg/day) for at least 3 months, in addition to iii) an adequate trial of at least one combination of DMARDs for 3 months; OR B. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide in combination with methotrexate for at least 3 months; OR C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.) Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For renewals beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. Approvals will only allow for standard dosing for adalimumab. The recommended dosing regimen is 40mg every two weeks.LU Authorization Period: 1 yearFor the treatment of polyarticular juvenile idiopathic arthritis (pJIA) in patients who have active disease (greater than or equal to 3 swollen joints and greater than or equal to 5 active joints) despite a trial of optimal doses of subcutaneously administered methotrexate (i.e. 15mg/m2 per week) for at least 3 months. If the patient is unable to tolerate or has a contraindication to subcutaneous methotrexate, the nature of the intolerance or contraindication should be documented. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. The recommended dosing regimen is for pediatric patients 2 years of age and older: - 10kg to less than 30kg: 20mg every other week* - 30kg and greater: 40mg every other week *a dose of 10mg every other week can be considered for patients weighing 10kg to less than 15kg It should be noted that some adalimumab products may not be available as 20mg injectables. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.LU Authorization Period: 1 yearFor the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite: i) treatment with methotrexate (20mg/week) for at least 3 months; AND ii) one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months. If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months is required. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must have objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 40mg every 2 weeks. Higher doses may be considered case-by-case through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of ankylosing spondylitis (AS) in patients who have severe active disease confirmed by radiographic evidence (see note below) with: - Age of disease onset equal to or younger than 50; AND - Low back pain and stiffness for greater than 3 months that improves with exercise and not relieved by rest; AND - Failure to respond to or documented intolerance to adequate trials of 2 non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks each; AND - Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of greater than or equal to 4 for at least 4 weeks while on standard therapy. Note: Radiographic evidence demonstrating the presence of "SI joint fusion" or "SI joint erosion" on x-ray or CT scan, or MRI demonstrating the presence of "inflammation" or "edema" of the SI joint. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 50 percent reduction in BASDAI score or greater than or equal to 2 absolute point reduction in BASDAI score. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 40mg every 2 weeks. Higher doses may be considered case-by-case through the Exceptional Access Program.LU Authorization Period: 1 yearLuminal Crohn's disease For the treatment of moderate to severe (luminal) Crohn's disease in patients who meet the following criteria: A. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine, methotrexate); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Adalimumab is being used to induce remission or as a steroid-sparing maintenance therapy. The recommended induction dosing regimen is 160mg at week 0, followed by 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., HBI score decrease greater than or equal to 50% from pre-treatment measurement), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. Patients with mild Crohn's disease (e.g., HBI less than 7) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFistulising Crohn's disease For the treatment of fistulising Crohn's disease with concomitant luminal disease in patients who meet the following criteria: A. Patient has actively draining perianal or enterocutaneous fistula(e) that have recurred OR persist despite a course of appropriate antibiotic therapy (e.g., ciprofloxacin and/or metronidazole); AND B. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease) The recommended induction dosing regimen is 160mg at week 0, followed by 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and achieve and maintain response to therapy (e.g., partial or complete resolution of fistulae and symptom improvement). Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded.LU Authorization Period: 1 yearUlcerative Colitis For the treatment of moderate to severe ulcerative colitis in patients who meet the following criteria: A. Mayo score greater than or equal to 6 with an endoscopic subscore* of at least 2 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Adalimumab is being used to induce remission or as a steroid-sparing maintenance therapy. *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. The recommended induction dosing regimen is up to 160mg at week 0, followed by up to 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., Mayo score less than 6), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory disease will not be funded. Patients with mild ulcerative colitis (e.g., Mayo score less than 6) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of patients with active moderate to severe hidradenitis suppurativa (HS) who have not responded to conventional therapy (including systemic antibiotics) and who meet all of the following: A. A total abscess and nodule count of 3 or greater; AND B. Lesions in at least two distinct anatomic areas, one of which must be Hurley Stage II or III; AND C. Experienced an inadequate response to a 90-day trial of oral antibiotics. Therapy must be prescribed by a practitioner with expertise in the management of patients with HS. The recommended adult dosing regimen is 160mg at week 0, followed by 80mg at week 2, then 40mg at week 4, and 40mg weekly thereafter. The recommended adolescent dosing regimen is 80mg at week 0, followed by 40mg every other week starting at week 1 up to 40mg weekly in those with inadequate response. If there is no improvement after 12 weeks of treatment with adalimumab at the Health Canada approved dose, higher doses are not recommended and the prescriber should discontinue treatment. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Maintenance/Renewal: Maintenance therapy is funded for patients beyond the first 12 weeks in those who meet the Ministry initiation criteria and who have responded to treatment defined as at least a 50% reduction in abscesses and inflammatory nodule count with no increase in abscess count or draining fistula count relative to baseline. Maintenance therapy beyond the second year is funded for patients using adalimumab for HS, where there is objective evidence of the preservation of treatment effect (i.e. the current abscess and inflammatory nodule count should be compared to the count prior to initiating treatment with adalimumab). The recommended maintenance dose is 40mg weekly. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.LU Authorization Period: 1 yearFor the treatment of severe* plaque psoriasis in patients 18 years of age or older who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies**. Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. *Definition of severe plaque psoriasis: Body Surface Area (BSA) involvement of at least 10 percent, or involvement of the face, hands, feet or genital regions, AND Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND Dermatology Life Quality Index (DLQI) score of at least 10. **Definition of failure, intolerance or contraindication to adequate trials of standard therapies: 6 month trial of at least 3 topical agents including vitamin D analogues and steroids 12 week trial of phototherapy (unless not accessible) 6 month trial of at least 2 systemic, oral agents used alone or in combination - Methotrexate 15-30mg per week - Acitretin (could have been used with phototherapy) - Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: - at least a 50% reduction in PASI, AND - at least a 50% reduction in BSA involvement, AND - at least a 5 point reduction in DLQI score Approvals will only allow for standard dosing for adalimumab. The recommended dose is an initial 80mg administered subcutaneously at week 0, followed by 40mg subcutaneously given every other week starting at week 1, as approved by Health Canada. If the patient has not responded adequately after 12 weeks of treatment at the Health Canada approved dose, higher doses are not recommended, and the physician should consider switching to an alternative biologic agent.LU Authorization Period: 1 yearFor the treatment of severe uveitis in patients meeting the following criteria: A. Has experienced failure or intolerance to an oral corticosteroid (or topical corticosteroid for anterior uveitis) or where the use of corticosteroids is contraindicated, and has experienced failure or intolerance to at least one immunosuppressive therapy; AND B. Treatment must be prescribed by an opthalmologist specialized in uveitis or retinal disease, a uveitis specialist, or a retina specialist familiar with ocular inflammatory diseases. Requests not meeting the above criteria may be considered on a case-by-case basis through the Exceptional Access Program. The recommended adult dose is an initial 80mg administered subcutaneously at week 0, followed by 40mg subsubcutaneously given every other week starting at week 1, as approved by Health Canada. Note: Higher doses up to 40mg weekly may be considered in patients who have failed to respond to lower doses. The recommended dose for pediatric patients (2 years of age and older) with anterior uveitis is: Less than 30kg: 20mg every other week in combination with methotrexate 30kg or greater: 40mg every other week in combination with methotrexate For patients 6 years of age or older and less than 30kg, an optional loading dose of 40mg at week 0 may be administered before starting maintenance therapy. For patients 6 years of age or older and weighing 30kg or greater, an optional loading dose of 80mg at week 0 may be administered before starting maintenance therapy. It should be noted that some adalimumab products may not be available as 20mg injectables. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Maintenance/Renewals: Maintenance therapy is funded for patients who meet the Ministry initiation criteria and who have experienced improvement and/or stability of vision and other treatment goals (e.g. reduction or control of ocular inflammation).LU Authorization Period: 1 year235240mg/0.8mLInj Sol-0.8mL Pref Syr (Preservative-Free)AbriladaPFI471.27002022-05-31471.2700For the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or, anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments: A. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide (20mg/day) for at least 3 months, in addition to iii) an adequate trial of at least one combination of DMARDs for 3 months; OR B. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide in combination with methotrexate for at least 3 months; OR C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.) Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For renewals beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. Approvals will only allow for standard dosing for adalimumab. The recommended dosing regimen is 40mg every two weeks.LU Authorization Period: 1 yearFor the treatment of polyarticular juvenile idiopathic arthritis (pJIA) in patients who have active disease (greater than or equal to 3 swollen joints and greater than or equal to 5 active joints) despite a trial of optimal doses of subcutaneously administered methotrexate (i.e. 15mg/m2 per week) for at least 3 months. If the patient is unable to tolerate or has a contraindication to subcutaneous methotrexate, the nature of the intolerance or contraindication should be documented. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. The recommended dosing regimen is for pediatric patients 2 years of age and older: - 10kg to less than 30kg: 20mg every other week* - 30kg and greater: 40mg every other week *a dose of 10mg every other week can be considered for patients weighing 10kg to less than 15kg It should be noted that some adalimumab products may not be available as 20mg injectables. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.LU Authorization Period: 1 yearFor the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite: i) treatment with methotrexate (20mg/week) for at least 3 months; AND ii) one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months. If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months is required. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must have objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 40mg every 2 weeks. Higher doses may be considered case-by-case through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of ankylosing spondylitis (AS) in patients who have severe active disease confirmed by radiographic evidence (see note below) with: - Age of disease onset equal to or younger than 50; AND - Low back pain and stiffness for greater than 3 months that improves with exercise and not relieved by rest; AND - Failure to respond to or documented intolerance to adequate trials of 2 non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks each; AND - Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of greater than or equal to 4 for at least 4 weeks while on standard therapy. Note: Radiographic evidence demonstrating the presence of "SI joint fusion" or "SI joint erosion" on x-ray or CT scan, or MRI demonstrating the presence of "inflammation" or "edema" of the SI joint. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 50 percent reduction in BASDAI score or greater than or equal to 2 absolute point reduction in BASDAI score. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 40mg every 2 weeks. Higher doses may be considered case-by-case through the Exceptional Access Program.LU Authorization Period: 1 yearLuminal Crohn's disease For the treatment of moderate to severe (luminal) Crohn's disease in patients who meet the following criteria: A. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine, methotrexate); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Adalimumab is being used to induce remission or as a steroid-sparing maintenance therapy. The recommended induction dosing regimen is 160mg at week 0, followed by 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., HBI score decrease greater than or equal to 50% from pre-treatment measurement), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. Patients with mild Crohn's disease (e.g., HBI less than 7) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFistulising Crohn's disease For the treatment of fistulising Crohn's disease with concomitant luminal disease in patients who meet the following criteria: A. Patient has actively draining perianal or enterocutaneous fistula(e) that have recurred OR persist despite a course of appropriate antibiotic therapy (e.g., ciprofloxacin and/or metronidazole); AND B. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease) The recommended induction dosing regimen is 160mg at week 0, followed by 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and achieve and maintain response to therapy (e.g., partial or complete resolution of fistulae and symptom improvement). Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded.LU Authorization Period: 1 yearUlcerative Colitis For the treatment of moderate to severe ulcerative colitis in patients who meet the following criteria: A. Mayo score greater than or equal to 6 with an endoscopic subscore* of at least 2 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Adalimumab is being used to induce remission or as a steroid-sparing maintenance therapy. *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. The recommended induction dosing regimen is up to 160mg at week 0, followed by up to 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., Mayo score less than 6), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory disease will not be funded. Patients with mild ulcerative colitis (e.g., Mayo score less than 6) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of patients with active moderate to severe hidradenitis suppurativa (HS) who have not responded to conventional therapy (including systemic antibiotics) and who meet all of the following: A. A total abscess and nodule count of 3 or greater; AND B. Lesions in at least two distinct anatomic areas, one of which must be Hurley Stage II or III; AND C. Experienced an inadequate response to a 90-day trial of oral antibiotics. Therapy must be prescribed by a practitioner with expertise in the management of patients with HS. The recommended adult dosing regimen is 160mg at week 0, followed by 80mg at week 2, then 40mg at week 4, and 40mg weekly thereafter. The recommended adolescent dosing regimen is 80mg at week 0, followed by 40mg every other week starting at week 1 up to 40mg weekly in those with inadequate response. If there is no improvement after 12 weeks of treatment with adalimumab at the Health Canada approved dose, higher doses are not recommended and the prescriber should discontinue treatment. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Maintenance/Renewal: Maintenance therapy is funded for patients beyond the first 12 weeks in those who meet the Ministry initiation criteria and who have responded to treatment defined as at least a 50% reduction in abscesses and inflammatory nodule count with no increase in abscess count or draining fistula count relative to baseline. Maintenance therapy beyond the second year is funded for patients using adalimumab for HS, where there is objective evidence of the preservation of treatment effect (i.e. the current abscess and inflammatory nodule count should be compared to the count prior to initiating treatment with adalimumab). The recommended maintenance dose is 40mg weekly. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.LU Authorization Period: 1 yearFor the treatment of severe* plaque psoriasis in patients 18 years of age or older who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies**. Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. *Definition of severe plaque psoriasis: Body Surface Area (BSA) involvement of at least 10 percent, or involvement of the face, hands, feet or genital regions, AND Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND Dermatology Life Quality Index (DLQI) score of at least 10. **Definition of failure, intolerance or contraindication to adequate trials of standard therapies: 6 month trial of at least 3 topical agents including vitamin D analogues and steroids 12 week trial of phototherapy (unless not accessible) 6 month trial of at least 2 systemic, oral agents used alone or in combination - Methotrexate 15-30mg per week - Acitretin (could have been used with phototherapy) - Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: - at least a 50% reduction in PASI, AND - at least a 50% reduction in BSA involvement, AND - at least a 5 point reduction in DLQI score Approvals will only allow for standard dosing for adalimumab. The recommended dose is an initial 80mg administered subcutaneously at week 0, followed by 40mg subcutaneously given every other week starting at week 1, as approved by Health Canada. If the patient has not responded adequately after 12 weeks of treatment at the Health Canada approved dose, higher doses are not recommended, and the physician should consider switching to an alternative biologic agent.LU Authorization Period: 1 yearFor the treatment of severe uveitis in patients meeting the following criteria: A. Has experienced failure or intolerance to an oral corticosteroid (or topical corticosteroid for anterior uveitis) or where the use of corticosteroids is contraindicated, and has experienced failure or intolerance to at least one immunosuppressive therapy; AND B. Treatment must be prescribed by an opthalmologist specialized in uveitis or retinal disease, a uveitis specialist, or a retina specialist familiar with ocular inflammatory diseases. Requests not meeting the above criteria may be considered on a case-by-case basis through the Exceptional Access Program. The recommended adult dose is an initial 80mg administered subcutaneously at week 0, followed by 40mg subsubcutaneously given every other week starting at week 1, as approved by Health Canada. Note: Higher doses up to 40mg weekly may be considered in patients who have failed to respond to lower doses. The recommended dose for pediatric patients (2 years of age and older) with anterior uveitis is: Less than 30kg: 20mg every other week in combination with methotrexate 30kg or greater: 40mg every other week in combination with methotrexate For patients 6 years of age or older and less than 30kg, an optional loading dose of 40mg at week 0 may be administered before starting maintenance therapy. For patients 6 years of age or older and weighing 30kg or greater, an optional loading dose of 80mg at week 0 may be administered before starting maintenance therapy. It should be noted that some adalimumab products may not be available as 20mg injectables. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Maintenance/Renewals: Maintenance therapy is funded for patients who meet the Ministry initiation criteria and who have experienced improvement and/or stability of vision and other treatment goals (e.g. reduction or control of ocular inflammation).LU Authorization Period: 1 year235380mg/0.8mLInj Sol-0.8mL Pref Syr (Preservative-Free)SimlandiJPC942.54002022-05-31942.5400235480mg/0.8mLInj Sol-0.8mL Pref Syr (Preservative-Free)YuflymaCEH942.54002023-11-30942.5400For the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or, anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments: A. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide (20mg/day) for at least 3 months, in addition to iii) an adequate trial of at least one combination of DMARDs for 3 months; OR B. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide in combination with methotrexate for at least 3 months; OR C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.) Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For renewals beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. Approvals will only allow for standard dosing for adalimumab. The recommended dosing regimen is 40mg every two weeks.LU Authorization Period: 1 yearFor the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite: i) treatment with methotrexate (20mg/week) for at least 3 months; AND ii) one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months. If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months is required. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must have objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 40mg every 2 weeks. Higher doses may be considered case-by-case through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of ankylosing spondylitis (AS) in patients who have severe active disease confirmed by radiographic evidence (see note below) with: - Age of disease onset equal to or younger than 50; AND - Low back pain and stiffness for greater than 3 months that improves with exercise and not relieved by rest; AND - Failure to respond to or documented intolerance to adequate trials of 2 non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks each; AND - Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of greater than or equal to 4 for at least 4 weeks while on standard therapy. Note: Radiographic evidence demonstrating the presence of "SI joint fusion" or "SI joint erosion" on x-ray or CT scan, or MRI demonstrating the presence of "inflammation" or "edema" of the SI joint. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 50 percent reduction in BASDAI score or greater than or equal to 2 absolute point reduction in BASDAI score. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 40mg every 2 weeks. Higher doses may be considered case-by-case through the Exceptional Access Program.LU Authorization Period: 1 yearLuminal Crohn's disease For the treatment of moderate to severe (luminal) Crohn's disease in patients who meet the following criteria: A. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine, methotrexate); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Adalimumab is being used to induce remission or as a steroid-sparing maintenance therapy. The recommended induction dosing regimen is 160mg at week 0, followed by 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., HBI score decrease greater than or equal to 50% from pre-treatment measurement), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. Patients with mild Crohn's disease (e.g., HBI less than 7) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFistulising Crohn's disease For the treatment of fistulising Crohn's disease with concomitant luminal disease in patients who meet the following criteria: A. Patient has actively draining perianal or enterocutaneous fistula(e) that have recurred OR persist despite a course of appropriate antibiotic therapy (e.g., ciprofloxacin and/or metronidazole); AND B. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease) The recommended induction dosing regimen is 160mg at week 0, followed by 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and achieve and maintain response to therapy (e.g., partial or complete resolution of fistulae and symptom improvement). Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded.LU Authorization Period: 1 yearUlcerative Colitis For the treatment of moderate to severe ulcerative colitis in patients who meet the following criteria: A. Mayo score greater than or equal to 6 with an endoscopic subscore* of at least 2 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Adalimumab is being used to induce remission or as a steroid-sparing maintenance therapy. *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. The recommended induction dosing regimen is up to 160mg at week 0, followed by up to 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., Mayo score less than 6), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory disease will not be funded. Patients with mild ulcerative colitis (e.g., Mayo score less than 6) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of patients with active moderate to severe hidradenitis suppurativa (HS) who have not responded to conventional therapy (including systemic antibiotics) and who meet all of the following: A. A total abscess and nodule count of 3 or greater; AND B. Lesions in at least two distinct anatomic areas, one of which must be Hurley Stage II or III; AND C. Experienced an inadequate response to a 90-day trial of oral antibiotics. Therapy must be prescribed by a practitioner with expertise in the management of patients with HS. The recommended adult dosing regimen is 160mg at week 0, followed by 80mg at week 2, then 40mg at week 4, and 40mg weekly thereafter. The recommended adolescent dosing regimen is 80mg at week 0, followed by 40mg every other week starting at week 1 up to 40mg weekly in those with inadequate response. If there is no improvement after 12 weeks of treatment with adalimumab at the Health Canada approved dose, higher doses are not recommended and the prescriber should discontinue treatment. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Maintenance/Renewal: Maintenance therapy is funded for patients beyond the first 12 weeks in those who meet the Ministry initiation criteria and who have responded to treatment defined as at least a 50% reduction in abscesses and inflammatory nodule count with no increase in abscess count or draining fistula count relative to baseline. Maintenance therapy beyond the second year is funded for patients using adalimumab for HS, where there is objective evidence of the preservation of treatment effect (i.e. the current abscess and inflammatory nodule count should be compared to the count prior to initiating treatment with adalimumab). The recommended maintenance dose is 40mg weekly. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.LU Authorization Period: 1 yearFor the treatment of severe* plaque psoriasis in patients 18 years of age or older who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies**. Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. *Definition of severe plaque psoriasis: Body Surface Area (BSA) involvement of at least 10 percent, or involvement of the face, hands, feet or genital regions, AND Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND Dermatology Life Quality Index (DLQI) score of at least 10. **Definition of failure, intolerance or contraindication to adequate trials of standard therapies: 6 month trial of at least 3 topical agents including vitamin D analogues and steroids 12 week trial of phototherapy (unless not accessible) 6 month trial of at least 2 systemic, oral agents used alone or in combination - Methotrexate 15-30mg per week - Acitretin (could have been used with phototherapy) - Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: - at least a 50% reduction in PASI, AND - at least a 50% reduction in BSA involvement, AND - at least a 5 point reduction in DLQI score Approvals will only allow for standard dosing for adalimumab. The recommended dose is an initial 80mg administered subcutaneously at week 0, followed by 40mg subcutaneously given every other week starting at week 1, as approved by Health Canada. If the patient has not responded adequately after 12 weeks of treatment at the Health Canada approved dose, higher doses are not recommended, and the physician should consider switching to an alternative biologic agent.LU Authorization Period: 1 yearPolyarticular Juvenile Idiopathic Arthritis For the treatment of polyarticular juvenile idiopathic arthritis (pJIA) in patients who have active disease (greater than or equal to 3 swollen joints and greater than or equal to 5 active joints) despite a trial of optimal doses of subcutaneously administered methotrexate (i.e. 15mg/m2 per week) for at least 3 months. If the patient is unable to tolerate or has a contraindication to subcutaneous methotrexate, the nature of the intolerance or contraindication should be documented. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. The recommended dosing regimen is for pediatric patients 2 years of age and older: - 30kg and greater: 40mg every other week Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. LU Authorization Period: 1 yearFor the treatment of severe uveitis in patients meeting the following criteria: A. Has experienced failure or intolerance to an oral corticosteroid (or topical corticosteroid for anterior uveitis) or where the use of corticosteroids is contraindicated, and has experienced failure or intolerance to at least one immunosuppressive therapy; AND B. Treatment must be prescribed by an ophthalmologist specialized in uveitis or retinal disease, a uveitis specialist, or a retina specialist familiar with ocular inflammatory diseases. Requests not meeting the above criteria may be considered on a case-by-case basis through the Exceptional Access Program. The recommended adult dose is an initial 80mg administered subcutaneously at week 0, followed by 40mg subcutaneously given every other week starting at week 1, as approved by Health Canada. Note: Higher doses up to 40mg weekly may be considered in patients who have failed to respond to lower doses. The recommended dose for pediatric patients (2 years or older) with anterior uveitis is: 30kg or greater: 40mg every other week in combination with methotrexate For patients 6 years of age or older and weighing 30kg or greater, an optional loading dose of 80mg at week 0 may be administered before starting maintenance therapy. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Maintenance/Renewals: Maintenance therapy is funded for patients who meet the Ministry initiation criteria and who have experienced improvement and/or stability of vision and other treatment goals (e.g. reduction or control of ocular inflammation).LU Authorization Period: 1 year235580mg/0.8mLInj Sol-0.8mL Pref Syr (Preservative-Free)HyrimozSDZ942.54002024-04-30942.5400For the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or, anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments: A. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide (20mg/day) for at least 3 months, in addition to iii) an adequate trial of at least one combination of DMARDs for 3 months; OR B. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide in combination with methotrexate for at least 3 months; OR C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.) Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For renewals beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. Approvals will only allow for standard dosing for adalimumab. The recommended dosing regimen is 40mg every two weeks.LU Authorization Period: 1 yearFor the treatment of polyarticular juvenile idiopathic arthritis (pJIA) in patients who have active disease (greater than or equal to 3 swollen joints and greater than or equal to 5 active joints) despite a trial of optimal doses of subcutaneously administered methotrexate (i.e. 15mg/m2 per week) for at least 3 months. If the patient is unable to tolerate or has a contraindication to subcutaneous methotrexate, the nature of the intolerance or contraindication should be documented. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. The recommended dosing regimen is for pediatric patients 2 years of age and older: - 10kg to less than 30kg: 20mg every other week* - 30kg and greater: 40mg every other week *a dose of 10mg every other week can be considered for patients weighing 10kg to less than 15kg It should be noted that some adalimumab products may not be available as 20mg injectables. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.LU Authorization Period: 1 yearFor the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite: i) treatment with methotrexate (20mg/week) for at least 3 months; AND ii) one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months. If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months is required. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must have objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 40mg every 2 weeks. Higher doses may be considered case-by-case through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of ankylosing spondylitis (AS) in patients who have severe active disease confirmed by radiographic evidence (see note below) with: - Age of disease onset equal to or younger than 50; AND - Low back pain and stiffness for greater than 3 months that improves with exercise and not relieved by rest; AND - Failure to respond to or documented intolerance to adequate trials of 2 non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks each; AND - Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of greater than or equal to 4 for at least 4 weeks while on standard therapy. Note: Radiographic evidence demonstrating the presence of "SI joint fusion" or "SI joint erosion" on x-ray or CT scan, or MRI demonstrating the presence of "inflammation" or "edema" of the SI joint. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 50 percent reduction in BASDAI score or greater than or equal to 2 absolute point reduction in BASDAI score. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 40mg every 2 weeks. Higher doses may be considered case-by-case through the Exceptional Access Program.LU Authorization Period: 1 yearLuminal Crohn's disease For the treatment of moderate to severe (luminal) Crohn's disease in patients who meet the following criteria: A. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine, methotrexate); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Adalimumab is being used to induce remission or as a steroid-sparing maintenance therapy. The recommended induction dosing regimen is 160mg at week 0, followed by 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., HBI score decrease greater than or equal to 50% from pre-treatment measurement), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. Patients with mild Crohn's disease (e.g., HBI less than 7) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFistulising Crohn's disease For the treatment of fistulising Crohn's disease with concomitant luminal disease in patients who meet the following criteria: A. Patient has actively draining perianal or enterocutaneous fistula(e) that have recurred OR persist despite a course of appropriate antibiotic therapy (e.g., ciprofloxacin and/or metronidazole); AND B. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease) The recommended induction dosing regimen is 160mg at week 0, followed by 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and achieve and maintain response to therapy (e.g., partial or complete resolution of fistulae and symptom improvement). Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded.LU Authorization Period: 1 yearUlcerative Colitis For the treatment of moderate to severe ulcerative colitis in patients who meet the following criteria: A. Mayo score greater than or equal to 6 with an endoscopic subscore* of at least 2 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Adalimumab is being used to induce remission or as a steroid-sparing maintenance therapy. *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. The recommended induction dosing regimen is up to 160mg at week 0, followed by up to 80mg at week 2. The recommended maintenance dosing regimen is up to 40mg every 2 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., Mayo score less than 6), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory disease will not be funded. Patients with mild ulcerative colitis (e.g., Mayo score less than 6) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFor the treatment of patients with active moderate to severe hidradenitis suppurativa (HS) who have not responded to conventional therapy (including systemic antibiotics) and who meet all of the following: A. A total abscess and nodule count of 3 or greater; AND B. Lesions in at least two distinct anatomic areas, one of which must be Hurley Stage II or III; AND C. Experienced an inadequate response to a 90-day trial of oral antibiotics. Therapy must be prescribed by a practitioner with expertise in the management of patients with HS. The recommended adult dosing regimen is 160mg at week 0, followed by 80mg at week 2, then 40mg at week 4, and 40mg weekly thereafter. The recommended adolescent dosing regimen is 80mg at week 0, followed by 40mg every other week starting at week 1 up to 40mg weekly in those with inadequate response. If there is no improvement after 12 weeks of treatment with adalimumab at the Health Canada approved dose, higher doses are not recommended and the prescriber should discontinue treatment. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Maintenance/Renewal: Maintenance therapy is funded for patients beyond the first 12 weeks in those who meet the Ministry initiation criteria and who have responded to treatment defined as at least a 50% reduction in abscesses and inflammatory nodule count with no increase in abscess count or draining fistula count relative to baseline. Maintenance therapy beyond the second year is funded for patients using adalimumab for HS, where there is objective evidence of the preservation of treatment effect (i.e. the current abscess and inflammatory nodule count should be compared to the count prior to initiating treatment with adalimumab). The recommended maintenance dose is 40mg weekly. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.LU Authorization Period: 1 yearFor the treatment of severe* plaque psoriasis in patients 18 years of age or older who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies**. Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. *Definition of severe plaque psoriasis: Body Surface Area (BSA) involvement of at least 10 percent, or involvement of the face, hands, feet or genital regions, AND Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND Dermatology Life Quality Index (DLQI) score of at least 10. **Definition of failure, intolerance or contraindication to adequate trials of standard therapies: 6 month trial of at least 3 topical agents including vitamin D analogues and steroids 12 week trial of phototherapy (unless not accessible) 6 month trial of at least 2 systemic, oral agents used alone or in combination - Methotrexate 15-30mg per week - Acitretin (could have been used with phototherapy) - Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: - at least a 50% reduction in PASI, AND - at least a 50% reduction in BSA involvement, AND - at least a 5 point reduction in DLQI score Approvals will only allow for standard dosing for adalimumab. The recommended dose is an initial 80mg administered subcutaneously at week 0, followed by 40mg subcutaneously given every other week starting at week 1, as approved by Health Canada. If the patient has not responded adequately after 12 weeks of treatment at the Health Canada approved dose, higher doses are not recommended, and the physician should consider switching to an alternative biologic agent.LU Authorization Period: 1 yearFor the treatment of severe uveitis in patients meeting the following criteria: A. Has experienced failure or intolerance to an oral corticosteroid (or topical corticosteroid for anterior uveitis) or where the use of corticosteroids is contraindicated, and has experienced failure or intolerance to at least one immunosuppressive therapy; AND B. Treatment must be prescribed by an opthalmologist specialized in uveitis or retinal disease, a uveitis specialist, or a retina specialist familiar with ocular inflammatory diseases. Requests not meeting the above criteria may be considered on a case-by-case basis through the Exceptional Access Program. The recommended adult dose is an initial 80mg administered subcutaneously at week 0, followed by 40mg subsubcutaneously given every other week starting at week 1, as approved by Health Canada. Note: Higher doses up to 40mg weekly may be considered in patients who have failed to respond to lower doses. The recommended dose for pediatric patients (2 years of age and older) with anterior uveitis is: Less than 30kg: 20mg every other week in combination with methotrexate 30kg or greater: 40mg every other week in combination with methotrexate For patients 6 years of age or older and less than 30kg, an optional loading dose of 40mg at week 0 may be administered before starting maintenance therapy. For patients 6 years of age or older and weighing 30kg or greater, an optional loading dose of 80mg at week 0 may be administered before starting maintenance therapy. It should be noted that some adalimumab products may not be available as 20mg injectables. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats. Maintenance/Renewals: Maintenance therapy is funded for patients who meet the Ministry initiation criteria and who have experienced improvement and/or stability of vision and other treatment goals (e.g. reduction or control of ocular inflammation).LU Authorization Period: 1 yearAPREMILAST235630mgTabOtezlaAMG2023-01-31GLN-ApremilastGLP18.72382023-01-31PMS-ApremilastPMS18.72382023-01-31Auro-ApremilastAUR18.72372023-03-31Mint-ApremilastMIN18.72382023-04-28Jamp ApremilastJPC18.72382023-03-31Sandoz ApremilastSDZ18.72382023-01-31Apo-ApremilastAPX18.72382023-09-28235710mg & 20mg & 30mgTab-27 Blister Starter PkOtezlaAMG2023-03-31Auro-ApremilastAUR505.54262023-05-31Jamp ApremilastJPC505.54262023-03-31Sandoz ApremilastSDZ505.54262024-01-31ETANERCEPT235825mg/0.5mLInj Sol-0.5mL Pref Syr PkErelziSDZ120.50002017-12-21120.5000235950mg/mLInj Sol-1mL Pref Syr PkErelziSDZ241.00002017-12-21241.0000236050mg/mLInj Sol-1mL Prefilled SensoReady Pen PkErelziSDZ241.00002017-12-21241.0000For the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or, anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments: A. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide (20mg/day) for at least 3 months, in addition to iii) an adequate trial of at least one combination of DMARDs for 3 months; OR B. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide in combination with methotrexate for at least 3 months; OR C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine(400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.) Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For renewals beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 50mg per week or 25mg twice weekly.LU Authorization Period: 1 yearFor the treatment of ankylosing spondylitis (AS) in patients who have severe active disease confirmed by radiographic evidence (see note below) with: - Age of disease onset equal to or younger than 50; AND - Low back pain and stiffness for greater than 3 months that improves with exercise and not relieved by rest; AND - Failure to respond to or documented intolerance to adequate trials of 2 non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks each; AND - Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of greater than or equal to 4 for at least 4 weeks while on standard therapy. NOTE: Radiographic evidence demonstrating the presence of "SI joint fusion" or "SI joint erosion" on x-ray or CT scan, or MRI demonstrating the presence of "inflammation" or "edema" of the SI joint. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 50 percent reduction in BASDAI score or greater than or equal to 2 absolute point reduction in BASDAI score. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 50mg per week or 25mg twice weekly.LU Authorization Period: 1 yearFor the treatment of polyarticular juvenile idiopathic arthritis (pJIA) in patients who have active disease (greater than or equal to 3 swollen joints and greater than or equal to 5 active joints) despite a trial of optimal doses of subcutaneously administered methotrexate (i.e. 15mg/m2 per week) for at least 3 months. If the patient is unable to tolerate or has a contraindication to subcutaneous methotrexate, the nature of the intolerance or contraindication should be documented. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. The recommended dosing regimen for pediatric patients ages 4 to 17 years with active pJIA is 0.8mg/kg per week (up to a maximum of 50mg per week). Prescribers should be informed and stay current with a drug's official Health Canada product monograph including available dosage formats.LU Authorization Period: 1 yearFor the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite treatment with methotrexate (20mg/week) for at least 3 months and one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20% reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For renewals beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 50mg per week or 25mg twice weekly. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.LU Authorization Period: 1 yearFor the treatment of severe* plaque psoriasis in patients who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies**. Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. * Definition of severe plaque psoriasis: Body Surface Area (BSA) involvement of at least 10%, or involvement of the face, hands, feet or genital regions, AND Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND Dermatology Life Quality Index (DLQI) score of at least 10. ** Definition of failure, intolerance or contraindication to adequate trials of standard therapies: 6 month trial of at least 3 topical agents including vitamin D analogues and steroids, AND 12 week trial of phototherapy (unless not accessible), AND 6 month trial of at least 2 systemic, oral agents used alone or in combination -Methotrexate 15-30mg per week -Acitretin (could have been used with phototherapy) -Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: -At least a 50% reduction in PASI, AND -at least a 50% reduction in BSA involvement, AND -at least a 5 point reduction in DLQI score Approvals will only allow for standard dosing for etanercept: The recommended dose is 50mg subcutaneous twice weekly for 12 weeks followed by maintenance therapy at 25-50mg subcutaneous once weekly as approved by Health Canada. If the patient has not responded adequately after 12 weeks of treatment at the Health Canada approved dose, higher doses are not recommended and the physician should consider switching to an alternative biologic agent. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.LU Authorization Period: 1 year236150mg/mLInj Sol-Pref Autoinj PenRymtiLUP236.18002024-03-28236.1800236250mg/mLInj Sol-Pref SyrBrenzysSAM236.18002017-07-31236.1800236350mg/mLInj Sol-Pref SyrRymtiLUP236.18002024-03-28236.1800236450mg/mLSol- Pref AutoInjBrenzysSAM236.18002017-07-31236.1800For the treatment of ankylosing spondylitis (AS) in patients who have severe active disease confirmed by radiographic evidence (see note below) with: - Age of disease onset less than or equal to 50; AND - Low back pain and stiffness for greater than 3 months that improves with exercise and not relieved by rest; AND - Failure to respond to or documented intolerance to adequate trials of 2 non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks each; AND - Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of greater than or equal to 4 for at least 4 weeks while on standard therapy. NOTE: Radiographic evidence demonstrating the presence of "SI joint fusion" or "SI joint erosion" on x-ray or CT scan, or MRI demonstrating the presence of "inflammation" or "edema" of the SI joint. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 50 percent reduction in BASDAI score or greater than or equal to 2 absolute point reduction in BASDAI score. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 50mg per week.LU Authorization Period: 1 yearFor the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or, anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments: A. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide (20mg/day) for at least 3 months, in addition to iii) an adequate trial of at least one combination of DMARDs for 3 months; OR B. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide in combination with methotrexate for at least 3 months; OR C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine(400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.) Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For renewals beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 50mg per week.LU Authorization Period: 1 yearFor the treatment of polyarticular juvenile idiopathic arthritis (pJIA) in patients who have active disease (greater than or equal to 3 swollen joints and greater than or equal to 5 active joints) despite a trial of optimal doses of subcutaneously administered methotrexate (i.e. 15mg/m2 per week) for at least 3 months. If the patient is unable to tolerate or has a contraindication to subcutaneous methotrexate, the nature of the intolerance or contraindication should be documented. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. The recommended dosing regimen for pediatric patients ages 4 to 17 years with active pJIA is 0.8mg/kg per week (up to a maximum of 50mg per week). Prescribers should be informed and stay current with a drug's official Health Canada product monograph including available dosage formats.LU Authorization Period: 1 yearFor the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite treatment with methotrexate (20mg/week) for at least 3 months and one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20% reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For renewals beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 50mg per week or 25mg twice weekly. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.LU Authorization Period: 1 yearFor the treatment of severe* plaque psoriasis in patients who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies**. Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. * Definition of severe plaque psoriasis: Body Surface Area (BSA) involvement of at least 10%, or involvement of the face, hands, feet or genital regions, AND Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND Dermatology Life Quality Index (DLQI) score of at least 10. ** Definition of failure, intolerance or contraindication to adequate trials of standard therapies: 6 month trial of at least 3 topical agents including vitamin D analogues and steroids, AND 12 week trial of phototherapy (unless not accessible), AND 6 month trial of at least 2 systemic, oral agents used alone or in combination -Methotrexate 15-30mg per week -Acitretin (could have been used with phototherapy) -Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: -At least a 50% reduction in PASI, AND -at least a 50% reduction in BSA involvement, AND -at least a 5 point reduction in DLQI score Approvals will only allow for standard dosing for etanercept: The recommended dose is 50mg subcutaneous twice weekly for 12 weeks followed by maintenance therapy at 25-50mg subcutaneous once weekly as approved by Health Canada. If the patient has not responded adequately after 12 weeks of treatment at the Health Canada approved dose, higher doses are not recommended and the physician should consider switching to an alternative biologic agent. Prescribers should be informed and stay current with a drug's official Health Canada approved product monograph including available dosage formats.LU Authorization Period: 1 yearINFLIXIMAB2365100mg/VialInj Pd-Vial PkRemdantryCEI493.00002016-02-25493.0000For the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or, anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments: A. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide (20mg/day) for at least 3 months, in addition to iii) an adequate trial of at least one combination of DMARDs for 3 months; OR B. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide in combination with methotrexate for at least 3 months; OR C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.) Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For renewals beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 3mg/kg/dose at 0, 2 and 6 weeks followed by maintenance therapy of 3mg/kg/dose every 8 weeks up to a maximum of six maintenance doses per year.LU Authorization Period: 1 yearFor the treatment of ankylosing spondylitis (AS) in patients who have severe active disease (confirmed by radiographic evidence (see notes below) with: -Age of disease onset less than or equal to 50; AND -Low back pain and stiffness for greater than 3 months that improves with exercise and not relieved by rest; AND -Failure to respond to or documented intolerance to adequate trials of 2 non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks each; AND -Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of greater than or equal to 4 for at least 4 weeks while on standard therapy. Note: Radiographic evidence demonstrating the presence of "SI joint fusion" or "SI joint erosion" on x-ray or CT scan, or MRI demonstrating the presence of "inflammation" or "edema" of the SI joint. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 50 percent reduction in BASDAI score or greater than or equal to 2 absolute point reduction in BASDAI score. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 3 to 5mg/kg/dose at 0, 2 and 6 weeks followed by maintenance therapy of up to 5mg/kg/dose every 6 to 8 weeks.LU Authorization Period: 1 yearFor the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite: i) treatment with methotrexate (20mg/week) for at least 3 months; AND ii) one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months. If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months is required. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must have objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 5mg/kg/dose at 0, 2 and 6 weeks followed by maintenance therapy of 5mg/kg/dose every 8 weeks. LU Authorization Period: 1 yearFor the treatment of severe (see Note 1 below) plaque psoriasis in patients 18 years of age or older who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies (see Note 2 below). Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. Note 1: Definition of severe plaque psoriasis: -Body Surface Area (BSA) involvement of at least 10 percent, or involvement of the face, hands, feet or genital regions, AND -Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND -Dermatology Life Quality Index (DLQI) score of at least 10. Note 2: Definition of failure, intolerance or contraindication to adequate trials of standard therapies: -6 month trial of at least 3 topical agents including vitamin D analogues and steroids, AND -12 week trial of phototherapy (unless not accessible), AND -6 month trial of at least 2 systemic, oral agents used alone or in combination -Methotrexate 15 to 30mg/week -Acitretin (could have been used with phototherapy) -Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: -At least a 50 percent reduction in PASI, AND -at least a 50 percent reduction in BSA involvement, AND -at least a 5 point reduction in DLQI score The recommended dosing regimen is 5mg/kg/dose at 0, 2 and 6 weeks followed by maintenance therapy of 5mg/kg/dose every 8 weeks.LU Authorization Period: 1 yearUlcerative Colitis For the treatment of moderate to severe ulcerative colitis in patients who meet the following criteria: A. Mayo score greater than or equal to 6 with an endoscopic subscore* of at least 2 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Infliximab is being used to induce remission or as a steroid-sparing maintenance therapy. *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. The recommended induction dosing regimen is 5mg/kg/dose at 0, 2, and 6 weeks. The recommended maintenance dosing regimen is 5mg/kg/dose every 8 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., Mayo score less than 6), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. Patients with mild ulcerative colitis (e.g., Mayo score less than 6) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearLuminal Crohn's disease For the treatment of moderate to severe (luminal) Crohn's disease in patients who meet the following criteria: A. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine, methotrexate); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Infliximab is being used to induce remission or as a steroid-sparing maintenance therapy. The recommended induction dosing regimen is 5mg/kg/dose at 0, 2, and 6 weeks. The recommended maintenance dosing regimen is 5mg/kg/dose every 8 weeks. (Note: higher doses up to 10mg/kg/dose may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., HBI score decrease greater than or equal to 50% from pre-treatment measurement), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. Patients with mild Crohn's disease (e.g., HBI less than 7) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFistulising Crohn's disease For the treatment of fistulising Crohn's disease in patients who meet the following criteria: - Patient has actively draining perianal or enterocutaneous fistula(e) that have recurred OR persist despite a course of appropriate antibiotic therapy (e.g., ciprofloxacin and/or metronidazole) The recommended induction dosing regimen is 5mg/kg/dose at 0, 2, and 6 weeks. The recommended maintenance dosing regimen is 5mg/kg/dose every 8 weeks. (Note: higher doses up to 10mg/kg/dose may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and achieve and maintain response to therapy (e.g., partial or complete resolution of fistulae and symptom improvement). Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded.LU Authorization Period: 1 year2366100mg/VialInj Pd-Vial PkRenflexisSAM493.00002018-09-27493.0000For the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or, anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments: A. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide (20mg/day) for at least 3 months, in addition to iii) an adequate trial of at least one combination of DMARDs for 3 months; OR B. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide in combination with methotrexate for at least 3 months; OR C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.) Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For renewals beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 3mg/kg/dose at 0, 2 and 6 weeks followed by maintenance therapy of 3mg/kg/dose every 8 weeks up to a maximum of six maintenance doses per year.LU Authorization Period: 1 yearFor the treatment of ankylosing spondylitis (AS) in patients who have severe active disease confirmed by radiographic evidence (see notes below) with: I. Age of disease onset less than or equal to 50; AND II. Low back pain and stiffness for greater than 3 months that improves with exercise and not relieved by rest; AND III. Failure to respond to or documented intolerance to adequate trials of 2 non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks each; AND IV. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of greater than or equal to 4 for at least 4 weeks while on standard therapy. Note: Radiographic evidence demonstrating the presence of "SI joint fusion" or "SI joint erosion" on x-ray or CT scan, or MRI demonstrating the presence of "inflammation" or "edema" of the SI joint. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 50 percent reduction in BASDAI score or greater than or equal to 2 absolute point reduction in BASDAI score. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 3 to 5mg/kg/dose at 0, 2 and 6 weeks followed by maintenance therapy of up to 5mg/kg/dose every 6 to 8 weeks.LU Authorization Period: 1 yearFor the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite: i) treatment with methotrexate (20mg/week) for at least 3 months; AND ii) one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months. If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months is required. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must have objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 5mg/kg/dose at 0, 2 and 6 weeks followed by maintenance therapy of 5mg/kg/dose every 8 weeks.LU Authorization Period: 1 yearFor the treatment of severe* plaque psoriasis in patients 18 years of age or older who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies**. Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. *Severe plaque psoriasis: - Body Surface Area (BSA) involvement of at least 10 percent, or involvement of the face, hands, feet or genital regions, AND - Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND - Dermatology Life Quality Index (DLQI) score of at least 10. **Failure, intolerance or contraindication to adequate trials of standard therapies: -6 month trial of at least 3 topical agents including vitamin D analogues and steroids, AND - 12 week trial of phototherapy (unless not accessible), AND - 6 month trial of at least 2 systemic, oral agents used alone or in combination - Methotrexate 15 to 30mg/week - Acitretin (could have been used with phototherapy) - Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: - At least a 50% reduction in PASI, AND - at least a 50% reduction in BSA involvement, AND - at least a 5 point reduction in DLQI score The recommended dosing regimen is 5mg/kg/dose at 0, 2 and 6 weeks followed by maintenance therapy of 5mg/kg/dose every 8 weeks.LU Authorization Period: 1 yearUlcerative Colitis For the treatment of moderate to severe ulcerative colitis in patients who meet the following criteria: A. Mayo score greater than or equal to 6 with an endoscopic subscore* of at least 2 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Infliximab is being used to induce remission or as a steroid-sparing maintenance therapy. *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. The recommended induction dosing regimen is 5mg/kg/dose at 0,2, and 6 weeks. The recommended maintenance dosing regimen is 5mg/kg/dose every 8 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., Mayo score less than 6), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): -Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. Patients with mild ulcerative colitis (e.g., Mayo score less than 6) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearLuminal Crohn's disease For the treatment of moderate to severe (luminal) Crohn's disease in patients who meet the following criteria: A. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine, methotrexate); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Infliximab is being used to induce remission or as a steroid-sparing maintenance therapy. The recommended induction dosing regimen is 5mg/kg/dose at 0, 2, and 6 weeks. The recommended maintenance dosing regimen is 5mg/kg/dose every 8 weeks. (Note: higher doses up to 10mg/kg/dose may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., HBI score decrease greater than or equal to 50% from pre-treatment measurement), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. Patients with mild Crohn's disease (e.g., HBI less than 7) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFistulising Crohn's disease For the treatment of fistulising Crohn's disease in patients who meet the following criteria: - Patient has actively draining perianal or enterocutaneous fistula(e) that have recurred OR persist despite a course of appropriate antibiotic therapy (e.g., ciprofloxacin and/or metronidazole) The recommended induction dosing regimen is 5mg/kg/dose at 0, 2, and 6 weeks. The recommended maintenance dosing regimen is 5mg/kg/dose every 8 weeks. (Note: higher doses up to 10mg/kg/dose may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and achieve and maintain response to therapy (e.g., partial or complete resolution of fistulae and symptom improvement). Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded.LU Authorization Period: 1 year2367100mg/VialInj Pd-Vial PkIxifiPFI493.00002025-04-30493.0000For the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or, anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments: A. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide (20mg/day) for at least 3 months, in addition to iii) an adequate trial of at least one combination of DMARDs for 3 months; OR B. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide in combination with methotrexate for at least 3 months; OR C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.) Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For renewals beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 3mg/kg/dose at 0, 2 and 6 weeks followed by maintenance therapy of 3mg/kg/dose every 8 weeks up to a maximum of six maintenance doses per year.LU Authorization Period: 1 yearFor the treatment of ankylosing spondylitis (AS) in patients who have severe active disease (confirmed by radiographic evidence (see notes below) with: -Age of disease onset less than or equal to 50; AND -Low back pain and stiffness for greater than 3 months that improves with exercise and not relieved by rest; AND -Failure to respond to or documented intolerance to adequate trials of 2 non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks each; AND -Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of greater than or equal to 4 for at least 4 weeks while on standard therapy. Note: Radiographic evidence demonstrating the presence of "SI joint fusion" or "SI joint erosion" on x-ray or CT scan, or MRI demonstrating the presence of "inflammation" or "edema" of the SI joint. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 50 percent reduction in BASDAI score or greater than or equal to 2 absolute point reduction in BASDAI score. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 3 to 5mg/kg/dose at 0, 2 and 6 weeks followed by maintenance therapy of up to 5mg/kg/dose every 6 to 8 weeks.LU Authorization Period: 1 yearFor the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite: i) treatment with methotrexate (20mg/week) for at least 3 months; AND ii) one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months. If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months is required. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must have objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 5mg/kg/dose at 0, 2 and 6 weeks followed by maintenance therapy of 5mg/kg/dose every 8 weeks. LU Authorization Period: 1 yearFor the treatment of severe (see Note 1 below) plaque psoriasis in patients 18 years of age or older who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies (see Note 2 below). Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. Note 1: Definition of severe plaque psoriasis: -Body Surface Area (BSA) involvement of at least 10 percent, or involvement of the face, hands, feet or genital regions, AND -Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND -Dermatology Life Quality Index (DLQI) score of at least 10. Note 2: Definition of failure, intolerance or contraindication to adequate trials of standard therapies: -6 month trial of at least 3 topical agents including vitamin D analogues and steroids, AND -12 week trial of phototherapy (unless not accessible), AND -6 month trial of at least 2 systemic, oral agents used alone or in combination -Methotrexate 15 to 30mg/week -Acitretin (could have been used with phototherapy) -Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: -At least a 50 percent reduction in PASI, AND -at least a 50 percent reduction in BSA involvement, AND -at least a 5 point reduction in DLQI score The recommended dosing regimen is 5mg/kg/dose at 0, 2 and 6 weeks followed by maintenance therapy of 5mg/kg/dose every 8 weeks.LU Authorization Period: 1 yearUlcerative Colitis For the treatment of moderate to severe ulcerative colitis in patients who meet the following criteria: A. Mayo score greater than or equal to 6 with an endoscopic subscore* of at least 2 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Infliximab is being used to induce remission or as a steroid-sparing maintenance therapy. *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. The recommended induction dosing regimen is 5mg/kg/dose at 0, 2, and 6 weeks. The recommended maintenance dosing regimen is 5mg/kg/dose every 8 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., Mayo score less than 6), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. Patients with mild ulcerative colitis (e.g., Mayo score less than 6) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearLuminal Crohn's disease For the treatment of moderate to severe (luminal) Crohn's disease in patients who meet the following criteria: A. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine, methotrexate); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Infliximab is being used to induce remission or as a steroid-sparing maintenance therapy. The recommended induction dosing regimen is 5mg/kg/dose at 0, 2, and 6 weeks. The recommended maintenance dosing regimen is 5mg/kg/dose every 8 weeks. (Note: higher doses up to 10mg/kg/dose may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., HBI score decrease greater than or equal to 50% from pre-treatment measurement), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. Patients with mild Crohn's disease (e.g., HBI less than 7) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFistulising Crohn's disease For the treatment of fistulising Crohn's disease in patients who meet the following criteria: - Patient has actively draining perianal or enterocutaneous fistula(e) that have recurred OR persist despite a course of appropriate antibiotic therapy (e.g., ciprofloxacin and/or metronidazole) The recommended induction dosing regimen is 5mg/kg/dose at 0, 2, and 6 weeks. The recommended maintenance dosing regimen is 5mg/kg/dose every 8 weeks. (Note: higher doses up to 10mg/kg/dose may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and achieve and maintain response to therapy (e.g., partial or complete resolution of fistulae and symptom improvement). Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded.LU Authorization Period: 1 year2368120mg/mLInj Sol-1mL Pref Pen Pk (Preservative-Free)Remsima SCCEH474.51002025-02-28474.51002369120mg/mLInj Sol-1mL Pref Syr Pk (Preservative-Free)Remsima SCCEH474.51002025-02-28474.5100For the treatment of rheumatoid arthritis (RA) in adult patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or, anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments: A. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide (20mg/day) for at least 3 months, in addition to iii) an adequate trial of at least one combination of DMARDs for 3 months; OR B. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide in combination with methotrexate for at least 3 months; OR C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.) Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For renewals beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. Recommended dose: Refer to the product monograph for full instructions. Loading dose of 120mg subcutaneous (SC) at week 0, 1, 2, 3, and 4, followed by maintenance with 120mg SC infliximab every 2 weeks thereafter. OR If intravenous loading doses of infliximab are given to initiate treatment, 2 intravenous infusions of infliximab 3mg/kg should be given 2 weeks apart, and the first dose of 120mg infliximab SC should be initiated 4 weeks after the second IV infliximab dose. Maintenance dose: 120mg SC once every 2 weeks. Infliximab SC should be given in combination with methotrexate. Note: There is insufficient information available to inform the use of appropriate SC dosing in patients who are using infliximab intravenously at doses greater than 3mg/kg for rheumatoid arthritis. LU Authorization Period: 1 yearI. For the treatment of moderate to severe ulcerative colitis in adult patients who meet the following criteria: A. Mayo score greater than or equal to 6 with an endoscopic subscore* of at least 2 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine) and subcutaneous (SC) infliximab is used as a steroid-sparing option in the maintenance setting; OR Conventional treatment with a corticosteroid is contraindicated; AND C. SC infliximab is being used in the maintenance setting after completing an induction regimen with intravenously administered infliximab; OR II. SC infliximab is being used in the maintenance setting in a patient stabilized on intravenous infliximab** in the maintenance setting. *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. **Note that there is insufficient information to inform the use and appropriate dosing of infliximab SC in patients who are using infliximab intravenously at doses greater than 5mg/kg for ulcerative colitis. Approved doses: 120mg SC every 2 weeks as maintenance dosing. The recommended maintenance dosing regimen is 120mg (given as one subcutaneous injection) once every 2 weeks, starting 4 weeks following completion of an induction regimen. For patients who have been on maintenance therapy with intravenous infliximab and who are switching to subcutaneous infliximab maintenance therapy, the first dose of subcutaneous infliximab may be administered 8 weeks after the last infliximab intravenous infusion. Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., Mayo score less than 6), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (Applies to both initial and renewal coverage): - Combination therapy with other advanced treatment options such as, biological treatments, sphingosine-1-phosphate receptor modulators, or JAK inhibitors used to treat inflammatory bowel disease will not be funded. Patients with mild ulcerative colitis (e.g., Mayo score less than 6) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearI. For the treatment of moderate to severe (luminal) Crohn's disease in adult patients who meet the following criteria: A. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine, methotrexate) and infliximab subcutaneous (SC) is used as a steroid-sparing option in the maintenance setting; OR Conventional treatment with a corticosteroid is contraindicated; AND C. SC infliximab is being used in the maintenance setting after completing an induction regimen with intravenously administered infliximab OR II. SC infliximab is being used in the maintenance setting in a patient stabilized on intravenous infliximab** in the maintenance setting. Approved doses: 120mg SC every 2 weeks as maintenance dosing. The recommended maintenance dosing regimen is 120mg (given as one subcutaneous injection) once every 2 weeks, starting 4 weeks following completion of an induction regimen. For patients who have been on maintenance therapy with intravenous infliximab and who are switching to subcutaneous infliximab maintenance therapy, the first dose of subcutaneous infliximab may be administered 8 weeks after the last infliximab intravenous infusion. **Note that there is insufficient information to inform the use and appropriate dosing of infliximab SC in patients who are using infliximab intravenously at doses greater than 5mg/kg for Crohn's disease. Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., HBI score decrease greater than or equal to 50% from pre-treatment measurement), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (Applies to both initial and renewal coverage): - Combination therapy with other advanced treatment options such as, biological treatments, or JAK inhibitors used to treat Crohn's disease will not be funded. Patients with mild Crohn's disease (e.g., HBI less than 7) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 year2370100mg/VialPd for Sol-Vial PkAvsolaAMG493.00002020-12-18493.0000For the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or, anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments: A. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide (20mg/day) for at least 3 months, in addition to iii) an adequate trial of at least one combination of DMARDs for 3 months; OR B. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide in combination with methotrexate for at least 3 months; OR C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.) Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For renewals beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 3mg/kg/dose at 0, 2 and 6 weeks followed by maintenance therapy of 3mg/kg/dose every 8 weeks up to a maximum of six maintenance doses per year.LU Authorization Period: 1 yearFor the treatment of ankylosing spondylitis (AS) in patients who have severe active disease confirmed by radiographic evidence (see notes below) with: I. Age of disease onset less than or equal to 50; AND II. Low back pain and stiffness for greater than 3 months that improves with exercise and not relieved by rest; AND III. Failure to respond to or documented intolerance to adequate trials of 2 non-steroidal anti-inflammatory drugs (NSAIDs) for at least 4 weeks each; AND IV. Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of greater than or equal to 4 for at least 4 weeks while on standard therapy. Note: Radiographic evidence demonstrating the presence of "SI joint fusion" or "SI joint erosion" on x-ray or CT scan, or MRI demonstrating the presence of "inflammation" or "edema" of the SI joint. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 50 percent reduction in BASDAI score or greater than or equal to 2 absolute point reduction in BASDAI score. For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 3 to 5mg/kg/dose at 0, 2 and 6 weeks followed by maintenance therapy of up to 5mg/kg/dose every 6 to 8 weeks.LU Authorization Period: 1 yearFor the treatment of psoriatic arthritis in patients who have severe active disease (greater than or equal to 5 swollen joints and radiographic evidence of psoriatic arthritis) despite: i) treatment with methotrexate (20mg/week) for at least 3 months; AND ii) one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months. If the patient has documented contraindications or intolerances to methotrexate, then only one of leflunomide (20mg/day) or sulfasalazine (1g twice daily) for at least 3 months is required. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For funding beyond the second year, the patient must have objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 5mg/kg/dose at 0, 2 and 6 weeks followed by maintenance therapy of 5mg/kg/dose every 8 weeks.LU Authorization Period: 1 yearFor the treatment of severe* plaque psoriasis in patients 18 years of age or older who have experienced failure, intolerance, or have a contraindication to adequate trials of several standard therapies**. Claims for the first 6 months must be written by a dermatologist. Monitoring of patients is required to determine if continuation of therapy beyond 12 weeks is required. Patients not responding adequately at 12 weeks should have treatment discontinued. *Severe plaque psoriasis: - Body Surface Area (BSA) involvement of at least 10 percent, or involvement of the face, hands, feet or genital regions, AND - Psoriasis Area and Severity Index (PASI) score of at least 10 (not required if there is involvement of the face, hands, feet or genital regions), AND - Dermatology Life Quality Index (DLQI) score of at least 10. **Failure, intolerance or contraindication to adequate trials of standard therapies: -6 month trial of at least 3 topical agents including vitamin D analogues and steroids, AND - 12 week trial of phototherapy (unless not accessible), AND - 6 month trial of at least 2 systemic, oral agents used alone or in combination - Methotrexate 15 to 30mg/week - Acitretin (could have been used with phototherapy) - Cyclosporine Maintenance/Renewal: After 3 months of therapy, patients who respond to therapy should have: - At least a 50% reduction in PASI, AND - at least a 50% reduction in BSA involvement, AND - at least a 5 point reduction in DLQI score The recommended dosing regimen is 5mg/kg/dose at 0, 2 and 6 weeks followed by maintenance therapy of 5mg/kg/dose every 8 weeks.LU Authorization Period: 1 yearUlcerative Colitis For the treatment of moderate to severe ulcerative colitis in patients who meet the following criteria: A. Mayo score greater than or equal to 6 with an endoscopic subscore* of at least 2 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Infliximab is being used to induce remission or as a steroid-sparing maintenance therapy. *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. The recommended induction dosing regimen is 5mg/kg/dose at 0, 2, and 6 weeks. The recommended maintenance dosing regimen is 5mg/kg/dose every 8 weeks. (Note: higher doses may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., Mayo score less than 6), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. Patients with mild ulcerative colitis (e.g., Mayo score less than 6) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearLuminal Crohn's disease For the treatment of moderate to severe (luminal) Crohn's disease in patients who meet the following criteria: A. Harvey Bradshaw Index (HBI) score greater than or equal to 7 (or other validated disease activity score confirming moderate to severe disease); AND B. Failed conventional treatment with a corticosteroid (prednisone 40-60mg/day [or equivalent]) for a minimum of 14 days (or intravenous corticosteroid for 1 week); OR Responded to/stabilized on conventional treatment with a corticosteroid, with or without an immunosuppressant (e.g., azathioprine, 6-mercaptopurine, methotrexate); OR Conventional treatment with a corticosteroid is contraindicated; AND C. Infliximab is being used to induce remission or as a steroid-sparing maintenance therapy. The recommended induction dosing regimen is 5mg/kg/dose at 0, 2, and 6 weeks. The recommended maintenance dosing regimen is 5mg/kg/dose every 8 weeks. (Note: higher doses up to 10mg/kg/dose may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and have demonstrated a treatment response or are in remission. Examples of treatment response include clinically meaningful reductions in disease activity scores (e.g., HBI score decrease greater than or equal to 50% from pre-treatment measurement), along with improvements in endoscopic findings and reduction or discontinuation of corticosteroids. Prescribers may wish to consider other funded alternatives for patients unable to discontinue corticosteroid therapy. Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded. Patients with mild Crohn's disease (e.g., HBI less than 7) may be considered on a case-by-case basis through the Exceptional Access Program.LU Authorization Period: 1 yearFistulising Crohn's disease For the treatment of fistulising Crohn's disease in patients who meet the following criteria: - Patient has actively draining perianal or enterocutaneous fistula(e) that have recurred OR persist despite a course of appropriate antibiotic therapy (e.g., ciprofloxacin and/or metronidazole) The recommended induction dosing regimen is 5mg/kg/dose at 0, 2, and 6 weeks. The recommended maintenance dosing regimen is 5mg/kg/dose every 8 weeks. (Note: higher doses up to 10mg/kg/dose may be considered in patients who have failed to respond to lower doses.) Maintenance/Renewal: Maintenance therapy is funded for patients who met the initiation criteria and achieve and maintain response to therapy (e.g., partial or complete resolution of fistulae and symptom improvement). Exclusion criteria (initial and renewal coverage): - Combination therapy with another biologic used to treat inflammatory bowel disease will not be funded.LU Authorization Period: 1 yearTOCILIZUMAB2371200mg/10mLInj Sol-10mL Vial PkTyenneFKC311.90252025-05-30311.9025For the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments: A. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide (20mg/day) for at least 3 months, in addition to iii) an adequate trial of at least one combination of DMARDs for 3 months; OR B. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide in combination with methotrexate for at least 3 months; OR C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.); AND Tocilizumab is not being used in combination with another biologic drug used for the treatment of RA; AND Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Maintenance/Renewal: After 12 months of treatment, ongoing maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints compared to baseline prior to the use of tocilizumab. For second and subsequent renewals (i.e., beyond 2 years of ongoing use of tocilizumab) the patient must demonstrate objective evidence of preservation of treatment effect. For renewal of funding, tocilizumab must not be used in combination with another biologic for the treatment of RA and must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Recommended Dose: The recommended intravenous dose of tocilizumab for adult patients is 4mg/kg followed by an increase to 8mg/kg (up to 800mg per dose as per product monograph) based on clinical response, given once every 4 weeks. The recommended subcutaneous dose of tocilizumab for adult patients weighing less than 100kg is a starting dose of 162mg sc every other week, followed by an increase to every week based on clinical response; AND For patients weighing 100 kg or more, a dosage of 162mg sc every week is recommended.LU Authorization Period: 1 yearFor the treatment of polyarticular juvenile idiopathic arthritis (pJIA) in patients who have active disease (greater than or equal to 3 swollen joints and greater than or equal to 5 active joints) despite a trial of optimal doses of subcutaneously administered methotrexate (i.e. 15mg/m2 per week) for at least 3 months. If the patient is unable to tolerate or has a contraindication to subcutaneous methotrexate, the nature of the intolerance or contraindication must be documented. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Tocilizumab is not being used in combination with another biologic drug used for the treatment of pJIA. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints compared to baseline prior to the start of tocilizumab therapy. For second and subsequent renewals (i.e., beyond 2 years of ongoing use of tocilizumab) the patient must demonstrate objective evidence of preservation of treatment effect. For renewal of funding, tocilizumab must not be used in combination with another biologic for the treatment of pJIA and must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Recommended Dose: The recommended intravenous (IV) dose of tocilizumab for patients 2 years of age and older: - 10mg/kg IV every 4 weeks for patients weighing less than 30kg - 8mg/kg IV every 4 weeks for patients weighing 30kg or greater (up to 800mg per dose as per product monograph) The recommended subcutaneous (sc) dose of tocilizumab for patients 2 years of age and older: - 162mg sc once every 3 weeks for patients weighing less than 30kg. - 162mg sc once every 2 weeks for patients weighing 30kg or greater.LU Authorization Period: 1 yearFor the treatment of systemic juvenile idiopathic arthritis (sJIA) in patients who meet all the following: 1. Patient is at least 2 years of age; AND 2. Diagnosed with sJIA with fever (temperature greater than 38 degrees Celsius) for at least two weeks; AND 3. Patient has at least one of the following: - rash of systemic JIA; OR - serositis (e.g. pericarditis, pleuritis, or peritonitis); OR - lymphadenopathy (e.g. cervical, axillary, inguinal); OR - hepatomegaly; OR - splenomegaly 4. Other potential etiologies such as malignancies, serious clinical infections, other inflammatory or connective tissue diseases, have been ruled out by the prescriber; AND 5. Patient was less than 16 years of age at the onset of sJIA; AND 6. Systemic glucocorticoids cannot be used for one or more of the following reasons: - The patient is unresponsive and/or refractory to systemic glucocorticoids; OR - The patient is glucocorticoid dependent (i.e., the patient has experienced a systemic reaction such as fever, rash of sJIA, serositis, lymphadenopathy, hepatomegaly or splenomegaly while on tapering doses of systemic glucocorticoids); OR - The patient has experienced an adverse drug reaction to a systemic glucocorticoid; OR - The use of systemic glucocorticoids is contraindicated; AND 7. Tocilizumab is not being used in combination with another biologic drug used for the treatment of sJIA; AND 8. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Maintenance/Renewals: Renewal will be considered for patients who have at least a 50% reduction in glucocorticoid dose (unless contraindicated, not tolerated, unresponsive or refractory at the time of initial request) and no evidence of active systemic disease (e.g., fever, rash of sJIA, serositis, lymphadenopathy, hepatomegaly or splenomegaly). For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. For renewal of funding, tocilizumab must not be used in combination with another biologic for the treatment of sJIA and must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Recommended Dose: The recommended intravenous (IV) dose of tocilizumab for patients 2 years of age and older: - 12mg/kg IV every 2 weeks for patients less than 30kg - 8mg/kg IV every 2 weeks for patients weighing 30kg or more (up to 800mg per dose as per product monograph). The recommended subcutaneous (sc) dose of tocilizumab for patients 2 years of age and older: - 162mg sc once every 2 weeks for patients less than 30kg. - 162mg sc once every week for patients weighing 30kg or moreLU Authorization Period: 1 year2372200mg/10mLInj Sol-10mL Vial Pk (Preservative-Free)AvtozmaCEI311.90252025-12-30311.9025For the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments: A. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide (20mg/day) for at least 3 months, in addition to iii) an adequate trial of at least one combination of DMARDs for 3 months; OR B. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide in combination with methotrexate for at least 3 months; OR C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.); AND Tocilizumab is not being used in combination with another biologic drug used for the treatment of RA; AND Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Maintenance/Renewal: After 12 months of treatment, ongoing maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints compared to baseline prior to the use of tocilizumab. For second and subsequent renewals (i.e., beyond 2 years of ongoing use of tocilizumab) the patient must demonstrate objective evidence of preservation of treatment effect. For renewal of funding, tocilizumab must not be used in combination with another biologic for the treatment of RA and must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Recommended Dose: The recommended intravenous dose of tocilizumab for adult patients is 4mg/kg followed by an increase to 8mg/kg (up to 800mg per dose as per product monograph) based on clinical response, given once every 4 weeks. The recommended subcutaneous dose of tocilizumab for adult patients weighing less than 100kg is a starting dose of 162mg sc every other week, followed by an increase to every week based on clinical response; AND For patients weighing 100 kg or more, a dosage of 162mg sc every week is recommended.LU Authorization Period: 1 yearFor the treatment of polyarticular juvenile idiopathic arthritis (pJIA) in patients who have active disease (greater than or equal to 3 swollen joints and greater than or equal to 5 active joints) despite a trial of optimal doses of subcutaneously administered methotrexate (i.e. 15mg/m2 per week) for at least 3 months. If the patient is unable to tolerate or has a contraindication to subcutaneous methotrexate, the nature of the intolerance or contraindication must be documented. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Tocilizumab is not being used in combination with another biologic drug used for the treatment of pJIA. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints compared to baseline prior to the start of tocilizumab therapy. For second and subsequent renewals (i.e., beyond 2 years of ongoing use of tocilizumab) the patient must demonstrate objective evidence of preservation of treatment effect. For renewal of funding, tocilizumab must not be used in combination with another biologic for the treatment of pJIA and must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Recommended Dose: The recommended intravenous (IV) dose of tocilizumab for patients 2 years of age and older: - 10mg/kg IV every 4 weeks for patients weighing less than 30kg - 8mg/kg IV every 4 weeks for patients weighing 30kg or greater (up to 800mg per dose as per product monograph) The recommended subcutaneous (sc) dose of tocilizumab for patients 2 years of age and older: - 162mg sc once every 3 weeks for patients weighing less than 30kg. - 162mg sc once every 2 weeks for patients weighing 30kg or greater.LU Authorization Period: 1 yearFor the treatment of systemic juvenile idiopathic arthritis (sJIA) in patients who meet all the following: 1. Patient is at least 2 years of age; AND 2. Diagnosed with sJIA with fever (temperature greater than 38 degrees Celsius) for at least two weeks; AND 3. Patient has at least one of the following: - rash of systemic JIA; OR - serositis (e.g. pericarditis, pleuritis, or peritonitis); OR - lymphadenopathy (e.g. cervical, axillary, inguinal); OR - hepatomegaly; OR - splenomegaly 4. Other potential etiologies such as malignancies, serious clinical infections, other inflammatory or connective tissue diseases, have been ruled out by the prescriber; AND 5. Patient was less than 16 years of age at the onset of sJIA; AND 6. Systemic glucocorticoids cannot be used for one or more of the following reasons: - The patient is unresponsive and/or refractory to systemic glucocorticoids; OR - The patient is glucocorticoid dependent (i.e., the patient has experienced a systemic reaction such as fever, rash of sJIA, serositis, lymphadenopathy, hepatomegaly or splenomegaly while on tapering doses of systemic glucocorticoids); OR - The patient has experienced an adverse drug reaction to a systemic glucocorticoid; OR - The use of systemic glucocorticoids is contraindicated; AND 7. Tocilizumab is not being used in combination with another biologic drug used for the treatment of sJIA; AND 8. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Maintenance/Renewals: Renewal will be considered for patients who have at least a 50% reduction in glucocorticoid dose (unless contraindicated, not tolerated, unresponsive or refractory at the time of initial request) and no evidence of active systemic disease (e.g., fever, rash of sJIA, serositis, lymphadenopathy, hepatomegaly or splenomegaly). For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. For renewal of funding, tocilizumab must not be used in combination with another biologic for the treatment of sJIA and must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Recommended Dose: The recommended intravenous (IV) dose of tocilizumab for patients 2 years of age and older: - 12mg/kg IV every 2 weeks for patients less than 30kg - 8mg/kg IV every 2 weeks for patients weighing 30kg or more (up to 800mg per dose as per product monograph). The recommended subcutaneous (sc) dose of tocilizumab for patients 2 years of age and older: - 162mg sc once every 2 weeks for patients less than 30kg. - 162mg sc once every week for patients weighing 30kg or moreLU Authorization Period: 1 year2373400mg/20mLInj Sol-20mL Vial PkTyenneFKC623.80502025-05-30623.8050For the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments: A. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide (20mg/day) for at least 3 months, in addition to iii) an adequate trial of at least one combination of DMARDs for 3 months; OR B. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide in combination with methotrexate for at least 3 months; OR C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.); AND Tocilizumab is not being used in combination with another biologic drug used for the treatment of RA; AND Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Maintenance/Renewal: After 12 months of treatment, ongoing maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints compared to baseline prior to the use of tocilizumab. For second and subsequent renewals (i.e., beyond 2 years of ongoing use of tocilizumab) the patient must demonstrate objective evidence of preservation of treatment effect. For renewal of funding, tocilizumab must not be used in combination with another biologic for the treatment of RA and must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Recommended Dose: The recommended intravenous dose of tocilizumab for adult patients is 4mg/kg followed by an increase to 8mg/kg (up to 800mg per dose as per product monograph) based on clinical response, given once every 4 weeks. The recommended subcutaneous dose of tocilizumab for adult patients weighing less than 100kg is a starting dose of 162mg sc every other week, followed by an increase to every week based on clinical response; AND For patients weighing 100 kg or more, a dosage of 162mg sc every week is recommended.LU Authorization Period: 1 yearFor the treatment of polyarticular juvenile idiopathic arthritis (pJIA) in patients who have active disease (greater than or equal to 3 swollen joints and greater than or equal to 5 active joints) despite a trial of optimal doses of subcutaneously administered methotrexate (i.e. 15mg/m2 per week) for at least 3 months. If the patient is unable to tolerate or has a contraindication to subcutaneous methotrexate, the nature of the intolerance or contraindication must be documented. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Tocilizumab is not being used in combination with another biologic drug used for the treatment of pJIA. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints compared to baseline prior to the start of tocilizumab therapy. For second and subsequent renewals (i.e., beyond 2 years of ongoing use of tocilizumab) the patient must demonstrate objective evidence of preservation of treatment effect. For renewal of funding, tocilizumab must not be used in combination with another biologic for the treatment of pJIA and must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Recommended Dose: The recommended intravenous (IV) dose of tocilizumab for patients 2 years of age and older: - 10mg/kg IV every 4 weeks for patients weighing less than 30kg - 8mg/kg IV every 4 weeks for patients weighing 30kg or greater (up to 800mg per dose as per product monograph) The recommended subcutaneous (sc) dose of tocilizumab for patients 2 years of age and older: - 162mg sc once every 3 weeks for patients weighing less than 30kg. - 162mg sc once every 2 weeks for patients weighing 30kg or greater.LU Authorization Period: 1 yearFor the treatment of systemic juvenile idiopathic arthritis (sJIA) in patients who meet all the following: 1. Patient is at least 2 years of age; AND 2. Diagnosed with sJIA with fever (temperature greater than 38 degrees Celsius) for at least two weeks; AND 3. Patient has at least one of the following: - rash of systemic JIA; OR - serositis (e.g. pericarditis, pleuritis, or peritonitis); OR - lymphadenopathy (e.g. cervical, axillary, inguinal); OR - hepatomegaly; OR - splenomegaly 4. Other potential etiologies such as malignancies, serious clinical infections, other inflammatory or connective tissue diseases, have been ruled out by the prescriber; AND 5. Patient was less than 16 years of age at the onset of sJIA; AND 6. Systemic glucocorticoids cannot be used for one or more of the following reasons: - The patient is unresponsive and/or refractory to systemic glucocorticoids; OR - The patient is glucocorticoid dependent (i.e., the patient has experienced a systemic reaction such as fever, rash of sJIA, serositis, lymphadenopathy, hepatomegaly or splenomegaly while on tapering doses of systemic glucocorticoids); OR - The patient has experienced an adverse drug reaction to a systemic glucocorticoid; OR - The use of systemic glucocorticoids is contraindicated; AND 7. Tocilizumab is not being used in combination with another biologic drug used for the treatment of sJIA; AND 8. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Maintenance/Renewals: Renewal will be considered for patients who have at least a 50% reduction in glucocorticoid dose (unless contraindicated, not tolerated, unresponsive or refractory at the time of initial request) and no evidence of active systemic disease (e.g., fever, rash of sJIA, serositis, lymphadenopathy, hepatomegaly or splenomegaly). For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. For renewal of funding, tocilizumab must not be used in combination with another biologic for the treatment of sJIA and must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Recommended Dose: The recommended intravenous (IV) dose of tocilizumab for patients 2 years of age and older: - 12mg/kg IV every 2 weeks for patients less than 30kg - 8mg/kg IV every 2 weeks for patients weighing 30kg or more (up to 800mg per dose as per product monograph). The recommended subcutaneous (sc) dose of tocilizumab for patients 2 years of age and older: - 162mg sc once every 2 weeks for patients less than 30kg. - 162mg sc once every week for patients weighing 30kg or moreLU Authorization Period: 1 year2374400mg/20mLInj Sol-20mL Vial Pk (Preservative-Free)AvtozmaCEI623.80502025-12-30623.8050For the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments: A. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide (20mg/day) for at least 3 months, in addition to iii) an adequate trial of at least one combination of DMARDs for 3 months; OR B. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide in combination with methotrexate for at least 3 months; OR C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.); AND Tocilizumab is not being used in combination with another biologic drug used for the treatment of RA; AND Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Maintenance/Renewal: After 12 months of treatment, ongoing maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints compared to baseline prior to the use of tocilizumab. For second and subsequent renewals (i.e., beyond 2 years of ongoing use of tocilizumab) the patient must demonstrate objective evidence of preservation of treatment effect. For renewal of funding, tocilizumab must not be used in combination with another biologic for the treatment of RA and must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Recommended Dose: The recommended intravenous dose of tocilizumab for adult patients is 4mg/kg followed by an increase to 8mg/kg (up to 800mg per dose as per product monograph) based on clinical response, given once every 4 weeks. The recommended subcutaneous dose of tocilizumab for adult patients weighing less than 100kg is a starting dose of 162mg sc every other week, followed by an increase to every week based on clinical response; AND For patients weighing 100 kg or more, a dosage of 162mg sc every week is recommended.LU Authorization Period: 1 yearFor the treatment of polyarticular juvenile idiopathic arthritis (pJIA) in patients who have active disease (greater than or equal to 3 swollen joints and greater than or equal to 5 active joints) despite a trial of optimal doses of subcutaneously administered methotrexate (i.e. 15mg/m2 per week) for at least 3 months. If the patient is unable to tolerate or has a contraindication to subcutaneous methotrexate, the nature of the intolerance or contraindication must be documented. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Tocilizumab is not being used in combination with another biologic drug used for the treatment of pJIA. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints compared to baseline prior to the start of tocilizumab therapy. For second and subsequent renewals (i.e., beyond 2 years of ongoing use of tocilizumab) the patient must demonstrate objective evidence of preservation of treatment effect. For renewal of funding, tocilizumab must not be used in combination with another biologic for the treatment of pJIA and must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Recommended Dose: The recommended intravenous (IV) dose of tocilizumab for patients 2 years of age and older: - 10mg/kg IV every 4 weeks for patients weighing less than 30kg - 8mg/kg IV every 4 weeks for patients weighing 30kg or greater (up to 800mg per dose as per product monograph) The recommended subcutaneous (sc) dose of tocilizumab for patients 2 years of age and older: - 162mg sc once every 3 weeks for patients weighing less than 30kg. - 162mg sc once every 2 weeks for patients weighing 30kg or greater.LU Authorization Period: 1 yearFor the treatment of systemic juvenile idiopathic arthritis (sJIA) in patients who meet all the following: 1. Patient is at least 2 years of age; AND 2. Diagnosed with sJIA with fever (temperature greater than 38 degrees Celsius) for at least two weeks; AND 3. Patient has at least one of the following: - rash of systemic JIA; OR - serositis (e.g. pericarditis, pleuritis, or peritonitis); OR - lymphadenopathy (e.g. cervical, axillary, inguinal); OR - hepatomegaly; OR - splenomegaly 4. Other potential etiologies such as malignancies, serious clinical infections, other inflammatory or connective tissue diseases, have been ruled out by the prescriber; AND 5. Patient was less than 16 years of age at the onset of sJIA; AND 6. Systemic glucocorticoids cannot be used for one or more of the following reasons: - The patient is unresponsive and/or refractory to systemic glucocorticoids; OR - The patient is glucocorticoid dependent (i.e., the patient has experienced a systemic reaction such as fever, rash of sJIA, serositis, lymphadenopathy, hepatomegaly or splenomegaly while on tapering doses of systemic glucocorticoids); OR - The patient has experienced an adverse drug reaction to a systemic glucocorticoid; OR - The use of systemic glucocorticoids is contraindicated; AND 7. Tocilizumab is not being used in combination with another biologic drug used for the treatment of sJIA; AND 8. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Maintenance/Renewals: Renewal will be considered for patients who have at least a 50% reduction in glucocorticoid dose (unless contraindicated, not tolerated, unresponsive or refractory at the time of initial request) and no evidence of active systemic disease (e.g., fever, rash of sJIA, serositis, lymphadenopathy, hepatomegaly or splenomegaly). For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. For renewal of funding, tocilizumab must not be used in combination with another biologic for the treatment of sJIA and must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Recommended Dose: The recommended intravenous (IV) dose of tocilizumab for patients 2 years of age and older: - 12mg/kg IV every 2 weeks for patients less than 30kg - 8mg/kg IV every 2 weeks for patients weighing 30kg or more (up to 800mg per dose as per product monograph). The recommended subcutaneous (sc) dose of tocilizumab for patients 2 years of age and older: - 162mg sc once every 2 weeks for patients less than 30kg. - 162mg sc once every week for patients weighing 30kg or moreLU Authorization Period: 1 year237580mg/4mLInj Sol-4mL Vial PkTyenneFKC124.76102025-05-30124.7610For the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments: A. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide (20mg/day) for at least 3 months, in addition to iii) an adequate trial of at least one combination of DMARDs for 3 months; OR B. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide in combination with methotrexate for at least 3 months; OR C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.); AND Tocilizumab is not being used in combination with another biologic drug used for the treatment of RA; AND Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Maintenance/Renewal: After 12 months of treatment, ongoing maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints compared to baseline prior to the use of tocilizumab. For second and subsequent renewals (i.e., beyond 2 years of ongoing use of tocilizumab) the patient must demonstrate objective evidence of preservation of treatment effect. For renewal of funding, tocilizumab must not be used in combination with another biologic for the treatment of RA and must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Recommended Dose: The recommended intravenous dose of tocilizumab for adult patients is 4mg/kg followed by an increase to 8mg/kg (up to 800mg per dose as per product monograph) based on clinical response, given once every 4 weeks. The recommended subcutaneous dose of tocilizumab for adult patients weighing less than 100kg is a starting dose of 162mg sc every other week, followed by an increase to every week based on clinical response; AND For patients weighing 100 kg or more, a dosage of 162mg sc every week is recommended.LU Authorization Period: 1 yearFor the treatment of polyarticular juvenile idiopathic arthritis (pJIA) in patients who have active disease (greater than or equal to 3 swollen joints and greater than or equal to 5 active joints) despite a trial of optimal doses of subcutaneously administered methotrexate (i.e. 15mg/m2 per week) for at least 3 months. If the patient is unable to tolerate or has a contraindication to subcutaneous methotrexate, the nature of the intolerance or contraindication must be documented. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Tocilizumab is not being used in combination with another biologic drug used for the treatment of pJIA. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints compared to baseline prior to the start of tocilizumab therapy. For second and subsequent renewals (i.e., beyond 2 years of ongoing use of tocilizumab) the patient must demonstrate objective evidence of preservation of treatment effect. For renewal of funding, tocilizumab must not be used in combination with another biologic for the treatment of pJIA and must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Recommended Dose: The recommended intravenous (IV) dose of tocilizumab for patients 2 years of age and older: - 10mg/kg IV every 4 weeks for patients weighing less than 30kg - 8mg/kg IV every 4 weeks for patients weighing 30kg or greater (up to 800mg per dose as per product monograph) The recommended subcutaneous (sc) dose of tocilizumab for patients 2 years of age and older: - 162mg sc once every 3 weeks for patients weighing less than 30kg. - 162mg sc once every 2 weeks for patients weighing 30kg or greater.LU Authorization Period: 1 yearFor the treatment of systemic juvenile idiopathic arthritis (sJIA) in patients who meet all the following: 1. Patient is at least 2 years of age; AND 2. Diagnosed with sJIA with fever (temperature greater than 38 degrees Celsius) for at least two weeks; AND 3. Patient has at least one of the following: - rash of systemic JIA; OR - serositis (e.g. pericarditis, pleuritis, or peritonitis); OR - lymphadenopathy (e.g. cervical, axillary, inguinal); OR - hepatomegaly; OR - splenomegaly 4. Other potential etiologies such as malignancies, serious clinical infections, other inflammatory or connective tissue diseases, have been ruled out by the prescriber; AND 5. Patient was less than 16 years of age at the onset of sJIA; AND 6. Systemic glucocorticoids cannot be used for one or more of the following reasons: - The patient is unresponsive and/or refractory to systemic glucocorticoids; OR - The patient is glucocorticoid dependent (i.e., the patient has experienced a systemic reaction such as fever, rash of sJIA, serositis, lymphadenopathy, hepatomegaly or splenomegaly while on tapering doses of systemic glucocorticoids); OR - The patient has experienced an adverse drug reaction to a systemic glucocorticoid; OR - The use of systemic glucocorticoids is contraindicated; AND 7. Tocilizumab is not being used in combination with another biologic drug used for the treatment of sJIA; AND 8. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Maintenance/Renewals: Renewal will be considered for patients who have at least a 50% reduction in glucocorticoid dose (unless contraindicated, not tolerated, unresponsive or refractory at the time of initial request) and no evidence of active systemic disease (e.g., fever, rash of sJIA, serositis, lymphadenopathy, hepatomegaly or splenomegaly). For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. For renewal of funding, tocilizumab must not be used in combination with another biologic for the treatment of sJIA and must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Recommended Dose: The recommended intravenous (IV) dose of tocilizumab for patients 2 years of age and older: - 12mg/kg IV every 2 weeks for patients less than 30kg - 8mg/kg IV every 2 weeks for patients weighing 30kg or more (up to 800mg per dose as per product monograph). The recommended subcutaneous (sc) dose of tocilizumab for patients 2 years of age and older: - 162mg sc once every 2 weeks for patients less than 30kg. - 162mg sc once every week for patients weighing 30kg or moreLU Authorization Period: 1 year237680mg/4mLInj Sol-4mL Vial Pk (Preservative-Free)AvtozmaCEI124.76102025-12-30124.7610For the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments: A. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide (20mg/day) for at least 3 months, in addition to iii) an adequate trial of at least one combination of DMARDs for 3 months; OR B. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide in combination with methotrexate for at least 3 months; OR C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.); AND Tocilizumab is not being used in combination with another biologic drug used for the treatment of RA; AND Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Maintenance/Renewal: After 12 months of treatment, ongoing maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints compared to baseline prior to the use of tocilizumab. For second and subsequent renewals (i.e., beyond 2 years of ongoing use of tocilizumab) the patient must demonstrate objective evidence of preservation of treatment effect. For renewal of funding, tocilizumab must not be used in combination with another biologic for the treatment of RA and must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Recommended Dose: The recommended intravenous dose of tocilizumab for adult patients is 4mg/kg followed by an increase to 8mg/kg (up to 800mg per dose as per product monograph) based on clinical response, given once every 4 weeks. The recommended subcutaneous dose of tocilizumab for adult patients weighing less than 100kg is a starting dose of 162mg sc every other week, followed by an increase to every week based on clinical response; AND For patients weighing 100 kg or more, a dosage of 162mg sc every week is recommended.LU Authorization Period: 1 yearFor the treatment of polyarticular juvenile idiopathic arthritis (pJIA) in patients who have active disease (greater than or equal to 3 swollen joints and greater than or equal to 5 active joints) despite a trial of optimal doses of subcutaneously administered methotrexate (i.e. 15mg/m2 per week) for at least 3 months. If the patient is unable to tolerate or has a contraindication to subcutaneous methotrexate, the nature of the intolerance or contraindication must be documented. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Tocilizumab is not being used in combination with another biologic drug used for the treatment of pJIA. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints compared to baseline prior to the start of tocilizumab therapy. For second and subsequent renewals (i.e., beyond 2 years of ongoing use of tocilizumab) the patient must demonstrate objective evidence of preservation of treatment effect. For renewal of funding, tocilizumab must not be used in combination with another biologic for the treatment of pJIA and must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Recommended Dose: The recommended intravenous (IV) dose of tocilizumab for patients 2 years of age and older: - 10mg/kg IV every 4 weeks for patients weighing less than 30kg - 8mg/kg IV every 4 weeks for patients weighing 30kg or greater (up to 800mg per dose as per product monograph) The recommended subcutaneous (sc) dose of tocilizumab for patients 2 years of age and older: - 162mg sc once every 3 weeks for patients weighing less than 30kg. - 162mg sc once every 2 weeks for patients weighing 30kg or greater.LU Authorization Period: 1 yearFor the treatment of systemic juvenile idiopathic arthritis (sJIA) in patients who meet all the following: 1. Patient is at least 2 years of age; AND 2. Diagnosed with sJIA with fever (temperature greater than 38 degrees Celsius) for at least two weeks; AND 3. Patient has at least one of the following: - rash of systemic JIA; OR - serositis (e.g. pericarditis, pleuritis, or peritonitis); OR - lymphadenopathy (e.g. cervical, axillary, inguinal); OR - hepatomegaly; OR - splenomegaly 4. Other potential etiologies such as malignancies, serious clinical infections, other inflammatory or connective tissue diseases, have been ruled out by the prescriber; AND 5. Patient was less than 16 years of age at the onset of sJIA; AND 6. Systemic glucocorticoids cannot be used for one or more of the following reasons: - The patient is unresponsive and/or refractory to systemic glucocorticoids; OR - The patient is glucocorticoid dependent (i.e., the patient has experienced a systemic reaction such as fever, rash of sJIA, serositis, lymphadenopathy, hepatomegaly or splenomegaly while on tapering doses of systemic glucocorticoids); OR - The patient has experienced an adverse drug reaction to a systemic glucocorticoid; OR - The use of systemic glucocorticoids is contraindicated; AND 7. Tocilizumab is not being used in combination with another biologic drug used for the treatment of sJIA; AND 8. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Maintenance/Renewals: Renewal will be considered for patients who have at least a 50% reduction in glucocorticoid dose (unless contraindicated, not tolerated, unresponsive or refractory at the time of initial request) and no evidence of active systemic disease (e.g., fever, rash of sJIA, serositis, lymphadenopathy, hepatomegaly or splenomegaly). For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. For renewal of funding, tocilizumab must not be used in combination with another biologic for the treatment of sJIA and must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Recommended Dose: The recommended intravenous (IV) dose of tocilizumab for patients 2 years of age and older: - 12mg/kg IV every 2 weeks for patients less than 30kg - 8mg/kg IV every 2 weeks for patients weighing 30kg or more (up to 800mg per dose as per product monograph). The recommended subcutaneous (sc) dose of tocilizumab for patients 2 years of age and older: - 162mg sc once every 2 weeks for patients less than 30kg. - 162mg sc once every week for patients weighing 30kg or moreLU Authorization Period: 1 year2377162mg/0.9mLInj Sol-Pref AutoinjTyenneFKC242.28752025-05-30242.2875For the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments: A. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide (20mg/day) for at least 3 months, in addition to iii) an adequate trial of at least one combination of DMARDs for 3 months; OR B. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide in combination with methotrexate for at least 3 months; OR C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.); AND Tocilizumab is not being used in combination with another biologic drug used for the treatment of RA; AND Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Maintenance/Renewal: After 12 months of treatment, ongoing maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints compared to baseline prior to the use of tocilizumab. For second and subsequent renewals (i.e., beyond 2 years of ongoing use of tocilizumab) the patient must demonstrate objective evidence of preservation of treatment effect. For renewal of funding, tocilizumab must not be used in combination with another biologic for the treatment of RA and must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Recommended Dose: The recommended intravenous dose of tocilizumab for adult patients is 4mg/kg followed by an increase to 8mg/kg (up to 800mg per dose as per product monograph) based on clinical response, given once every 4 weeks. The recommended subcutaneous dose of tocilizumab for adult patients weighing less than 100kg is a starting dose of 162mg sc every other week, followed by an increase to every week based on clinical response; AND For patients weighing 100 kg or more, a dosage of 162mg sc every week is recommended.LU Authorization Period: 1 yearFor the treatment of polyarticular juvenile idiopathic arthritis (pJIA) in patients who have active disease (greater than or equal to 3 swollen joints and greater than or equal to 5 active joints) despite a trial of optimal doses of subcutaneously administered methotrexate (i.e. 15mg/m2 per week) for at least 3 months. If the patient is unable to tolerate or has a contraindication to subcutaneous methotrexate, the nature of the intolerance or contraindication must be documented. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Tocilizumab is not being used in combination with another biologic drug used for the treatment of pJIA. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints compared to baseline prior to the start of tocilizumab therapy. For second and subsequent renewals (i.e., beyond 2 years of ongoing use of tocilizumab) the patient must demonstrate objective evidence of preservation of treatment effect. For renewal of funding, tocilizumab must not be used in combination with another biologic for the treatment of pJIA and must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Recommended Dose: The recommended intravenous (IV) dose of tocilizumab for patients 2 years of age and older: - 10mg/kg IV every 4 weeks for patients weighing less than 30kg - 8mg/kg IV every 4 weeks for patients weighing 30kg or greater (up to 800mg per dose as per product monograph) The recommended subcutaneous (sc) dose of tocilizumab for patients 2 years of age and older: - 162mg sc once every 3 weeks for patients weighing less than 30kg. - 162mg sc once every 2 weeks for patients weighing 30kg or greater.LU Authorization Period: 1 yearFor the treatment of systemic juvenile idiopathic arthritis (sJIA) in patients who meet all the following: 1. Patient is at least 2 years of age; AND 2. Diagnosed with sJIA with fever (temperature greater than 38 degrees Celsius) for at least two weeks; AND 3. Patient has at least one of the following: - rash of systemic JIA; OR - serositis (e.g. pericarditis, pleuritis, or peritonitis); OR - lymphadenopathy (e.g. cervical, axillary, inguinal); OR - hepatomegaly; OR - splenomegaly 4. Other potential etiologies such as malignancies, serious clinical infections, other inflammatory or connective tissue diseases, have been ruled out by the prescriber; AND 5. Patient was less than 16 years of age at the onset of sJIA; AND 6. Systemic glucocorticoids cannot be used for one or more of the following reasons: - The patient is unresponsive and/or refractory to systemic glucocorticoids; OR - The patient is glucocorticoid dependent (i.e., the patient has experienced a systemic reaction such as fever, rash of sJIA, serositis, lymphadenopathy, hepatomegaly or splenomegaly while on tapering doses of systemic glucocorticoids); OR - The patient has experienced an adverse drug reaction to a systemic glucocorticoid; OR - The use of systemic glucocorticoids is contraindicated; AND 7. Tocilizumab is not being used in combination with another biologic drug used for the treatment of sJIA; AND 8. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Maintenance/Renewals: Renewal will be considered for patients who have at least a 50% reduction in glucocorticoid dose (unless contraindicated, not tolerated, unresponsive or refractory at the time of initial request) and no evidence of active systemic disease (e.g., fever, rash of sJIA, serositis, lymphadenopathy, hepatomegaly or splenomegaly). For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. For renewal of funding, tocilizumab must not be used in combination with another biologic for the treatment of sJIA and must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Recommended Dose: The recommended intravenous (IV) dose of tocilizumab for patients 2 years of age and older: - 12mg/kg IV every 2 weeks for patients less than 30kg - 8mg/kg IV every 2 weeks for patients weighing 30kg or more (up to 800mg per dose as per product monograph). The recommended subcutaneous (sc) dose of tocilizumab for patients 2 years of age and older: - 162mg sc once every 2 weeks for patients less than 30kg. - 162mg sc once every week for patients weighing 30kg or moreLU Authorization Period: 1 yearFor the treatment of giant cell arteritis (GCA) in symptomatic adult patients who meet the following: 1. A confirmed diagnosis of GCA by temporal artery biopsy and/or imaging tests (i.e., ultrasonography, magnetic resonance angiography, computed tomography angiography or positron emission scanning); AND 2. Tocilizumab is initiated as combination therapy with 20mg to 60mg of prednisone (or an equivalent glucocorticoid) with subsequent glucocorticoid tapering as symptoms stabilize; AND 3. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in the diagnosis and management of GCA; AND 4. The patient is using tocilizumab for up to 52 weeks. Note: Patients with other sight-threatening ocular diseases must have their prescribers apply for case-by-case funding consideration through the ministry's Compassionate Review Policy. Limited Renewal: Renewal after an initial treatment period of 52 weeks can occur in limited circumstances when directed by a prescriber based on the patient's clinical remission status, disease activity and relevant bloodwork, imaging results, severity of disease manifestations, and risk of relapse. Recommended Dose: The recommended dose of tocilizumab for adult patients is 162mg subcutaneously once every week in combination with a tapering dose of glucocorticoids. A dose of 162mg subcutaneously once every other week, in combination with a tapering dose of glucocorticoids, may be considered based on clinical considerations.LU Authorization Period: 1 year2378162mg/0.9mLInj Sol-Pref Autoinj (Preservative-Free)AvtozmaCEI242.28752025-12-30242.2875For the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments: A. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide (20mg/day) for at least 3 months, in addition to iii) an adequate trial of at least one combination of DMARDs for 3 months; OR B. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide in combination with methotrexate for at least 3 months; OR C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.); AND Tocilizumab is not being used in combination with another biologic drug used for the treatment of RA; AND Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Maintenance/Renewal: After 12 months of treatment, ongoing maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints compared to baseline prior to the use of tocilizumab. For second and subsequent renewals (i.e., beyond 2 years of ongoing use of tocilizumab) the patient must demonstrate objective evidence of preservation of treatment effect. For renewal of funding, tocilizumab must not be used in combination with another biologic for the treatment of RA and must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Recommended Dose: The recommended intravenous dose of tocilizumab for adult patients is 4mg/kg followed by an increase to 8mg/kg (up to 800mg per dose as per product monograph) based on clinical response, given once every 4 weeks. The recommended subcutaneous dose of tocilizumab for adult patients weighing less than 100kg is a starting dose of 162mg sc every other week, followed by an increase to every week based on clinical response; AND For patients weighing 100 kg or more, a dosage of 162mg sc every week is recommended.LU Authorization Period: 1 yearFor the treatment of polyarticular juvenile idiopathic arthritis (pJIA) in patients who have active disease (greater than or equal to 3 swollen joints and greater than or equal to 5 active joints) despite a trial of optimal doses of subcutaneously administered methotrexate (i.e. 15mg/m2 per week) for at least 3 months. If the patient is unable to tolerate or has a contraindication to subcutaneous methotrexate, the nature of the intolerance or contraindication must be documented. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Tocilizumab is not being used in combination with another biologic drug used for the treatment of pJIA. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints compared to baseline prior to the start of tocilizumab therapy. For second and subsequent renewals (i.e., beyond 2 years of ongoing use of tocilizumab) the patient must demonstrate objective evidence of preservation of treatment effect. For renewal of funding, tocilizumab must not be used in combination with another biologic for the treatment of pJIA and must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Recommended Dose: The recommended intravenous (IV) dose of tocilizumab for patients 2 years of age and older: - 10mg/kg IV every 4 weeks for patients weighing less than 30kg - 8mg/kg IV every 4 weeks for patients weighing 30kg or greater (up to 800mg per dose as per product monograph) The recommended subcutaneous (sc) dose of tocilizumab for patients 2 years of age and older: - 162mg sc once every 3 weeks for patients weighing less than 30kg. - 162mg sc once every 2 weeks for patients weighing 30kg or greater.LU Authorization Period: 1 yearFor the treatment of systemic juvenile idiopathic arthritis (sJIA) in patients who meet all the following: 1. Patient is at least 2 years of age; AND 2. Diagnosed with sJIA with fever (temperature greater than 38 degrees Celsius) for at least two weeks; AND 3. Patient has at least one of the following: - rash of systemic JIA; OR - serositis (e.g. pericarditis, pleuritis, or peritonitis); OR - lymphadenopathy (e.g. cervical, axillary, inguinal); OR - hepatomegaly; OR - splenomegaly 4. Other potential etiologies such as malignancies, serious clinical infections, other inflammatory or connective tissue diseases, have been ruled out by the prescriber; AND 5. Patient was less than 16 years of age at the onset of sJIA; AND 6. Systemic glucocorticoids cannot be used for one or more of the following reasons: - The patient is unresponsive and/or refractory to systemic glucocorticoids; OR - The patient is glucocorticoid dependent (i.e., the patient has experienced a systemic reaction such as fever, rash of sJIA, serositis, lymphadenopathy, hepatomegaly or splenomegaly while on tapering doses of systemic glucocorticoids); OR - The patient has experienced an adverse drug reaction to a systemic glucocorticoid; OR - The use of systemic glucocorticoids is contraindicated; AND 7. Tocilizumab is not being used in combination with another biologic drug used for the treatment of sJIA; AND 8. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Maintenance/Renewals: Renewal will be considered for patients who have at least a 50% reduction in glucocorticoid dose (unless contraindicated, not tolerated, unresponsive or refractory at the time of initial request) and no evidence of active systemic disease (e.g., fever, rash of sJIA, serositis, lymphadenopathy, hepatomegaly or splenomegaly). For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. For renewal of funding, tocilizumab must not be used in combination with another biologic for the treatment of sJIA and must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Recommended Dose: The recommended intravenous (IV) dose of tocilizumab for patients 2 years of age and older: - 12mg/kg IV every 2 weeks for patients less than 30kg - 8mg/kg IV every 2 weeks for patients weighing 30kg or more (up to 800mg per dose as per product monograph). The recommended subcutaneous (sc) dose of tocilizumab for patients 2 years of age and older: - 162mg sc once every 2 weeks for patients less than 30kg. - 162mg sc once every week for patients weighing 30kg or moreLU Authorization Period: 1 yearFor the treatment of giant cell arteritis (GCA) in symptomatic adult patients who meet the following: 1. A confirmed diagnosis of GCA by temporal artery biopsy and/or imaging tests (i.e., ultrasonography, magnetic resonance angiography, computed tomography angiography or positron emission scanning); AND 2. Tocilizumab is initiated as combination therapy with 20mg to 60mg of prednisone (or an equivalent glucocorticoid) with subsequent glucocorticoid tapering as symptoms stabilize; AND 3. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in the diagnosis and management of GCA; AND 4. The patient is using tocilizumab for up to 52 weeks. Note: Patients with other sight-threatening ocular diseases must have their prescribers apply for case-by-case funding consideration through the ministry's Compassionate Review Policy. Limited Renewal: Renewal after an initial treatment period of 52 weeks can occur in limited circumstances when directed by a prescriber based on the patient's clinical remission status, disease activity and relevant bloodwork, imaging results, severity of disease manifestations, and risk of relapse. Recommended Dose: The recommended dose of tocilizumab for adult patients is 162mg subcutaneously once every week in combination with a tapering dose of glucocorticoids. A dose of 162mg subcutaneously once every other week, in combination with a tapering dose of glucocorticoids, may be considered based on clinical considerations.LU Authorization Period: 1 year2379162mg/0.9mLInj Sol-Pref SyrTyenneFKC244.95252025-05-30244.9525For the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments: A. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide (20mg/day) for at least 3 months, in addition to iii) an adequate trial of at least one combination of DMARDs for 3 months; OR B. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide in combination with methotrexate for at least 3 months; OR C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.); AND Tocilizumab is not being used in combination with another biologic drug used for the treatment of RA; AND Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Maintenance/Renewal: After 12 months of treatment, ongoing maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints compared to baseline prior to the use of tocilizumab. For second and subsequent renewals (i.e., beyond 2 years of ongoing use of tocilizumab) the patient must demonstrate objective evidence of preservation of treatment effect. For renewal of funding, tocilizumab must not be used in combination with another biologic for the treatment of RA and must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Recommended Dose: The recommended intravenous dose of tocilizumab for adult patients is 4mg/kg followed by an increase to 8mg/kg (up to 800mg per dose as per product monograph) based on clinical response, given once every 4 weeks. The recommended subcutaneous dose of tocilizumab for adult patients weighing less than 100kg is a starting dose of 162mg sc every other week, followed by an increase to every week based on clinical response; AND For patients weighing 100 kg or more, a dosage of 162mg sc every week is recommended.LU Authorization Period: 1 yearFor the treatment of polyarticular juvenile idiopathic arthritis (pJIA) in patients who have active disease (greater than or equal to 3 swollen joints and greater than or equal to 5 active joints) despite a trial of optimal doses of subcutaneously administered methotrexate (i.e. 15mg/m2 per week) for at least 3 months. If the patient is unable to tolerate or has a contraindication to subcutaneous methotrexate, the nature of the intolerance or contraindication must be documented. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Tocilizumab is not being used in combination with another biologic drug used for the treatment of pJIA. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints compared to baseline prior to the start of tocilizumab therapy. For second and subsequent renewals (i.e., beyond 2 years of ongoing use of tocilizumab) the patient must demonstrate objective evidence of preservation of treatment effect. For renewal of funding, tocilizumab must not be used in combination with another biologic for the treatment of pJIA and must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Recommended Dose: The recommended intravenous (IV) dose of tocilizumab for patients 2 years of age and older: - 10mg/kg IV every 4 weeks for patients weighing less than 30kg - 8mg/kg IV every 4 weeks for patients weighing 30kg or greater (up to 800mg per dose as per product monograph) The recommended subcutaneous (sc) dose of tocilizumab for patients 2 years of age and older: - 162mg sc once every 3 weeks for patients weighing less than 30kg. - 162mg sc once every 2 weeks for patients weighing 30kg or greater.LU Authorization Period: 1 yearFor the treatment of systemic juvenile idiopathic arthritis (sJIA) in patients who meet all the following: 1. Patient is at least 2 years of age; AND 2. Diagnosed with sJIA with fever (temperature greater than 38 degrees Celsius) for at least two weeks; AND 3. Patient has at least one of the following: - rash of systemic JIA; OR - serositis (e.g. pericarditis, pleuritis, or peritonitis); OR - lymphadenopathy (e.g. cervical, axillary, inguinal); OR - hepatomegaly; OR - splenomegaly 4. Other potential etiologies such as malignancies, serious clinical infections, other inflammatory or connective tissue diseases, have been ruled out by the prescriber; AND 5. Patient was less than 16 years of age at the onset of sJIA; AND 6. Systemic glucocorticoids cannot be used for one or more of the following reasons: - The patient is unresponsive and/or refractory to systemic glucocorticoids; OR - The patient is glucocorticoid dependent (i.e., the patient has experienced a systemic reaction such as fever, rash of sJIA, serositis, lymphadenopathy, hepatomegaly or splenomegaly while on tapering doses of systemic glucocorticoids); OR - The patient has experienced an adverse drug reaction to a systemic glucocorticoid; OR - The use of systemic glucocorticoids is contraindicated; AND 7. Tocilizumab is not being used in combination with another biologic drug used for the treatment of sJIA; AND 8. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Maintenance/Renewals: Renewal will be considered for patients who have at least a 50% reduction in glucocorticoid dose (unless contraindicated, not tolerated, unresponsive or refractory at the time of initial request) and no evidence of active systemic disease (e.g., fever, rash of sJIA, serositis, lymphadenopathy, hepatomegaly or splenomegaly). For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. For renewal of funding, tocilizumab must not be used in combination with another biologic for the treatment of sJIA and must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Recommended Dose: The recommended intravenous (IV) dose of tocilizumab for patients 2 years of age and older: - 12mg/kg IV every 2 weeks for patients less than 30kg - 8mg/kg IV every 2 weeks for patients weighing 30kg or more (up to 800mg per dose as per product monograph). The recommended subcutaneous (sc) dose of tocilizumab for patients 2 years of age and older: - 162mg sc once every 2 weeks for patients less than 30kg. - 162mg sc once every week for patients weighing 30kg or moreLU Authorization Period: 1 yearFor the treatment of giant cell arteritis (GCA) in symptomatic adult patients who meet the following: 1. A confirmed diagnosis of GCA by temporal artery biopsy and/or imaging tests (i.e., ultrasonography, magnetic resonance angiography, computed tomography angiography or positron emission scanning); AND 2. Tocilizumab is initiated as combination therapy with 20mg to 60mg of prednisone (or an equivalent glucocorticoid) with subsequent glucocorticoid tapering as symptoms stabilize; AND 3. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in the diagnosis and management of GCA; AND 4. The patient is using tocilizumab for up to 52 weeks. Note: Patients with other sight-threatening ocular diseases must have their prescribers apply for case-by-case funding consideration through the ministry's Compassionate Review Policy. Limited Renewal: Renewal after an initial treatment period of 52 weeks can occur in limited circumstances when directed by a prescriber based on the patient's clinical remission status, disease activity and relevant bloodwork, imaging results, severity of disease manifestations, and risk of relapse. Recommended Dose: The recommended dose of tocilizumab for adult patients is 162mg subcutaneously once every week in combination with a tapering dose of glucocorticoids. A dose of 162mg subcutaneously once every other week, in combination with a tapering dose of glucocorticoids, may be considered based on clinical considerations.LU Authorization Period: 1 year2380162mg/0.9mLInj Sol-Pref Syr (Preservative-Free)AvtozmaCEI244.95252025-12-30244.9525For the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments: A. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide (20mg/day) for at least 3 months, in addition to iii) an adequate trial of at least one combination of DMARDs for 3 months; OR B. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide in combination with methotrexate for at least 3 months; OR C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.); AND Tocilizumab is not being used in combination with another biologic drug used for the treatment of RA; AND Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Maintenance/Renewal: After 12 months of treatment, ongoing maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints compared to baseline prior to the use of tocilizumab. For second and subsequent renewals (i.e., beyond 2 years of ongoing use of tocilizumab) the patient must demonstrate objective evidence of preservation of treatment effect. For renewal of funding, tocilizumab must not be used in combination with another biologic for the treatment of RA and must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Recommended Dose: The recommended intravenous dose of tocilizumab for adult patients is 4mg/kg followed by an increase to 8mg/kg (up to 800mg per dose as per product monograph) based on clinical response, given once every 4 weeks. The recommended subcutaneous dose of tocilizumab for adult patients weighing less than 100kg is a starting dose of 162mg sc every other week, followed by an increase to every week based on clinical response; AND For patients weighing 100 kg or more, a dosage of 162mg sc every week is recommended.LU Authorization Period: 1 yearFor the treatment of polyarticular juvenile idiopathic arthritis (pJIA) in patients who have active disease (greater than or equal to 3 swollen joints and greater than or equal to 5 active joints) despite a trial of optimal doses of subcutaneously administered methotrexate (i.e. 15mg/m2 per week) for at least 3 months. If the patient is unable to tolerate or has a contraindication to subcutaneous methotrexate, the nature of the intolerance or contraindication must be documented. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Tocilizumab is not being used in combination with another biologic drug used for the treatment of pJIA. Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints compared to baseline prior to the start of tocilizumab therapy. For second and subsequent renewals (i.e., beyond 2 years of ongoing use of tocilizumab) the patient must demonstrate objective evidence of preservation of treatment effect. For renewal of funding, tocilizumab must not be used in combination with another biologic for the treatment of pJIA and must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Recommended Dose: The recommended intravenous (IV) dose of tocilizumab for patients 2 years of age and older: - 10mg/kg IV every 4 weeks for patients weighing less than 30kg - 8mg/kg IV every 4 weeks for patients weighing 30kg or greater (up to 800mg per dose as per product monograph) The recommended subcutaneous (sc) dose of tocilizumab for patients 2 years of age and older: - 162mg sc once every 3 weeks for patients weighing less than 30kg. - 162mg sc once every 2 weeks for patients weighing 30kg or greater.LU Authorization Period: 1 yearFor the treatment of systemic juvenile idiopathic arthritis (sJIA) in patients who meet all the following: 1. Patient is at least 2 years of age; AND 2. Diagnosed with sJIA with fever (temperature greater than 38 degrees Celsius) for at least two weeks; AND 3. Patient has at least one of the following: - rash of systemic JIA; OR - serositis (e.g. pericarditis, pleuritis, or peritonitis); OR - lymphadenopathy (e.g. cervical, axillary, inguinal); OR - hepatomegaly; OR - splenomegaly 4. Other potential etiologies such as malignancies, serious clinical infections, other inflammatory or connective tissue diseases, have been ruled out by the prescriber; AND 5. Patient was less than 16 years of age at the onset of sJIA; AND 6. Systemic glucocorticoids cannot be used for one or more of the following reasons: - The patient is unresponsive and/or refractory to systemic glucocorticoids; OR - The patient is glucocorticoid dependent (i.e., the patient has experienced a systemic reaction such as fever, rash of sJIA, serositis, lymphadenopathy, hepatomegaly or splenomegaly while on tapering doses of systemic glucocorticoids); OR - The patient has experienced an adverse drug reaction to a systemic glucocorticoid; OR - The use of systemic glucocorticoids is contraindicated; AND 7. Tocilizumab is not being used in combination with another biologic drug used for the treatment of sJIA; AND 8. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Maintenance/Renewals: Renewal will be considered for patients who have at least a 50% reduction in glucocorticoid dose (unless contraindicated, not tolerated, unresponsive or refractory at the time of initial request) and no evidence of active systemic disease (e.g., fever, rash of sJIA, serositis, lymphadenopathy, hepatomegaly or splenomegaly). For funding beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. For renewal of funding, tocilizumab must not be used in combination with another biologic for the treatment of sJIA and must be prescribed by a rheumatologist or a prescriber with expertise in rheumatology. Recommended Dose: The recommended intravenous (IV) dose of tocilizumab for patients 2 years of age and older: - 12mg/kg IV every 2 weeks for patients less than 30kg - 8mg/kg IV every 2 weeks for patients weighing 30kg or more (up to 800mg per dose as per product monograph). The recommended subcutaneous (sc) dose of tocilizumab for patients 2 years of age and older: - 162mg sc once every 2 weeks for patients less than 30kg. - 162mg sc once every week for patients weighing 30kg or moreLU Authorization Period: 1 yearFor the treatment of giant cell arteritis (GCA) in symptomatic adult patients who meet the following: 1. A confirmed diagnosis of GCA by temporal artery biopsy and/or imaging tests (i.e., ultrasonography, magnetic resonance angiography, computed tomography angiography or positron emission scanning); AND 2. Tocilizumab is initiated as combination therapy with 20mg to 60mg of prednisone (or an equivalent glucocorticoid) with subsequent glucocorticoid tapering as symptoms stabilize; AND 3. Therapy must be prescribed by a rheumatologist or a prescriber with expertise in the diagnosis and management of GCA; AND 4. The patient is using tocilizumab for up to 52 weeks. Note: Patients with other sight-threatening ocular diseases must have their prescribers apply for case-by-case funding consideration through the ministry's Compassionate Review Policy. Limited Renewal: Renewal after an initial treatment period of 52 weeks can occur in limited circumstances when directed by a prescriber based on the patient's clinical remission status, disease activity and relevant bloodwork, imaging results, severity of disease manifestations, and risk of relapse. Recommended Dose: The recommended dose of tocilizumab for adult patients is 162mg subcutaneously once every week in combination with a tapering dose of glucocorticoids. A dose of 162mg subcutaneously once every other week, in combination with a tapering dose of glucocorticoids, may be considered based on clinical considerations.LU Authorization Period: 1 yearTOFACITINIB23815mgTabXeljanzPFI24.77332016-12-225.9897Taro-TofacitinibTAR5.98972023-01-315.9897PMS-TofacitinibPMS5.98972023-01-315.9897Jamp TofacitinibJPC5.98972023-11-305.9897Auro-TofacitinibAUR5.98972023-01-315.9897Sandoz TofacitinibSDZ5.98972025-09-295.9897For the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or, anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments: A. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide (20mg/day) for at least 3 months, in addition to iii) an adequate trial of at least one combination of DMARDs for 3 months; OR B. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide in combination with methotrexate for at least 3 months; OR C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.) Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For renewals beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 5mg administered twice dailyLU Authorization Period: 1 yearFor the treatment of ulcerative colitis disease in patients who meet the following criteria: 1. Moderate disease a. Mayo score between 6 and 10 (inclusive) AND b. Endoscopic* subscore of 2 AND c. Failed 2 weeks of oral prednisone at daily doses greater than or equal to 40mg (or a 1 week course of IV equivalent) OR d. Stabilized with 2 weeks oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent) but demonstrated that the corticosteroid dose cannot be tapered despite 3 months of AZA/6MP (or where the use of immunosuppressants is contraindicated). 2. Severe disease a. Mayo score greater than 10 AND b. Endoscopy* subscore of greater than or equal to 2 AND c. Failed 2 weeks of oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent) OR d. Stabilized with 2 weeks oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent) but demonstrated that the corticosteroid dose cannot be tapered despite 3 months of AZA/6MP (or where the use of immunosuppressants is contraindicated). *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. The recommended dosing regimen for induction is 10mg twice daily for at least 8 weeks. Maintenance/Renewal: Maintenance therapy is funded for patients who meet the Ministry initiation criteria and whose disease is maintained at Mayo score less than 6 AND who demonstrate at least 50% reduction in the dose of prednisone compared with the starting dose following the first 6 months of treatment with tofacitinib or be off corticosteroids after the first year of treatment. The recommended dosing regimen is 5mg twice daily. Depending on therapeutic response; 10mg twice daily may also be used for maintenance in some patients. However, the lowest effective dose possible should be used for maintenance therapy to minimize adverse effects. LU Authorization Period: 1 year238210mgTabXeljanzPFI43.78332020-09-3010.5859Taro-TofacitinibTAR10.58592023-01-3110.5859Auro-TofacitinibAUR10.58592023-01-3110.5859Sandoz TofacitinibSDZ10.58592025-09-2910.5859For the treatment of ulcerative colitis disease in patients who meet the following criteria: 1. Moderate disease a. Mayo score between 6 and 10 (inclusive) AND b. Endoscopic* subscore of 2 AND c. Failed 2 weeks of oral prednisone at daily doses greater than or equal to 40mg (or a 1 week course of IV equivalent) OR d. Stabilized with 2 weeks oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent) but demonstrated that the corticosteroid dose cannot be tapered despite 3 months of AZA/6MP (or where the use of immunosuppressants is contraindicated). 2. Severe disease a. Mayo score greater than 10 AND b. Endoscopy* subscore of greater than or equal to 2 AND c. Failed 2 weeks of oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent) OR d. Stabilized with 2 weeks oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent) but demonstrated that the corticosteroid dose cannot be tapered despite 3 months of AZA/6MP (or where the use of immunosuppressants is contraindicated). *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. The recommended dosing regimen for induction is 10mg twice daily for at least 8 weeks. Maintenance/Renewal: Maintenance therapy is funded for patients who meet the Ministry initiation criteria and whose disease is maintained at Mayo score less than 6 AND who demonstrate at least 50% reduction in the dose of prednisone compared with the starting dose following the first 6 months of treatment with tofacitinib or be off corticosteroids after the first year of treatment. The recommended dosing regimen is 5mg twice daily. Depending on therapeutic response; 10mg twice daily may also be used for maintenance in some patients. However, the lowest effective dose possible should be used for maintenance therapy to minimize adverse effects. LU Authorization Period: 1 yearTOFACITINIB CITRATE238311mgER TabXeljanz XRPFI49.54672019-08-3027.2507Taro-Tofacitinib XRTAR27.25072025-03-3127.2507For the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or, anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments: A. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide (20mg/day) for at least 3 months, in addition to iii) an adequate trial of at least one combination of DMARDs for 3 months; OR B. i) Methotrexate (20mg/week) for at least 3 months, AND ii) leflunomide in combination with methotrexate for at least 3 months; OR C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.) Maintenance/Renewal: After 12 months of treatment, maintenance therapy is funded for patients with objective evidence of at least a 20 percent reduction in swollen joint count and a minimum of improvement in 2 swollen joints over the previous year. For renewals beyond the second year, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 11mg once daily.LU Authorization Period: 1 yearUPADACITINIB238415mgER TabRinvoqABV51.68102022-10-3151.6810For the treatment of rheumatoid arthritis (RA) in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or, anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of treatment with other disease modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments: i) Methotrexate (i.e. 20mg/week for at least 3 months) ii) Methotrexate (20mg/week) for at least 3 months AND leflunomide (20mg/day) for at least 3 months iii) Methotrexate 20mg/week, sulfasalazine (2g/day) AND hydroxychloroquine (dose based on weight up to 400mg per day) for at least 3 months. In patients who demonstrated initial response to treatment (defined as an achievement of an American College of Rheumatology [ACR] improvement criteria of at least 20% [ACR20] at week 12), ongoing maintenance therapy is funded. Maintenance/Renewal: After 12 weeks of treatment, maintenance therapy is funded for patients who achieved an American College of Rheumatology (ACR) improvement criteria of at least 20% (ACR20) and a minimum of improvement in 2 swollen joints by week 12. For renewals beyond 12 months, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 15mg administered once daily. Upadacitinib shoud not be used in combination with other Janus kinase (JAK) inhibitors or other biologic DMARDs to treat the patient's RA. LU Authorization Period: 1 yearFor the treatment of ulcerative colitis disease in patients who meet the following criteria: 1. Moderate disease a. Mayo score between 6 and 10 (inclusive) AND b. Endoscopic* subscore of 2 AND c. Failed 2 weeks of oral prednisone at daily doses greater than or equal to 40mg (or a 1 week course of IV equivalent) OR d. Stabilized with 2 weeks oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent) but demonstrated that the corticosteroid dose cannot be tapered despite 3 months of AZA/6MP (or where the use of immunosuppressants is contraindicated). 2. Severe disease a. Mayo score greater than 10 AND b. Endoscopy* subscore of greater than or equal to 2 AND c. Failed 2 weeks of oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent) OR d. Stabilized with 2 weeks oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent) but demonstrated that the corticosteroid dose cannot be tapered despite 3 months of AZA/6MP (or where the use of immunosuppressants is contraindicated). *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. Maintenance/Renewal: Maintenance therapy is funded for patients who meet the Ministry initiation criteria and whose disease is maintained at Mayo score less than 6 AND who demonstrate at least 50% reduction in the dose of prednisone compared with the starting dose following the first 6 months of treatment with upadacitinib or be off corticosteroids after the first year of treatment. Approved Dose: Induction: Up to 45mg once daily for 8 weeks Maintenance: 15mg or 30mg once daily. For patients greater or equal to 65 years of age, the maintenance dose is 15mg once daily. Depending on therapeutic response, 30mg once daily may also be used for maintenance in some patients younger than 65 years of age. However, the lowest effective dose possible should be used for maintenance therapy to minimize adverse effects.LU Authorization Period: 1 year238530mgER TabRinvoqABV80.03842024-08-3080.0384238645mgER TabRinvoqABV105.88242024-08-30105.8824For the treatment of ulcerative colitis disease in patients who meet the following criteria: 1. Moderate disease a. Mayo score between 6 and 10 (inclusive) AND b. Endoscopic* subscore of 2 AND c. Failed 2 weeks of oral prednisone at daily doses greater than or equal to 40mg (or a 1 week course of IV equivalent) OR d. Stabilized with 2 weeks oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent) but demonstrated that the corticosteroid dose cannot be tapered despite 3 months of AZA/6MP (or where the use of immunosuppressants is contraindicated). 2. Severe disease a. Mayo score greater than 10 AND b. Endoscopy* subscore of greater than or equal to 2 AND c. Failed 2 weeks of oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent) OR d. Stabilized with 2 weeks oral prednisone at daily doses greater than or equal to 40mg (or 1 week of IV equivalent) but demonstrated that the corticosteroid dose cannot be tapered despite 3 months of AZA/6MP (or where the use of immunosuppressants is contraindicated). *The endoscopy procedure must be done within the 12 months prior to initiation of treatment. Maintenance/Renewal: Maintenance therapy is funded for patients who meet the Ministry initiation criteria and whose disease is maintained at Mayo score less than 6 AND who demonstrate at least 50% reduction in the dose of prednisone compared with the starting dose following the first 6 months of treatment with upadacitinib or be off corticosteroids after the first year of treatment. Approved Dose: Induction: Up to 45mg once daily for 8 weeks Maintenance: 15mg or 30mg once daily. For patients greater or equal to 65 years of age, the maintenance dose is 15mg once daily. Depending on therapeutic response, 30mg once daily may also be used for maintenance in some patients younger than 65 years of age. However, the lowest effective dose possible should be used for maintenance therapy to minimize adverse effects.LU Authorization Period: 1 yearIMMUNOSUPPRESSIVE AGENTSBARICITINIB23872mgTabOlumiantLIL59.43672021-08-3159.4367For the treatment of rheumatoid arthritis (RA) in combination with methotrexate in patients who have severe active disease (greater than or equal to 5 swollen joints and rheumatoid factor positive and/or, anti-CCP positive, and/or radiographic evidence of rheumatoid arthritis) and have experienced failure, intolerance, or have a contraindication to adequate trials of disease-modifying anti-rheumatic drugs (DMARDs) treatment regimens, such as one of the following combinations of treatments: A. i) Methotrexate (20mg/week) for at least 3 months, AND ii) Leflunomide (20mg/day) for at least 3 months, in addition to iii) An adequate trial of at least one combination of DMARDs for 3 months; OR B. i) Methotrexate (20mg/week) for at least 3 months, AND ii) Leflunomide in combination with methotrexate for at least 3 months; OR C. i) Methotrexate (20mg/week), sulfasalazine (2g/day) and hydroxychloroquine (400mg/day) for at least 3 months. (Hydroxychloroquine is based by weight up to 400mg per day.) In patients who demonstrated initial response to treatment (defined as an achievement of an American College of Rheumatology [ACR] improvement criteria of at least 20% [ACR20] at week 12), ongoing maintenance therapy is funded. Maintenance/Renewal: After 12 weeks of treatment, maintenance therapy is funded for patients who achieved an American College of Rheumatology (ACR) improvement criteria of at least 20% (ACR20) and a minimum of improvement in 2 swollen joints by week 12. For renewals beyond 12 months, the patient must demonstrate objective evidence of preservation of treatment effect. Therapy must be prescribed by a rheumatologist or a physician with expertise in rheumatology. The recommended dosing regimen is 2mg administered once daily. Baricitinib should not be used in combination with other Janus kinase (JAK) inhibitors or other biologic DMARDs to treat the patient's RA. LU Authorization Period: 1 yearInitiation criteria: For the treatment of adult patients with severe alopecia areata (AA) who meet the following criteria: 1. Have a Severity of Alopecia Tool (SALT) score of 50 or above, and 2. Have experienced the current episode of AA for more than 6 months but less than 8 years. The maximum duration of initial authorization is 36 weeks. Renewal criteria: For continuation of reimbursement, the patient must demonstrate beneficial clinical effect, defined as achieving a SALT score of 20 or less at 36 weeks after treatment initiation. Maintenance of a SALT score of 20 or less every 12 months thereafter is required for reimbursement renewal. Dosing and prescribing: The recommended dose is 2mg once daily. The maximum funded dose is 4mg once daily. Baricitinib should be prescribed by a dermatologist with expertise managing patients with severe AA. Baricitinib should not be used in combination with other JAK inhibitors, biologic immunomodulators, or systemic immunosuppressants.LU Authorization Period: 1 year23884mgTabOlumiantLIL59.43672025-12-3059.4367Initiation criteria: For the treatment of adult patients with severe alopecia areata (AA) who meet the following criteria: 1. Have a Severity of Alopecia Tool (SALT) score of 50 or above, and 2. Have experienced the current episode of AA for more than 6 months but less than 8 years. The maximum duration of initial authorization is 36 weeks. Renewal criteria: For continuation of reimbursement, the patient must demonstrate beneficial clinical effect, defined as achieving a SALT score of 20 or less at 36 weeks after treatment initiation. Maintenance of a SALT score of 20 or less every 12 months thereafter is required for reimbursement renewal. Dosing and prescribing: The recommended dose is 2mg once daily. The maximum funded dose is 4mg once daily. Baricitinib should be prescribed by a dermatologist with expertise managing patients with severe AA. Baricitinib should not be used in combination with other JAK inhibitors, biologic immunomodulators, or systemic immunosuppressants.LU Authorization Period: 1 yearCLADRIBINE238910mgTabMavencladEMS3212.00002026-01-302409.0000Apo-CladribineAPX2409.00002026-01-302409.0000TACROLIMUS23900.75mgER TabEnvarsus PAEVL2.09992020-09-302.099923911mgER TabEnvarsus PAEVL2.74302020-09-302.743023924mgER TabEnvarsus PAEVL10.97192020-09-3010.9719For the prophylaxis of organ rejection in allogenic kidney or liver transplant adult patients in combination with other immunosuppressants.LU Authorization Period: IndefiniteOTHER MISCELLANEOUS THERAPEUTIC AGENTSABOBOTULINUM TOXIN A2393300U/VialPd Inj-Vial PkDysport TherapeuticIPS385.56002018-09-27385.56002394500U/VialPd Inj-Vial PkDysport TherapeuticIPS642.60002018-09-27642.6000Dysport Therapeutic should be administered personally by a neurologist, pediatrician, or a physician with equivalent post-graduate training and experience with neuromuscular disorders.To reduce the subjective symptoms and objective signs of cervical dystonia (spasmodic torticollis) in adults.LU Authorization Period: 1 yearFor the management of focal spasticity, due to stroke or spinal cord injury in adults.LU Authorization Period: 1 yearFor the treatment of focal spasticity secondary to cerebral palsy in patients two years of age or older.LU Authorization Period: 1 yearFAMPRIDINE239510mgER TabFampyraBIG2020-12-18Taro-FampridineTAR8.47302020-12-18PMS-FampridinePMS8.47302021-04-30MISCELLANEOUSNUTRITION PRODUCTSNUTRITIONAL PRODUCT1.2kcal/mL1500mL Ready-to-hangIsosource Fibre 1.2NES13.82442017-05-3113.82441.5kcal/mL1500mL Ready-to-hangIsosource Fibre 1.5NES17.25642017-05-3117.25641.5kcal/mL1500mL Ready-to-HangIsosource 1.5NES11.49752017-09-2811.49752kcal/mL200mL Pk bottleRenastepVIT9.23002024-12-309.23001.2kcal/mL250mL Tetra PkIsosource Fibre 1.2NES2.30402017-05-312.30401.2Kcal/mL250mL Tetra PkIsosource 1.2NES1.53302017-09-281.53301.5kcal/mL250mL Tetra PkIsosource Fibre 1.5NES2.87602017-05-312.87601.5kcal/mL250mL Tetra PkIsosource 1.5NES1.91632017-09-281.91631.5Kcal/mLLiq - 250mL Tetra PkPeptamen Junior 1.5NES13.22242017-07-3113.22241.5kcal/mLLiq - 250mL Tetra PkPeptamen 1.5 with PrebioNES13.22252025-05-3013.2225Liq-1000mL PkPerativeROS11.48002002-07-2911.48001.2kcal/mLLiq-1000mL PkJevity 1.2 CalABB9.13002003-04-169.13001.5kcal/mLLiq-1000mL PkPeptamen 1.5NES52.89002004-11-0452.89001.5kcal/mLLiq-1000mL PkJevity 1.5 CalABB11.52002008-12-0311.5200Liq-1000mL Ready-To-HangCompleat 1.06NES7.97002001-10-117.97001.06kcal/mLLiq-1500mL PkOsmolite 1 CalABB8.01002003-04-168.01001.06kcal/mLLiq-1500mL PkJevity 1 CalABB12.22002003-04-1612.22001.2kcal/mLLiq-1500mL PkOsmolite 1.2 CalABB9.07002003-04-169.07001.2kcal/mLLiq-1500mL PkJevity 1.2 CalABB13.70002003-04-1613.70001.5kcal/mLLiq-1500mL PkJevity 1.5 CalABB17.28002008-12-0317.28001kcal/mLLiq-1500mL PkPeptamen with PrebioNES52.89002004-07-2052.89001.5kcal/mLLiq-1500mL Ready-to-HangPeptamen 1.5 with PrebioNES79.33512025-05-3079.3351Liq-235mL PkOsmolite 1 CALABB1.26001996-10-011.2600Liq-235mL PkPediaSureABB2.47001996-10-012.4700Liq-235mL PkSuplenaABB2.09001998-12-312.0900Liq-235mL PkOsmolite 1.2 CALABB1.44002001-10-111.44001.06kcal/mLLiq-235mL PkJevity 1 CalABB1.92001996-10-011.92001.2kcal/mLLiq-235mL PkJevity 1.2 CalABB2.17002000-01-172.17001.5kcal/mLLiq-235mL PkPediasure Plus with FibreROS2.74002003-09-042.74001.5kcal/mLLiq-235mL PkJevity 1.5 CalABB2.70252010-04-232.70251kcal/mLLiq-235mL PkPediasure with FibreROS2.47002003-01-302.47002kcal/mLLiq-235mL PkTwoCal HNABB2.36882003-01-302.3688Liq-235mL Pk CansEnsure PlusABB1.79001996-10-011.7900Liq-237mL PkBoost Fruit Flavoured BeverageNES1.53001996-10-011.5300Liq-237mL PkResource 2.0NES2.40412000-07-172.4041Liq-237mL PkNovaSource RenalNES2.39402001-10-112.3940Liq-237mL PkPerativeROS2.72002002-07-292.72001.5kcal/mLLiq-237mL PkBoost 1.5 Plus CaloriesNES1.73921996-10-011.73921.5kcal/mLLiq-237mL PkResource Kid Essentials 1.5NES3.29782005-09-273.29781kcal/mLLiq-237mL PkNeocate Splash Junior (Grape Flavour)NUT7.05612019-01-317.05611kcal/mLLiq-237mL PkNeocate Splash Junior (Orange-Pineapple)NUT7.05612019-01-317.05611kcal/mLLiq-237mL PkNeocate Splash Junior (Unflavoured)NUT7.05612019-01-317.05611kcal/mLLiq-237mL PkNeocate Splash Junior (Tropical Fruit)NUT7.05612019-01-317.05611.0kcal/mLLiq-237mL Pk Reclosable Plastic BottlePediaSure Peptide 1 CalABB2.68922015-05-282.68921.2kcal/mLLiq-237mL Reclosable Carton PkOsmolite 1.2 CALABB1.45332025-11-281.45331.2kcal/mLLiq-237mL Reclosable Carton PkJevity 1.2 CalABB2.18422025-11-282.18421.5kcal/mLLiq-237mL Reclosable Carton PkJevity 1.5 CalABB2.73022025-09-292.73022kcal/mLLiq-237mL Reclosable Carton PkTwoCal HNABB2.38902025-09-292.38901.5kcal/mLLiq-237mL Tetra PkKetoCal 4:1 (Vanilla Flavoured)NUT5.74632011-08-045.74631.5kcal/mLLiq-237mL Tetra PkKetoCal 4:1 (Unflavoured)NUT5.74632014-09-255.74631.50kcal/mLLiq-250mL CartonKetoVie 4:1 Plant Based Protein(Vanilla)CAM9.24482023-06-309.24481.50kcal/mLLiq-250mL Carton BoxKetoVie 4:1 UnflavouredCAM6.54512022-08-316.54511.04kcal/mLLiq-250mL Carton Box (Unflavoured)KetoVie 3:1CAM6.54512022-10-316.5451Liq-250mL PkPeptamenNES8.81501996-10-018.8150Liq-250mL PkPeptamen JuniorNES8.81501996-10-018.81501.06kcal/mLLiq-250mL PkResource Diabetic 1.05NES2.03522003-09-042.03521.49kcal/mLLiq-250mL PkKetoVie Peptide 4:1CAM9.24482021-11-309.24481.5kcal/mLLiq-250mL PkPeptamen 1.5NES13.22252000-07-1713.22251kcal/mLLiq-250mL PkNutren Junior 1.0NES2.62752001-10-112.62751kcal/mLLiq-250mL PkNutren Junior Fibre 1.0NES2.62752001-10-112.62751kcal/mLLiq-250mL PkPeptamen with PrebioNES8.81502004-07-208.81501kcal/mLLiq-250mL PkCompleat Junior 1.0NES2.59202006-01-122.5920Liq-250mL Tetra PkCompleat 1.06NES2.03001996-10-012.0300239668kcal/100mLLiq-384mL CanNutramigen Liquid ConcentrateMJC8.32002022-06-308.3200Liq-384mL PkRCFABB6.27001996-10-016.2700Liq-4x237mL PkAlimentumABB6.71521996-10-016.71527.7kcal/mLLiq-946mL PkMCT OilNES39.28331996-10-0139.28331.56kcal/mLLiq-Chocolate Flavour, 250mL PkKetoVie 4:1CAM6.54512020-06-306.54511.5Kcal/mLLiq-Vanilla Flavour, 220mL Pk bottleVital Peptide 1.5 CalABB7.74722020-01-317.74721Kcal/mLLiq-Vanilla Flavour, 220mL Pk bottleVital Peptide 1 CalABB5.37212020-01-315.37211.44kcal/mLLiq-Vanilla Flavour, 250mL PkKetoVie 4:1CAM6.54512020-06-306.54511.5Kcal/mLLiq-Vanilla Flavour,1000mL Ready to Hang containerVital Peptide 1.5 CalABB35.21452020-01-3135.214522kcal/30mLPd for Liq-363g PkEnfamil EnfaCare A+MJS17.37002006-01-1217.3700810.7143Kcal/227gPd-227g Pk Canister (Unflavoured)BeneproteinNES12.89042019-11-2912.89047.05kcal/gPd-300g PkKetoCal 4:1 (Vanilla Flavour)NUT31.80002018-11-2931.80005.15kcal/gPd-363g PkSimilac Advance NeoSureABB14.99002004-07-2014.990023974.9301kcal/gPd-400g BottleGerber Good Start Extensive HANEC17.62002022-06-3017.62001976kcal/400gPd-400g CanRenastartVIT42.27502021-11-3042.275023981976Kcal/400gPd-400g CanAlfaminoNES64.02002022-07-2964.020023992024Kcal/400gPd-400g CanAltheraNES18.07002022-07-2918.07000.2071g/kcalPd-400g Can PkNeocate DHA & ARANUT62.56002019-08-3062.56005.17Kcal/gPd-400g Can PkSimilac AlimentumABB16.47002017-10-3016.470024004.41cal/gPd-400g Can with DHA & ARA (Unflavoured)MonogenNUT38.33332023-09-2838.33331.0kcal/mLPd-400g CanisterAlfamino JuniorNES64.67592023-12-2964.67591kcal/mLPd-400g PkNeocate Junior (Unflavoured)NUT54.26992002-04-0454.26991kcal/mLPd-400g PkModulenNES34.79642011-09-1534.79641kcal/mLPd-400g PkNeocate Junior (Tropical Flavour)NUT54.26992018-03-2954.26995kcal/gPd-400g PkPurAmino A+MJN55.79002010-10-2855.79001.0kcal/mLPd-400g Pouch PkEssential Care Junior (Unflavored)CAM57.78002024-12-3057.78001.02kcal/mLPd-454g PkPortagenMJN55.78002003-01-3055.78005kcal/gPd-454g PkNutramigen A+MJN29.13002010-03-0229.13005Kcal/gPd-561g Can PkNutramigen A+ with LGGMJN35.99002017-08-3035.99005kcal/gPd-561g PkNutramigen A+MJN35.99002025-11-2835.9900Pd-79.5g PkVivonex PlusNES9.83451996-10-019.834525Kcal/7gPd-7g Pk Sachet (Unflavoured)BeneproteinNES.39752019-11-29.3975Pd-80.4g PkVivonex T.E.N.NES9.78431996-10-019.7843Pd-80g PkTolerexNES7.06431996-10-017.064324010.677kcal/mLPd-946mL BottleSimilac AlimentumABB5.62782022-06-305.62781.5Kcal/mLReady-to-Hang - 1L PkPivot 1.5 CALABB52.79992024-10-3152.79992.0kcal/mLReady-To-Hang 1000mL PkIsosource 2.0NES10.08002020-08-2810.08001.5Kcal/mLTetrapack-237mL PkPivot 1.5 CALABB12.51352024-10-3112.5135DIABETIC TESTING AGENTSFAD GLUCOSE DEHYDROGENASE (ASPERGILLUS SP.)StripContour Next Blood Glucose Test StripsADC.72902013-09-27.7290FAD-GLUCOSE DEHYDROGENASE (FAD-GDH)StripGE200 Blood Glucose Test StripsBIN.55082015-05-28.5508StripAccu-Chek Guide Test StripsRCH.71542017-07-31.7154StripGlucoDr. Auto Test StripAMC.72902018-03-29.7290Test StripFora Test N' Go Test StripTAI.72442016-09-29.7244GDH-FAD ENZYMEStripFreestyle LiteABB.72902008-08-28.7290GDH-FAD GLUCOSE DEHYDROGENASEStripOne Touch VerioLIF.72902011-09-15.7290GLUCOSE DEHYDROGENASEStripContour Blood Glucose Test StripsADC.72902004-11-04.7290StripFreeStyle Precision Test StripsABD.72902014-10-29.7290GLUCOSE OXI-REDUCTASEStripAccu-Chek MobileRCH.74812013-07-30.7481GLUCOSE OXIDASEStripSpirit Blood Glucose Test StripARA.69122016-08-30.6912StripSuretest Blood Glucose Test StripsSKY.72902015-04-30.7290StripCareSens N Blood Glucose Test StripISE.69122015-07-29.6912StripIdeal Life Glucose Test StripIDL.68002016-02-25.6800GLUCOSE OXIDASE A. NIGERStripTykess Blood Glucose Test StripsTAI1.07982023-04-281.0798GLUCOSE OXIDASE REAGENTStripAccutrendROD.76791996-10-01.7679StripAccu-Chek AdvantageROD.74811996-10-01.7481StripAdvantage ComfortROD.74811999-04-15.7481StripPrecision XtraABB.72902001-10-11.7290StripAccu-Chek CompactRCH.74812002-04-04.7481StripOne Touch UltraLIF.72902002-04-04.7290StripFreestyleTER.72902003-09-04.7290StripBDBED.76552005-02-22.7655StripAccu-Chek AvivaRCH.74812006-04-19.7481StripTrueTrack Smart SystemHOM.40002007-12-19.4000StripBreeze 2 Blood Glucose Test StripADC.72902008-04-09.7290StripNova MaxNOB.72902008-12-23.7290StripOn Call PlusACO.45002010-01-05.4500StripEZ Health OracleTRE.72902010-07-20.7290StripMediSure Blood Glucose StripMEH.69002013-01-29.6900StripMyGlucoHealthEHS.68512013-10-31.6851QUINOPROTEIN GLUCOSE DEHYDROGENASEStripAccu-Chek Inform II Test StripsROD.65952014-03-27.6595VALVED HOLDING CHAMBERSVALVED HOLDING CHAMBERA2A Spacer with Small MaskCCI12.00002018-01-0112.0000A2A Spacer with Medium MaskCCI12.00002018-01-0112.0000Optichamber Diamond ChamberRRD16.34002018-01-0116.3400Optichamber Diamond Chamber + Small MaskRRD27.93002018-01-0127.9300Optichamber Diamond Chamber+Medium MaskRRD27.93002018-01-0127.9300Optichamber Diamond Chamber + Large MaskRRD30.78002018-01-0130.7800AeroChamber Plus FlowVu Infant Sm. MaskTMI40.50002018-01-0140.5000AeroChamber Plus FlowVu Child Med. MaskTMI40.50002018-01-0140.5000AeroChamber Plus FlowVu Youth MouthpieceTMI25.32002018-01-0125.3200AeroChamber Plus FlowVu Girls MouthpieceTMI25.32002018-01-0125.3200AeroChamber Plus FlowVu Adult MouthpieceTMI25.32002018-01-0125.3200AeroChamber Plus FlowVu Adult Sm. MaskTMI42.85002018-01-0142.8500AeroChamber Plus FlowVu Adult Large MaskTMI42.85002018-01-0142.8500AeroChamber2go with MouthpieceTMI29.95002026-02-2729.9500ChamberA2A Aerosol to Airways SpacerCCI9.00002018-01-019.0000CONTINUOUS GLUCOSE MONITORING SYSTEMSGLUCOSE MONITORING SYSTEM2402Continuous Glucose Monitoring System - ReaderFreeStyle Libre 3 ReaderABD60.0000Reimbursement Criteria and Maximum Reimbursed Quantity: All ODB eligible recipients on insulin therapy for diabetes who have a valid prescription from a physician or nurse practitioner for CGM sensors and/or a CGM reader/receiver designated on the Formulary are eligible to receive the prescribed ODB-funded CGM sensors and/or reader/receiver. Patients who meet the reimbursement criteria are eligible for a maximum reimbursed quantity of 31 sensors over the course of a 365-day period. Please refer to the Ontario Drug Programs Reference Manual for more information related to CGM systems (e.g., pharmacy billing procedure, HNS response codes and messages).2025-11-2860.00002403Continuous Glucose Monitoring System - SensorFreeStyle Libre 3 Plus SensorABD97.5000Reimbursement Criteria and Maximum Reimbursed Quantity: All ODB eligible recipients on insulin therapy for diabetes who have a valid prescription from a physician or nurse practitioner for CGM sensors and/or a CGM reader/receiver designated on the Formulary are eligible to receive the prescribed ODB-funded CGM sensors and/or reader/receiver. Patients who meet the reimbursement criteria are eligible for a maximum reimbursed quantity of 31 sensors over the course of a 365-day period. Please refer to the Ontario Drug Programs Reference Manual for more information related to CGM systems (e.g., pharmacy billing procedure, HNS response codes and messages).2025-11-2897.50002404Continuous Glucose Monitoring System-Receiver KitDexcom G7 ReceiverDEX60.0000Reimbursement Criteria and Maximum Reimbursed Quantity: All ODB eligible recipients on insulin therapy for diabetes who have a valid prescription from a physician or nurse practitioner for CGM sensors and/or a CGM reader/receiver designated on the Formulary are eligible to receive the prescribed ODB-funded CGM sensors and/or reader/receiver. Patients who meet the reimbursement criteria are eligible for a maximum reimbursed quantity of 45 sensors over the course of a 365-day period. Please refer to the Ontario Drug Programs Reference Manual for more information related to CGM systems (e.g., pharmacy billing procedure, HNS response codes and messages).2025-07-3160.00002405Continuous Glucose Monitoring System-Sensor KitDexcom G7 SensorDEX75.0000Reimbursement Criteria and Maximum Reimbursed Quantity: All ODB eligible recipients on insulin therapy for diabetes who have a valid prescription from a physician or nurse practitioner for CGM sensors and/or a CGM reader/receiver designated on the Formulary are eligible to receive the prescribed ODB-funded CGM sensors and/or reader/receiver. Patients who meet the reimbursement criteria are eligible for a maximum reimbursed quantity of 45 sensors over the course of a 365-day period. Please refer to the Ontario Drug Programs Reference Manual for more information related to CGM systems (e.g., pharmacy billing procedure, HNS response codes and messages).2025-07-3175.0000READER KIT AND SENSOR KIT2406Flash Glucose Monitoring System - ReaderFreeStyle Libre 2 ReaderABD49.0000Reimbursement Criteria and Maximum Reimbursed Quantity: All ODB eligible recipients on insulin therapy for diabetes who have a valid prescription from a physician or nurse practitioner for CGM sensors and/or a CGM reader/receiver designated on the Formulary are eligible to receive the prescribed ODB-funded CGM sensors and/or reader/receiver. Patients who meet the reimbursement criteria are eligible for a maximum reimbursed quantity of 33 sensors over the course of a 365-day period. Please refer to the Ontario Drug Programs Reference Manual for more information related to CGM systems (e.g., pharmacy billing procedure, HNS response codes and messages).2021-11-3049.00002407Flash Glucose Monitoring System - SensorFreeStyle Libre 2 SensorABD91.0000Reimbursement Criteria and Maximum Reimbursed Quantity: All ODB eligible recipients on insulin therapy for diabetes who have a valid prescription from a physician or nurse practitioner for CGM sensors and/or a CGM reader/receiver designated on the Formulary are eligible to receive the prescribed ODB-funded CGM sensors and/or reader/receiver. Patients who meet the reimbursement criteria are eligible for a maximum reimbursed quantity of 33 sensors over the course of a 365-day period. Please refer to the Ontario Drug Programs Reference Manual for more information related to CGM systems (e.g., pharmacy billing procedure, HNS response codes and messages).2021-11-3091.0000