Overview

The Exceptional Access Program (EAP) facilitates patient access to drugs not funded on the Ontario Drug Benefit (ODB) Formulary, or where no listed alternative is available. In order to receive coverage, the patient must be eligible to receive benefits under the Ontario Drug Benefit (ODB) program.

The Executive Officer, on behalf of the Ministry of Health, makes funding decisions for drug products covered under the ODB program's EAP based on recommendations and guidelines from the ministry's expert advisory committee, the Committee to Evaluate Drugs (CED). All EAP requests will be considered according to the policies described below to ensure a fair and consistent review of each request.

Funding decision

For manufacturer-initiated reviews, each complete submission is reviewed by the CED. The CED then makes recommendations to the Executive Officer if a drug product should be:

  • listed as a formulary benefit
  • designated as an interchangeable drug product (for generic drugs)
  • funded by the ODB program following case-by-case review of a request

The CED also makes recommendations on if the drug products should be available through the EAP. Typically, the CED recommends consideration through the EAP for drug products where strong clinical evidence is not available to support efficacy or cost-effectiveness, when compared to other drugs already funded through the ODB program. The CED may also recommend clinical criteria for drugs considered through the EAP.

The Executive Officer may also request that the CED perform a review and provide a recommendation for a drug or indication in the absence of a manufacturer submission for the purposes of consideration under EAP.

EAP requests are only considered for a drug or indication which has been approved for funding by the Executive Officer.

Please note, the EAP does not consider funding for non-drug products such as diabetic test strips, medical or assistive devices, natural health products, or nutritional products.

Please refer to the ODB formulary for nutritional products and diabetic test strips that are covered on the ODB Program.

EAP drugs, criteria and required information

Check if the drug your patient needs is covered through the Exceptional Access Program.

To see a list of EAP drugs with Drug Identification Numbers (DINs) (Excel).

Find reimbursement criteria for some of the drugs considered through the EAP.

Approval is not guaranteed. Only requests that meet all the criteria will be approved for reimbursement.

Some of the drugs considered through EAP are also listed on the ODB Formulary as Limited Use (LU) or as General Benefits with Therapeutic Notes for specific indications. Patients who do not meet the Limited Use criteria or the Therapeutic Notes may be eligible for EAP reimbursement.

For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. This includes:

  • funding for continued treatment that was previously supplied through a clinical trial, or paid for by other means, such as a third-party payer (Note: First time requests for the funding of ongoing treatments must meet both initial and renewal criteria for the drug being requested, unless otherwise specified)
  • funding for a renewal beyond the previously approved initial period, unless otherwise specified.

Selected drug-specific criteria is used in the consideration of EAP requests, in order to improve transparency and assist authorized prescribers (physicians or nurse practitioners) in making EAP drug requests.

Submitting an EAP request

Requests for authorization of EAP listed drugs can be submitted to the ministry through one of the following channels.

The Special Authorization Digital Information Exchange (SADIE) portal.

The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program. Find more information about SADIE.

EAP requests for hospitalized patients who are imminently awaiting hospital discharge may be submitted electronically through SADIE or on the hospital discharge form.

SADIE will ask for all of the required information when a request is created and identify any missing information before the request is submitted. If you are submitting a request by fax or mail, please ensure that all of the following information is provided:

  • patient information: name as it appears on the Ontario Health card, the Ontario Health card number, date of birth
  • authorized prescriber (physician or nurse practitioner) information: name, office address, phone number, fax number, CPSO (for physicians) or Registration Number (for nurse practitioners), signature
  • drug being requested: name and dosages/strengths or treatment schedule, indication
  • clinical information outlining how patient meets the reimbursement criteria
  • laboratory tests and objective clinical measures as applicable to the reimbursement criteria
  • details of previous treatment with Formulary products, if applicable

Fax

Submitting the completed request form/information by fax to the Exceptional Access Program

In Ontario:
1-866-811-9908 or 416-327-7526 (Toronto area).

Outside Ontario:
1-833-905-4260

The Telephone Request Service

For selected drugs, the Telephone Request Service is available to authorized prescribers or their delegates. In most cases, the funding decision is provided by the end of the call and processed within one business day.

Physicians, nurse practitioners and their delegates are encouraged to review the TRS reimbursement criteria before using TRS to ensure they have all of the necessary information available during the call.

Callers who wish to submit a request for drug products or indications not currently available through TRS will be asked to submit the request online through SADIE (ontario.ca/sadie) or by fax.

The caller will be asked a series of questions to:

  1. Ensure that the request is being made for a drug and indication covered by TRS;
  2. Authenticate the caller;
  3. Obtain relevant patient information; and
  4. Complete the assessment of the request.

If the caller provides all required information, the ministry TRS assessor will inform them whether the reimbursement criteria have been met or if further review is needed. In cases where the assessor is able to make a determination that the request either meets or does not meet the reimbursement criteria, the authorized prescribers will receive the decision during the call.

A written confirmation will be provided following the call within one business day. If the request is approved, the eligible ODB recipient will be able to fill prescriptions and be reimbursed within one business day.

The TRS can be accessed by calling toll-free at 1-866-811-9893 or 416-327-8109 (Toronto area) between 8:30 a.m. and 5:00 p.m. Monday through Friday (except holidays) and selecting the TRS option.

Mail

For authorized prescribers unable to use any of the above options, requests may be mailed.  Submission by mail may delay the receipt of the request by the Exceptional Access Program.

Exceptional Access Program
5700 Yonge Street — 3rd Floor
North York, Ontario M2M 4K5

Only authorized prescribers may submit an EAP request. Under the Ontario Drug Benefit Act (ODBA), authorized prescribers are Ontario physicians and nurse practitioners, and physicians and nurses in the provinces of Manitoba and Quebec who have the authority to prescribe drugs.

Where to apply

Fax

In Ontario:
1-866-811-9908 or 416-327-7526 (Toronto area).
Outside Ontario:
1-833-905-4260

Hospital Discharge

Online: Submit EAP request via the Special Authorization Digital Information Exchange (SADIE) and check the box “Patient is awaiting hospital discharge” when creating a request.
Fax: The Hospital Discharge Form can be faxed toll-free to 1-844-829-6807 or 416-314-3857 (Toronto area).

Telephone Request Service

Phone: 1-866-811-9893 or 416-327-8109
(available 8:30 a.m. to 5:00 p.m., Monday through Friday except holidays; please select the TRS option by pressing 3 from the menu options)

Mail

Exceptional Access Program
5700 Yonge Street — 3rd Floor
North York, Ontario M2M 4K5

Request forms

Submitting requests via SADIE is recommended for faster response times and reduced need for additional information to be requested from you. If you are submitting a request via fax or mail, authorized prescribers (physicians and nurse practitioners) can use the Standard Form [Request for an Unlisted Drug Product — Exceptional Access Program (EAP)], or for certain drugs, authorized prescribers can use a drug specific electronic form (e-form).

FormEAP drug request form explanation
Standard Form [Request for an Unlisted Drug Product Exceptional Access Program (EAP)]Can be used for any EAP Drug Requests
Oxycodone HCl controlled release (OxyNEO)Oxycodone HCl controlled release (OxyNEO) Drug Request
(drug specific & interactive)
Elaprase (idursulfase)Elaprase (idursulfase) Drug Request (drug specific & interactive)
Ilaris (canakinumab)Ilaris (canakinumab) Drug Request (drug specific & interactive)
Myozyme (alglucosidasae alfa) for both infantile and adult/late onset Pompe diseaseMyozyme (alglucosidasae alfa) Drug Request (drug specific & interactive)
Zavesca (miglustat)Zavesca (miglustat) Drug Request (drug specific & interactive)

EAP coverage durations

For requests that meet EAP criteria and are approved, the effective date of coverage and the expiry date of coverage will be communicated to the physician or nurse practitioner in the ministry’s response letter.

The physician or nurse practitioner should provide a copy of the response letter to the patient or the pharmacy as this may help to avoid a gap in treatment should an extension of the request be required.

The effective date of an approved EAP request will be the date the clinical decision was made or 30 business days before the date the request was received by the program, whichever is shorter. It is the prescriber’s responsibility to ensure that a request is received in time for the patient’s earliest dispense date to fall within the coverage period. The EAP will not backdate earlier than 30 business days. Submission via SADIE is encouraged as the request is received instantaneously by the EAP and you receive a copy of the submitted request as confirmation.

Not all EAP requests are eligible to have an effective date prior to the date an EAP request is received. Only eligible approved requests that meet EAP criteria at the time of receipt by the program will be provided an effective date earlier than the date an EAP request is received. For example:

  • the effective date of coverage cannot be earlier than the date an EAP request is received for requests with a short duration of approval (an antibiotic, a drug required before surgery)
  • for renewal requests that are approved before the expiry date of existing funding
  • for requests that do not meet EAP criteria at the time of receipt, for requests made through the Telephone Request Service (TRS)
  • for requests made through the Compassionate Review Policy (CRP)

Approval is not guaranteed as requests must meet EAP clinical criteria. Prescribers should inform patients who choose to purchase unlisted drugs in advance of an EAP decision that they will be responsible for out-of-pocket costs.

To be covered for a drug approved by the EAP, the patient must be eligible for the Ontario Drug Benefit Program, which includes Ontarians enrolled in the Trillium Drug Program (TDP).

Turnaround times

The Exceptional Access Program receives between 250 and 500 requests a day. Requests are categorized in order of priority based on how quickly a drug is needed, the type of drug, and the condition for which the drug is being used.

Turnaround times begin on the business day on which the EAP receives a complete request from a physician or nurse practitioner. You may have to wait longer if the request is missing information or supporting documents required by the EAP criteria, if a request requires external review, or if documents are sent by fax or mail instead of submitted via SADIE.

EAP Weekly Progress Report

Date: June 17, 2024

Processing categories and examplesTargetCurrent
Priority 1 — for drugs such as antibiotics, cancer medications, and initial requests for pain medications3 business days1 business day
Priority 2 — for antiviral drugs to treat HIV, drugs for multiple sclerosis, and pulmonary hypertension5 business days1 business day
Biologics — for biologic drugs to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease10 business days3 business days
Chronic — for drugs used for chronic conditions such as migraines, chronic pain, Ménière's disease and symptoms of Parkinson’s disease.4 to 6 weeks8 business days

Requests from prescribers in Manitoba and Quebec

Manitoba and Quebec physicians and nurses who have authority to prescribe can submit EAP requests. As SADIE requires credentials that are only available to Ontario prescribers, requests from Manitoba and Quebec prescribers must be submitted by fax.

Compassionate Review Policy

Where there are rare clinical circumstances in immediately life, limb, or organ-threatening conditions, the Executive Officer will also consider requests for drugs or indications in situations where there has not been a decision by the Executive Officer to provide funding of the drug or indication as part of the Ontario Drug Benefit program (and the EAP), and the drug or indication requested would not circumvent the established review process for new drugs or indications as part of the drug submission process for listing within the Ontario Drug Benefit program. Requests must meet the criteria for the Compassionate Review Policy.

To assist physicians or nurse practitioners making requests under the CRP, a standardized CRP form has been developed. You are encouraged to use this form in order to ensure completeness of requests and quicker turnaround time.

Note: Requests for cancer drugs are considered under the Case-by-Case Review Program (CBCRP) which is administered by Ontario Health (Cancer Care Ontario) on behalf of the Ministry of Health. The CBCRP considers funding requests for drugs (both oral therapies and injectable drugs) for the treatment of cancer in patients who have a rare clinical circumstance that is immediately life-threatening (death is likely within a matter of months) and who require treatment with an unfunded drug, because there is no other satisfactory and funded treatment. Please refer to the Ontario Health website for information on the application process, FAQs, eligibility criteria and program policies.

While Ontario Health administers the CBCRP, the Executive Officer of Ontario Public Drug Programs makes all final funding decisions.

Funding for Drugs being used in clinical trials

This section is intended to clarify the circumstances in which EAP funding will be considered for drugs being used within the context of a clinical trial. Generally, the ODB program does not fund drugs being studied under a clinical trial. These costs should be funded by the trial organizer and accounted for within the study budget. Supportive therapies will be considered for funding under all of the following circumstances:

  • the patient must be eligible for the ODB Program at the time of enrolment in the trial)
  • the supportive therapy must currently be funded by the ODB Program according to the approved criteria
  • the requested product must be used as supportive therapy for the patient as part of a clinical trial

Manufacturer sponsored trials are excluded asit is expected that manufacturers will provide funding for study treatments as part of the trial budget. For trials that are not manufacturer sponsored, investigators are asked to provide prior notification to the ministry of impending requests for funding of supportive therapies for a clinical trial. Requestors should indicate trial details, funding details, patient numbers, and timelines for their request prior to submitting the first request to the EAP. Please contact an EAP Operations Manager at the address below.

Contact us

Program Inquiries regarding the Exceptional Access Program should be directed to: