The Exceptional Access Program (EAP) facilitates patient access in exceptional circumstances to drugs not funded on the Ontario Drug Benefit (ODB) Formulary, or where no listed alternative was available.

The Executive Officer, on behalf of the ministry, 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. Other modernization initiatives will minimize the impact of the EAP on prescribers and will make the process more transparent to prescribers and patients. The ministry will also be introducing an improved system to speed up the application and decision process.

Typically the CED recommends consideration through EAP for drug products where strong clinical evidence is not available to support efficacy and/or cost-effectiveness, when compared to other drugs already funded through the ODB program.

EAP requests are only considered for a drug or indication which has been approved for funding by the Executive Officer. For manufacturer-initiated reviews, each complete submission undergoes a rigorous review by the CED. The CED then makes recommendations to the Executive Officer as to whether a drug product should be listed as a Formulary benefit or designated as an interchangeable drug product (for generic drugs). The CED also makes recommendations as to whether or not drug products should be available through EAP, and may develop clinical criteria.

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. Normally, this occurs for indications which have not been approved by Health Canada (i.e., off-label indications). For Health Canada approved indications, the onus is on the manufacturer to submit information to the Ontario Public Drug Programs to request a product review.

Following the CED’s review, the Executive Officer makes the final decision regarding the reimbursement of the product.

To apply through EAP, the patient’s physician must submit a request documenting complete and relevant medical information to the ministry, providing the clinical rationale for requesting the unlisted drug and reasons why covered benefits are not suitable. All requests are reviewed according to the guidelines and criteria established by the CED and include a thorough assessment of the patient’s specific case and clinical circumstances, as provided by the physician, as well as the scientific evidence available.

The reimbursement criteria must always be met - even in cases where EAP drug coverage is required to provide continued treatment that was previously supplied through a clinical trial, or paid for by other means (such as a third party payor).

Selected drug-specific criteria used in the consideration of EAP requests are available on the ministry website at: www.health.gov.on.ca/english/providers/program/drugs/eap_criteria.html in order to improve transparency and assist physicians in making EAP drug requests.

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 the absence of a final funding decision. Requests must meet the criteria for the Compassionate Review Policy

Note: For cancer drugs, Cancer Care Ontario (CCO) administers the Case-by-Case Review Program (CBCRP) on behalf of the Ministry of Health and Long-Term Care. The new CBCRP extends and adapts the Compassionate Review Policy to therapies that will be administered in cancer centres and hospitals.

The CBCRP considers funding requests for cancer drugs (both oral therapies and injectable drugs) for cancer patients who have a rare clinical circumstance that is immediately life threatening (i.e. 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. Program policies, FAQs, eligibility criteria and how to apply to the CBCRP online are on the CCO website at: www.cancercare.on.ca/cbcrp.

While CCO will administer the CBCRP, the Executive Officer of Ontario Public Drug Programs makes all final funding decisions.

To assist physicians applying for exceptional access, the ministry has developed a standard form. In addition, for a limited group of drugs, physicians can call to submit requests through the Telephone Request Service (TRS) and obtain faster approvals for patients who qualify. Reimbursement criteria specific to drugs and indications considered through the TRS are posted at: www.health.gov.on.ca/english/public/pub/drugs/trs/trs_guide.pdf

Inquiries regarding the Exceptional Access Program should be directed to :
E-mail : EAPFeedback.MOH@ontario.ca
Phone : 416-327-8109 or 1-866-811-9893
Fax : 416-327-7526 or 1-866-811-9908

Exceptional Access Program
3rd Floor, 5700 Yonge St.
North York, ON M2M 4K5