Through the Ontario Drug Benefit (ODB) program, the Ministry of Health and Long-Term Care covers most of the cost of over 3,200 prescription drug products listed in the Ontario Drug Benefit Formulary /Comparative Drug Index (Formulary).

In some circumstances, you may have tried drug products listed in the Formulary, which may not have been effective for you. In these exceptional circumstances, if an alternative is available which is not listed in the Formulary, a request for funding consideration may be made through the Exceptional Access Program (EAP). 

Through this process, individuals with uncommon clinical circumstances could be provided exceptional access to certain drugs.

To apply for funding consideration through the EAP, a patient’s physician submits an Individual Clinical Review (ICR) request.  An individual’s physician must apply for EAP coverage by submitting 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.  Each ICR request is reviewed individually, according to specific criteria by either internal or by external experts.

In general, you must already be eligible for drug coverage under the ODB program before a request for special coverage can be considered through the EAP. If you belong to one of the following groups of Ontario residents and you have a valid Ontario health card, you are eligible for drug coverage under the ODB program :

• people 65 years of age and older;
• residents of long-term care homes;
• residents of Homes for Special Care;
• people receiving professional services under the Home Care program;
• social assistance recipients (Ontario Works or Ontario Disability Support Program recipients);
• Trillium Drug Program (TDP) registrants (TDP applicants-see note below re: costs).

Only a physician may request coverage for a particular drug product not listed in the Formulary. As part of the request, your physician must submit relevant medical information including an indication of why you cannot use other products listed in the Formulary. The request made by your physician, on your behalf, should also indicate the period of time for which you will require the drug.

To assist physicians applying for funding consideration through the EAP, the ministry has developed a standard form for ICR requests. While use of these forms is not mandatory, it is encouraged as a means of ensuring that as much relevant information as possible is submitted, thus facilitating timely review of the request and response to your physician.

Your physician’s request is reviewed according to guidelines developed by the ministry’s expert advisory committee, the Committee to Evaluate Drugs (CED). When the review is completed, the ministry sends a written response to the requesting physician confirming whether or not coverage has been approved in your particular case. If approved, the coverage period has specific effective and expiry dates. If an extension is required, your physician must request an extension using the same process. It is generally recommended that information on your medical history and progress on the therapy with the unlisted drug be submitted to the ministry at least six weeks prior to the expiry date.

Your personal medical information that is included in the request is confidential and will not be released to anyone else.

Like drug products listed in the Formulary, if your ICR request is approved, you may be asked to pay some portion of the drug product cost as follows :

• Single seniors (people aged 65 or older) who have an annual net income of $16,018 or more and senior couples with a combined annual net income of $24,175 or more pay a $100 deductible per senior per year in ODB eligible prescription charges before they are eligible for drug coverage under the ODB program. After the $100 deductible is paid, they pay up to $6.11 toward the dispensing fee each time they fill an ODB eligible prescription. Seniors who have an annual net income under the above mentioned levels and all other ODB eligible recipients, including Trillium Drug Program recipients (after their Trillium deductible is paid), may be asked to pay up to $2 each time they fill a prescription for a drug product approved through the ICR mechanism.

Seniors and Trillium Drug Program applicants should note that out of pocket expenses for unlisted drugs will not count toward the Trillium deductible. The ministry will, however, consider ICR requests for unlisted drugs while your application to the Trillium Drug Program is being processed. If your physician's request for one of these drugs is pre-approved through the ICR mechanism, you will be able to purchase prescriptions for the drug and have the costs count toward your Trillium deductible depending on the start date requested on your Trillium application.

Requests for unlisted drugs must be approved by the ministry before the costs may count towards the deductible for both Trillium clients and seniors. If your request is not approved before purchasing an unlisted drug, the costs will not count towards the deductible.