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Ministry Status: Activation Status

Improving Patient Access to Drugs

Product Listing Agreements and Exceptional Access Program

Product List Agreements

A listing agreement refers to a negotiated agreement between a pharmaceutical manufacturer and the Executive Officer.  These agreements support reimbursement of some products on the Formulary, through the New Drug Funding Program (NDFP), or through the Exceptional Access Program (EAP).

Agreements are intended to provide access to new and existing drugs according to certain conditions, and are based on a number of factors including the CED's recommendations, clinical evidence, therapeutic need, and cost-effectiveness.  Listing agreements may include multiple components:

  • commitment to promote appropriate use;
  • requirement to collect outcomes data;
  • requirement to gather further evidence related to clinical or economic information for future consideration by CED; and
  • cost and utilization considerations.

Criteria for reimbursement may be published in the Formulary as therapeutic notes and it is the responsibility of the prescriber to prescribe the drug to ODB recipients in accordance with the listed criteria. Product Listing Agreements  will allow ODB recipients to access new drugs while the information that might support continued listing is in the process of being collected and reviewed.

Exceptional Access Program

Exceptional Access is intended to handle requests for drugs not funded under the Ontario Drug Benefit Program. Through this progress, individuals with uncommon clinical circumstances could be provided exceptional access to certain drugs. Each case is reviewed individually, according to specific criteria by either internal or by external experts. 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/en/public/programs/drugs/publications/trs/trs_guide.pdf

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