Ontario has set a process for reviewing requests for drug funding under the ODB program. Drug products may be considered for reimbursement under the ODB program, under the Ontario Drug Benefit Act (ODBA) or the Drug Interchangeability and Dispensing Act (DIDFA), if the manufacturer makes a complete submission to the Ministry. All submissions require a CED review and a thorough assessment of the scientific and clinical evidence contained in a manufacturer's submission. The CED then makes a recommendation to the Executive Officer of Ontario Public Drug Programs on whether or not the drug should be funded under the ODB program, the New Drug Funding Program, for cancer care or through the Exceptional Access program. The Executive Officer makes the final decision, taking into consideration the recommendations and public interest.

For drug products being considered through the CDR process, the Ministry will normally receive a final recommendation from CEDAC prior to considering listing status under the ODB programs. Once a final CEDAC recommendation is made, the CED reviews it and makes a recommendation to the Executive Officer regarding whether or not the product should be reimbursed for eligible recipients under the ODB program. The CED also provides advice on the type of listing and clinical criteria.

Exceptions are made for drugs approved for Rapid Review, where CED makes funding recommendations prior to CEDAC.

The CDR process does not replace the decision-making responsibility of provincial drug plans. Based on the final CEDAC recommendation, it is up to each provincial drug plan to decide whether to list the drug product as a benefit in its own provincial drug Formulary.

See also :

• Common Drug Review (CDR) Process
• New Chemical Entity or Combination Drug Products (New Brand Name/Innovator Drug Products)
• Types of Listing Recommendations
• New Drug Funding Program for Cancer Care
• Formulary