Drug products can now be considered for the Formulary, New Drug Funding Program for cancer care and the Exceptional Access program prior to Health Canada's approval to market a drug by assignment of a Notice of Compliance (NOC) and Drug Identification Number (DIN). To be considered for funding all new drugs and previously approved CDR drug products for new indications have to go through the CDR process, with a recommendation by CEDAC and a subsequent review and recommendation by the CED to the OPDP Executive Officer.

Role of Health Canada

Approval of a product for marketing by Health Canada does not mean that it will be listed as a benefit under the ODB program or through the Exceptional Access program. Health Canada is responsible for approving a drug for sale and marketing anywhere in Canada, but does not make any recommendations regarding funding.

Once Health Canada approves the product for sale in Canada, it is the drug manufacturer's responsibility to seek listing on the Ontario Formulary by filing a complete submission to the Ministry for review by the CED.

For brand name product submissions, the CED evaluates the :

• Clinical evidence (efficacy and safety) for the patient populations covered by ODB;
• Cost-effectiveness (evidence of value for use of scarce resources) of the product in comparison to other products and treatments;
• Burden of the disease on patients; and
• Impact on other provincial health care services.

When reviewing a drug product for funding, the true question that the CED asks is : "Will this drug provide good clinical value and good use of scarce health care resources if it is included as a benefit?"

Other factors that may be considered by the CED and/or the Ministry include current formulary listings and the need for clinical criteria.

Those products that do not go through the CDR process (e.g., old drug products [for existing indications] new strengths and new formats of existing drugs, etc.) are reviewed by the CED which then makes a recommendation to the OPDP Executive Officer.

See also :

• Common Drug Review (CDR) Process
• Ontario Drug Benefit (ODB) Review Process
• Types of Listing Recommendations
• New Drug Funding Program for Cancer Care
• Formulary