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Before a Drug is Covered

Before a drug can be used in Canada, it must go through a rigorous approval process by Health Canada. If the clinical benefit of the new treatment is proven to be statistically significant over the standard of care treatment and its potential therapeutic value outweighs the risks associated with its use (eg, side effects or toxicity), the pharmaceutical company or sponsor will apply to the Health Products and Food Branch (HPFB) of Health Canada to have the drug officially approved for use in Canada.

If the drug company’s submission is approved, Health Canada will issue a Notice of Compliance (NOC) and give the drug a Drug Identification Number (DIN). This means the company is now allowed to market the new drug in Canada

Once a new cancer drug is approved for use in Canada, it goes through a health technology assessment (HTA) process that evaluates the clinical benefit versus the cost.

The manufacturer must make a submission to the Canadian Agency for Drugs and Technologies in Health (CADTH) pan-Canadian Oncology Drug Review (pCODR) for evaluation. The pCODR makes recommendations to Canada's provinces and territories to guide their drug funding decisions. In Quebec, the Institut national d’excellence en santé et en services sociaux (INESSS) is doing these recommendations. All new drugs receiving a positive recommendation then undergo price negotiation through the pCPA.

Despite the national review processes that are in place, most publically-funded drug plans continue to make their own decisions as to which medications they will or will not list. As a result, the coverage of new treatments often varies across the country.