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How drugs are approved in Canada

by Peter Winters on January 2nd, 2015

This 6 minute video provides a great introduction to the lengthy and difficult approval process for drug coverage in public healthcare in Canada. It is provided by Amgen Canada via a site called If you watch the video you can see that the video looks to raise issues about the high proportion of drugs which are not approved, and how strict the regulation is for drugs compared to other healthcare costs.

Yet it is very important to take account this video is talking about public healthcare coverage. There is also a significant private healthcare sector in Canada where drug access tends to be much faster, and more likely to be approved – especially for open formularies. Around two-thirds of private plans are open formulary which would accept any Health Canada approved medicine (although there is a trend towards having more closed formularies in the private healthcare sector). I believe that a crucial factor in the slow and difficult process of getting drugs publically covered in Canada is that once they are, there is no cost to the patient (at least for drugs administered in hospitals). For private plans, there is a significant patient co-pay, with various tiering levels, which can help moderate demand for a drug, and encourage cost-effective lines of therapy.

When I am working on a Canadian study, it is quite typical to have some of the new innovative medicines only available to the private sector (usually through insurance but sometimes with an out-of-pocket cash payment). Public coverage is indication-specific, varies by province and may need ‘special authorization’ – e.g. to limit drug usage by lines of therapy and patient type. is my ‘go to’ resource to find out the coverage status of any drug, and an overview of the rules for each province. To search a drug, use the MEDICATION SEARCH box in the upper-middle of the screen.



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