Monday, January 20, 2014

Health Canada: Sovaldi The deadly toll of drug-approval drag

The deadly toll of drug-approval drag

The new drug is called sofosbuvir (brand name Sovaldi) and Gilead has obtained almost complete "clearance" with patients so far. Unfortunately, Health Canada requires up to 225 days to review the research and findings made by Gilead in order to issue a "notice of compliance." Then the drug must go through CDR (common drug review process), which "is a pan-Canadian process for conducting objective, rigorous reviews of the clinical, cost-effectiveness and patient evidence for drugs." CDR also provides formulary listing recommendations to Canada's publicly funded drug plans (except Quebec)."
Following that, the Pan Canadian Pricing Alliance (PCPA) gets together to develop a national price for the drug and then, finally, all the information is turned over to the provinces, basically to repeat the entire process because health care is, after all, a provincial responsibility. Currently, Sovaldi has been assigned a notice of compliance and is through the CDR process. But it may be another 12 to 18 months before Manitobans will have access to this therapy.
The total time it takes for the drug to be researched and then made available in Canada by prescription? At least five years.


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