CLHIA-ACCAP

CLHIA Report on Prescription Drug Policy

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22 Currently, the provinces subsequently conduct an additional assessment of the generic drug through their expert committees to establish whether or not to cover the generic drug. It is unclear what the benefit is of the additional review by the provinces in cases where bioequivalence has been established with the Canadian brand reference product. That is, if a brand drug has already been listed on the provincial formulary and a generic has been approved as bio-equivalent with the Canadian reference product by Health Canada, it would seem reasonable that the generic drug should be automatically deemed interchangeable. The additional expert committee review in these cases delays access by Canadians to the generic drug and delays savings to payers (both public and private) without any clear benefit. Costs to Canadians of Delayed Listing of Generics - Example of Rosuvastatin The current delay in time between when a generic drug is deemed bio-equivalent by Health Canada and when it is listed on a provincial formularies results in millions of dollars of unnecessary costs for Canadians on an annual basis. The recent experience with rosuvastatin - the generic version of the popular anti-cholesterol drug Crestor - is illustrative in this regard. As shown below, the delays in listing rosuvastatin provincially extended from 18 days up to six months in different provinces from the date rosuvastatin received its notice of compliance. Rosuvastatin notice of compliance Received on March 15, 2012 Province Listing Date Delays from NOC British Columbia April 2, 2012 18 Alberta May 1, 2012 47 Saskatchewan May 1, 2012 47 Ontario May 29, 2012 75 Quebec June 1, 2012 78 Manitoba September 24, 2012 193 Newfoundland October 1, 2012 200 Source: CGPA The cumulative delays in listing of rosuvastatin cost Canadians over $42 million in additional costs than they would have incurred had the drug been listed automatically.

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