Access to New Oncology Drugs in Canada Compared with the United States and Europe

Cancer is the leading cause of premature death in Canada and the numbers of new cases of several major cancers have remained relatively stable. New, better treatments are needed as soon as they can be introduced.

Using previously published information, this study compares the number of new oncology drugs approved by each agency and their review times. Of 33 new oncology drugs, 30 were approved in the United States, 26 in the European Community, and 24 in Canada between 2003 and 2011. The median review times (the time within which 50% of the drugs were approved) of these drugs were 182 days in the United States, 410 days in Europe, and 356 days in Canada.

Twenty-one drugs were approved by all three agencies by the end of 2011. The Canadian submission dates were close to those in Europe (for 48% of these drugs) and the United States (for 33% of these drugs), but longer review times led to Canadian approval dates being more than 180 days after those in the European Community (for 48% of the 21 drugs) and the United States (for 90% of the drugs).

Marketing approval by a drug regulatory agency allows a product to be sold, but it does not guarantee patient access to it. By the end of 2011, only three of the 24 drugs approved in Canada were covered to some degree by government drug plans in all 10 provinces, while seven others had government subsidized access in some provinces. However, almost 60% had no government subsidized access in any province.

Cancer is a much feared disease. Patients and health care providers want access to drugs that may help treat it as soon as possible. The findings of this analysis raise concern about timely access to new drugs for Canadian cancer patients.