Slow Regulatory Approval in Canada Hinders Cancer Survival

November 25, 2013

Slow regulatory and reimbursement approvals in Canada are affecting cancer survival, says Dr. Nigel Rawson, a pharmacoepidemiologist and president of Eastlake Research Group in Oakville, Ontario, Canada.

More than 5,000 patients could have been negatively affected by delayed federal regulatory and provincial reimbursement approval for five new oncology drugs approved in Canada between 2003 and 2011 for the treatment of advanced solid tumors.

  • If each of these patients had received the drugs and achieved the median survival benefit identified in each drug's pivotal randomized clinical trial, a total extension in survival over standard therapy of 1,696 patient-years would have resulted.
  • The monetary value of this extension in life was estimated to be between $339.2 million and $559.6 million.
  • Each drug received approval from Health Canada between 205 and 591 days after the U.S. Federal Drug Administration approval, and the time required to review each drug was 1.5 to 4.5 times longer in Canada than in the United States.

The delays in approving reimbursement were not due to high prices but to a slow approval process. New approaches to evaluate drugs have been proposed, but few, if any, have been put into action. The magnitude of the number of patients who could have been affected by delays demonstrates that the slow regulatory and reimbursement approval processes in Canada needs to be reformed. More importantly, their suffering is real and should not be ignored.

Source: Nigel S.B. Rawson, "Potential Impact of Delayed Access to Five Oncology Drugs in Canada," Fraser Institute, November 2013.

 

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