Main Conclusions

Slow regulatory and reimbursement approvals in Canada are affecting cancer survival.

• More than 5,000 patients could have been negatively affected by delayed federal regulatory and provincial reimbursement approval for Avastin, Halaven, Jevtana, Tarceva and Torisel (five new oncology drugs approved in Canada between 2003 and 2011 for the treatment of advanced solid tumours), according to an evaluation that conservatively assumed only 25% of patients would have responded to the drugs.
• 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 and $559.6 million.
• Since several types of patients for whom the drugs may have been appropriate could not be included, the calculated numbers are almost guaranteed to be underestimates.
• Patients affected by slow regulatory and reimbursement approval procedures are anonymous and receive less attention from decision-makers than victims of adverse drug reactions. This study identifies a substantial number of real people who should not be ignored.