Study
| EST. READ TIME 1 MIN.Potential Impact of Delayed Access to Five Oncology Drugs in Canada
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.
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Dr. Nigel Rawson
Senior Fellow, Fraser InstituteDr. Nigel Rawson is a pharmacoepidemiologists and pharmaceutical policy researcher in Saskatoon, Saskatchewan. Educated in the United Kingdom, he holdsan MSc in statistics and a PhD in pharmacoepidemiology. Dr. Rawson has performed epidemiologic studies of the use of drugs and their outcomes for over 40 years and published more than 150 book chapters and articles in peer-reviewed journals. He is also the author of the monograph “Drug Safety: Problems, Pitfalls and Solutions in Identifying and Evaluating Risk.”Dr. Rawson held academic research positions in the United Kingdom until the end of 1989 and subsequently held professorships at the University of Saskatchewan and Memorial University of Newfoundland in Canada. His research activities focused on population-based studies of the use and safety of drugs using administrative healthcare utilization data and the evaluation of issues impacting access to new drugs. Dr. Rawson has also been a senior researcher in an independent research centre in one of the United States’ largest health insurers, where he collaborated with the Food and Drug Administration on drug safety studies, and GlaxoSmithKline’s only epidemiologist in Canada, providing advice and analysis for the company’s current and developing medicines and vaccines. Between 2012 and 2020, Dr. Rawson was President of Eastlake Research Group whose mission was to create evidence-based responses to pharmaceutical and health policy issues. He continues this work as an independent researcher.… Read more