Abstract

Cancer treatment has evolved significantly over the past decade with the emergence of a multitude of new treatments across cancer types. Alongside the pace of drug discovery, the cost of cancer drugs has also increased. In the face of this growth in development and spending, it is crucial to have an understanding of the processes and pressures new drugs navigate to get to the market in Canada. This paper is a review of the complex, multi-step regulatory and funding process undertaken by cancer drugs in Canada. It reviews the role of Health Canada, the Patented Medicine Prices Review Board, the Health Technology Assessment, the pan-Canadian Pharmaceutical Alliance, and finally, the provincial, territorial, and federal payers. Recent developments are highlighted. Strategies to minimize duplication of effort, improve timeliness, and increase efficiency are explored. The cancer drug regulatory and funding process in Canada is complex, and an understanding of the current system and ongoing evolution is essential.

Highlights

  • Cancer treatment has evolved significantly over the past decade with the emergence of dozens of new treatments across cancer types

  • Multiple new oral cancer drugs are available as targeted therapies for multiple cancer types, perhaps most clearly in the identification and treatment of multiple subtypes of lung cancer defined by targetable driver mutations

  • Drugs rejected by the participating plans are generally not eligible for public funding even though they have been approved by HC

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Summary

Introduction

Cancer treatment has evolved significantly over the past decade with the emergence of dozens of new treatments across cancer types. Multiple new oral cancer drugs are available as targeted therapies for multiple cancer types, perhaps most clearly in the identification and treatment of multiple subtypes of lung cancer defined by targetable driver mutations. The. Patented Medicines Prices Review Board (PMPRB) released a report in 2020 describing the change in cost of cancer drugs over the prior decade [1]. This report describes a tripling of annual spending on cancer drugs to $3.9 billion in 2019, representing 14.6% of the drugs market compared to 7.1% in 2009. In the face of this growth in development and spending, it is important to have an understanding of the processes and pressures new drugs navigate to get to the market in Canada, in order to make the system effective, equitable, affordable and sustainable. We limit the manuscript to the description of new, patented, or single-source cancer drugs, rather than off-patent or generic medications

The Process
Health
Health Canada
Health Technology Assessment
Pan-Canadian Pharmaceutical Alliance
Provinces and Territories
Other Mechanisms of Access
Discussion
Duplication of Effort
Timeliness
Efficiency
Findings
Conclusions

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