The Pathway for New Cancer Drug Access in Canada

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.

Impact of Systemic Delays for Patient Access to Oncology Drugs on Clinical, Economic, and Quality of Life Outcomes in Canada: A Call to Action

“…These disparities between Canada and other countries are partly attributable to complex, overlapping sequential multi-step regulatory and funding processes involving federal, provincial, and private authorities (Health Canada, PMPRB, HTA organizations (CADTH and INESSS), pCPA, and different provincial and private payers) [ 19 ]. One study investigated the determinants of cancer drug funding decisions and timelines in Canada [ 20 ].…”

Access to Oncology Medicines in Canada: Consensus Forum for Recommendations for Improvement

“…All were established by Canadian federal, provincial and territorial governments and are responsible to them. Furthermore, drugs that successfully pass these barriers are not necessarily approved by these governments for reimbursement coverage in their drug plans [11] and, in some provinces, patients must pay significant copayments for oncology drugs [12].…”

“…Many new oncology therapies now in use or on the pharmaceutical horizon are targeted treatments for cancers caused by genetic mutations that can advance treatment beyond traditional options of surgery, radiation and chemotherapy [13]. These new drugs are often expensive and the obstacles created by Canadian governments frequently delay or deny patient access to them [11,[14][15][16], prevent health care providers from prescribing optimal therapy, cause concern among patients and their families, and lead to lives being lost [17]. If Canadians with cancers are to fully benefit from new advanced treatments, current processes need to change [13].…”

Impact of Oncology Drug Review Times on Public Funding Recommendations

“…Drug review timelines in public healthcare systems like Canada are longer than in private healthcare systems like the United States [ 2 ]. For a new cancer drug to make it from a successful clinical trial to a publicly reimbursed standard of care, there are multiple regulatory, evaluation, and funding steps [ 3 ]. After submission to and approval of the drug by Health Canada (HC), the cancer medicine is reviewed by the Canadian Agency for Drugs and Technologies in Health (CADTH).…”