The world of cancer treatment is rapidly advancing. Scientists are discovering new ways to target cancers, making drugs more effective and more precise. But with these new advancements, comes a long process of approvals involving many steps to allow Canadians to access them. Not only do new drugs need to be approved for safety and efficacy by regulatory bodies like Health Canada and the Canadian Drug Agency (CDA; formerly known as Canadian Agency for Drugs and Technologies in Health, or CADTH), but then they also need to go through price negotiations between the drug manufacturers and the provinces (known as the Pan-Canadian Pharmaceutical Alliance or pCPA). These negotiations set the cost that every province will pay to the drug company once the drug is added to public drug plans.
While this system is a thorough and robust review process, it also delays patient access to the latest advancements in cancer drugs— sometimes for up to four years. Between 2010 and 2014, Canada was ranked 17th out of 21 similarly developed nations in providing timely access to cancer drugs. The number of drugs first approved for use in Europe and the United States that were later approved in Canada decreased from an average of 86% between 2006 and 2014 to just 50% in 2020. Even if a drug successfully passes these reviews, there is no guarantee that it will be covered by provincial drug plans, which can leave patients without affordable access to life-saving cancer treatments.
With this issue in mind, 18 Canadian clinicians—from the fields of medicine, nursing, and pharmacy— came together to develop a set of recommendations aimed at improving the current processes and timelines surrounding cancer drug approval and access. Today, we’ll be summarizing their recommendations and arguments so that you can learn how some of Canada’s leading oncology experts are advocating for better access to the latest treatments.
The goal for their discussion was not to ensure every drug is funded in Canada. Instead, they aimed to demonstrate the consensus among experts in the cancer community regarding the changes needed to improve performance standards, timelines, accountability, and unmet targets. There was strong agreement that patients’ needs were not being met and that there is a need to establish reasonable processes that do meet these needs.
The main method by which opinions and perspectives were shared by the participants was by completing a questionnaire. This was developed to measure the participants’ understanding of drug approval and access issues, public drug reimbursement processes, and their knowledge of if and how many of their patients encountered barriers accessing treatments. Based on their responses to the questionnaire, along with an in-person meeting, the clinicians were able to develop consensus on 5 key points:
- Accountability within the system: It was agreed that clearer accountability between regulatory drug approval and public funding of the medicine is essential. There was strong consensus (89%) among the clinicians regarding shortening of timelines from the evidence review to the funding decision from the current two to four years down to six months or less. Additionally, most (94%) wanted the pCPA to recognize cancer as an exceptional disease, starting price negotiations within one month of a positive recommendation from CDA.
- Disparities within and across the system: There was unanimous agreement that drug navigator positions should be funded to assist patients in accessing their prescribed treatments. Furthermore, the clinicians saw no reason why the approvals for CDA and INESSS (Quebec’s equivalent of the CDA) shouldn’t be integrated, and that the CDA should consider a “drug’s societal value” as INESSS already does. This includes the drug’s impact on public health, overall quality of life, and the economic benefits it can have on the population. Finally, 83% of participants agreed that provinces should decide on funding within one month.
- Endpoints that should be accepted within the system: Another majority proposal was the streamlining and updating of regulatory processes to adapt to rapidly emerging medical science. Treatments are presently being invented, clinically tested, and submitted with evidence of their benefit faster than the system can currently handle them. Endpoints—outcomes used in clinical trials to measure the safety and effectiveness of a drug—are essential to understanding the benefits of treatment. Broader acceptance of certain widely used endpoints, like progression-free survival or disease-free survival, should be used when evaluating emerging drugs. The clinicians in this meeting also agreed that real-world evidence—data gathered from everyday clinical practice—should be taken into consideration by Health Canada and CDA.
- Timely access to new oncology medicines: In addition to the shortened timelines mentioned above, they agreed that there was a need for access programs in Canada that allow patients to receive new treatments even before they are fully approved or widely available. This would allow for rapid, publicly funded access for new cancer therapies that treat rare forms of cancer, provide treatments where there are unmet needs, or for novel breakthrough drugs. If health technology assessments ultimately give these drugs negative recommendations, they agreed that it would be acceptable to withdraw the funding. These special access programs can not only allow patients to benefit from treatments while formal reviews are ongoing but can also add to the evidence of the effectiveness of the drug.
- Cost-effectiveness within the system: There was strong consensus (83%) that the Patented Medicines Prices Review Board (PMPRB) recognize cancer and rare diseases as being unique conditions requiring separate review pathways when setting drug prices. There was also agreement that the current benchmark of $50,000 per quality-adjusted life year (QALY) threshold for cost-effectiveness is outdated and unreasonable. The QALY measures how well different kinds of medical treatments lengthen and/or improve patients’ lives, and therefore has served as a fundamental component of cost-effectiveness analyses around the world for more than 30 years. All the clinicians agreed that $50,000 was no longer appropriate, as this amount hasn’t been reviewed or updated for inflation, rising drug costs, or the complexity of new treatments since the 1980s.
While a drug might get regulatory approval in Canada, it doesn’t mean patients will be able to automatically access it through their provincial drug plan right away. Sometimes, a drug won’t get approval for months, years, or even at all. This review and consensus from leading Canadian clinicians in oncology highlights how the current processes are time and resource-consuming and can sometimes deter drug developers from launching new treatments in Canada, limiting the available pool of treatments for patients. It underscores the importance of transparent drug assessments and timely access to life-saving treatments for cancer patients in Canada.
This is a condensed summary. To read the full article, click here.
About the Article Authors
Authors of this paper include: Sandeep R. Sedhev, Nigel S. B. Rawson, Olexiy I. Aseyev, Catriona J. Buick, Marcus O. Butler, Scott Edwards, Sharlene Gill, Joanna M. Gotfrit, Cyrus C. Hsia, Rosalyn A. Juergens, Mita Manna, Joy S. McCarthy, Som D. Mukherjee, Stephanie L. Snow, Silvana Spadafora and David J. Stewart, Jason R. Wentzell, Ralph P. W. Wong, and Pawel G. Zalewski.
The in person meeting that lead to these recommendations comprised of 18 Canadian experts in oncology. This included15 medical oncologists, 2 lead oncology pharmacists and 1 oncology nurse practising in Ontario, British Columbia, Saskatchewan, Manitoba, Nova Scotia, and Newfoundland and Labrador. The threshold for consensus was set at 80% or above. The questionnaire that guided discussions consisted of 38 questions and was developed by the lead author, Dr. Sedhev. Dr. Sedhev also sits on CBCN’s medical advisory board.
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