Canadian Oncologists Report Costly Delays in Their Drug Regulatory Process

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Canada’s publicly funded health-care system has a complex drug approval and funding process. Due to multiple assessment steps and bureaucratic processes, newly developed cancer drugs can often experience long delays before oncologists may use them to treat their patients with cancer. Several Canadian oncologists recently analyzed the potential life-years lost during this lengthy process. To shed light on this and other issues, The ASCO Post spoke with two of the researchers, Joanna Gotfrit, MD, and Paul Wheatley-Price, MBChB, BSc, MD, of the Ottawa Hospital Cancer Centre and the University of Ottawa.

Joanna Gotfrit, MD

Joanna Gotfrit, MD

Paul Wheatley-Price, MBChB, BSc, MD

Paul Wheatley-Price, MBChB, BSc, MD

Researchers’ Backgrounds

Please tell our readers about your current positions and work.

Dr. Wheatley-Price: I am a lung cancer specialist at the Ottawa Hospital Cancer Centre. I am currently serving as President of Lung Cancer Canada (LCC), where we do a lot of work on the full spectrum of access-to-care issues.

Dr. Gotfrit: I am also a medical oncologist at the Ottawa Hospital Cancer Centre and specialize in gastrointestinal and head/neck cancers. My academic focus and research efforts are on drug funding and regulation. I also have a leadership role as a representative for my region on the Ontario Medical Association, where, among other topics, we examine access-to-care issues.

Glimpse at Cancer Drug Approval in Canada

Please give our readers a sense of the drug regulatory procedure in Canada and whether or not the pharmaceutical industry plays a large role in clinical trials, as is the case in the United States.

Dr. Wheatley-Price: There are two main steps toward drug approval in Canada. First, any new cancer drug must receive approval from Health Canada, which in structure and oversight power is equivalent to the U.S. Food and Drug Administration. Health Canada looks at a drug’s efficacy and safety. Once a drug has Health Canada approval, I can prescribe it without coverage payment.

Second, for coverage, the cancer drug undergoes a Health Technology Assessment by the pan-Canadian Oncology Drug Review (pCODR). The goal is to make an evidence-based funding recommendation to the provinces (except Quebec) to fund the drug, to fund the drug conditionally, or not to fund the drug. If the cancer drug receives pCODR approval, it then enters the next step, which is price negotiation by the Pan Canadian Pharmaceutical Alliance (PCPA). It’s a confidential arbitration among the provinces that in turn negotiate with the drug maker. Moreover, the PCPA process is a bit of a black box in that it is not held to any particular time frame, unlike the other agencies. Once a drug price has been agreed upon by the PCPA, it gets kicked back to each individual province, who offer it within their respective health systems. Only then will the cancer drug be covered by the single-payer system within my province.

There is a nuanced step that precedes the ones I’ve mentioned called the Patent Medicine Prices Review Board, which basically sets a price ceiling for drugs. This review board calculates the ceiling by comparing the price in Canada with the prices of five comparator European nations. There are some proposed changes to the Patent Medicine Prices Review Board; one is to drastically cut the ceiling price, which in principle would make cancer drugs less expensive. It’s still an ongoing process, but the flip side is that lowering the ceiling price may discourage pharmaceutical companies in other countries from bringing their cancer drugs to the Canadian market. Drug companies launch products in waves. The United States, because it’s the largest market, is always in the first wave, as is Canada. The concern is that we’ll be pushed down on the list.

Dr. Gotfrit: As Dr. Wheatley-Price noted, although we do have a single-payer system from a public payer perspective, one may access drugs out of system in a variety of ways, which would be for a minority of our patients with cancer. For instance, drug companies have compassionate-use programs for patients without the wherewithal to pay out-of-pocket expenses. Certain Canadians have private or workplace drug coverage plans, but again, that’s a minority of the population.

Moreover, in Canada, we have a notice of compliance with conditions policy, which gives earlier market access to drugs for “serious, life-threatening, or severely debilitating diseases,” particularly when few treatments are available for such diseases or when the drug demonstrates potential for significant improvement over existing treatment options. Cancer drugs are frequently eligible for these expedited conditional authorizations.

We recognized that the multiple steps in Canada’s drug approval process often create long delays before promising new cancer drugs can be prescribed.
— Joanna Gotfrit, MD

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Costly Delays

You were looking at potential life-years lost among patients with cancer due specifically to the regulatory and funding process. Please, in a nutshell, describe the design and conclusions drawn.

Dr. Gotfrit: We recognized that the multiple steps in Canada’s drug approval process often create long delays before promising new cancer drugs can be prescribed. So, we set out to quantify the number of life-years lost due to these delays by looking at 21 different drugs that had documented survival advantages in advanced lung, breast, and colorectal cancers.1 Our calculations were determined by multiplying documented improvement in progression-free and overall survival, the number of eligible patients, and the time from proof of efficacy to first public funding. We assumed that all eligible patients in Canada had access at the time of first public funding, whereas, in reality, as we mentioned, provinces fund at different time points.

For the 21 drugs going through the process, we found that the total overall life-years lost were about 39,000. Of note, one of the main drivers of this costly delay from the time from proof of efficacy to first public reimbursement was the long interval while awaiting drug submission to pCODR by the drug manufacturer. The other interesting conclusion was the great variability in the time to funding across different provinces.

Dr. Wheatley-Price: We were a bit surprised to find that, more than all of the complicated regulatory steps, the single biggest delay was getting pharmaceutical companies to bring their drugs to the Canadian market, which speaks to the previous point about how pharmaceutical companies deliver in waves of preference. So, if Canada has dropped on the list, one can imagine the delays experienced in low-income countries. Our drug development and delivery system is also struggling with ways to handle drugs that are clearly efficacious but have only been in expanded phase I or II studies and not randomized trials. Hopefully we’ll solve this issue in the near future.

Closing Thoughts

Please give the readers of The ASCO Post some closing thoughts on cancer care with the single-payer system in Canada.

Dr. Gotfrit: I’m optimistic that our single-payer system will continue to evolve and offer better and more equitable outcomes for our patients with cancer. However, as our population continues to age, I do worry about potential wait lists for care. Universal coverage is a good thing, but as we’ve seen in our study, long delays in treatment result in the loss of life-years. It’s a complex issue, one that we spend a lot of time thinking about.

Dr. Wheatley-Price: I’m a fan of Canada’s public health-care system. I became a Canadian citizen about 6 years ago, and I’ve found that the whole theme of Canada is based on fairness and equity. Universal access to health care is very much a part of that equitable spirit, and the best way to ensure that is with a single-payer system. 

DISCLOSURE: Dr. Gotfrit reported no conflicts of interest. Dr. Wheatley-Price has received honoraria from AstraZeneca, Bayer, Merck, Pfizer, and Takeda; has served as a consultant or advisor to AstraZeneca, Bayer, Bristol Myers Squibb, EMD Serono, Merck, Novartis, Pfizer, and Roche Canada; and has received institutional research funding from Bristol Myers Squibb, Pfizer, and Roche Canada.


1. Gotfrit J, Shin JJW, Mallick R, et al: Potential life-years lost: The impact of the cancer drug regulatory and funding process in Canada. Oncologist 25:e130-e137, 2020.