International – England and Canada diverge from US on cancer drug decisions

Regulatory and health technology assessment agencies in Canada and England are diverging from the US when it comes to oncology drugs. But they often rely on the same surrogate endpoints to make their decisions, according to two new analyses published in JAMA Internal Medicine.
The first study, led by Avi Cherla, MSc, of the London School of Economics and Political Science, revealed that among 68 cancer indications with accelerated approval in the US that also received market approval in the EU, just 45 indications (66.2%) were recommended by the National Institute for Health Care Excellence (NICE) for public coverage through the National Health Service. But about 60% of NICE decisions were based on surrogate endpoints like response rates and progression-free survival, rather than overall survival or quality of life benefits.
Similarly, in an analysis of Canada’s assessment of cancer drugs for coverage, Daniel E. Meyers, MD, of the University of Calgary and colleagues found that just 75% of the submissions for cancer drugs for solid tumors (78 out of 104) received a positive recommendation for coverage by the pan-Canadian Oncology Drug Review (pCODR). During the same period between 2011 and 2020, the US Food and Drug Administration (FDA) approved 163 drugs for adult solid tumors and none of the submissions that were turned down by the pCODR were rejected by the FDA. Canada also relied on surrogate endpoints in reaching its coverage decisions. In half of the positive recommendations for coverage, surrogate endpoints were used. In the other half, the median overall survival gain was 3.7 months…