Approval and Coverage of Cancer Drugs in England, Canada, and the US Invited Commentary Invited Commentary Vinay Prasad, MD, MPH; Myung S. Kim, MD For approval of cancer drugs, the US Food and Drug Adminis- The differences between the 3 countries raise a key policy tration (FDA) is tolerant of uncertainty and prioritizes speed over question: does the current US system of drug approval and re- other factors. Most drug approvals are based on surrogate mark- imbursement speed access to better drugs and lead to better ers, such as tumor shrinkage in a fraction of patients (response outcomes for patients with cancer? The US system of ap- rate) or delayed tumor growth proval of drugs with uncertain clinical benefit followed by man- (progression-free survival). dated coverage by Medicare without any ability to negotiate Related articles on prices ensures access. It is less clear that the US system ben- These surrogates use arbi- trary percentage cutoffs and are not optimized to ensure that a efits patients with cancer. drug can improve the length or quality of life. The 2 studies and previous work highlight additional con- After a cancer drug is approved, insurance coverage usu- siderations. First, the US reliance
JAMA Internal Medicine – American Medical Association
Published: Apr 22, 2021
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