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Approval and Coverage of Cancer Drugs in England, Canada, and the US

Approval and Coverage of Cancer Drugs in England, Canada, and the US 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 http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA Internal Medicine American Medical Association

Approval and Coverage of Cancer Drugs in England, Canada, and the US

JAMA Internal Medicine , Volume 181 (4) – Apr 22, 2021

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Publisher
American Medical Association
Copyright
Copyright 2021 American Medical Association. All Rights Reserved.
ISSN
2168-6106
eISSN
2168-6114
DOI
10.1001/jamainternmed.2020.8587
Publisher site
See Article on Publisher Site

Abstract

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

Journal

JAMA Internal MedicineAmerican Medical Association

Published: Apr 22, 2021

References

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