In Reply The US Food and Drug Administration’s (FDA’s) accelerated approval pathway is reserved for drugs treating serious medical conditions or diseases with unmet need. Drugs granted accelerated approval have shorter clinical development times and enter the US market faster. The FDA’s accelerated approval of cancer drugs has implications for patients, clinicians, and payers in other health care systems. In our study,1 30 cancer drug indications that were granted accelerated approval by the FDA were not subsequently reviewed by either European regulators or the National Institute for Health and Care Excellence (NICE) in England, and 12 drugs were denied authorization or coverage owing to insufficient safety, clinical efficacy, or cost-effectiveness.
Cherla A, Naci H, Mossialos E. The Coverage in England of US-Approved Cancer Drugs—Reply. JAMA Intern Med. 2021;181(9):1263–1264. doi:10.1001/jamainternmed.2021.3339
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