The Accelerated Approval Program for Oncology Drugs: Celebrating More Than 250,000 Life-Years Gained and Counting
NPC’s commentary in AJMC examines evidence regarding the clinical benefit of the FDA’s Accelerated Approval Program and finds it is working for patients.
AUTHORS
Julie A. Patterson, PharmD, PhD, John Michael O’Brien, PharmD, MPH, and Jonathan D. Campbell, PhD, MS
PUBLICATION
The American Journal of Managed Care
OVERVIEW
An NPC analysis in the American Journal of Managed Care supports the FDA’s conclusion that the Accelerated Approval (AA) Program is successfully working to address unmet medical needs.
The commentary, “The Accelerated Approval Program for Oncology Drugs: Celebrating More Than 250,000 Life-Years Gained and Counting,” evaluates two recent studies from the Journal of the National Comprehensive Cancer Network (JNCCN) and the Journal of the American Medical Association (JAMA) — both of which aimed to estimate the AA Program’s clinical benefit by analyzing the impact of AA oncology drugs on overall survival, yet came to different conclusions.
Takeaway Points
- The AA program provides expedited access to new drugs for patients with serious conditions and high unmet medical need.
- The contrasting studies, published in the Journal of the National Comprehensive Cancer Network and the Journal of the American Medical Association, highlight the importance of patient-centered approaches to estimating the impact of health policies.
- Good research and placing that research in the appropriate context tip the scales in favor of continued evidence generation and early access for patients with high unmet medical needs.
- Evidence suggests that the program’s benefits outweigh its potential risks; multistakeholder coordination is needed to maximize these benefits and improve patient health.