Evidence suggests commercial health plans are more likely to delay specialty drug coverage decisions in response to FDA label expansions vs contractions.
WASHINGTON, DC, UNITED STATES, March 2, 2026 /EINPresswire.com/ — New research published in Health Affairs Scholar from the National Pharmaceutical Council (NPC) and the Center for the Evaluation of Value and Risk in Health (CEVR) at Tufts Medical Center evaluates how quickly commercial health plans updated specialty drug coverage after new label decisions from the Food and Drug Administration (FDA).
“The Timeliness of Health Plan Drug Coverage Policy Changes to FDA Label Revisions” found response times were longer for label expansions than contractions, underscoring the need for policy and operational approaches that better align coverage timelines with evolving scientific evidence. This alignment can ensure timely patient access, notes the study authors Daniel E. Enright, Molly T. Beinfeld, MPH, Claire H. Brennan, Angela Lin, and James Chambers, PhD, MPharm of CEVR, James Motyka, PharmD of Plenful, and Jon D. Campbell, PhD, MS of NPC.
“This evidence shows that, on average, plans updated their specialty drug coverage policies to restrict coverage 10 weeks sooner than they updated policies to expand coverage” shares Dr. Chambers, Professor of Medicine at Tufts Medical Center and Founder of the CEVR Specialty Drug Evidence and Coverage (SPEC) Database. “This coverage delay can have implications for patients living with diseases requiring specialty therapies.”
The authors reviewed over 1,200 commercial health plan policies for specialty drugs with FDA label changes from 2019 – 2022. Label expansions broadened the approved patient population for a specialty drug, while label contractions narrowed the approved patient population. Using a multi-method approach, the authors found that label contractions were associated with faster health plan coverage updates compared to label expansions.
“The American healthcare system is under a lot of pressure to address affordability challenges, but access to innovation shouldn’t be sacrificed for short-term budgetary cuts,” says Dr. Campbell, NPC Chief Science Officer. “It’s critical that health plans promptly revise their coverage criteria to reflect evidence-based label changes and evolving standards of care, so that patients can better access today’s cutting-edge therapies.”
About the National Pharmaceutical Council
NPC serves patients and society with policy-relevant research on the value of patient access to innovative medicines and the importance of scientific advancement. We envision a world where advances in medicine are accessible to patients, valued by society, and sustainably reimbursed by payers to ensure continued innovation. For more information, visit www.npcnow.org and follow NPC on LinkedIn.
About the Center for the Evaluation of Value and Risk in Health (CEVR) at Tufts University
CEVR is a leader on issues pertaining to value, cost-effectiveness, and risk tradeoffs in health care decisions. We inform national clinical and public health policy issues through our analysis of the benefits, risks and costs of strategies to improve health and health care. Our organization is a member of the Institute for Clinical Research and Health Policy Studies at Tufts Medical Center, Boston. We undertake scientific research projects, advance methods development for the field, train the next generation of practitioners and users, and work with policymakers worldwide to develop reasoned policy solutions.
Michael Pratt
National Pharmaceutical Council (NPC)
+1 202-827-2088
media@npcnow.org
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