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New Research Explores Gaps in Health Plan Coverage Updates
Study finds commercial plans slower to expand specialty drug coverage after FDA label changes.
Published on Mar. 2, 2026
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New research from the National Pharmaceutical Council and Tufts Medical Center's Center for the Evaluation of Value and Risk in Health found that commercial health plans are more likely to delay updating specialty drug coverage policies in response to FDA label expansions compared to label contractions. The study reviewed over 1,200 plan policies from 2019-2022, showing plans updated coverage to restrict access 10 weeks sooner on average than they did to expand access.
Why it matters
This coverage delay can have implications for patients living with diseases requiring specialty therapies, as it can limit their timely access to innovative treatments. The findings highlight the need for policy and operational approaches that better align coverage timelines with evolving scientific evidence.
The details
The study, published in Health Affairs Scholar, used a multi-method approach to analyze how quickly commercial health plans updated specialty drug coverage after new FDA label decisions. Label expansions broadened the approved patient population, while label contractions narrowed it. The authors found that label contractions were associated with faster health plan coverage updates compared to label expansions.
- The study reviewed commercial health plan policies from 2019 to 2022.
The players
National Pharmaceutical Council
An organization that serves patients and society with policy-relevant research on the value of patient access to innovative medicines and the importance of scientific advancement.
Center for the Evaluation of Value and Risk in Health (CEVR) at Tufts University
A leader on issues pertaining to value, cost-effectiveness, and risk tradeoffs in health care decisions, informing national clinical and public health policy issues through analysis of the benefits, risks and costs of strategies to improve health and health care.
Daniel E. Enright
Co-author of the study and researcher at CEVR.
James Chambers, PhD, MPharm
Co-author of the study, Professor of Medicine at Tufts Medical Center, and Founder of the CEVR Specialty Drug Evidence and Coverage (SPEC) Database.
Jon D. Campbell, PhD, MS
Co-author of the study and Chief Science Officer at the National Pharmaceutical Council.
What they’re saying
“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”
— James Chambers, PhD, MPharm, Professor of Medicine at Tufts Medical Center and Founder of the CEVR Specialty Drug Evidence and Coverage (SPEC) Database
“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. 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.”
— Jon D. Campbell, PhD, MS, Chief Science Officer at the National Pharmaceutical Council
What’s next
The authors suggest that policy and operational approaches are needed to better align health plan coverage timelines with evolving scientific evidence, in order to ensure timely patient access to innovative therapies.
The takeaway
This study highlights the need for health plans to promptly update their specialty drug coverage policies in response to FDA label changes, in order to provide patients with timely access to the latest treatments. Delays in expanding coverage can have significant implications for those living with serious diseases.
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