(18) Assessing commercial health plan responsiveness to FDA label changes

Background: : Health plan coverage policies play a critical role in determining patient access to specialty drugs and should reflect the most current understanding of their use. Timely updates help ensure that coverage aligns with evolving standards of care. However, it is unclear how promptly health plans revise specialty drug coverage policies in response to new evidence. One way to assess this is by measuring plan responses to FDA label revisions.

Objective: : To evaluate how quickly commercial health plans update specialty drug coverage policies following FDA label revisions.

Methods: : We used the Tufts Medical Center Specialty Drug Evidence and Coverage (SPEC) database, which includes coverage decisions from 18 large US commercial health plans. We identified FDA label revisions from 2019-2022 for all drug-indication pairs in SPEC, categorizing each as an expansion (broader population) or contraction (narrower population). For each revision, we assessed the timing of corresponding policy updates. We used Kaplan-Meier (KM) curves to estimate and visualize time to update, stratified by revision category (expansion vs contraction), drug type (oncology, orphan status), and plan. We then used Cox proportional hazards models to examine how these factors influenced response time.

Results: : We identified 858 changes to coverage decisions corresponding to 87 FDA label revisions (763 across 79 expansions; 95 across 8 contractions). Overall KM-adjusted median response time to revision was 29.7 weeks (95% CI: 26.9-33.6 weeks). Health plans were slower to adopt label expansions (median 32.1 weeks) than contractions (21.4 weeks). Updates were faster for oncology than for non-oncology drug drugs (28.6 vs. 31.0 weeks) as well as for orphan vs. non-orphan treatments (28.7 vs. 30.1 weeks). Median response time varied by plan (15.1 weeks-55.4 weeks). In Cox models, contractions (HR=1.38; p=0.006) and oncology status (HR=1.35; p=0.000) were associated with faster updates. Orphan status was not statistically significant (HR=1.09; p= 0.296).

Conclusions: : Health plans responded faster to label contractions than expansions, with substantial variation across plans for any type of label revision. Delays in updating coverage policies, particularly for label expansions, may limit access to broadened indications.

Sponsorship:: National Pharmaceutical Council.