# The timeliness of health plan drug coverage policy changes to FDA label revisions

## TL;DR

This study examines how quickly US health plans update drug coverage policies after FDA label changes, finding significant delays that may affect patient access to care.

## Contribution

The study provides empirical evidence on the timeliness of health plan policy updates in response to FDA label revisions.

## Key findings

- The median time to policy update following label revisions was 29.7 weeks.
- Coverage updates were faster for label contractions, oncology drugs, and self-administered drugs.
- There was substantial variation in update times across different health plans.

## Abstract

Health plan coverage policies determine specialty drug access and should reflect evolving standards of care; however, the timeliness of policy updates remains unclear.

We used the Tufts Medical Center Specialty Drug Evidence and Coverage (SPEC) Database to evaluate how quickly US commercial health plans updated coverage following Food and Drug Administration (FDA) label changes from 2019 to 2022. We calculated time from label revision to policy update using Kaplan–Meier methods, with new indications for existing drugs as a comparator, and applied Cox proportional hazards models to assess factors associated with update speed.

We identified 79 label expansions and 8 contractions across 1279 policies and excluded 421 already aligned with the revised label or using sufficiently broad language. Among 858 remaining decisions, the median time to policy update following label revisions was 29.7 weeks (95% CI: 26.9-33.6), compared to 13.4 weeks for new indications. Coverage updates were faster for label contractions vs expansions (hazard ratio [HR] = 1.30; P = 0.024), oncology vs non-oncology (HR = 1.82; P < 0.001), and self-administered vs physician-administered drugs (HR = 1.76; P < 0.001). We observed substantial variation across plans (15.1-55.4 weeks).

Despite many policies already aligning with FDA label revisions, coverage updates were often slow and inconsistent. Improving timeliness may improve equitable access to care.