Evaluating the Timing of Payer Coverage Policy Issuance for Specialty Drugs with Expedited Review

The FDA has 4 expedited review programs, including fast-track designation, breakthrough therapy designation, accelerated approval, and priority review designation, to facilitate timely approvals of important clinical advancements; however, the time in which commercial health insurers develop and implement coverage policies subsequent to these expedited approvals is not well understood. Therefore, this study aimed to assess the frequency and speed of coverage policy issuance for drugs included in various FDA-expedited programs among commercial health plans.

The data set included coverage policies issued by 17 large US commercial health plans for drugs approved by the FDA in 2018. Policies that were active 1 year following each drug’s approval were included, and the dates that plans issued included policies were recorded. The relationship between coverage frequency and speed, and the number of expedited programs to which each drug was assigned by the FDA were investigated. Kaplan-Meier survival curves and Cox proportional hazards regression accounted for how frequently and fast plans issued policies.

Of 1190 coverage policies issued by insurers, there were 448 instances (38%) in which coverage policies were not issued within 1 year of a drug’s FDA approval. The median time to policy issuance was 209 days. Findings showed that plans issued policies 47 days faster for drugs included in at least 1 expedited program (median, 178 days) versus drugs excluded from expedited review programs (median, 235 days). Policy issuance speed was found to increase with each additional expedited program (manufacturers can apply for more than 1 expedited review program). After controlling for cancer and orphan disease indication, the number of expedited programs in which the FDA included a drug was not found to be associated with policy issuance speed or frequency (hazard ratio, 0.95; P = .209). Cancer indication (hazard ratio, 1.24; P <.01) and orphan disease indication (hazard ratio, 1.41; P <.01) were both found to be associated with faster policy issuance.

After controlling for key variables (cancer or orphan disease indication), this study did not find differences in coverage plan issuance speed or frequency for drugs approved through multiple FDA-expedited review programs. These findings raise the question of why plans are not able to accelerate coverage issuance to increase patient access to drugs deemed worthy of expedited approval.


Panzer A, Ingham M, Martin S, et al. The association between US Food and Drug Administration expedited approval designations and health plan specialty drug coverage issuance speed. Presented at: 2022 Academy of Managed Care Pharmacy Nexus Annual Meeting; October 11-14, 2022; National Harbor, MD. Poster U10.

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