Abstract
This cohort study examines the variability in time to pharmacy and therapeutics committees’ determinations of coverage of approved oncology drugs across multiple payers.
Patient access to drugs after US Food and Drug Administration (FDA) approval is controlled by payers, principally comprising private insurers.1 Specifically, pharmacy and therapeutics committees (PTCs) within these institutions determine the coverage of drugs and their inclusion in formularies.2 We characterize the time to PTC determinations after FDA approval for oncology drugs between 2010 and 2019 across multiple payers and examine whether year of approval, drug class, orphan drug status, and expedited FDA approval is associated with variability and delays in drug coverage.
Methods
In this cohort study, coverage determination dates for oncology drugs receiving initial FDA approval between 2010 and 2019 were abstracted from publicly accessible PTC meeting minutes and pharmacy documents using an online search engine, with search terms iteratively refined to maximize the number of search results. The PTC data were identified across 127 payers (1031 health insurers filed with the National Association of Insurance Commissioners in 2019), including several of the largest US health insurers (Anthem, UnitedHealthcare, Centene, Cigna, Kaiser, Humana).
Per the Common Rule (45 CFR §46), institutional review board approval was not sought because the study is not human participant research. This study followed the STROBE reporting guideline.
Search terms used for the final analysis were drug name, followed by AND (pharmacy and therapeutics OR P&T) AND (determination OR coverage OR policy OR criteria). The top 1000 ranked search results according to the search engine algorithm were reviewed annually up to 4 years after the date of initial FDA approval, from January 1, 2016, through December 31, 2019. For drugs approved before 2012, searches were performed between January 1 and May 31, 2016, and approval dates beyond 4 years were excluded to maintain consistency in the range of PTC determination dates. Only determination dates pertaining to the first FDA-approved indication were included. Coverage lag was defined as the time from the date of FDA approval to PTC determination. Drug characteristics were obtained from the FDA website. For regression analyses, 90th percentile cutoffs were used to define long coverage lag and high ranges. Data analyses were performed between April 4 and June 27, 2023, using SPSS, version 24 (IBM Corporation).
Results
Across 974 PTC determination dates for 89 oncology drugs, the median coverage lag was 4.2 (IQR, 2.3-8.2) months, and the median lag range was 32.2 (IQR, 17.0-39.6) months (Figure). Between 2010 and 2018, there was a steady decline in the median coverage lag from 10.9 (IQR, 8.8-12.7) to 3.4 (IQR, 2.9-3.7) months and in the median range from 39.8 (IQR, 33.1-45.0) to 14.4 (IQR, 10.5-16.8) months. Multivariable regression showed that a more recent year of FDA approval, but not drug class, orphan drug status, or expedited review (fast track, priority review, accelerated approval) was associated with a lower odds of a longer coverage lag and high lag range (odds ratios, 0.20 [95% CI, 0.07-0.59] and 0.54 [95% CI, 0.34-0.85], respectively).
Figure. Coverage Lag Across Oncology Drugs.
Coverage lag was calculated as the number of months from the first US Food and Drug Administration approval of a drug to pharmacy and therapeutics committee determination for the same indication. Data points indicate individual payers; red squares, median coverage lags.
Discussion
These results indicate that PTC determinations are frequently delayed for months after initial FDA approval and that lag periods are highly variable among payers. However, coverage lags and their ranges have declined over time, suggesting that PTC determinations are becoming more efficient. A limitation of this study is the reliance on public documents and the lack of data available for many payers. Coverage determination dates also may be based on different schedules of PTC meetings among payers, which may not be flexible to the timing of FDA approvals.
Coupled with drug coverage being frequently subject to formulary exclusions and restrictions across many coverage plans, our results indicate that the existing payer system for oncology care may severely hamper patient access to effective drugs.3,4 Because oncology drugs are legally required to be covered by Medicare programs, delays in coverage determinations are conceivably needless. This dilemma could be exacerbated as the number of oncology drug approvals rise, indicating that new policies are necessary to address unreasonable coverage lags.
Data Sharing Statement
References
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Associated Data
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Supplementary Materials
Data Sharing Statement
