Formulary-Related Insurance Denials of Single-Source Branded Drugs in the United States

How frequently are prescriptions rejected because of insurance formulary restrictions in the United States, and how often are the rejected medicines ultimately dispensed?In this longitudinal, all-payer cohort study of approximately 1.17 million individuals attempting to fill more than 2 million single-source branded drugs between 2018 and 2024, 32.0% were rejected. Once rejected, 38.6% of individuals obtained the prescribed drug, 13.0% received a medication in the same therapeutic class, and nearly half (48.4%) received no medication in the same therapeutic class within 90 days.Formulary rejections are becoming more common over time, across all insurance, and often prevent patients from obtaining initially prescribed treatments, highlighting trade-offs between cost and access to medicines.

Corresponding Author: Joseph F. Levy, PhD, Johns Hopkins Bloomberg School of Public Health, 1812 Ashland Ave, Baltimore, MD 21205 (jlevy@jhu.edu).

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