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Analysis of Drug Formulary Exclusions from the Patient's Perspective: 2023 Update

Chea, S.; Sydor, A. M.; Popovian, R.

2023-11-06 health policy
10.1101/2023.11.01.23297921 medRxiv
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ObjectivePharmacy benefit management companies (PBMs) often determine medication reimbursement, out-of-pocket costs, and access through formularies. Formularies were initially intended to ensure the use of cost-effective medication. Today, formularies are designed to maximize concessions (i.e., rebates, discounts, fees, and other concessions) to PBMs from the biopharmaceutical industry. Formulary exclusions enhance the ability to drive profits through rebate contracting for PBMs. Our 2022 research analyzed whether formulary exclusions benefit patients medically or economically. This update provides an analysis of exclusions based on the 2023 Express Scripts (ESI) national formulary. MethodsWe analyzed ESIs 2023 national preferred formulary exclusions. ESI is the second-largest PBM in the U.S. and makes its national preferred formulary exclusions list publicly available. We categorized substitutions as equivalent (same active agent used) vs. therapeutic (different active agent). From a patient perspective, we evaluated each exclusion by potential clinical or economic outcomes and compared it to the results from the 2022 analysis. ResultsMore than half (57.4%) of the formulary exclusions had questionable economic or medical benefits or both for patients. The results demonstrate a 9% increase in questionable patient benefits compared with 48.4% in 2022. ConclusionsBecause patient co-pays and deductibles are based on retail prices, some formulary exclusions force patients to pay substantially more for a preferred drug or use a medication with questionable medical benefits for their condition. Exclusions also force prescribers to choose treatments that may have adverse financial or medical outcomes for their patients.

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