340B合同药房真的能‘增加340B患者的可及性’吗？

Do 340B Contract PharmaciesReally “Increase Access” for340B Patients? WILLIAM SARRAILLE, JD,University of Maryland Francis King Carey School of LawSHANYUE ZENG, MA,IQVIA Market Access Technology SolutionsRORY MARTIN, PHD,IQVIA Market Access Technology Solutions Table of contents Abstract1Introduction2A short history of contract pharmacies2Digging deeper into the competing narratives4Data and methods4Limitations5Findings6Discussion8Conclusion9References10About the authors11Acknowledgements11Funding11Conflictsof11 Abstract Advocates for 340B hospitals and clinics assert thatcontract pharmacy arrangements increase patient accessto medications. They also contend that manufacturerpolicies limiting such arrangements have substantiallyreduced patient access to those medications. Using a national sample of drug sales data, wefound that less than 1% of contract pharmacies wereclosed, and this proportion remained stable aftermanufacturer policies were implemented. Before theimplementation of manufacturer policies limiting theuse of contract pharmacies, 25 pharmacies were closedcontract pharmacies (0.10%), while after manufacturerpolicies were implemented, 40 pharmacies were closedcontract pharmacies (0.13%). During the same period,the number of non-contract pharmacies fell, and thenumber of prescriptions and 340B sales involvingcontract pharmacies — both open and closed —increased substantially. While patient access is multi-factorial, it often hingeson two key dimensions: drug affordability and drugavailability. Our prior work has studied the role ofcontract pharmacies in affordability, and showed that340B discounts are rarely shared with patients atcontract pharmacies. This study focuses on the role ofcontract pharmacies in drug availability. We examinecontract pharmacies that are “closed” (they serve only340B patients) versus contract pharmacies that are“open” (they serve all patients regardless of their 340Bstatus). Closed pharmacies may represent increasedaccess, because they would not exist without the 340Bprogram, while open pharmacies do not. In summary, for the vast majority of cases, drugavailability at contract pharmacies does not depend onpatients’ 340B eligibility. We therefore find no evidencethat 340B contract pharmacies increase drug availabilityin a meaningful way or that manufacturer policiesreduced patient access at contract pharmacies. Introduction Recently, the Majority Staff of the Senate Health,Education, Labor, and Pensions Committee (HELP) issueda report on the 340B Drug Pricing Program (“340Bprogram”).1In doing so, the Committee addressedan issue that has been a source of dispute between340B advocates and critics, who offer starkly differentassessments of whether 340B contract pharmaciesincrease access for patients to drug therapy and whethermanufacturer policies that seek to limit the use of thosecontract pharmacies have adversely affected patientdrug access. Under controversial guidance issued bythe Health Resources and Services Administration(HRSA) — the agency responsible for oversight of the340B program — 340B hospitals and clinics have usedcontract pharmacies that the 340B covered entities donot own or operate to leverage 340B profits. Consideringthe importance of the issue of patient access tomedicines, we set out to determine whether 340Bcontract pharmacies can be shown to have meaningfullyexpanded access and whether the subsequentintroduction of manufacturer contract pharmacy policiesdecreased patient access. such as commercial plans, employer sponsors, and theMedicare program — at reimbursement rates that arenot discounted for the lower 340B acquisition prices, theresulting “spread” between the 340B acquisition priceand the reimbursement value is a source of enormousprofits to both covered entities and contract pharmacies.Members of our group recently estimated that 340Bacquisition costs in 2024 were $68.4 billion, the list pricevalue of those drugs — a measure of reimbursementvalue — was $147.8 billion, and the resulting spread was$79.4 billion.3 A short history of contract pharmacies The 340B program mandates that drug manufacturersprovide significant discounts to a specified group ofhealthcare providers known as covered entities.2Enactedunder the Public Health Service Act, the 340B programspecifically limits the entities that may purchase at theheavily discounted price specified by statute.2 After HRSA permitted an unlimited number of contractpharmacies in 2010,4the 340B program tripled in sizeover the following decade, even as the vulnerablepopulation the statute was designed to assist halvedin size.5In April 2010, there were approximately 2,321contract pharmacy arrangements. By 2020, this figurehad grown to over 100,000 such arrangements.6 Notwithstanding that statutory restriction, HRSApermits 340B covered entities to expand their use of340B priced drugs using contract pharmacies. Contractpharmacies often consist of large, for-profit nationalchain pharmacies or