美国医疗福利生物仿制药报销建模政策建议

An analysis of average sales price andprovider net cost recovery dynamics Introduction Spending on biologic medicines in the United States has increased rapidly inrecent years, reaching $262Bn in 2024 and accounting for more than half of totalmedicine spending. As many high-cost biologics face patent expiry, biosimilarshave the potential to continue introducing competition and generatingmeaningful savings for the healthcare system while maintaining clinicaloutcomes. However, the economic and policy environment governing biosimilarsreimbursed under the medical benefit presents a distinct and increasinglycomplex set of challenges that may limit their long-term sustainability. If leftunaddressed, these issues could lead to reduced investment in future biosimilardevelopment, biosimilar market exits, diminished healthcare system savings,and fewer treatment choices for patients and providers. This report evaluates five policy proposals intendedto address these challenges by modifying ASP-basedreimbursement for medical benefit biosimilars.These include smoothing ASP calculations over multiplequarters to reduce volatility, extending the initial period ofWholesale Acquisition Cost (WAC) based reimbursementfollowing biosimilar launch, increasing add-on paymentsfor biosimilar reimbursements, establishing minimumASP reimbursement floors, and redefining ASP to excludediscounts provided to non-provider stakeholders.Using historical ASP data and modeled estimates ofprovider net cost recovery, the analysis examines howeach policy could affect providers, manufacturers, payers,and total healthcare system savings. near-term savings with the long-term sustainabilityof the biosimilar market and the incentives needed tosupport continued development and adoption. This study was produced independently by the IQVIAInstitute for Human Data Science and the IQVIA U.S.Market Access Strategy Consulting team. The BiosimilarsForum provided funding and consulted on this researchand report. The contributions to this report of SenayGokcebel, Zohar Gorman, and others at IQVIA aregratefully acknowledged. Find Out More If you wish to receive future reports from the IQVIAInstitute for Human Data Science or join our mailing list,visit iqviainstitute.org. As the story of biosimilars continues to evolve, it is criticalto understand not only the level of savings they achieve,but also the market conditions necessary to support acompetitive and sustainable medical benefit biosimilarsystem in the long run. These findings aim to informpolicymakers as they consider reforms that balance MURRAY AITKENExecutive DirectorIQVIA Institute for Human Data Science REFERENCING THIS REPORT Please use this format when referencing content from this report:Source: IQVIA Institute for Human Data Science. Modeling Poli cy Proposals for Medical Benefit Biosimilar Reimbursement i n the U.S. February 2026.Available from www.iqviainstitute.org ©2026 IQVIA and its affiliates. All reproduction rights, quotations, broadcasting, publications reserved. No part of this publication may be reproduced ortransmitted in any form or by any means, electronic or mechanical, including photocopy, recording, or any information storage and retrieval system, withoutexpress written consent of IQVIA and the IQVIA Institute. Modeling Policy Proposals for Medical Benefit Biosimilar Reimbursement in the U.S. Table of Contents Overview2Background4Policyproposals8Modelingmethodologies11Impactsof 14Estimatedsavings22Discussion27Appendix34References37Aboutthe39Aboutthe41 Overview Spending on biologic medicines in the United Stateshas grown rapidly in recent years, nearly doublingsince 2019 to reach $262Bn in 2024 and accountingfor 54% of the $487Bn spent on medicines overall. Aspatent protections expire for many high-cost biologics,biosimilars offer an important opportunity to introducecompetition, reduce healthcare spending, and maintainclinical outcomes, much as generics have done forsmall molecule medicines. However, the economic andpolicy environment governing biosimilars reimbursedunder the medical benefit presents a distinct andincreasingly complex set of challenges that may limittheir long-term sustainability. Various stakeholders have recently raised concerns thatthe current ASP-based reimbursement system mayundermine the sustainability of the medical benefitbiosimilar market. Providers can face unfavorable andvolatile net cost recovery as reimbursements decline overtime, while manufacturers may be pushed into ASP spiralsdriven by continuous discounting. In prior research, theIQVIA Institute identified four key challenges to biosimilarsustainability in this setting, including rebating andaccess dynamics, provider net cost recovery, ASP-relatedimpacts on manufacturer viability, and a lack of incentivesfor patients to switch to biosimilars. If left unaddressed,these issues could lead to biosimilar market exits, reducedinvestment in future biosimilar development, diminishedhealth