Selected drugs, therapeutic alternatives, and price benchmarks for IPAY 2027 Medicare drug price negotiation.

IF 2.9 4区 医学 Q2 HEALTH CARE SCIENCES & SERVICES
Sean D Sullivan, Emma M Cousin, Kevin H Li, Nico Gabriel, Kristi Martin
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引用次数: 0

Abstract

Background: On or before November 1, 2025, the Centers for Medicare & Medicaid Services (CMS) will report the agreed-upon negotiated prices (maximum fair prices [MFPs]) for the second round of up to 15 Medicare Part D drugs selected for price negotiation (Initial Price Applicability Year 2027).

Objective: To propose guideline-recommended therapeutic alternatives and estimate price benchmarks that may be considered by CMS for negotiation.

Methods: We identified US Food and Drug Administration (FDA)-approved indications for the 15 drugs selected for negotiation. We used 2022 Medicare claims data to identify drug-specific beneficiary utilization. Medical claims with International Classification of Diseases, Tenth Revision, Clinical Modification diagnosis codes for each indication were evaluated to estimate relative indication-specific utilization. We examined published clinical guidelines to identify and propose therapeutic alternatives for each drug and the most prevalent, FDA-approved indication. For negotiation price benchmarks, we report (1) the list price, (2) the estimated net price after manufacturer discounts, (3) the minimum statutory discount, and (4) the ceiling of the MFP. All price benchmarks were estimated at the product level, for a 30-day equivalent dosing, using Medicare Part D dashboard and IQVIA data. We also estimated net prices for the proposed therapeutic alternatives.

Results: Four drugs were identified to have 1 (deutetrabenazine, linaclotide, and nintedanib-esylate) or no (rifaximin) therapeutic alternative. Eight of the 15 selected drugs will have the ceiling price set by the minimum statutory discount. Four products (acalabrutinib, semaglutide, linagliptin, and sitagliptin/metformin) will include therapeutic alternatives and MFPs from the first round of negotiation. The selection of therapeutic alternatives and estimation of price benchmarks by CMS will set the initial conditions for subsequent price negotiation.

Conclusions: These analyses identify the likely ceiling price and various initial price offer scenarios for the second round of Medicare price negotiation. We report price benchmarks and likely therapeutic alternatives to improve transparency around the opaque CMS negotiation process.

IPAY 2027医保药品价格谈判的选择药品、治疗方案和价格基准。
背景:在2025年11月1日或之前,医疗保险和医疗补助服务中心(CMS)将报告第二轮最多15种医疗保险D部分药物的商定谈判价格(最高公平价格[mfp]),这些药物被选中进行价格谈判(2027年初始价格适用年)。目的:提出指南推荐的治疗方案和估计价格基准,CMS可能会考虑进行谈判。方法:我们确定了美国食品药品监督管理局(FDA)批准的15种药物的适应症,选择进行谈判。我们使用2022年医疗保险索赔数据来确定特定药物的受益人使用情况。采用国际疾病分类第十版临床修改诊断代码对每个适应症的医疗索赔进行评估,以估计相对的适应症特异性利用。我们检查了已发表的临床指南,以确定并提出每种药物的治疗方案和最普遍的,fda批准的适应症。对于谈判价格基准,我们报告(1)标价,(2)制造商折扣后的估计净价,(3)最低法定折扣,以及(4)MFP的上限。使用医疗保险D部分仪表板和IQVIA数据,在30天等效剂量的产品水平上估计所有价格基准。我们还估计了建议的治疗方案的净价格。结果:鉴定出4种药物有1种(去四苯那嗪、利那洛肽和尼达尼布磺酸盐)或无治疗选择(利福昔明)。15种选定药物中的8种将以最低法定折扣确定最高价格。四种产品(阿卡拉布替尼、西马鲁肽、利格列汀和西格列汀/二甲双胍)将包括第一轮谈判的治疗方案和mfp。CMS对治疗方案的选择和价格基准的估计将为后续的价格谈判设定初始条件。结论:这些分析确定了第二轮医疗保险价格谈判可能的最高价格和各种初始价格提供方案。我们报告价格基准和可能的治疗方案,以提高围绕不透明的CMS谈判过程的透明度。
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来源期刊
Journal of managed care & specialty pharmacy
Journal of managed care & specialty pharmacy Health Professions-Pharmacy
CiteScore
3.50
自引率
4.80%
发文量
131
期刊介绍: JMCP welcomes research studies conducted outside of the United States that are relevant to our readership. Our audience is primarily concerned with designing policies of formulary coverage, health benefit design, and pharmaceutical programs that are based on evidence from large populations of people. Studies of pharmacist interventions conducted outside the United States that have already been extensively studied within the United States and studies of small sample sizes in non-managed care environments outside of the United States (e.g., hospitals or community pharmacies) are generally of low interest to our readership. However, studies of health outcomes and costs assessed in large populations that provide evidence for formulary coverage, health benefit design, and pharmaceutical programs are of high interest to JMCP’s readership.
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