Integrating Price Benchmarks and Comparative Clinical Effectiveness to Inform the Medicare Drug Price Negotiation Program

IF 4.9 2区 医学 Q1 ECONOMICS Value in Health Pub Date : 2024-08-21 DOI:10.1016/j.jval.2024.08.001
Sean D. Sullivan BScPharm, PhD , Olivier J. Wouters PhD , Emma M. Cousin PharmD , Ayuri S. Kirihennedige BSc , Inmaculada Hernandez PharmD, PhD
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Abstract

Objectives

By September 2024, the Centers for Medicare and Medicaid Services (CMS) will publicly report the negotiated prices (Maximum Fair Prices) for the first 10 drugs selected for price negotiation. We estimate initial price offers based on net prices, statutorily defined ceilings, and comparative effectiveness data for the 10 drugs and their therapeutic alternatives.

Methods

We utilized net prices and other price benchmarks for the 10 drugs and their therapeutic alternatives. We searched for data on comparative clinical effectiveness for the primary indications. We outlined a range of plausible initial price offers based on CMS guidance and our interpretation of regulatory intent.

Results

For ibrutinib and ustekinumab, statutorily defined ceiling prices will likely determine the initial price offers. The integration of net pricing and clinical evidence from comparator branded products will inform the initial price offers for apixaban, empagliflozin, etanercept, and insulin aspart. Rivaroxaban and sacubitril/valsartan have therapeutic alternatives that are generics; therefore, CMS may apply a discount to current net prices. To achieve savings in the negotiation of dapagliflozin and sitagliptin, CMS will have to leverage additional negotiation factors because statutory defined ceilings and net prices of therapeutic alternatives are similar or higher.

Conclusions

This analysis sheds light on important price benchmarks and clinical evidence factors for the determination of the initial price offers. Although we were not able to simulate the offer and counter-offer process, our findings provide a transparent and systematic way to produce initial offers that are consistent with CMS guidance.
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整合价格基准和临床效果比较,为医疗保险药品价格谈判计划提供信息。
目标:到 2024 年 9 月,医疗保险和医疗补助服务中心(CMS)将公开报告首批选定进行价格谈判的十种药物的谈判价格(最高公平价格)。我们根据这十种药物及其替代治疗药物的净价、法定最高限价和比较效果数据估算了初始报价:我们利用了这十种药物及其替代治疗药物的净价格和其他价格基准。我们搜索了主要适应症的临床疗效比较数据。根据 CMS 指南和我们对监管意图的理解,我们列出了一系列合理的初始报价:对于伊布替尼和乌司替尼,法定的最高限价可能会决定初始报价。阿哌沙班、恩格列净、依那西普和阿斯巴甜胰岛素的初始报价将参考参照品牌产品的净定价和临床证据。利伐沙班和sacubitril/valsartan的治疗替代品是仿制药,因此CMS可能会在当前净价的基础上打折。为了在达帕利洛嗪和西他列汀的谈判中实现节约,CMS 将不得不利用更多的谈判因素,因为法定定义的上限和治疗替代品的净价格相似或更高:本分析揭示了确定初始报价的重要价格基准和临床证据因素。虽然我们无法模拟报价和还价过程,但我们的研究结果为制定初始报价提供了一种透明、系统的方法。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Value in Health
Value in Health 医学-卫生保健
CiteScore
6.90
自引率
6.70%
发文量
3064
审稿时长
3-8 weeks
期刊介绍: Value in Health contains original research articles for pharmacoeconomics, health economics, and outcomes research (clinical, economic, and patient-reported outcomes/preference-based research), as well as conceptual and health policy articles that provide valuable information for health care decision-makers as well as the research community. As the official journal of ISPOR, Value in Health provides a forum for researchers, as well as health care decision-makers to translate outcomes research into health care decisions.
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