A Comparative Analysis of International Drug Price Negotiation Frameworks: An Interview Study of Key Stakeholders

ISELIN DAHLEN SYVERSEN, KEVIN SCHULMAN, AARON S. KESSELHEIM, WILLIAM B. FELDMAN
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Abstract

Policy Points Health care systems around the world rely on a range of methods to ensure the affordability of prescription drugs, including negotiating prices soon after drug approval and relying on formal clinical assessments that compare newly approved therapies with existing alternatives. The negotiation framework established under the Inflation Reduction Act is far more limited than other frameworks explored in this study. Adding elements from these frameworks could lead to more effective price negotiation in the United States. ContextIn 2022, Congress passed the Inflation Reduction Act, which allowed Medicare, for the first time, to begin negotiating the prices for certain high‐cost brand‐name prescription drugs. Many other industrialized countries negotiate drug prices, and we sought to compare and contrast key features of the negotiation process across several health systems. We focused, in particular, on the criteria for selecting drugs for price negotiation, procedures for negotiation, factors that influence negotiated prices, and how prices are implemented.MethodsWe included four G7 countries in our analysis (Canada, France, Germany, and the United Kingdom [England]), two Benelux countries (Belgium and the Netherlands), and one Scandinavian country (Norway) with long‐established frameworks for drug price negotiation. We also analyzed the Veterans Affairs Health System in the United States. For each system, we gathered relevant legislation, government publications, and guidelines to understand negotiation frameworks, and we reached out to key drug price negotiators in each system to conduct semistructured interviews. All interviews were recorded, transcribed, and coded, and data were analyzed based on an internal assessment tool that we developed.FindingsAll eight systems negotiate the prices of brand‐name prescription drugs soon after approval and rely on formal clinical assessments that compare newly approved drugs with existing therapies. Systems in our study differed on characteristics such as whether the body performing clinical assessments is separate from the negotiating authority, how added health benefit is assessed, whether explicit willingness‐to‐pay thresholds are employed, and how specific approaches for priority disease areas are taken.ConclusionsHigh‐income countries around the world adopt different approaches to conducting price negotiations on brand‐name drugs but coalesce around a set of practices that will largely be absent from the current Medicare negotiation framework. US policymakers might consider adding some of these characteristics in the future to improve negotiation outcomes.
国际药品价格谈判框架的比较分析:主要利益相关者访谈研究
政策要点 世界各地的医疗保健系统都依靠一系列方法来确保处方药的可负担性,包括在药品批准后不久就进行价格谈判,以及依靠正式的临床评估将新批准的疗法与现有的替代疗法进行比较。与本研究探讨的其他框架相比,根据《降低通货膨胀法》建立的谈判框架要有限得多。加入这些框架中的元素可以使美国的价格谈判更加有效。背景2022 年,美国国会通过了《通货膨胀削减法》,首次允许医疗保险开始对某些高价品牌处方药进行价格谈判。许多其他工业化国家也在进行药品价格谈判,我们试图比较和对比几个医疗系统谈判过程的主要特点。我们的分析包括四个七国集团国家(加拿大、法国、德国和英国)、两个比荷卢国家(比利时和荷兰)和一个斯堪的纳维亚国家(挪威),这些国家的药品价格谈判框架由来已久。我们还分析了美国退伍军人事务卫生系统。对于每个系统,我们都收集了相关立法、政府出版物和指南,以了解谈判框架,并与每个系统的主要药品价格谈判人员进行了半结构化访谈。我们对所有访谈进行了记录、转录和编码,并根据我们开发的内部评估工具对数据进行了分析。研究结果所有八个系统都是在品牌处方药获得批准后不久进行价格谈判,并依赖于正式的临床评估,将新批准的药物与现有疗法进行比较。在我们的研究中,各系统的特点各不相同,如进行临床评估的机构是否独立于谈判机构,如何评估额外的健康益处,是否采用了明确的支付意愿阈值,以及如何针对重点疾病领域采取特定的方法。美国的政策制定者可以考虑在未来增加其中的一些特点,以改善谈判结果。
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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