Syversen Iselin Dahlen, Schulman Kevin, Kesselheim Aaron S, Feldman William B
Brigham and Women's Hospital and Harvard Medical School.
Stanford University School of Medicine.
Milbank Q. 2024 Dec;102(4):1004-1031. doi: 10.1111/1468-0009.12714. Epub 2024 Sep 17.
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.
In 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.
We 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.
All 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.
High-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.
政策要点 世界各地的医疗保健系统依靠一系列方法来确保处方药的可负担性，包括在药物获批后不久就进行价格谈判，以及依靠正式的临床评估来比较新获批的疗法与现有替代方案。《降低通胀法案》设立的谈判框架比本研究探讨的其他框架要有限得多。纳入这些框架的要素可能会使美国的价格谈判更有效。
2022年，国会通过了《降低通胀法案》，该法案首次允许医疗保险开始就某些高成本品牌处方药的价格进行谈判。许多其他工业化国家都对药品价格进行谈判，我们试图比较和对比多个医疗系统中谈判过程的关键特征。我们特别关注了用于价格谈判的药品选择标准、谈判程序、影响谈判价格的因素，以及价格是如何实施的。
我们的分析纳入了四个七国集团国家（加拿大、法国、德国和英国[英格兰]）、两个比荷卢三国（比利时和荷兰）以及一个有着长期药品价格谈判框架的斯堪的纳维亚国家（挪威）。我们还分析了美国的退伍军人事务医疗系统。对于每个系统，我们收集了相关立法、政府出版物和指南以了解谈判框架，并联系了每个系统中的关键药品价格谈判人员进行半结构化访谈。所有访谈都进行了录音、转录和编码，并基于我们开发的内部评估工具对数据进行了分析。
所有八个系统在药品获批后不久就对品牌处方药的价格进行谈判，并依靠正式的临床评估来比较新获批药物与现有疗法。我们研究中的系统在以下特征方面存在差异，比如进行临床评估的机构是否与谈判机构分开、如何评估额外的健康效益、是否采用明确的支付意愿阈值，以及如何针对优先疾病领域采取具体方法。
世界各地的高收入国家在对品牌药进行价格谈判时采用不同的方法，但都围绕着一系列目前医疗保险谈判框架中基本没有的做法。美国政策制定者未来可能会考虑纳入其中一些特征以改善谈判结果。
