The U.S. pharmaceutical industry is actively lobbying for revisions to the Medicare drug price negotiation provisions of the Inflation Reduction Act (IRA).
The IRA empowers Medicare to negotiate prices for costly drugs, potentially leading to price cuts ranging from the statutory minimum of 25% to a significant 60%.
In September, the U.S. Department of Health and Human Services (HHS), working via the Centers for Medicare & Medicaid Services (CMS), released final guidance for the second cycle of the Medicare Drug Price Negotiation Program.
The initiative aims to provide lower drug prices starting in 2026 and 2027.
The first round of negotiations focused on ten specific drugs.
Medicare recipients could save approximately $1.5 billion in out-of-pocket costs when the new prices take effect in 2026.
Industry representatives are targeting changes under a potential Trump administration, aiming to extend the timeline for certain drugs' eligibility for negotiations, Reuters highlighted, citing sources familiar with the matter.
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By February 2025, CMS will select up to 15 additional drugs for the second round of negotiations. The selected drugs will undergo negotiations in 2025, with new prices becoming effective in 2027.
President Joe Biden wants to expand the number of prescription drugs eligible for Medicare price negotiations. Instead of the current limit of 20 drugs per year, he suggests raising it to at least 50. Also, some popular weight loss and diabetes drugs could be targeted in the next round of negotiations, which is set for 2027.
A Reuters report highlights that lobbyists and executives from major pharmaceutical and biotech companies are advocating for a four-year delay in negotiating eligibility for small-molecule drugs, such as pills, which comprise the majority of medications.
Under current rules, these drugs are subject to negotiations nine years after launch, compared to 13 years for biologics. Drugmakers argue this timeline discourages innovation for more affordable, convenient therapies.
Since its passage in 2022, the IRA has drawn industry criticism, with claims that it could stifle research and development.
Also, major pharmaceutical companies involved in the first U.S. negotiations over Medicare drug prices expect limited business impact despite anticipated price cuts.
Some pharmaceutical firms have engaged directly with President-elect Donald Trump's transition team members to propose amendments to the IRA.
These companies hope that Republican majorities in Congress will be receptive to aligning negotiation timelines for all drugs, removing distinctions between pills and biologics.
Not everyone agrees with the industry's position. The report cites S. Sean Tu, a law professor at West Virginia University, who says the proposed changes unfairly benefit drug companies. He told Reuters that the current nine-year exclusivity period already supports innovation and warns that extending it would burden patients more without offering significant benefits.
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美国制药业正在积极游说修订《通货膨胀降低法》（IRA）的医疗保险药品价格谈判条款。
IRA授权Medicare就昂贵药品的价格进行谈判，这有可能导致降价幅度从法定最低25％到显著的60％不等。
9月，美国卫生与公共服务部（HHS）通过医疗保险和医疗补助服务中心（CMS）发布了第二周期医疗保险药品价格谈判计划的最终指导方针。
该计划旨在从2026年和2027年开始提供更低的药品价格。
第一轮谈判侧重于十种特定药物。
当新价格于2026年生效时，医疗保险接受者可以节省约15亿美元的自付费用。
路透社援引知情人士的话强调，行业代表的目标是特朗普可能成立的政府领导下的变革，旨在延长某些药品的谈判资格。
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到2025年2月，CMS将为第二轮谈判选择多达15种额外的药物。选定的药物将在2025年进行谈判，新价格将于2027年生效。
乔·拜登总统希望扩大有资格参加医疗保险价格谈判的处方药的数量。他建议不要将目前的每年20种药物的上限提高到至少50种。此外，一些流行的减肥和糖尿病药物可能会成为定于2027年的下一轮谈判的目标。
路透社的一份报告强调，主要制药和生物技术公司的游说者和高管主张将占大多数药物的药丸等小分子药物资格的谈判推迟四年。
根据现行规定，这些药物在上市九年后必须进行谈判，而生物制剂的谈判期为13年。制药商认为，这个时间表阻碍了为更实惠、更便捷的疗法而进行创新。
自2022年通过以来，IRA一直受到业界的批评，声称它可能会扼杀研发。
此外，尽管预计会降价，但参与美国首次医疗保险药品价格谈判的主要制药公司预计，业务影响有限。
一些制药公司已直接与当选总统唐纳德·特朗普的过渡团队成员接触，以提出对IRA的修正案。
这些公司希望，共和党在国会的多数派能够接受调整所有药物的谈判时间表，消除药丸和生物制剂之间的区别。
并非所有人都同意该行业的立场。该报告援引西弗吉尼亚大学法学教授涂肖恩的话说，拟议的变更不公平地使制药公司受益。他告诉路透社，目前的九年独家经营期已经为创新提供了支持，并警告说，延长独家期限将在不带来重大好处的情况下给患者带来更多负担。
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