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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Photo by Martin Gregor via Shutterstock
美國製藥業正在積極遊說修訂《通貨膨脹降低法》（IRA）的醫療保險藥品價格談判條款。
IRA授權Medicare就昂貴藥品的價格進行談判，這有可能導致降價幅度從法定最低25％到顯著的60％不等。
9月，美國衛生與公共服務部（HHS）通過醫療保險和醫療補助服務中心（CMS）發佈了第二週期醫療保險藥品價格談判計劃的最終指導方針。
該計劃旨在從2026年和2027年開始提供更低的藥品價格。
第一輪談判側重於十種特定藥物。
當新價格於2026年生效時，醫療保險接受者可以節省約15億美元的自付費用。
路透社援引知情人士的話強調，行業代表的目標是特朗普可能成立的政府領導下的變革，旨在延長某些藥品的談判資格。
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到2025年2月，CMS將爲第二輪談判選擇多達15種額外的藥物。選定的藥物將在2025年進行談判，新價格將於2027年生效。
喬·拜登總統希望擴大有資格參加醫療保險價格談判的處方藥的數量。他建議不要將目前的每年20種藥物的上限提高到至少50種。此外，一些流行的減肥和糖尿病藥物可能會成爲定於2027年的下一輪談判的目標。
路透社的一份報告強調，主要製藥和生物技術公司的遊說者和高管主張將佔大多數藥物的藥丸等小分子藥物資格的談判推遲四年。
根據現行規定，這些藥物在上市九年後必須進行談判，而生物製劑的談判期爲13年。製藥商認爲，這個時間表阻礙了爲更實惠、更便捷的療法而進行創新。
自2022年通過以來，IRA一直受到業界的批評，聲稱它可能會扼殺研發。
此外，儘管預計會降價，但參與美國首次醫療保險藥品價格談判的主要製藥公司預計，業務影響有限。
一些製藥公司已直接與當選總統唐納德·特朗普的過渡團隊成員接觸，以提出對IRA的修正案。
這些公司希望，共和黨在國會的多數派能夠接受調整所有藥物的談判時間表，消除藥丸和生物製劑之間的區別。
並非所有人都同意該行業的立場。該報告援引西弗吉尼亞大學法學教授塗肖恩的話說，擬議的變更不公平地使製藥公司受益。他告訴路透社，目前的九年獨家經營期已經爲創新提供了支持，並警告說，延長獨家期限將在不帶來重大好處的情況下給患者帶來更多負擔。
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照片由馬丁·格雷戈爾通過 Shutterstock 拍攝
