2026-06-25 10:02:24 / 路透社
6月25日（路透社）——一项新分析显示，2025年经美国监管机构批准的处方药上市价格较上年有所下降，但由于罕见病高价药物的存在，中位价格仍高达21.6万美元。
2024年新药的年度挂牌价中位值超过37万美元，高于2023年的30万美元和2022年的22.2万美元。
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药品定价专家将此次价格回落归因于获批药物类型的结构变化，而非定价策略或政府降低处方药价格政策的重大调整。美国食品药品监督管理局（FDA）去年批准了5款细胞和基因疗法，而2024年和2023年获批数量均为7款。一次性使用的基因疗法定价可达数百万美元。
美国制药研究与制造商协会（PhRMA）在一封电子邮件中表示，许多新药针对的是几乎没有或根本没有治疗选择的严重复杂疾病，将这类药物的价格与其他类型药物进行比较是“具有误导性的”。
2025年FDA批准的药物中，超过67%为小分子药物（即通过化学合成的药片等），而非成本高昂、结构复杂的活细胞衍生生物制剂。这一比例高于2024年的62%和2023年的57%。
布鲁金斯学会卫生政策中心主任理查德·弗兰克表示，新型生物制剂往往是首创药物，没有竞争对手，因此制药商可以收取高价。
2025年获批药物的平均上市价格为41.6万美元，其中低成本药物拉低了整体均价：比如LENZ Therapeutics用于治疗视力模糊的眼部滴眼液Vizz售价1050美元，LIB Therapeutics的降胆固醇药物Lerochol售价5400美元；而Mighty Therapeutics用于治疗巴尔特综合征的罕见遗传病药物Forzinity年定价近80万美元，这类高价治疗拉抬了整体均价。
政治因素发挥作用
哈佛大学医学院研究药物价格的助理教授本杰明·罗姆博士表示：“很难仅凭单一年份就对趋势做出太多评估”，并补充称“2025年是不同寻常的一年”。
他指出，FDA曾受到特朗普政府机构重组的冲击，包括人员裁减和领导层更迭。该机构驳回了多款基因疗法，引发了患者维权人士的反对和政治争议。今年早些时候，FDA表示将采取更灵活的监管方式。
制药商面临着来自唐纳德·特朗普总统的压力。特朗普曾试图通过特朗普Rx直销平台以及与大型企业达成协议，使美国药品价格与其他发达国家看齐，以此宣称自己在解决美国高药价问题上取得了胜利。
布鲁金斯学会的弗兰克表示，这些协议不太可能在本届政府任期结束后继续生效。
罗姆还表示，如果没有相关立法，这些协议不会对定价决策产生重大影响。
南加州大学舍费尔卫生政策与经济中心主任杰弗里·乔伊斯称，目前存在一种普遍现象：“大家都在标榜自己在降低药价方面做了多少工作”，但其中很多都是“表面功夫”。
针对癌症和罕见病的新药
FDA去年批准了51款新药，其中46款来自其主要审批部门，另有5款为细胞和基因疗法。该机构2024年批准了57款新药，2023年为55款。上述统计不包括造影剂、血液检测试剂或疫苗。
3 Axis Advisors对42种药品价格的分析还排除了间歇性使用的药物（如抗生素）和尚未商业化上市的产品。
抗癌药物仍是最主要的治疗领域，约占2025年FDA获批药物的三分之一。
与近年情况一致，超过一半的获批药物为“孤儿药”，即用于治疗美国患者人数少于20万的疾病。制药商可获得罕见病研究投资激励，包括更长的市场独占期，且通常会为这类小众产品收取溢价。
南加州大学的乔伊斯在称这一政策“明智”的同时，也指出制药商“钻了这些激励政策的空子”。
他说：“他们可以开发一种对多种疾病都有效的药物，但只为其申请针对‘低患病率疾病’的审批，从而获得所有政策红利和税收减免。其逻辑就是以你认为能承受的最高价格上市（定价）。”
制药企业强调，新药能够带来成本节约价值，包括可能减少急诊室就诊和住院次数。
该分析仅关注挂牌价格，未包括保险公司可从制造商处获得的未公开折扣和返利。
“无论大多数新药是否比现有药物带来巨大益处，或是仅为未提供太多新价值的创新产品，你仍需为它们支付数十万美元，”哈佛大学的罗姆说道。
本报记者迪娜·比斯利报道；编辑：卡罗琳·休默、比尔·伯克罗特
我们的准则：汤森路透信任原则
US prices for new drugs fell in 2025 as fewer costly gene therapies were launched
2026-06-25 10:02:24 / Reuters
June 25 (Reuters) – Launch prices for prescription medicines approved by U.S. regulators in 2025 fell from the previous year, but remained high at a median of $216,000 due to expensive drugs for rare diseases, a new analysis shows.
In 2024, the median annual list price of a new drug was over $370,000, up from $300,000 in 2023 and $222,000 in 2022.
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Drug pricing experts attributed the dip to the mix of types of drugs approved rather than a significant shift in pricing strategy or government policies aimed at lowering prescription drug prices. The Food and Drug Administration last year approved five cell and gene therapies versus seven in both 2024 and 2023. Gene therapies, which are given once, can have prices in the millions of dollars.
Many new medicines target serious, complex diseases with few or no treatment options, and it is “misleading” to compare those prices to other drug types, trade group Pharmaceutical Research and Manufacturers of America said in an email.
More than 67% of FDA approvals in 2025 were for
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drugs, such as pills, which are made from chemicals, rather than costly, complex biologics derived from living cells. That number was up from 2024, when small molecules accounted for 62% of approvals, and 2023, when it was 57%.
New biologics are often first-in-class and do not have competitors, allowing drugmakers to charge high prices, said Richard Frank, director at the Brookings Institution’s Center on Health Policy.
The average launch price for a drug approved in 2025 was $416,000, as lower-cost products like $1,050 for LENZ Therapeutics’ Vizz eye drops for blurry vision and $5,400 cholesterol drug Lerochol from LIB Therapeutics offset expensive treatments for rare genetic disorders like Mighty Therapeutics’ Forzinity for Barth syndrome, priced at nearly $800,000 a year.
POLITICS PLAYS A ROLE
“It is hard to make a lot of assessments about trends based on a single year,” said Dr. Benjamin Rome, an assistant professor at Harvard Medical School who researches drug prices, adding that “2025 was an odd year.”
He said the FDA was buffeted by Trump administration reorganization efforts, including staff cuts and leadership changes. The agency rejected several gene therapies, leading to a backlash from patient advocates and political controversy. Earlier this year, the FDA said it would take a more
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approach.
Drugmakers came under pressure from President Donald Trump, who has sought to claim victory in tackling high U.S. pharmaceutical prices with the TrumpRx platform for direct-to-consumer sales, and deals with large companies to bring U.S. prices in line with those in other developed nations.
Those agreements are unlikely to last beyond the current administration, said Brookings’ Frank.
Rome also said that without legislation, the agreements will not significantly impact pricing decisions.
“There’s been this broad trend to say look what I’m doing to lower drug prices,” but a lot of it is “performative,” said Geoffrey Joyce, director at the University of Southern California’s Schaeffer Center for Health Policy & Economics.
NEW DRUGS FOR CANCER, RARE DISEASES
The FDA approved 51 new drugs last year, 46 at its main division and the five cell and gene therapies. The agency approved 57 new drugs in 2024 and 55 in 2023. Those tallies do not include imaging agents, blood testing reagents or vaccines.
The analysis of 42 drug prices compiled by 3 Axis Advisors also excluded drugs used intermittently like antibiotics and products that have not yet launched commercially.
Cancer drugs remained the most represented therapeutic area, accounting for about a third of 2025 FDA approvals.
As in recent years, more than half of the approvals were “orphan” drugs, meaning they treat conditions affecting fewer than 200,000 Americans. Drugmakers are given incentives to invest in research for rare diseases, including longer market exclusivity, and often charge premium prices for the niche products.
While calling that “wise public policy,” USC’s Joyce noted that drugmakers have “gamed” those incentives.
They can develop a drug that’s effective for a wide range of conditions but seek approval for “a low-prevalence disease… and get all the benefits and all the tax write-offs,” he said. “The logic is to launch (at a price) as high as you think you can get away with.”
Drug companies emphasize that new medicines can offer cost-saving value, including potentially fewer emergency room visits and hospital stays.
The analysis looked only at list prices and did not include the undisclosed discounts and rebates that insurers can receive from manufacturers.
“You’re still paying hundreds of thousands of dollars for most new drugs… irrespective of whether they offer a huge benefit over existing drugs or are sort of novel products that don’t offer much benefit,” Harvard’s Rome said.
Reporting By Deena Beasley; Editing by Caroline Humer and Bill Berkrot
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