College of Pharmacy, University of Illinois, Chicago, Illinois, USA.
J Clin Pharm Ther. 2022 Nov;47(11):1738-1751. doi: 10.1111/jcpt.13783. Epub 2022 Oct 7.
After more than a year of negotiation, a $740 billion climate and health care bill known as The Inflation Reduction Act (IRA) became law on 16 August 2022. In addition to its impact on the environment, job creation and reducing inflation, a key focus is to reduce the burden of Medicare by over $100B per year and other benefits to 65 million Medicare patients. A fixed number of top expenditures drugs that have stayed as single-source chemical products for 8 years and the biologicals for 12 years; 2 years more are allowed if the approval of a generic or biosimilar is imminent. Once a second source appears, as a generic or biosimilar, the price reduction is removed. The number of products negotiated for price reduction goes from 10 to 20 over the years and stays fixed at this number. Reaching any significant number out of the 14,000 reimbursed will take forever if biosimilars and generics keep entering. The IRA does not apply to private markets.
The IRA legislation and related statutes were analysed in consultation with legal teams; the spending data were derived from the CMS portals and the FDA databases to rank the most likely products selected when the selection process is initiated.
The savings to Medicare will come from reducing the price of only a few products, primarily with $1B and upward spending; when Plan B product scheduling enters, these will be at the bottom of the selection because of their lower expenditure. The total number of products subject to price reduction may be negligible if generics and biosimilars are introduced after the exclusivity period of the listed drug or reference product. The private market with an 80% share may benefit due to price spillover but mainly by the expedited entry of generics and biosimilars.
The entry of generics and biosimilars will now be encouraged by brand-name product companies, reducing the intellectual property hurdles like the "patent dance" for biosimilars. The IRA includes restrictions to prevent the brand name companies from exploiting the entry of generics and biosimilars to assure their independence.
经过一年多的谈判，一项被称为《降低通胀法案》（IRA）的 7400 亿美元气候和医疗保健法案于 2022 年 8 月 16 日成为法律。除了对环境、创造就业机会和降低通胀的影响外，该法案的一个关键重点是每年为 Medicare 减少超过 1000 亿美元的负担和其他 6500 万 Medicare 患者的福利。对于已经作为单一来源化学产品存在 8 年的少数顶级支出药物和已经存在 12 年的生物制剂，允许再有 2 年时间，如果即将批准仿制药或生物类似药；一旦出现第二个来源，无论是仿制药还是生物类似药，价格就会降低。多年来，用于降低价格的谈判产品数量从 10 个增加到 20 个，并保持不变。如果生物类似药和仿制药不断进入市场，要从 14000 种报销药物中达到任何显著数量都将需要永远。IRA 不适用于私人市场。
与法律团队协商分析了 IRA 立法和相关法规；支出数据来自 CMS 门户网站和 FDA 数据库，以对启动选择过程时最有可能选择的产品进行排名。
医疗保险的节省将来自于仅降低少数几种产品的价格，主要是支出超过 10 亿美元的产品；当计划 B 产品安排进入市场时，由于支出较低，这些产品将处于选择的底部。如果在上市药物或参考产品的专有权期过后引入仿制药和生物类似药，那么受降价影响的产品总数可能微不足道。拥有 80%份额的私人市场可能会受益于价格溢出效应，但主要是通过加快仿制药和生物类似药的进入。
现在，品牌药物公司将被鼓励引入仿制药和生物类似药，从而降低像生物类似药的“专利舞蹈”这样的知识产权障碍。IRA 包括限制条款，以防止品牌药物公司利用仿制药和生物类似药的进入来确保其独立性。
