Lauenroth Victoria D, Kesselheim Aaron S, Sarpatwari Ameet, Stern Ariel D
Victoria D. Lauenroth was a research associate at the Hamburg Center for Health Economics, in Hamburg, Germany, and a visiting researcher at the Harvard-MIT Center for Regulatory Science, Harvard Medical School, in Boston, Massachusetts, when this work was conducted.
Aaron S. Kesselheim is a professor of medicine and the director of the Program on Regulation, Therapeutics, and Law in the Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, in Boston.
Health Aff (Millwood). 2020 Jul;39(7):1185-1193. doi: 10.1377/hlthaff.2019.01122.
Worldwide spending on prescription drugs has increased dramatically in recent years. Although this increase has been particularly pronounced in the US, it remains largely unaddressed there. In Europe, however, different approaches to regulating drug prices have been implemented. Under the 2011 German Pharmaceutical Market Restructuring Act (Arzneimittelmarktneuordnungsgesetz, or AMNOG), for example, manufacturers freely set the prices of newly authorized drugs during their first year on the market. Benefit assessments are carried out during this year and then used in price negotiations between manufacturers and representatives of the country's statutory health insurers. Using data on fifty-seven anticancer drugs launched in Germany from 2002 to 2017, we found that implementation of AMNOG was associated with drug prices being more closely aligned with clinical benefit. Introducing price negotiations led to a 24.5 percent decrease in negotiated prices relative to launch prices. We did not find evidence that manufacturers responded by setting higher launch prices. AMNOG is an example of how government price negotiation can be designed to better align prices with clinical benefit without delaying patient access.
近年来，全球处方药支出急剧增加。尽管这种增长在美国尤为显著，但在那里仍基本未得到解决。然而，在欧洲，已经实施了不同的药品价格监管方法。例如，根据2011年德国药品市场结构调整法案（Arzneimittelmarktneuordnungsgesetz，简称AMNOG），制造商在新授权药品上市的第一年可以自由设定价格。在这一年进行效益评估，然后用于制造商与该国法定健康保险公司代表之间的价格谈判。利用2002年至2017年在德国推出的57种抗癌药物的数据，我们发现AMNOG的实施使药品价格与临床效益的匹配度更高。引入价格谈判导致谈判价格相对于上市价格下降了24.5%。我们没有发现制造商通过设定更高的上市价格来做出回应的证据。AMNOG是一个例子，说明政府价格谈判如何能够设计得使价格与临床效益更好地匹配，同时又不延迟患者获得药物。
