Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, MA; Harvard Medical School, Boston, MA.
Program on Regulation, Therapeutics, and Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, MA; Harvard Medical School, Boston, MA; Harvard Medical School Center for Bioethics, Boston, MA.
Value Health. 2021 Apr;24(4):473-476. doi: 10.1016/j.jval.2020.11.009. Epub 2020 Dec 31.
Many countries use international (or external) reference pricing-benchmarking prices against those in other countries-to manage spending on prescription drugs. By contrast, the United States (US) allows manufacturers to set drug prices freely. In December 2019, a major bill passed the House of Representatives that would introduce international reference pricing to reduce US drug spending. In September 2020, President Trump issued an executive order to apply international reference pricing for drugs purchased under Medicare. As US policymakers consider adopting reference pricing, it is important to recognize four key administrative issues that have complicated other countries' experiences.
We analyzed the US policy proposals and literature on international experience with international reference pricing to identify implementation challenges and potential effects of US adoption of international reference pricing.
Four key administrative issues were identified: lack of price transparency, delays in market approvals, the frequency of price revisions, and the prevalence of cross-referencing.
Failure to account for the key issues in the emerging US approach will lead to overspending from overestimation of prices. Policymakers also need to recognize the collateral effects that the US adoption of international reference pricing may have on other countries' prices. Given the size of the pharmaceutical market in the US and other market issues, US reference pricing will likely increase drug list and net prices in other countries. Because of limitations in implementation and collateral effects, US policymakers should consider international reference pricing as a supportive tool alongside other cost containment policies, such as value-based pricing or volume agreements. International reference pricing could limit drug spending in the US but faces implementation challenges and will negatively affect other countries.
许多国家使用国际(或外部)参考定价——将其他国家的价格作为基准——来管理处方药的支出。相比之下,美国允许制造商自由设定药品价格。2019 年 12 月,众议院通过了一项主要法案,该法案将引入国际参考定价以降低美国的药品支出。2020 年 9 月,特朗普总统发布行政命令,对医疗保险购买的药品采用国际参考定价。随着美国政策制定者考虑采用参考定价,重要的是要认识到使其他国家经验复杂化的四个关键行政问题。
我们分析了美国的政策提案和关于国际参考定价经验的文献,以确定实施挑战和美国采用国际参考定价的潜在影响。
确定了四个关键的行政问题:缺乏价格透明度、市场批准延迟、价格修订的频率以及交叉参考的普遍性。
如果不考虑美国新方法中出现的关键问题,将导致因高估价格而过度支出。政策制定者还需要认识到美国采用国际参考定价可能对其他国家价格产生的附带影响。鉴于美国制药市场的规模和其他市场问题,美国的参考定价可能会提高其他国家的药品清单和净价格。由于实施的限制和附带影响,美国政策制定者应该将国际参考定价视为与基于价值的定价或数量协议等其他成本控制政策一起的支持性工具。国际参考定价可以限制美国的药品支出,但面临实施挑战,并将对其他国家产生负面影响。