Vogler Sabine, Paris Valérie, Ferrario Alessandra, Wirtz Veronika J, de Joncheere Kees, Schneider Peter, Pedersen Hanne Bak, Dedet Guillaume, Babar Zaheer-Ud-Din
WHO Collaborating Centre for Pharmaceutical Pricing and Reimbursement Policies, Pharmacoeconomics Department, Gesundheit Österreich GmbH (Austrian Public Health Institute), 1010, Vienna, Austria.
Health Division, Organisation for Economic Co-operation and Development (OECD), 75116, Paris, France.
Appl Health Econ Health Policy. 2017 Jun;15(3):307-321. doi: 10.1007/s40258-016-0300-z.
This article discusses pharmaceutical pricing and reimbursement policies in European countries with regard to their ability to ensure affordable access to medicines. A frequently applied pricing policy is external price referencing. While it provides some benchmark for policy-makers and has been shown to be able to generate savings, it may also contribute to delay in product launch in countries where medicine prices are low. Value-based pricing has been proposed as a policy that promotes access while rewarding useful innovation; however, implementing it has proven quite challenging. For high-priced medicines, managed-entry agreements are increasingly used. These agreements allow policy-makers to manage uncertainty and obtain lower prices. They can also facilitate earlier market access in case of limited evidence about added therapeutic value of the medicine. However, these agreements raise transparency concerns due to the confidentiality clause. Tendering as used in the hospital and offpatent outpatient sectors has been proven to reduce medicine prices but it requires a robust framework and appropriate design with clear strategic goals in order to prevent shortages. These pricing and reimbursement policies are supplemented by the widespread use of Health Technology Assessment to inform decision-making, and by strategies to improve the uptake of generics, and also biosimilars. While European countries have been implementing a set of policy options, there is a lack of thorough impact assessments of several pricing and reimbursement policies on affordable access. Increased cooperation between authorities, experience sharing and improving transparency on price information, including the disclosure of confidential discounts, are opportunities to address current challenges.
本文讨论了欧洲国家在确保药品可负担性方面的药品定价和报销政策。一种常用的定价政策是外部价格参考。虽然它为政策制定者提供了一些基准，并且已被证明能够节省成本，但在药品价格较低的国家，它也可能导致产品上市延迟。基于价值的定价被提议作为一种既能促进药品可及性又能奖励有益创新的政策；然而，事实证明实施起来颇具挑战性。对于高价药品，管理式进入协议的使用越来越多。这些协议使政策制定者能够应对不确定性并获得更低的价格。在药品附加治疗价值的证据有限的情况下，它们还能促进更早进入市场。然而，由于保密条款，这些协议引发了透明度方面的担忧。事实证明，医院和非专利门诊部门采用的招标能够降低药品价格，但这需要一个强有力的框架和明确战略目标的适当设计，以防止药品短缺。这些定价和报销政策通过广泛使用卫生技术评估为决策提供信息、以及提高仿制药和生物类似药的使用比例等策略得到补充。虽然欧洲国家一直在实施一系列政策选项，但对于若干定价和报销政策对可负担药品可及性的影响缺乏全面评估。当局之间加强合作、经验分享以及提高价格信息的透明度，包括披露机密折扣，都是应对当前挑战的契机。
