目的:梳理国际上基于风险分担协议（risk-sharing agreement,RSA）的创新药支付风险管理案例,以期为我国相关政策制定提供参考。方法:针对不同风险分担协议类型开展案例研究。结果:创新药的快速上市和医保准入为患者带来健康收益的同时,也带来预算超支和健康收益不确定等风险。本文针对创新药支付风险管理内涵与准入路径,梳理了国际上基于财务的协议、基于疗效的协议及增值协议等3类RSA案例。RSA能够使药品供付双方分担预算风险和健康风险,有助于提高创新药准入和支付管理水平。结论:我国可探索RSA用于创新药支付准入的风险管理,依托试点医院开展创新药上市后再评价,构建基于卫生技术评估的创新药价值评价体系。
Abstract
Objective: This paper sorts out different risk-sharing agreements (RSAs) cases in the access and payment of innovative drugs, in order to provide a reference for the formulation of relevant policies in China.Methods: The paper applies case study based on different RSA types.Results: The rapid listing and medical insurance access of innovative drugs brings risks of budget overrun or less health effectiveness than the paid price. This article clarifies the concept of risk management for the access and payment of innovative drugs, and introduces three kinds of RSA cases, including finance-based agreements, performance-based agreements, and value-added agreements. RSA makes both drug suppliers and payers share budgetary risks and health risks, and helps to improve the access and payment management of innovative drugs.Conclusion: China can explore the use of RSA for risk management in innovative drug payment access, rely on pilot hospitals to conduct post-marketing re-evaluation of innovative drugs, and build an innovative drug re-evaluation system based on health technology assessment.
关键词
创新药 /
准入 /
支付 /
风险管理 /
风险分担协议
Key words
innovative drugs /
access /
payment /
risk management /
risk-sharing agreements
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