摘要
创新药品“高成本”和“高不确定性”特征为公共医保支付机制带来了显著挑战,目前国际上主要通过管理准入协议（Managed Entry Agreements,MEA）来应对创新药品疗效不确定性风险。英国较早开始探索管理准入协议,其核心机制是通过有条件支付和标准化的数据收集与证据生成,充分发挥真实世界证据作用,将药品价格与实际疗效挂钩,最终实现以价值为导向的支付匹配。本研究通过深度剖析英国管理准入协议的制度框架、核心要素与应用场景,为我国探索高值创新药品的创新支付路径提供参考,助力实现价值最大化的医保战略购买。
Abstract
The characteristics of “high cost” and “high uncertainty” of innovative drugs pose significant challenges to public health insurance payment mechanisms. Internationally, Managed Entry Agreements (MEA) are currently the main tool to address the uncertainty of the clinical effectiveness of innovative drugs. The United Kingdom started exploring MEA relatively early. The core mechanism involves conditional payment and standardized data collection and evidence generation, fully leveraging real-world evidence to link drug prices with actual clinical effectiveness, ultimately achieving value-oriented payment alignment. This study provides an in-depth analysis of the institutional framework, core elements, and application scenarios of the UK MEA, offering a reference for exploring innovative payment pathways for high-value innovative drugs in China and supporting the strategic purchasing of medical insurance aimed at maximizing value.
关键词
管理准入协议 /
创新支付 /
真实世界证据 /
国际经验
Key words
managed entry agreements /
innovative payment /
real-world evidence /
international experience
王知, 吕兰婷.
英国创新药风险分担协议的应用经验及启示[J]. 中国医疗保险. 2026, 0(4): 120-127 https://doi.org/10.19546/j.issn.1674-3830.2026.4.013
Application Experience of the UK Innovative Drug Risk-Sharing Agreement and Its Implications[J]. China Health Insurance. 2026, 0(4): 120-127 https://doi.org/10.19546/j.issn.1674-3830.2026.4.013
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