欧盟统一卫生技术评估对我国药品价值评估的启示

赵明月; 韩雨倍; 赵昱涵; 王水潮; 方宇

doi:10.19546/j.issn.1674-3830.2025.8.014

中国医疗保险 ›› 2025, Vol. 0 ›› Issue (8) : 119-127. DOI: 10.19546/j.issn.1674-3830.2025.8.014

国际（地区）比较

欧盟统一卫生技术评估对我国药品价值评估的启示

赵明月^1,2, 韩雨倍^1,2, 赵昱涵^1,2, 王水潮^1,2, 方宇^1,2

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The Enlightenment of the EU's Unified HTA for the Value Assessment of Medicines in China

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文章历史 +

摘要

本文剖析欧盟统一卫生技术评估（HTA）制度并借鉴其先进经验,旨在为我国药品价值评估决策提供参考。首先,介绍欧盟HTA法规及内容,分析实施主体,指出关键机构为卫生技术评估协调小组（HTACG）及其亚组（SG）。其次,深入剖析欧盟《卫生技术评估条例》（HTAR）核心内容——联合临床评估（JCA）与联合科学咨询（JSC）。JCA使用人群、干预、对照和结局（PICO）作为核心方法学的多层次评估工具,并以PICO量化临床疗效、分层呈现安全性、三维评估效度作为主要评估内容;JSC则为开发者提供证据与指导,同步制定符合监管与HTA双重标准的证据方案,促进医疗技术创新。最终,提出完善我国HTA的启示,包括创新药临床价值评估的专业与精细化、构建多适应症导向的多PICO并行评估框架、推动数据基础建设与数据共享、构建沟通咨询平台与机制、探索多元主体参与机制。

Abstract

This study undertakes a comprehensive examination of the EU’s unified HTA system and draws on its advanced experience to provide reference for drug value assessment and decision-making in China. Initially, we delineate the EU HTA regulatory architecture and its provisions, identifying the HTACG and its constituent subgroups as the pivotal governance entities. Subsequently, we dissect the two core mechanisms of HTAR (EU)—Joint Clinical Assessment (JCA) and Joint Scientific Consultation (JSC). JCA operationalizes the PICO framework as a multi-tiered analytical instrument, systematically quantifying clinical efficacy, stratifying safety outcomes, and executing three-dimensional validity appraisals. Concurrently, JSC furnishes developers with evidence and guidance, aligning evidence plans with both regulatory approval and HTA criteria, thereby fostering therapeutic innovation. Finally, we advance recommendations for enhancing HTA in China: professionalizing and refining the assessment of innovative drugs’ clinical value, constructing a parallel, multi-indication-oriented PICO framework, strengthening data infrastructure and data sharing, establishing communication and consultation platforms and mechanisms, and exploring multi-stakeholder engagement mechanisms.

导出引用

赵明月, 韩雨倍, 赵昱涵, 王水潮, 方宇. 欧盟统一卫生技术评估对我国药品价值评估的启示[J]. 中国医疗保险. 2025, 0(8): 119-127 https://doi.org/10.19546/j.issn.1674-3830.2025.8.014

The Enlightenment of the EU's Unified HTA for the Value Assessment of Medicines in China[J]. China Health Insurance. 2025, 0(8): 119-127 https://doi.org/10.19546/j.issn.1674-3830.2025.8.014

中图分类号： F840.684 C913.7

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