摘要
药品评价可用于药品全周期管理的不同场景,但在不同评价目的下,维度和评价方法选择有所差异,建立一个全面的、通用的药品评价体系,可减少决策成本、增加政策协同性。本研究通过综述中、英、法、美等国家和地区药品评价维度异同,将评价维度归结为安全性、有效性、经济性、创新性、适宜性和可及性,总结在不同情境下评价维度侧重点和同一维度内涵的差异。在药品上市准入、医保准入等具体政策应用场景下,基于决策目标、重点,选择所需的评价指标、设置适宜的权重,以提供最佳决策证据。
Drug evaluation can be used in different scenarios of full-cycle drug management,but under different evaluation purposes,the selection of dimensions and evaluation methods are different.Establishing a comprehensive and universal drug evaluation system can reduced the cost of decisionmaking and increase policy synergy.This paper reviewed the similarities and differences in drug evaluation dimension in China,Britain,France,the United States and other countries and regions.The dimensions covered security,effectiveness and economy,innovation,suitability and accessibility.Difference in evaluation dimensions in different situation and the connotation of the same dimension were summed up.In specific policy application scenarios,such as drug market access and medical insurance access,the required evaluation indicators are selected and appropriate weights are set based on the decision-making objectives and priorities to provide evidence for the best decision.
作者
李芬
谢印
朱碧帆
胡嘉浩
刘宇晗
倪元峰
魏馨
金春林
LI Fen;XIE Yin;ZHU Bi-fan;HU Jia-hao;LIU Yu-han;NI Yuan-feng;WEI Xin;JIN Chunlin(Shanghai Health Development Research Center(Shanghai Medical Technology Intelligence Institute),Shanghai 200031;Shanghai University of Traditional Chinese Medicine,Shanghai 201203;Shanghai Health Commission,Shanghai 200125)
出处
《中南药学》
CAS
2023年第4期973-978,共6页
Central South Pharmacy
基金
上海市重点药品遴选及临床综合评价指标库构建项目(No.22Y10001)
依洛尤单抗药品临床综合评价项目(No.2022010B)
PD-1/PD-L1抑制剂药品临床综合评价指标体系构建研究项目(No.2021043B)。
关键词
药品临床综合评价
指标体系
政策应用
clinical comprehensive evaluation of drug
indicator system
policy application