基于风险-效益的美国FDA药品价值评估框架分析与启示

Introduction and analysis of FDA’s benefit-risk drug value assessment framework

药品价值评估框架的构建作为药物政策研究的一个新兴领域已得到广泛的关注。美国食品药品管理局(FDA)从2009年开始组织专家构建了以药品风险-效益评估框架为基础的药品价值评估体系,并将其用于人用药品的管理决策中。从FDA风险-效益评估框的构成、每个价值维度的评估要点以及框架的特点等方面对其进行了深度的解析,并结合我国药品价值评估工作开展的现状,从我国建立药品价值评估框架迫切性与必要性、以药品发现阶段为切入点构建全生命周期动态评估框架和将定性与定量方法相结合的框架体系构建等3个方面提出建议。

Construction of drug value assessment framework has gained extensive attention in the field of drug policy research.U.S FDA has been set out to establish the drug value assessment framework based on the benefit-risk evaluation since 2009.This paper systematically introduced the composition,basic elements and key assessment considerations of FDA benefit-risk evaluation framework,and also analyzed the characteristics of FDA framework.Moreover,we put forward three suggestions about the establishment of China drug value evaluation system,including(1)the necessity and urgency for establishment of drug value assessment system in China;(2)establishing a dynamic framework covering life-time evaluation beginning with drug discovery phase;(3)Combing qualitative and quantitative methods together to construct the drug value assessment framework.