基于卫生技术评估的药品附加价值评价指南

Health Technology Assessment Based Guideline for Drug Added-value Evaluation

目的 为构建客观、科学的药品评价指标体系和遴选方法,规范药品评价与遴选工作,并拓展卫生技术评估(HTA)在医疗机构的应用范围,制订《基于卫生技术评估的药品附加价值评价指南》。方法 指南通过充分的证据检索、评价,形成初步的评价指标和细则,再运用德尔菲(Delphi)法和层次分析法进一步确定评价指标维度和权重值。结果 最终构建了以4个一级指标,11个二级指标为核心的药品评价体系和相关标准操作规程。结论 该指南适用于在特定适应证下两种药品相互比较的情形,如医疗机构新药遴选、药品临床综合评价、合理用药等,有助于提高决策过程的科学性、合理性、公平性、透明性,为药品附加价值的评价提供参考。

Objective The Health Technology Assessment(HTA)Based Guideline for Drug Added-value Evaluation was formulated in order to set up an objective and scientific drug evaluation indicator system and selection method,standardize drug evaluation and selection operation procedures,and expand the application scenarios of HTA in medical institutions.Methods During the construction of the guideline,preliminary evaluation indicators and detailed rules were formed through sufficient evidence retrieval and evaluation.Then,the dimensions and weight values of evaluation indicators were further determined using Delphi method and Analytical Hierarchy Processes.Results Eventually,a drug evaluation system and a relevant standard operating procedure with four primary indicators and eleven secondary indicators were constructed as the core.Conclusion This guideline is suitable for scenarios where two drugs are compared with each other for specific indications,such as the selection of new drugs in medical institutions,comprehensive clinical evaluation of drugs,rational use of medicine,etc.As such,it helps to improve the scientism,fairness and transparency of the decision-making process while also providing reference for the evaluation of the drugs'added value.