目的 基于中医药特点和团队前期发表的《中成药全生命周期价值评估核心指标专家共识》的工作基础,定量化开展中成药上市后价值评估。方法 使用德尔菲专家咨询法结合层次分析法,通过26位专家,2轮咨询,确定上市后中成药价值评估指标的权重。结果 2轮专家积极系数为88.46%、100%,权威程度为0.86、0.84,Kendall协调系数为0.231、0.234、各指标间变异系数为0.071~0.262;最终形成定量化的包括7个评估维度51个评估指的中成药上市后价值评估指标体系,权重分别为“安全性及风险管理32.42%”“有效性25.65%”“药品质量15.62%”“可及性9.21%”“适宜性7.71%”“创新性5.53%”和“成本3.85%”。结论 不仅进一步明确了上市后中成药价值评估的核心要素,也为精准评价不同中成药的价值内涵及优势提供有效支持。

Objective Based on the characteristics of traditional Chinese medicine(TCM) and the expert consensus on the core indicators of the evaluation of the whole life Cycle Value of proprietary Chinese medicine(PCM) published by the team, the postmarket value evaluation of proprietary Chinese medicine was quantitatively carried out.Methods The weight of the value evaluation index of PCM after listing was determined by using Delphi expert consultation method combined with analytic hierarchy process(AHP) through 26 experts and two rounds of consultation.Results Expert positive coefficient, authority degree and Kendall coordination coefficient were 88.46% and 100%, 0.86 and 0.84, 0.231 and 0.234, respectively, and the coefficient of variation among each index ranged from 0.071 to 0.262. Finally, a quantitative value evaluation index system including seven evaluation dimensions and 51 evaluation indexes was formed after the listing of proprietary Chinese medicines. Weights respectively as "32.42% security and risk management", "effectiveness 25.65%", "15.62% drug quality", "9.21% accessibility" and "7.71% suitability", " 5.53%innovative" and "3.85% cost".Conclusion This study not only further clarified the core elements of value evaluation of proprietary Chinese medicines after listing, but also provided effective support for accurate evaluation of the value connotation and advantages of different proprietary Chinese medicines.

R951

首都医科大学医疗保障研究院开放性课题(YB2022B10); 中央级公益性科研院所基本科研业务费专项资金(ZZ13-YQ-076)