英国和加拿大卫生技术评估报告对中国药品临床综合评价的启示

Review of health technology assessment reports in the UK and Canada and its enlightenment to clinical comprehensive evaluation of drugs in China

目的借鉴英国和加拿大的卫生技术评估报告,为中国药品临床综合评价工作的开展提供建议。方法在国际卫生技术评估机构网络官方网站的国际卫生技术评估(health technology assessment,HTA)数据库中,检索2015年1月1日至2022年8月4日,英国和加拿大发表的完整且已完成的卫生技术评估评估报告。利用Excel提取HTA报告中的安全性、有效性、经济性等维度信息以及其他关键信息,并进行描述统计分析。结果最终纳入325项HTA报告,评价维度占比最高的为有效性、经济性和安全性,分别为250项(77%)、233项(72%)和195项(60%)。除此以外,153项(47%)报告对其他维度进行评估。而在103项药物相关的HTA报告中评价维度占比最高的为有效性、安全性和经济性,分别有89项(86%)、83项(81%)和73项(71%)。此外,有30项(29%)药物相关的HTA报告对其他维度进行评估。结论中国药品临床综合评价可以借鉴英国和加拿大HTA报告中的以下特点来进一步完善其工作机制:明确药品临床综合评价项目需要回答的问题;合理选择药品临床综合评价的维度;以文献综述为起点开展药品临床综合评价;经济性评价通常需要团队开展原始研究来完成;有明确的证据使用者和必要性才开展预算影响分析;多准则决策分析可能并非HTA报告本身必不可少的组成部分;单个药品临床综合评价项目可以仅回答有限问题。

The article drew on the health technology assessment reports of the UK and Canada to provide suggestions for the development of comprehensive clinical evaluation of drugs in China.The completed full health technology assessment reports published by the United Kingdom(UK)and Canada from January 1,2015 to August 4,2022 were retrieved from the international HTA database on the official website of International Network of Agencies for Health Technology Assessment(INATA).Microsoft excel was used to extract the dimension information such as safety,effectiveness,cost-effectiveness and other key information in the HTA report,and descriptive statistical analysis was performed.A total of 325 HTA reports were finally included.Effectiveness,cost-effectiveness,and safety accounted for the highest proportions of evaluation dimensions,which were 250(77%),233(72%),and 195(60%),respectively.In addition,153(47%)reports assessed other dimensions.Among the 103 drug-related HTA reports,effectiveness,safety and cost-effectiveness accounted for the highest proportions of evaluation dimensions,which were 89(86%),83(81%)and 73(71%),respectively.In addition,30(29%)drug-related HTA reports assessed other dimensions.In conclusion,the comprehensive clinical evaluation of drugs in China can learn from the following characteristics of HTA reports of the UK and Canada to further improve its working mechanism:clarify the questions that need to be addressed in the comprehensive clinical evaluation of drugs,rationally select the dimensions of comprehensive clinical evaluation of drugs,carrying out comprehensive clinical evaluation of drugs starting from literature review,cost-effectiveness evaluation usually requires the team to carry out the original research to complete,budget impact analysis is only carried out with clear evidence users and necessity,multi-criteria decision analysis may not be an essential part of the HTA report itself,a comprehensive clinical evaluation of a drug can only answer limited questions.