METHODS: Technology appraisal (TA) documents from HTA agencies in England, France, Germany, and the US between 2019 and 2021 were reviewed to identify documents which discussed MID of EQ-5D data as a clinical outcome assessment (COA) endpoint.
RESULTS: Of 151 TAs utilising EQ-5D as a COA endpoint, 58 (38%) discussed MID of EQ-5D data. Discussion of MID was most frequent in Germany, in 75% (n = 12/16) of Gemeinsamer Bundesausschuss (G-BA) and 44% (n = 34/78) of Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, (IQWiG) TAs. MID was predominantly applied to the EQ-VAS (n = 50), most frequently using a threshold of > 7 or > 10 points (n = 13). G-BA and IQWiG frequently criticised MID analyses, particularly the sources of MID thresholds for the EQ-VAS, as they were perceived as being unsuitable for assessing the validity of MID.
CONCLUSIONS: MID of the EQ-5D was not frequently discussed outside of Germany, and this did not appear to negatively impact decision-making of these HTA agencies. While MID thresholds were often applied to EQ-VAS data in German TAs, analyses were frequently rejected in benefit assessments due to concerns with their validity. Companies should pre-specify analyses of continuous data in statistical analysis plans to be considered for treatment benefit assessment in Germany.
方法:来自英国HTA机构的技术评估(TA)文件,法国,德国,对2019年至2021年的美国进行了审查,以确定讨论EQ-5D数据MID作为临床结果评估(COA)终点的文件。
结果:在151个使用EQ-5D作为COA终点的TA中,58(38%)讨论了EQ-5D数据的MID。MID的讨论在德国最为频繁,在Gesundheitswesen的GemeinsamerBundesausschuss(G-BA)的75%(n=12/16)和质量研究所的44%(n=34/78),(IQWiG)TA。MID主要应用于EQ-VAS(n=50),最常使用>7或>10点的阈值(n=13)。G-BA和IQWiG经常批评MID分析,特别是EQ-VAS的MID阈值的来源,因为他们被认为不适合评估MID的有效性。
结论:EQ-5D的MID在德国以外并不经常被讨论,这似乎并没有对这些HTA机构的决策产生负面影响。虽然MID阈值通常应用于德国TA的EQ-VAS数据,由于担心分析的有效性,在获益评估中经常被拒绝.公司应预先指定统计分析计划中的连续数据分析,以考虑在德国进行治疗效益评估。