■相对有效性评估的证据要求在欧洲卫生技术评估(HTA)机构中有所不同,影响HTA决策的时间,并可能延迟患者进入的时间。改进的对齐可能会减少这个时间;因此,我们的目标是分析欧洲HTA机构在肿瘤药物评估证据要求方面的差异,并为提高一致性提供建议.
■与意大利药物评估中的利益相关者进行了访谈,荷兰,波兰,葡萄牙,英格兰和威尔士,和瑞典关于几个子领域的证据要求,以识别差异并获得解决差异的建议。对访谈结果进行了分析,分析了每个HTA机构的证据可接受性程度以及HTA机构之间证据要求的一致性。
■显示值得注意的差异的子域涉及外推到其他人群的可接受性,类效果,无进展生存期和(其他)替代终点作为结果,缺乏生活质量数据,单臂试验,交叉试验设计,试用期短,以及效应大小的临床相关性。
■可以增强对齐,以减少决策时间,并提高患者获取的公平性。实现这一目标的拟议建议包括联合早期对话,加强国家之间的合作和交流,联合相对有效性评估,以及访问协议的使用。
UNASSIGNED: Evidentiary requirements for relative effectiveness assessment vary among European health technology assessment (HTA) bodies, affecting the time to HTA decision-making and potentially delaying time to patient access. Improved alignment may reduce this time; therefore, we aim to analyze the differences in evidentiary requirements for oncology drug assessments among European HTA bodies and provide recommendations toward an increased alignment.
UNASSIGNED: Interviews were conducted with stakeholders in drug assessments of Italy, the Netherlands, Poland, Portugal, England and Wales, and Sweden about evidentiary requirements for several subdomains to identify differences and obtain recommendations for addressing differences. The interview results were analyzed on degrees of evidence acceptability per HTA body and alignment on evidentiary requirements among HTA bodies.
UNASSIGNED: Subdomains demonstrating noteworthy differences concerned the acceptability of extrapolation to other populations, class effects, progression-free survival and (other) surrogate endpoints as outcomes, the absence of quality-of-life data, single-arm trials, cross-over trial designs, short trial duration, and the clinical relevance of effect size.
UNASSIGNED: Alignment can be enhanced to reduce time to decision-making and to improve equity in patient access. Proposed recommendations to achieve this included joint early dialogues, intensified collaboration and exchange between countries, joint relative effectiveness assessments, and the use of access agreements.