Alshreef Abualbishr, Jenks Michelle, Green William, Dixon Simon
Health Economics and Decision Science, School of Health and Related Research, University of Sheffield, Regent Court, 30 Regent Street, Sheffield, S1 4DA, UK.
York Health Economics Consortium, University of York, Enterprise House, Innovation Way, York, YO10 5NQ, UK.
Appl Health Econ Health Policy. 2016 Dec;14(6):623-634. doi: 10.1007/s40258-016-0262-1.
The economic evaluation of medical devices is increasingly used to inform decision making on adopting new or novel technologies; however, challenges are inevitable due to the unique characteristics of devices. Cost-consequence analyses are recommended and employed by the English National Institute for Health and Care Excellence (NICE) Medical Technologies Evaluation Programme (MTEP) to help address these challenges. The aim of this work was to review the critiques raised for previous MTEP submissions and explore if there were common problems across submissions. We reviewed a sample of 12 economic submissions to MTEP representing 50 % of 24 sets of guidance issued to July 2015. For each submission, we reviewed the External Assessment Centre's (EAC) report and the guidance document produced by NICE. We identified the main problems raised by the EAC's assessments and the committee's considerations for each submission, and explored strategies for improvement. We found that the identification and measurement of costs and consequences are the main shortcomings within economic submissions to MTEP. Together, these shortcomings accounted for 42 % of criticisms by the EACs among the reviewed submissions. In certain circumstances problems with these shortcomings may be unavoidable, for example, if there is a limited evidence base for the device being appraised. Nevertheless, strategies can often be adopted to improve submissions, including the use of more appropriate time horizons, whilst cost and resource use information should be taken, where possible, from nationally representative sources.
医疗器械的经济评估越来越多地用于为采用新技术或创新技术的决策提供依据；然而，由于器械的独特特性，挑战不可避免。英国国家卫生与临床优化研究所（NICE）医疗技术评估计划（MTEP）推荐并采用成本后果分析来帮助应对这些挑战。这项工作的目的是回顾对先前提交给MTEP的材料所提出的批评意见，并探讨各份材料中是否存在共同问题。我们回顾了提交给MTEP的12份经济评估材料样本，这些样本占截至2015年7月发布的24套指南的50%。对于每份材料，我们回顾了外部评估中心（EAC）的报告以及NICE编制的指南文件。我们确定了EAC评估提出的主要问题以及委员会对每份材料的考量，并探讨了改进策略。我们发现，成本和后果的识别与衡量是提交给MTEP的经济评估材料中的主要不足之处。在经审查的材料中，这些不足共同占了EAC批评意见的42%。在某些情况下，这些不足所导致的问题可能不可避免，例如，如果被评估器械的证据基础有限。尽管如此，通常可以采用一些策略来改进材料，包括使用更合适的时间范围，同时成本和资源使用信息应尽可能取自具有全国代表性的来源。
