LSE Health, Department of Health Policy, London School of Economics and Political Science, Houghton Street, 20 Houghton St, London, WC2A 2AE, UK.
NICE Scientific Advice, National Institute for Health and Care Excellence, 10 Spring Gardens, London, SW1A 2BU, UK.
Appl Health Econ Health Policy. 2019 Apr;17(2):189-211. doi: 10.1007/s40258-018-0438-y.
The Medical Technologies Evaluation Programme (MTEP) of NICE in England aims to evaluate medical devices that are deemed to be cost-saving or cost-neutral and produce Medical Technology Guidance (MTG) to encourage their adoption.
To review the MTGs since MTEP's inception in 2009 until February 2017.
One researcher assessed all published MTGs and extracted data on the clinical and economic evidence supporting each technology. The NICE Committee's decision outcome for each assessment was also recorded. A qualitative analysis was performed on technologies that were not supported for adoption to identify the main drivers of the decision.
Thirty-one MTGs were reviewed. The committee fully supported the medical devices in 14 MTGs, 11 were partially supported and six were not supported. Of the MTGs, 58% had no RCT data available and the main source of evidence came from non-experimental studies. There was no statistically significant difference in the average number of RCTs and non-experimental studies between the fully-supported, partially-supported, and not-supported technologies. Whilst all the fully-supported MTGs demonstrated cost-saving results, only 50% of the not-supported MTGs did. The sponsor estimated a higher average cost-saving than the EAC in most of the cases (20/31). The qualitative evaluation suggests that the main drivers for negative decisions were the quantity or quality of studies, and costs incurred in the economic evaluation results.
The main drivers of the decision-making process are the quality and quantity of the submitted evidence supporting the technologies, as well as the economic evaluation results.
英国国家卫生与临床优化研究所（NICE）的医疗技术评估计划（MTEP）旨在评估那些被认为具有成本节约或成本中性效益，并能产生医疗技术指导（MTG）以鼓励采用的医疗设备。
回顾自 2009 年 MTEP 成立以来至 2017 年 2 月发布的所有 MTG。
一名研究人员评估了所有已发表的 MTG，并提取了支持每项技术的临床和经济证据的数据。还记录了 NICE 委员会对每项评估的决策结果。对未被支持采用的技术进行了定性分析，以确定决策的主要驱动因素。
共审查了 31 项 MTG。委员会完全支持 14 项 MTG 中的医疗器械，11 项部分支持，6 项不支持。在这些 MTG 中，58%没有 RCT 数据，主要证据来源是非实验研究。完全支持、部分支持和不支持的技术之间，平均 RCT 数量和非实验研究数量没有统计学上的显著差异。虽然所有完全支持的 MTG 都显示出成本节约的结果，但只有 50%的不支持的 MTG 如此。赞助商在大多数情况下（20/31）估计的平均成本节约高于 EAC。定性评估表明，负面决策的主要驱动因素是支持技术的研究数量和质量，以及经济评估结果中的成本。
决策过程的主要驱动因素是支持技术的提交证据的质量和数量，以及经济评估结果。
