Meads Catherine, Lovato Eleonora, Longworth Louise
Health Economics Research Group, Brunel University, Uxbridge, UB8 3PH, UK.
IMS Health, 210 Pentonville Road, London, N1 9JY, UK.
Appl Health Econ Health Policy. 2015 Dec;13(6):583-94. doi: 10.1007/s40258-015-0195-0.
As part of its Medical Technology Evaluation Programme, the National Institute for Health and Care Excellence (NICE) invited a manufacturer to provide clinical and economic evidence for the evaluation of the Debrisoft(®) monofilament debridement pad for use in acute or chronic wounds. The University of Birmingham and Brunel University, acting as a consortium, was commissioned to act as an External Assessment Centre (EAC) for NICE, independently appraising the submission. This article is an overview of the original evidence submitted, the EAC's findings and the final NICE guidance issued. The sponsor submitted a simple cost analysis to estimate the costs of using Debrisoft(®) to debride wounds compared with saline and gauze, hydrogel and larvae. Separate analyses were conducted for applications in home and applications in a clinic setting. The analysis took an UK National Health Service (NHS) perspective. It incorporated the costs of the technologies and supplementary technologies (such as dressings) and the costs of their application by a district nurse. The sponsor concluded that Debrisoft(®) was cost saving relative to the comparators. The EAC made amendments to the sponsor analysis to correct for errors and to reflect alternative assumptions. Debrisoft(®) remained cost saving in most analyses and savings ranged from £77 to £222 per patient compared with hydrogel, from £97 to £347 compared with saline and gauze, and from £180 to £484 compared with larvae depending on the assumptions included in the analysis and whether debridement took place in a home or clinic setting. All analyses were severely limited by the available data on effectiveness, in particular a lack of comparative studies and that the effectiveness data for the comparators came from studies reporting different clinical endpoints compared with Debrisoft(®). The Medical Technologies Advisory Committee made a positive recommendation for adoption of Debrisoft(®) and this has been published as a NICE medical technology guidance (MTG17).
作为其医疗技术评估计划的一部分，英国国家卫生与临床优化研究所（NICE）邀请一家制造商提供临床和经济证据，以评估用于急性或慢性伤口的Debrisoft（®）单丝清创垫。伯明翰大学和布鲁内尔大学作为一个联合体，受委托作为NICE的外部评估中心（EAC），独立评估提交的材料。本文概述了提交的原始证据、EAC的调查结果以及NICE发布的最终指南。赞助商提交了一份简单的成本分析，以估计与盐水、纱布、水凝胶和蛆虫相比，使用Debrisoft（®）清创伤口的成本。分别对家庭应用和诊所应用进行了分析。该分析采用了英国国家医疗服务体系（NHS）的视角。它纳入了技术和辅助技术（如敷料）的成本以及地区护士应用这些技术的成本。赞助商得出结论，与对照产品相比，Debrisoft（®）具有成本节约优势。EAC对赞助商的分析进行了修正，以纠正错误并反映替代假设。在大多数分析中，Debrisoft（®）仍然具有成本节约优势，与水凝胶相比，每位患者节省77至222英镑，与盐水和纱布相比节省97至347英镑，与蛆虫相比节省180至484英镑，这取决于分析中包含的假设以及清创是在家庭还是诊所环境中进行。所有分析都受到有效性现有数据的严重限制，特别是缺乏比较研究，而且对照产品的有效性数据来自报告与Debrisoft（®）不同临床终点的研究。医疗技术咨询委员会积极建议采用Debrisoft（®），这已作为NICE医疗技术指南（MTG17）发布。
