Exemplar studies in assessing the value of innovative medical devices for adoption within the NHS

医疗保健技术中心（MATCH）和NHS之间的这份为期11个月的合作提案旨在确定如何最有效地使用卫生经济方法来评估采购和创新评估决策的价值。该研究基于对一组样本的健康经济学研究，这些样本被选择用于涵盖采购和供应局（PASA）遇到的三种重要的器械相关采购类别：增量技术，颠覆性技术和“一揽子护理”，另外三个样本是国家创新中心（NIC）希望评估的医疗器械创新。我们将采用的方法包括基于生活质量调整生命年的短期成本效用评估，这些评估由国家健康和临床卓越研究所等卫生技术评估机构使用。我们将调查的替代方案包括成本效益的“支付意愿”方法。最重要的是，这两种卫生经济学评估方法的目的是平衡患者的利益或偏好对成本时，确定的价值的创新。本研究的背景下，在严重的预算约束的环境下，国家卫生服务所面临的问题做出适当的决定购买创新的医疗设备，以及雄心勃勃的国家和地区的医疗重点。虽然很明显，“物有所值”应始终包括与所作选择有关的临床有效性证据，但如果没有将患者结果和/或临床意见完全纳入采购框架，采用创新很容易成为以最低成本购买的牺牲品。或者，被认定为医疗保健改进者的创新可能不会被认为是负担得起的，这有浪费投入医疗保健研发的巨大资源的危险。为确保国家相关性，研究结果将通过MATCH合作伙伴关系在NHS创新和改进研究所、NHS协作采购中心、循证采购中心和医疗器械行业传播。在项目开始时与英国医疗保健行业协会（ABHI）进行磋商，并邀请他们参加传播活动，将确保更多的行业参与。报告将包括一份范例研究报告，并通过PASA/NIC研讨会和欧洲卫生技术评估会议介绍进行全国传播。这项工作与其战略实施小组正在制定的医疗保健行业工作组（HITF）的目标高度一致。该提案还将回答有关创新方法的问题，这些创新方法是在拉夫堡大学医疗保健工程小组领导的正在进行的“促进NHS中的破坏性医疗保健”指导小组会议上提出的，其中包括PASA和NIC，ABHI，HaCIRIC和MATCH。预计在这里提议的工作中，这些关系将得到维护和加强。对于MATCH来说，这是一个独特的机会，可以与创新/采购难题的双方合作，并提供一些基本的、共同的价值观。这可能是英国第一次出现这样的机会。此外，孤立地设想这类项目是不可能的-将整个方案作为一项独立的研究来进行，其费用要高得多，但通过利用匹配方案的核心资金和伙伴关系供资流，其价值实际上翻了一番。

This 11 month collaborative proposal between the Multidisciplinary Assessment of Technology Centre for Healthcare (MATCH) and the NHS aims to determine how health economic approaches can be used most effectively to assess value for the purposes of procurement and innovation assessment decision-making. The research is based on health economic study of a set of exemplars that have been chosen to cover three important classes of device-related purchases that are encountered by the Purchasing and Supply Agency (PASA): incremental technologies, disruptive technologies and 'packages of care', A further three exemplars are medical device innovations that the National Innovation Centre (NIC) wishes to evaluate. Methods we will employ include short run versions of cost-utility evaluations based on Quality-of-life Adjusted Life Years that are used by health technology assessment bodies like the National Institute for Heath and Clinical Excellence. Alternatives we will investigate include cost-benefit 'Willingness to Pay' methods. Most importantly, both kinds of health economic evaluation method aim to balance patient benefit or preference against cost when determining the value of an innovation.The context for this research is the problem faced by the National Health Service in making appropriate decisions about the purchase of innovative healthcare devices in an environment of severe budgetary constraints and alongside ambitious national and regional healthcare priorities. Whilst is it clear that 'value for money' should always include evidence of clinical effectiveness relating to the choices made, without a full integration of patient outcomes and/or clinical opinion into the procurement framework, adoption of innovations can easily become a victim of purchase at lowest cost. Alternatively, innovations that have been identified as improvers of healthcare may not be judged to be affordable, with a danger of wasting the huge resources being put into healthcare R&D. To ensure national relevance, the results of the studies will be disseminated across the NHS Institute for Innovation and Improvement, the NHS Collaborative Procurement Hubs, the Centre for Evidence-based Procurement, and the medical devices industry through the MATCH partnership. Consultation with the Association of British Healthcare Industries (ABHI) at the beginning of the project and their invitation to dissemination events will ensure additional industry engagement. Deliverables will include a report of the exemplar studies and national dissemination by means of a PASA/NIC workshop and a European Health Technology Assessment conference presentation. The work is strongly aligned to the objectives of the Healthcare Industries Task Force (HITF) that is being enacted by its Strategic Implementation Group.The proposal will also answer questions about approaches to innovation that are being raised in ongoing 'Promoting Disruptive Healthcare in the NHS' Steering Group meetings led by the Healthcare Engineering Group at Loughborough University and including representatives from both PASA and NIC, the ABHI, HaCIRIC and MATCH. It is anticipated that these relationships will be preserved and enhanced during the work proposed here. For MATCH, there is a unique opportunity to work with both sides of the innovation/procurement puzzle and to provide some underpinning, common view of, value. This is probably the first time that such an opportunity has arisen in the UK. Moreover, it would be impossible to conceive of this type of project in isolation - it would cost considerably more to conduct the whole programme as a piece of stand-alone research, but the value is effectively doubled by drawing on core MATCH funds and the partnership funding stream.