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

这份为期11个月的医疗技术中心多学科评估(Match)和NHS的合作提案旨在确定如何最有效地使用医疗经济方法来评估采购和创新评估决策的价值。这项研究是基于对一组样本的卫生经济学研究，这些样本被选择来涵盖采购和供应局(PASA)遇到的三种重要的与设备相关的购买：增量技术、颠覆性技术和医疗服务套餐，另外三种样本是国家创新中心(NIC)希望评估的医疗设备创新。我们将采用的方法包括基于生活质量调整后寿命年的成本效用评估的短期版本，国家卫生与临床卓越研究所等卫生技术评估机构使用这种评估方法。我们将调查的替代方案包括成本效益“支付意愿”方法。最重要的是，这两种医疗经济评估方法都旨在确定创新的价值时，平衡患者的利益或偏好与成本。本研究的背景是，在严重的预算约束环境下，以及雄心勃勃的国家和地区医疗保健优先事项的同时，国家医疗服务机构在做出关于购买创新医疗设备的适当决策时所面临的问题。虽然很明显，“物有所值”应该始终包括与所做选择相关的临床有效性的证据，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受害者。或者，被确定为医疗保健改进剂的创新可能无法被判断为负担得起，有浪费投入医疗研发的巨大资源的危险。为了确保国家相关性，研究结果将通过Match合作伙伴关系在NHS创新与改进研究所、NHS协作采购中心、循证采购中心和医疗器械行业中传播。在项目开始时与英国医疗保健工业协会(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。交付成果将包括示范研究报告，并通过PASA/NIC讲习班和欧洲卫生技术评估会议演示文稿在全国范围内传播。这项工作与其战略实施小组正在制定的医疗保健产业特别工作组(HITF)的目标密切相关。该提案还将回答有关创新方法的问题，这些问题正在由拉夫堡大学医疗工程小组领导的指导小组会议上提出，指导小组会议的成员包括PASA和NIC、ABHI、HaCIRIC和Match的代表。预计在这里提出的工作期间，这些关系将得到保留和加强。对于Match来说，这是一个独特的机会，可以与创新/采购之谜的双方合作，并提供一些支撑的、共同的价值观。这可能是英国第一次出现这样的机会。此外，不可能孤立地设想这种类型的项目--将整个方案作为一项独立研究进行的成本要高得多，但通过利用核心匹配资金和伙伴关系资金流，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.