Owusu Achiaw Samuel, Hawkins Neil, Wu Olivia, Mercer John
Health Economics and Health Technology Assessment (HEHTA), School of Health and Wellbeing, University of Glasgow, Glasgow G12 8TB, UK;
BHF Cardiovascular Research Centre, University of Glasgow, Glasgow G12 8TA, UK;
J Mark Access Health Policy. 2025 Jan 15;13(1):1. doi: 10.3390/jmahp13010001. eCollection 2025 Mar.
This study illustrates the utility of a mixed-methods approach in assessing the value of an example novel technology-biosensor-integrated self-reporting arteriovenous grafts (smart AVGs). Currently in preclinical development, the device will detect arteriovenous graft stenosis (surveillance-only use case) and treat stenosis (interventional use case). The approach to value assessment adopted in this study was multifaceted, with one stage informing the next and comprised a stakeholder engagement with clinical experts to explore the device's clinical value, a cost-utility analysis (CUA) from a US Medicare perspective to estimate pricing headroom, and an investment model estimating risk-adjusted net present value analysis (rNPVs) to determine commercial viability. The stakeholder engagement suggested that it would currently be difficult to establish the current value of the surveillance-only use case due to the lack of well-established interventions for preclinical stenosis. Based on this, the CUA focused on the interventional use case and estimated economically justifiable prices at assumed effectiveness levels. Using these prices, rNPVs were estimated over a range of scenarios. This value assessment informs early decision-making on health technology R&D by identifying the conditions (including clinical study success, potential market size and penetration, market access strategies, and assumptions associated with CUA) under which investment may be considered attractive.
本研究阐述了采用混合方法评估一种新型技术——生物传感器集成式自我报告动静脉移植物（智能AVG）价值的效用。目前该设备正处于临床前开发阶段，它将用于检测动静脉移植物狭窄（仅用于监测的用例）以及治疗狭窄（介入用例）。本研究采用的价值评估方法是多方面的，各阶段相互关联，包括与临床专家进行利益相关者参与以探索该设备的临床价值、从美国医疗保险的角度进行成本效用分析（CUA）以估计定价空间，以及采用投资模型估计风险调整后的净现值分析（rNPV）以确定商业可行性。利益相关者参与表明，由于缺乏针对临床前狭窄的成熟干预措施，目前很难确定仅用于监测用例的当前价值。基于此，CUA聚焦于介入用例，并在假定的有效性水平下估计经济上合理的价格。利用这些价格，在一系列情景下估计了rNPV。这种价值评估通过确定投资可能被认为具有吸引力的条件（包括临床研究成功、潜在市场规模和渗透率、市场准入策略以及与CUA相关的假设），为卫生技术研发的早期决策提供信息。
