Assessing the Value of Further Investment in R&D Using Mixed Methods: A Case Study of Biosensor-Integrated Arteriovenous Grafts.

Q2 Medicine
Journal of market access & health policy Pub Date : 2025-01-15 eCollection Date: 2025-03-01 DOI:10.3390/jmahp13010001
Samuel Owusu Achiaw, Neil Hawkins, Olivia Wu, John Mercer
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Abstract

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.

利用混合方法评估进一步研发投资的价值:以生物传感器集成动静脉移植物为例。
本研究说明了混合方法在评估一种新型技术--集成生物传感器的自我报告动静脉移植物(智能动静脉移植物)--的价值方面的实用性。该设备目前处于临床前开发阶段,将用于检测动静脉移植物狭窄(仅用于监测)和治疗狭窄(用于介入)。本研究采用的价值评估方法是多方面的,一个阶段为下一阶段提供信息,包括与临床专家进行利益相关者接触以探讨该设备的临床价值、从美国医疗保险角度进行成本效用分析(CUA)以估算定价空间,以及投资模型估算风险调整后净现值分析(rNPV)以确定商业可行性。利益相关者的参与表明,由于缺乏完善的临床前狭窄干预措施,目前很难确定仅监测用例的当前价值。在此基础上,CUA 将重点放在干预用例上,并按照假定的有效性水平估算出经济上合理的价格。利用这些价格,对各种情况下的 rNPV 进行了估算。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(包括临床研究的成功、潜在市场规模和渗透率、市场准入战略以及与 CUA 相关的假设),为医疗技术研发的早期决策提供信息。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
4.90
自引率
0.00%
发文量
0
审稿时长
14 weeks
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