Centre for Health Economics and Medicines Evaluation, Bangor University, Bangor, Gwynedd, Wales, United Kingdom.
School of Health and Society, University of Salford, Manchester, United Kingdom.
PLoS One. 2021 Jan 14;16(1):e0244851. doi: 10.1371/journal.pone.0244851. eCollection 2021.
Critical limb ischaemia is a severe stage of lower limb peripheral artery disease which can lead to tissue loss, gangrene, amputation and death. FlowOx™ therapy is a novel negative-pressure chamber system intended for home use to increase blood flow, reduce pain and improve wound healing for patients with peripheral artery disease and critical limb ischaemia.
A Markov model was constructed to assess the relative cost-effectiveness of FlowOx™ therapy compared to standard care in lower limb peripheral artery disease patients with intermittent claudication or critical limb ischaemia. The model used data from two European trials of FlowOx™ therapy and published evidence on disease progression. From an NHS analysis perspective, various FlowOx™ therapy scenarios were modelled by adjusting the dose of FlowOx™ therapy and the amount of other care received alongside FlowOx™ therapy, in comparison to standard care.
In the base case analysis, consisting of FlowOx™ therapy plus nominal care, the cost estimates were £12,704 for a single dose of FlowOx™ therapy per annum as compared with £15,523 for standard care. FlowOx™ therapy patients gained 0.27 additional quality adjusted life years compared to standard care patients. This equated to a dominant incremental cost-effectiveness ratio per QALY gained. At the NICE threshold WTP of £20,000 and £30,000 per QALY gained, FlowOx™ therapy in addition to standard care had a 0.80 and 1.00 probability of being cost-effectiveness respectively.
FlowOx™ therapy delivered as a single annual dose may be a cost-effective treatment for peripheral artery disease. FlowOx™ therapy improved health outcomes and reduced treatment costs in this modelled cohort. The effectiveness and cost-effectiveness of FlowOx™ therapy is susceptible to disease severity, adherence, dose and treatment cost. Research assessing the impact of FlowOx™ therapy on NHS resource use is needed in order to provide a definitive economic evaluation.
严重肢体缺血是下肢外周动脉疾病的严重阶段，可导致组织丧失、坏疽、截肢和死亡。FlowOx™ 疗法是一种新型的负压室系统，旨在供家庭使用，以增加血流、减轻疼痛并改善外周动脉疾病和严重肢体缺血患者的伤口愈合。
构建了一个马尔可夫模型，以评估 FlowOx™ 疗法相对于间歇性跛行或严重肢体缺血的下肢外周动脉疾病患者的标准护理的相对成本效益。该模型使用了来自 FlowOx™ 疗法的两项欧洲试验的数据和关于疾病进展的已发表证据。从英国国家医疗服务体系分析的角度来看，通过调整 FlowOx™ 疗法的剂量和与 FlowOx™ 疗法一起接受的其他护理量，对各种 FlowOx™ 疗法方案进行建模，与标准护理进行比较。
在基本案例分析中，FlowOx™ 疗法加名义护理的费用估计为每年接受一次 FlowOx™ 疗法治疗的费用为 12704 英镑，而标准护理的费用为 15523 英镑。FlowOx™ 疗法患者比标准护理患者获得 0.27 个额外的质量调整生命年。这相当于每获得一个质量调整生命年的增量成本效益比。在 NICE 愿意支付的 20000 英镑和 30000 英镑的阈值下，FlowOx™ 疗法加上标准护理分别有 0.80 和 1.00 的概率具有成本效益。
作为每年一次的剂量使用 FlowOx™ 疗法可能是外周动脉疾病的一种具有成本效益的治疗方法。FlowOx™ 疗法改善了该模型队列的健康结果并降低了治疗成本。FlowOx™ 疗法的有效性和成本效益易受疾病严重程度、依从性、剂量和治疗成本的影响。为了提供明确的经济评估，需要研究评估 FlowOx™ 疗法对英国国家医疗服务体系资源利用的影响。
