Abstract
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.
Highlights
Peripheral artery disease (PAD) is estimated to affect around 13% of adults aged over 50 years old in Western populations [1]
FlowOxTM therapy patients gained 0.27 additional quality adjusted life years compared to standard care patients
Research assessing the impact of FlowOxTM therapy on NHS resource use is needed in order to provide a definitive economic evaluation
Summary
Peripheral artery disease (PAD) is estimated to affect around 13% of adults aged over 50 years old in Western populations [1]. Lower limb PAD is a manifestation of systemic atherosclerotic disease and is commonly caused by hardening of the arteries, where blood flow to affected limbs is restricted due to obstruction of atherosclerotic plaque. In its severe forms, such as critical limb ischaemia (CLI), PAD can lead to tissue loss (i.e. ulceration), gangrene and lower limb amputation (LLA). The classification of PAD varies from the mild asymptomatic stage where there is a partial artery obstruction to severe necrosis and/or gangrene of the limb, leading to amputation [2]. Critical limb ischaemia is a severe stage of lower limb peripheral artery disease which can lead to tissue loss, gangrene, amputation and death. FlowOxTM therapy is a novel negativepressure 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
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