Economic model to examine the cost-effectiveness of FlowOx home therapy compared to standard care in patients with peripheral artery disease

Abstract

Background 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. Methods 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. Results 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. Conclusions 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.

International Systematic Review of Utility Values Associated with Cardiovascular Disease and Reflections on Selecting Evidence for a UK Decision-Analytic Model

“…Six used the EQ-5D-5L. 37 , 39 , 40 , 49 , 58 , 59 Seven were international studies with some non-UK participants (although all used the UK tariff). 34 , 36 , 38 , 39 , 46 , 54 , 57 …”

“…We assessed risk of bias to be low for 20 studies and potentially serious in 9: 5 because of selection bias (e.g., due to low response rate, 37 , 39 , 43 loss to follow-up, 46 or recruiting volunteers only 45 ), 3 because of partial proxy responses, 41 , 34 , 56 and 1 because EQ-5D was mapped from another outcome measure. 58 …”

“…37,39,40,49,58,59 Seven were international studies with some non-UK participants (although all used the UK tariff). 34,36,38,39,46,54,57 We assessed risk of bias to be low for 20 studies and potentially serious in 9: 5 because of selection bias (e.g., due to low response rate, 37,39,43 loss to follow-up, 46 or recruiting volunteers only 45 ), 3 because of partial proxy responses, 41,34,56 and 1 because EQ-5D was mapped from another outcome measure. 58 Figure 2 shows the HSUV for each study included in the analysis, compared with an age-and sex-matched baseline utility.…”

Patient and clinician experiences and opinions of the use of a novel home use medical device in the treatment of peripheral vascular disease ‐ a qualitative study

“…The value for those having perceived benefits of limb salvage and as clinicians described, the subsequent societal costs savings, along with patient reported outcomes in shared decision making, highlight the vital importance of patient voices in patient centred care [ 73 ]; though the positive benefits identified in this study require further research. Recent published cost-effective analysis, comparing FlowOx™ home treatment to standard hospital care, has demonstrated a cost advantage in favour of the home treatment depending on the severity of the disease [ 74 ].…”

Discrete Event Simulation Model for Cost-Effectiveness Evaluation of Screening for Asymptomatic Patients with Lower Extremity Arterial Disease

“…The following supporting information can be downloaded at: , Table S1: Description of used packages in R, Table S2: Parameters for modeling the time of occurrence of simulated events; Table S3: Parameters and assumptions used in the model; Figure S1: Model logic diagram–screening with ABI; Figure S2: Model logic diagram–Exercise therapy for Fontaine classification IIa and IIb; Figure S3: Model logic diagram–Interventional therapy decision; Figure S4: A: Cost-effectiveness scatter plane using different pseudo-random number; B: Cost-effectiveness acceptability curve for probabilistic analysis using different pseudo-random numbers. References [ 51 , 52 , 53 , 54 , 55 , 56 , 57 , 58 , 59 , 60 , 61 , 62 , 63 , 64 , 65 , 66 , 67 , 68 , 69 , 70 , 71 , 72 ] are cited in Supplementary Materials.…”