Abstract
The aim of this study was to estimate the cost‐effectiveness of using dehydrated human amnion/chorion membrane (dHACM) allografts (Epifix) as an adjunct to standard care, compared with standard care alone, to manage non‐healing diabetic foot ulcers (DFUs) in secondary care in the United Kingdom, from the perspective of the National Health Service (NHS). A Markov model was constructed to simulate the management of diabetic lower extremity ulcers over a period of 1 year. The model was used to estimate the cost‐effectiveness of using adjunctive dHACM, compared with standard care alone, to treat non‐healing DFUs in the United Kingdom, in terms of the incremental cost per quality‐adjusted life year (QALY) gained at 2019/2020 prices. The study estimated that at 12 months after the start of treatment, use of adjunctive dHACM instead of standard care alone is expected to lead to a 90% increase in the probability of healing, a 34% reduction in the probability of wound infecti on, a 57% reduction in the probability of wound recurrence, a 6% increase in the probability of avoiding an amputation, and 8% improvement in the number of QALYs. Additionally, if £4062 is spent on dHACM allografts per ulcer, then adjunctive use of dHACM instead of standard care alone is expected to lead to an incremental cost per QALY gain of £20 000. However, if the amount spent on dHACM allografts was ≤£3250 per ulcer, the 12‐month cost of managing an ulcer treated with adjunctive dHACM would break‐even with that of DFUs treated with standard care, and it would have a 0.95 probability of being cost‐effective at the £20 000 per QALY threshold. In conclusion, within the study's limitations, and within a certain price range, adjunctive dHACM allografts afford the NHS a cost‐effective intervention for the treatment of non‐healing DFUs within secondary care among adult patients with type 1 or 2 diabetes mellitus in the United Kingdom.
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