Potential cost-effectiveness of using adjunctive dehydrated human amnion/chorion membrane allograft in the management of non-healing diabetic foot ulcers in the United Kingdom.

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 infection, 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.