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Dehydrated human amnion and chorion allograft versus standard of care alone in treatment of Wagner 1 diabetic foot ulcers: a trial-based health economics study

Abstract Aims The aim of this health economics study was to estimate the cost-utility of an aseptically processed, dehydrated human amnion and chorion allograft (dHACA) plus standard of care (SOC) (group 1) versus SOC alone (group 2) based on a published randomized controlled trial in which patients who had an eligible Wagner 1 diabetic foot ulcer wound were randomized to either of these treatments. Materials and methods A Markov microsimulation was used to project trial results out to a 1-year horizon time with a third-party payer perspective. The starting health state was an unhealed non-infected ulcer with other health states of healed ulcer, infected non-healed ulcer, cellulitis, osteomyelitis, and absorbing states of dead or amputation. All patients started with unhealed non-infected ulcers at cycle 0. Costs were incurred by patients for procedures at hospital outpatient wound care provider-based departments (PBDs) and hospitals (if complications occurred) and were calculated using time-based activity costing methods. Effectiveness units were quality-adjusted life years (QALYs) computed from literature utility values. One-way and probabilistic sensitivity analysis (PSA) were also conducted. Results After 1 year, the calculated incremental cost-effectiveness ratio (ICER) for group 1 versus group 2 was –$4,373 with group 1 (dHACA) being dominant over group 2 (SOC). PSA demonstrated that group 1 had 69.2% lower cost values with increased positive incremental effectiveness for 94.9% of values. A willingness to pay (WTP) curve showed that about 92% of interventions were cost effective for group 1 when $50,000 was paid. Conclusions The results of this study demonstrated that dHACA added to SOC compared to SOC alone was extremely cost-effective in the defined trial population.