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

J Med Econ. 2020 Nov;23(11):1273-1283. doi: 10.1080/13696998.2020.1803888. Epub 2020 Aug 8.


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.

Keywords: Cellular and/or tissue-based product; I15; I19; Markov microsimulation; cost-utility; diabetic foot ulcers; probabilistic sensitivity analysis.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Amnion / transplantation*
  • Chorion / transplantation*
  • Cost-Benefit Analysis
  • Diabetic Foot / therapy*
  • Health Expenditures / statistics & numerical data*
  • Health Status
  • Humans
  • Markov Chains
  • Models, Econometric
  • Patient Acceptance of Health Care / statistics & numerical data
  • Quality-Adjusted Life Years
  • Severity of Illness Index
  • Wound Healing*