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.

Keywords:

• Cellular and/or tissue-based product
• cost-utility
• Markov microsimulation
• diabetic foot ulcers
• probabilistic sensitivity analysis

JEL classification codes:

• I19
• I15

Transparency

Declaration of funding

This study was funded by MTF Biologics.

Declaration of financial/other relationships

The author is a paid consultant to MTF Biologics. JME peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

The sole author of this study conceived it, developed the models and carried out the modeling, as well as drafting and polishing the manuscript.

Acknowledgements

The author would like to thank the trial investigators for their assistance.

Previous presentations

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