Health economics for treatment of diabetic foot ulcers: a cost-effectiveness analysis of eight skin substitutes

Abstract

Aim: Skin substitutes are frequently used to treat chronic diabetic foot ulcers (DFU), and many different options are available. While the clinical efficacy of many products has been evaluated, a comprehensive cost-effectiveness analysis comparing the most popular skin substitutes and using the most recent cost data has been lacking. Methods: This study compared eight skin substitutes using published efficacy rates combined with the Centers for Medicare and Medicaid Services (CMS) 2018 cost data. The study criteria resulted in the inclusion of seven studies that described efficacy rates for treatment of DFUs using the skin substitutes. Results: The results revealed wide discrepancies between these skin substitutes for the costs of treatments and healing rates in hospital outpatient departments and physician office settings. Healing rates for 12 and 16 weeks ranged from 28% to 68%, while the average cost for treating one DFU varied from $2001 to $14,507 and $1207 to $8791 in the hospital outpatient department and physician's office setting, respectively. The estimated patient share of costs for treating a single DFU ranged from $400 to $2901 and $241 to $1758 in the hospital outpatient department and physician's office setting, respectively. Most importantly, the estimated number of wounds healed out of 100 DFUs per $1000 expenditure with each patient ranged from 3.9–26.5 DFUs in the hospital outpatient department, and 4.3–36.4 DFUs in the physicians' office setting. Conclusions: This study revealed that the costs of a skin substitute itself did not necessarily correlate with its healing efficacy. These results provide a comprehensive cost-effectiveness analysis to enable integrated health-care systems, health professionals and reimbursement payers to make informed value decisions when treating DFUs.

SkinTE for the Treatment of a Complicated Wound after Synovial Sarcoma Resection: A Case Report

“…While other alternatives could compensate for these disadvantages, a less time-consuming approach—such as a free flap—would have implied greater risks in our case due to the patient’s previous exposure to radiation which affected adequate vascularization of the affected tissue. Regarding wound healing costs, Samsell et al 9 compared cost-effectiveness among several skin-substitute products in the management of diabetic foot ulcers. Products, such as DermACELL (D, LifeNet Health; Virgina Beach, Va.), EpiFix (EF, MiMedx; Marietta, Ga.), and Integra Dermal Regeneration Template (IDRT, Integra LifeSciences; Plainsboro, N.J.), among others, were studied.…”

“…For example, Integra DRT had a product cost per application of $901.01, but a cost per treated wound of $1802.02. 9 This article was used as reference and analyzed by PolarityTE Inc.—the SkinTE manufacturer company—to compare SkinTE costs with these skin-substitute alternatives. The interim analysis revealed that SkinTE cost was 61% lower than the mean cost of product per treated wound reported by Samsell et al, 9 with a mean total cost of around $1300; 10 however, costs may vary depending on the wound size and location.…”

“… 9 This article was used as reference and analyzed by PolarityTE Inc.—the SkinTE manufacturer company—to compare SkinTE costs with these skin-substitute alternatives. The interim analysis revealed that SkinTE cost was 61% lower than the mean cost of product per treated wound reported by Samsell et al, 9 with a mean total cost of around $1300; 10 however, costs may vary depending on the wound size and location. Further research is warranted to explore the potential for successful wound healing using AHSCs in other types of patients.…”

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

“…Authors of a recent health economics study examining the cost-effectiveness of 8 common CTPs in the treatment of DFUs using 2018 Medicare reimbursement costs and efficacy rates from the associated RCTs reported that the percentage of wounds healed per $1000 expenditure with each patient ranged from 3.9-26.5 DFUs in the hospital outpatient department, and 4.3-36.4 DFUs in the physicians' office setting 36 . In addition, the authors noted that costs of each CTP did not necessarily correlate with healing efficacy.…”

Comparison of Skin Substitutes for Acute and Chronic Wound Management

“…64 Some studies, however, suggest that Apligraf may not be the most cost-effective skin substitute available. [64][65][66][67] TheraSkin (LifeNet Health, Virginia Beach, VA [procurement and processing] and Solsys Medical, Newport News, VA [distribution]) is a cadaveric-derived epidermal and dermal replacement. Tissue is harvested within 24 hours postmortem from an organ donor who cleared standard safety screenings for organ procurement.…”