A comparative analysis of skin substitutes used in the management of diabetic foot ulcers

Objective: To compare the relative product cost and clinical outcomes of four skin substitutes used as adjunctive treatments for diabetic foot ulcers (DFUs). Method: Medicare claims data from 2011 to 2014 were used to identify beneficiaries with diabetes and foot ulcers. Patients treated with one of four types of skin substitute (Apligraf, Dermagraft, OASIS, and MatriStem) were identified. The skin substitutes were compared on episode length; amputation rate; skin substitute utilisation; and skin substitute costs. Results: There were 13,193 skin substitute treatment episodes: Apligraf (HML) was used in 4926 (37.3%), Dermagraft (HSL) in 5530 (41.9%), OASIS (SIS) in 2458 (18.6%) and MatriStem (UBM) in 279 (2.1%). The percentage of DFUs that healed at 90 days were: UBM 62%; SIS 63%; HML 58%; and HSL 58%. Over the entire time, UBM was non-inferior to SIS (p<0.001), and either was significantly better than HML or HSL (p<0.005 in all four tests). HML was marginally superior to HSL (p=0.025 unadjusted for multiple testing). Medicare reimbursements for skin substitutes per DFU episode for UBM ($1435 in skin substitutes per episode) and SIS ($1901) appeared to be equivalent to each other, although non-inferiority tests were not significant. Both were less than HML ($5364) or HSL ($14,424) (p<0.0005 in all four tests). HML was less costly than HSL (p<0.0005). Conclusion: Various types of skin substitutes appear to be able to confer important benefits to both patients with DFUs and payers. Analysis of the four skin-substitute types resulted in a demonstration that UBM and SIS were associated with both shorter DFU episode lengths and lower payer reimbursements than HML and HSL, while HML was less costly than HSL but equivalent in healing. Declaration of interest: MM and NM are health economic consultants who completed and authored this analysis. They have no financial interest in ACell, Inc. Their fees were not contingent on the outcome of this analysis.