Comparative evaluation of skin substitutes for diabetic foot ulcers and venous leg ulcers using the Medicare Administrative Claims Database

Abstract

Aims: In response to the rapidly increasing number of skin substitute products available as adjunctive treatments for diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs), the Centers for Medicare & Medicaid Services (CMS) issued Local Coverage Determinations (LCDs) across all Medicare Administrative Contractors (L39764, L39760, L35041, L39806, L39828, L39865, L39756, L36377) to create policies consistent with current evidence that covers skin substitute grafts for DFUs and VLUs in the Medicare population. As a result, 13 covered products remain indicated for treatment of DFUs and 5 products remain indicated for VLUs. All other commercially available products must provide sufficient evidence of clinical performance in line with these covered products to be considered for coverage. Evidence sources can include real world evidence (RWE) which has a significant role in the body of evidence used to appraise health procedures and technology.

Methods: Using the Medicare administrative database, the aim of this RWE study was to compare the claims-related clinical outcomes between covered products and two amnion-based noncovered products (Cygnus Matrix & Cygnus Dual (Vivex Biologics, USA)). Outcomes related to comparative product effectiveness included total units billed for the index procedure; inpatient admissions and length-of-stay; emergency department visits; and lower-extremity amputations. A surrogate measure of wound healing was the comparative frequency of patients who show ≥1 subsequent claim with fewer units than the index claim, providing an objective measure of clinical response. Median duration of therapy was also compared.

Results: For both Cygnus products combined, the average number of units billed was similar or significantly lower (P<0.05) than 18 of 22 matched comparators for DFUs. Similarly, there was only 1 instance out of 22 possible comparisons where a covered product showed statistical superiority over Cygnus products with respect to the frequency of patients who show ≥1 subsequent claim for the index procedure, which included a lower number of units than billed on the index claim. For this outcome, Cygnus products showed statistically superiority in 9 comparisons. Cygnus products also offered generally similar or significantly lower median durations of therapy for both DFUs and VLUs compared to covered products. Comparing the Cygnus products with all covered products combined provided further confirmation of the equivalent clinical performance to products on the covered list.

Conclusion: Aggregating claims-based clinical outcomes provides RWE of similar or superior performance by the Cygnus products in comparison to an array of skin substitute products on the LCD covered lists.