Abstract

Determine the cost-effectiveness of becaplermin gel for the treatment of diabetic foot ulcers (DFU) relative to good wound care (GWC) alone. Wound surface area (WSA) reduction rates were used to predict the expected costs and outcomes of wound healing for becaplermin versus GWC cohorts over a 1-year time horizon. Changes in WSA were taken from the Phase 3 pivotal trials. The outcomes of the analysis include the average percent reduction of baseline WSA, the direct costs of DFU therapy and the cost per centimeter squared of WSA reduction. The costs for becaplermin gel and DFU patient evaluation and management were derived from standard cost references. Becaplermin utilization was calculated using the manufacturer’s recommended dosing algorithm. The economic perspective was that of the payer. Costs are reported in 2013 US dollars. The average WSA at baseline was 2.2 centimeters squared. At 20 weeks in the clinical study the becaplermin group demonstrated a statistically higher probability of complete wound closure compared to the GWC group (p=0.015) at 50% versus 35%, respectively. Given the reported WSA reduction rates, becaplermin treated DFU were expected to close 100% at 27 weeks while the GWC group reached an expected 88% reduction in WSA at 52 weeks. When costs were compared by wound closure rates, the cost per 1 centimeter reduction in WSA was $1,285 in the becaplermin group compared to $3,446 in the GWC group. The total expected direct cost of DFU care across the 1-year time horizon was estimated at $6,702 in the GWC group compared to $2,827 in the becaplermin group. DFU patients treated with becaplermin experienced better clinical outcomes than those treated with GWC alone. As a result of the improved outcomes becaplermin demonstrated economic dominance over GWC providing better outcomes at a lower direct cost.

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