Cost-effectiveness of Apligraf in the treatment of venous leg ulcers.

Venous ulcers are the most common chronic wounds of the lower leg. Skin substitutes recently have been introduced to stimulate nonhealing wounds. To conduct an incremental cost-effectiveness analysis, a model was developed to compare the four-layer bandage system, with and without one application of skin substitute, for the outpatient treatment of venous leg ulcers. The model estimated the costs and consequences of treatment with and without the skin substitute application. Two analytic horizons were explored: 3 months and 6 months. Determined by seven physicians, data and assumptions for the 3-month model were based on information from a clinical trial, published studies, and clinical experience. Data for the 6-month model were extrapolated from the shorter model. The model results indicate that over 3 months, the use of the skin substitute provided a benefit of 22 ulcer days averted per patient at an incremental cost of $304 (societal). The incremental cost-effectiveness ratio was $14 per ulcer day averted. Over 6 months, the incremental cost-effectiveness ratio was less than $5 per ulcer-day averted. The skin substitute plus a four-layer bandage was more costly and more effective than the four-layer bandage alone. The skin substitute is increasingly cost-effective over a longer analytic horizon and in a subgroup of patients with ulcers of long duration (greater than 1-year duration at baseline). The results come from a model that is based on a series of estimates and assumptions, and accordingly, confirmation of this finding in a prospective study is encouraged.