An economic assessment of Apligraf (R) (Graftskin) for the treatment of hard-to-heal venous leg ulcers

Several recent advances in wound care may offer promise for the treatment o f hard-to-heal venous leg ulcers. One such treatment is Apligraf(R) (Grafts kin), a bilayered, living human skin construct. To assess the economic impa ct of Graftskin, a model was constructed to compare the annual medical cost s and cost-effectiveness of treating hard-to-heal venous leg ulcers with Gr aftskin vs. compression therapy using Unna's boot. A semi-Markov model was used to describe the pattern of ulcer treatment, healing, and recurrence am ong patients with venous leg ulcers. Patients received 1 of 2 treatment reg imens, Graftskin or Unna's boot, and were followed in the model for a 12-mo nth period. The analysis was done from the perspective of a commercial heal th plan: therefore, only direct medical costs were included. Health care re source use included the primary therapeutic intervention, additional compre ssion dressings, physician office visits, home health visits, laboratory te sts and procedures, management of adverse events, and hospitalizations. The model estimated the annual medical cost of managing patients with hard-to- heal venous leg ulcers to be $20,041 for those treated with Graftskin and $ 27,493 for those treated with Unna's boot. In addition, treatment with Graf tskin led to approximately 3 more months in the healed state per person per year than did treatment with Unna's boot. Because patients treated with Gr aftskin experienced improved healing compared with those treated with compr ession therapy using Unna's boot, they required fewer months of treatment f or unhealed ulcers. As a result, the use of Graftskin for treating hard-to- heal venous leg ulcers resulted in lower overall treatment costs.