Background: Diabetic foot ulcers (DFUs) present a treatment challenge and result in a large economic burden, requiring careful evaluation of the clinical efficacy and cost effectiveness of new treatment modalities. DFU clinical trials of the bio-engineered skin substitute Apligraf® (Novartis Pharma AG, Basel, Switzerland) have demonstrated improved clinical efficacy compared with good wound care (GWC) alone. Objective: To determine the economic impact and cost effectiveness of Apligraf® plus GWC compared with GWC alone in the treatment of DFUs. Study perspective: Societal. Methods: A Markov-based simulation model was created to compare the costs and effects of Apligraf® plus GWC to those of GWC alone over a 12-month period. The primary health states were 'uninfected ulcer', 'infected ulcer', 'gangrene', and 'healed ulcer'. Transition probabilities were based on clinical trial results, while cost estimates were based on estimates of resource utilisation in the Netherlands. The cost-effectiveness outcome measures were the incremental cost per ulcer-free month gained and the incremental cost per amputation avoided. Results: Costs in the first year of treatment were €4656 for Apligraf® plus GWC and €5310 for GWC alone (1999 values). Treatment with Apligraf® led to lower costs since its greater effectiveness offset the added cost of the product. This benefit was realised after 5 months, the crossover point of the two cost curves. Apligraf® use increased the amount of ulcer-free time by by 1.53 months (7.78 vs 6.25) and reduced the risk of amputation (6.3% vs 17.1%). Sensitivity analyses showed that cost parameters (e.g. units of Apligraf® required, cost of treatment practice) and transition probabilities between health states affected the cost results. Conclusions: Treatment with Apligraf® plus GWC resulted in a 12% reduction in costs over the first year of treatment compared with GWC alone. The increased ulcer-free time coupled with a reduced risk of amputation to a large extent offset the initial costs of the product.

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Journal PharmacoEconomics
Redekop, W.K, McDonnell, J, Verboom, P, Lovas, K, & Kaló, Z. (2003). The Cost Effectiveness of Apligraf® Treatment of Diabetic Foot Ulcers. PharmacoEconomics, 21(16), 1171–1183. doi:10.2165/00019053-200321160-00003