OBJECTIVES: To determine whether a new biopharmaceutical, AUP-16, was more cost-effective than the current standard of care (SOC) at healing a diabetic foot ulcer. AUP-16 is a Recombinant Live Biotherapeutic applied topically on chronic wounds, from food-grade lactic acid bacteria genetically engineered to synthesize and secrete 3 therapeutic proteins (FGF-2, IL-4, CSF-1). Threshold analysis was used to determine the maximum price for AUP-16 before the incremental cost-effectiveness ratio exceeded the commonly accepted value of $100,000/QALY.

METHODS: A Markov model was used to compare AUP-16 and SOC over 35 years at outcomes including number of QALY's, costs, healing diabetic foot ulcers, ulcer reoccurrence, death, infections, and amputation. Costs were from the United States Medicare and Managed Care perspectives. Transition probabilities, rates of amputation and infection, death from diabetic foot ulcer, rates of ulcer reoccurrence and QOL scores using EUROQOL were obtained from published literature. Efficacy rates for AUP-16 were from the company's Phase 1 trial.

RESULTS: In the base case, using a presumed treatment cost for AUP-16 of $3,000, the ICER was $3,909/QALY in favor of AUP-16. Threshold analysis revealed there was no reasonable higher price in which the ICER exceeded the $100,000/QALY threshold. In univariate sensitivity analysis, the ICER ranged from a low of $1 to $7,434 per QALY. In no case was AUP-16 dominant, and in no case was the current SOC ever cost-effective over AUP-16. With probabilistic sensitivity analysis, as the rate of variation increased from 5% to 20%, the ICER increased to a maximum of $7,500/QALY but increased the likelihood of AUP-16 dominance over SOC.

CONCLUSIONS: AUP-16 was more cost-effective than the current standard of care at healing diabetic foot ulcers with a baseline ICER of $3,909. The model was robust to a comprehensive sensitivity analysis, with the ICER never exceeding the threshold of $100,000/QALY.