OBJECTIVES

: We evaluated the cost-effectiveness of a novel treatment - ON101 cream, which was recently introduced for treating diabetic foot ulcer (DFU) as add-on to standard care (SC), versus SC among diabetic patients from the healthcare sector perspective.

METHODS

: A Markov model with six health states (i.e., uninfected DFU, infected DFU, healed DFU, history of amputation, gangrene, and all-cause death) was adopted to assess the cost-effectiveness of ON101 versus SC for treating DFU, with one-month cycle length for a 5-year simulation in the base-case analysis. Data from the ON101 phase 3 trial involving 236 DFU cases for a 16-week follow-up were used to generate efficacy parameters (transition probabilities between health states) for the model. Costs and health utilities associated with health states were drawn from published literature and estimated using Taiwan’s National Health Insurance Research Database. Costs were expressed in 2020 U.S. dollars. Future costs and effectiveness were discounted at 3% annually. One-way and probabilistic sensitivity analyses were performed to examine the robustness of study results.

RESULTS

: Attributed by a higher healing rate and shorter healing time of using ON101, the base-case analysis showed that ON101 treatment was associated with lower costs and higher quality-adjusted life years (QALYs) over 5 years. The total healthcare cost per ON101-treated patient was lower than that of a patient with SC (i.e., $14,270 versus $22,135), while QALYs per ON101-treated patient were higher than those of a patient with SC (i.e., 3.565 versus 3.545 QALYs). Results were robust across the sensitivity analyses.

CONCLUSIONS

: The novel treatment, ON101, versus SC would be cost-saving for DFU owing to its better efficacy.