OBJECTIVES:

Diabetic foot ulcers (DFUs) incur enormous health and economic burdens to individual patients and healthcare systems. ON101 (Fespixon^®), a novel macrophage-regulating drug, was recently demonstrated to accelerate the wound healing with superior healing rates among patients with DFUs in a phase 3 clinical trial. This study thus aimed to determine the cost-effectiveness of ON101 versus general wound care (GWC) and further explore its cost-effectiveness among patient subgroups.

METHODS:

Within-trial and model-based cost-effectiveness analyses (CEAs) were conducted from the Taiwan healthcare sector perspective. ON101’s effectiveness obtained from its phase 3 trial was estimated as the number needed to treat (NNT) to obtain one additional patient with complete healing in the within-trial CEA, and as quality-adjusted life years (QALYs) in the model-based CEA. Cost data was derived from the ON101 trial, published literature, and Taiwan’s National Health Insurance program, and presented in 2021 US dollars. CEAs were further stratified by baseline patient characteristics (i.e., glycemic level, ulcer wound size, and smoking status).

RESULTS:

Within the 28-week trial, the NNT was 5.33 of ON101 versus GWC to obtain a patient with complete healing at an extra cost of $4,366, resulting in $23,252 per complete-healing patient gained. Over a 5-year model simulation, ON101 versus GWC yielded a gain of 0.038 QALYs at an extra cost of $571, resulting in $14,922 per QALY gained. Against the pre-defined willingness-to-pay threshold ($33,011, one time the per capita gross domestic product of Taiwan), using ON101 was highly cost-effective versus GWC in both within-trial and model-based CEAs among overall DFU patients, and such favorable result was even more prominent among those with poor glycemic control, larger ulcer sizes, and current smokers.

CONCLUSIONS:

ON101 represents good value for money, especially for patients with high risks of DFU progression, and therefore may be considered in future standard wound care.