Within-trial cost-effectiveness of novel macrophage-regulating treatment on wound healing in patients with diabetic foot ulcers
Hsuan-Yu Sua, Chen-Yi Yanga, Yi-Hsin Changa, Shyi-Gen Chenb,c, Jui-Ching Chenb, Hui-Ju Hod, Huang-Tz Oua,e*, Shihchen Kuoa,f
a Institute of Clinical Pharmacy and Pharmaceutical Sciences, College of Medicine, National Cheng Kung University, Tainan, Taiwan
b Department of Medical Science, Oneness Biotech Co., Ltd., Taipei, Taiwan
c Department of Surgery, Tri-Service General Hospital, Taipei, Taiwan
d Department of Clinical Research, Oneness Biotech Co., Ltd., Taipei, Taiwan
e Department of Pharmacy, College of Medicine, National Cheng Kung University, Tainan, Taiwan
f Division of Metabolism, Endocrinology & Diabetes, Department of Internal Medicine, University of Michigan Medical School, Ann Arbor, Michigan, United States
An M1/M2 macrophage-regulating treatment, ON101 cream, has shown its superior healing efficacy for diabetic foot ulcers (DFUs) versus standard absorbent dressing, according to a phase Ⅲ trial. Given its high cost, corroborating the economic value of ON101 treatment can facilitate clinical and policy decision-makings. This study sought to evaluate the cost-effectiveness of ON101 versus an absorbent dressing for patients with DFUs from Taiwan's healthcare sector perspective. This economic evaluation utilized effectiveness and cost data (in 2022 USD) from a randomized controlled trial of ON101, published literature, and Taiwan’s National Health Insurance program. Incremental cost-effectiveness ratio (ICER) against willingness-to-pay (WTP) threshold was estimated to determine the cost-effectiveness of treatment. Over a mean follow-up of 12.69 weeks in the full analysis set of patients (n=236), 6 patients would need to be treated with ON101 versus the absorbent dressing to obtain a case of complete healing, which costed US$21,128 per complete-healing case gained. This ICER value was below WTP threshold of US$32,788. Cost-effective findings were consistent across sensitivity analyses, and more remarkable for patients with Wagner grade 2 ulcers, HbA1c >7%, and plantar ulcers. All these results were similar in modified intention-to-treat set. The high upfront drug cost of ON101 could be offset by its superior healing efficacy. Considering key prognostic factors for DFUs while optimizing the allocation of limited healthcare budgets, ON101 should be prioritized for severe cases with poor ulcer prognosis.
Keywords: Cost, cost-effectiveness analysis, diabetic foot ulcer, number needed to treat