Add-on ON101 cost-effective for DFUs

An economic analysis shows the cost-effectiveness of adding ON101 to general wound care (GWC) for the treatment of diabetic foot ulcers (DFUs) in individuals with type 2 diabetes (T2D) in Singapore, with robust results across subgroup and sensitivity analyses.

A hypothetical cohort that aligned with the characteristics of patients in the ON101 trial was adopted for this analysis. The ON101 trial included individuals with type 1 diabetes or T2D who were followed for up to 16 weeks. All participants received GWC, comprising wound examinations, treatments (eg, cleansing, debridement, antibiotics), comorbidity control, patient education, and multidisciplinary care. Those in the ON101 group received the novel ON101 topical cream.

A Markov state-transition model was used for this analysis. The primary endpoint was the incremental cost-effectiveness ratio (ICER). All cost values, presented in US dollars, were standardized into 2023 costs using healthcare inflation rates in Singapore. [Diabetes Obes Metab 2025;27:4344-4353]

Over the 5-year simulation, 25 percent of participants in the ON101 group achieved complete healing; only 18 percent achieved this outcome with GWC alone.

Compared with the GWC-alone group, the ON101 group generally had lower cumulative probabilities of adverse DFU complications, such as uninfected DFUs (11.4 percent vs 13.4 percent), infected DFUs (7.2 percent vs 7.6 percent), gangrene (9.4 percent vs 10.3 percent), post-amputation (4.8 percent vs 5.2 percent), and death (41.9 percent vs 46 percent).

The combination group also had lower total healthcare costs in 5 years than the GWC-alone group for uninfected ($104,060 vs 110,465) and infected ($61,802 vs 62,102) DFUs. According to the researchers, the cost savings with the combo regimen may be due to fewer costly DFU-associated complications (eg, gangrene, post-amputation) and more healing events.

ON101 + GWC yielded an additional 0.15 QALYs* while reducing total healthcare costs by $16,237 per patient over a 5-year simulation, resulting in an ICER of -$109,677 per QALY gained.

Other analyses

In the sensitivity analysis, the most influential driver of the ICER is the relative risk of ON101 vs GWC for the healing event, followed by the drug cost and the monthly treatment cost for uninfected DFU. The PSA** results showed the cost-effectiveness of ON101 + GWC in ~88 percent of simulations for a predefined WTP*** threshold of $34,000.

Under this WTP threshold, ON101 was highly cost-effective in 86–100 percent of simulations across subgroups, except for participants with ulcer size <5 cm² (76 percent).

The combination treatment also yielded substantial cost savings for treating complex DFUs (ie, Hb_A1c ≥9 percent, ulcer size >5 cm², and ulcer duration ≥6 months), with ICERs of -USD161,963, -USD181,726, and -USD199,130 per QALY gained, respectively.

“[The] enhanced healing effect in these vulnerable populations is likely to contribute to a reduction in subsequent treatment costs associated with DFU complications,” the researchers noted. “The greater economic benefits for patients with complex DFUs prove the value of ON101 to facilitate resource allocation and prioritization for these vulnerable subsets.”

High acquisition cost may be a barrier

In Singapore, the incidence of diabetic foot increased between 2017 and 2020. [PLoS One 2022;17:e0275920] “Accordingly, the rise in healthcare utilization and expenditures attributable to DFUs has imposed a tremendous financial burden on individual patients and the health system, highlighting the urgent need for appropriate and timely intervention,” they said.

Studies have demonstrated the efficacy of ON101 for DFUs (even for complex cases) when added to GWC. However, its high acquisition cost may be an issue, especially in budget-constrained regions. [JAMA Netw Open 2021;4:e2122607; Adv Wound Care (New Rochelle) 2025;14:381-392]

“[Nonetheless,] the high upfront cost of adding ON101 to GWC is offset by subsequent reductions in medical costs driven by the decreased incidence of costly DFU-associated complications and shorter time spent managing these harmful events,” the researchers said.

“Our findings thus provide supporting evidence for the rational use of ON101 as add-on therapy to GWC in clinical practice in a multiethnic Southeast Asian country with a high-income economy,” they noted. The estimated value-based price of ON101 across WTP thresholds may also inform policymakers’ decisions on pricing and reimbursement.