Discussion
DFUs, deteriorative QoL.Given
Given the results of the ON101 trial,Healing of DFUs may take months to years, and without complete healing, patients with DFUs are susceptible to a series of costly health consequences associated with deteriorative QoL.Given the apparent efficacy on wound healing, it is not surprising to find that the healing efficacy of ON101 with GWC vs GWC alone was the most dominant factor for the economic results in sensitivity analyses. However, this result should be interpreted with caution because we used a wide range for healing efficacy (ie, ±50% of the base-case OR value) to bias against the outcomes associated with ON101, and also, the healing effect size was based on a 28-week clinical trial. The drug cost of ON101 was found to be the second most influential factor for the economic results. ON101 with GWC was still cost-effective even at a 1.9-fold increase in cost (eFigure 3 in Consistent with the findings in the base-case analyses, the ON101 with GWC strategy was cost-effective or even cost-saving across patient subgroups, with 65% to 94% certainty for such cost-effectiveness under the WTP threshold of $98 361 according to the results of PSAs (eTable 5 in Previous cost-effective studies favor most preventive or treatment strategies for DFUs. A recent systematic review revealed that the intervention with optimal wound care in compliance with clinical guidelines or adjunctive therapies added on to GWC would be cost-effective or cost-saving, except for the use of an epidermal growth factor due to its high acquisition cost.