Cost-effectiveness of using adjunctive porcine small intestine submucosa trilayer matrix compared with standard care in managing diabetic foot ulcers in the US

Objective: To estimate the cost-effectiveness of using tri-layer porcine small intestine submucosa (SIS; Oasis Ultra) as an adjunct to standard care compared with standard care alone in managing diabetic foot ulcers (DFUs) in the US, from the perspective of Medicare. Method: A Markov model was constructed to simulate the management of diabetic neuropathic lower extremity ulcers over a period of one year in the US. The model was used to estimate the costeffectiveness of initially using adjunctive SIS compared with standard care alone to treat a DFU in the US at 2016 prices. Results: At 12 months after the start of treatment, the use of adjunctive SIS instead of standard care alone is expected to lead to a 42 % increase in the number of ulcer-free months, 32 % increase in the probability of healing, a 3 % decrease in the probability of developing complicated ulcers and a 1 % decrease in the probability of undergoing an amputation. Health-care resource use is expected to be reduced by 11-14 % among patients who are initially managed with adjunctive SIS compared with those initially managed with standard care alone, with the exception of debridement, which is expected to be reduced by 35 %. Hence, the total health-care cost of starting treatment with adjunctive SIS instead of standard care alone was estimated to reduce payer costs by 1% (i.e. $105 per patient) over 12 months following the start of treatment. Conclusion: Within the study's limitations, the use of adjunctive SIS instead of standard care alone improves outcome for less cost and thereby affords a cost-effective use of Medicare-funded resources in the management of neuropathic foot ulcers among adult patients with type 1 or 2 diabetes mellitus in the US. Declaration of interest: The authors certify that they have no affiliation with or financial involvement in any organisation or entity with a direct financial interest in the subject matter or materials discussed in this manuscript, although CRW is an employee of the sponsor, Smith and Nephew, Inc. JLF, AG and CJA are speakers and/or clinical trial investigators in the field of diabetes, all of which are independent of this current study. Additionally, JLF and AG have provided consultancy/advisory services to Smith and Nephew Inc., and received research funding independently of this current study. The authors have no other conflicts of interest that are directly relevant to the content of this manuscript.