Cost-effectiveness of using adjunctive porcine small intestine submucosa tri-layer 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 cost-effectiveness 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.

Wound closure in patients with DFU: a cost-effectiveness analysis of two cellular/tissue-derived products.

OBJECTIVE: Determine the cost-effectiveness of extracellular matrix (ECM) relative to human fibroblast-derived dermal substitute (HFDS) on diabetic foot ulcer (DFU) wound closure. METHOD: Outcomes data were obtained from a 12-week, randomised, clinical trial of adults aged 18 years or older diagnosed with type 1 or type 2 diabetes with a DFU. Patients were treated with either ECM or HFDS treatment. A two-state Markov model (healed and unhealed) with a 1-week cycle length was developed using wound-closure rates from the trial to estimate the number of closed-wound weeks and the expected DFU cost per patient. Results were recorded over 12 weeks to estimate the number of closed-wound weeks per treatment and the average cost to achieve epithelialisation (primary outcome). The perspective of the analysis was that of the payer, specifically the Centers for Medicare and Medicaid Services. No cost discounting was performed because of the short duration of the study. RESULTS: The study consisted of 26 patients, with 13 in each group. In the ECM group, 10 wounds closed (77%), with an average closure time of 36 days; 11 wounds closed in the HFDS group (85%), with an average closure time of 41 days. There was no significant difference between these results (p=0.73). Over 12 weeks, the expected cost per DFU was $2522 (£1634) for ECM and $3889 (£2524) for HFDS. Patients treated with HFDS incurred total treatment costs that were approximately 54% higher than those treated with ECM. Sensitivity analyses revealed that the total cost of care for two applications of HFDS was more costly than eight applications of ECM by approximately $500 (£325). CONCLUSION: In patients with DFU, ECM yielded similar clinical outcomes to HFDS but at a lower cost. Health-care providers should consider ECM as a cost-saving alternative to HFDS. DECLARATION OF INTEREST: A.M. Gilligan, and C.R. Waycaster, are employees of Smith & Nephew Inc.. This study was funded by Smith & Nephew Inc.. A.L. Landsman, reports no conflicts of interest.