Cost-effectiveness of commonly used cellular and/or tissue-based products in the management of diabetic foot ulcers

Introduction: As many as a quarter of patients with diabetes mellitus will experience a diabetic foot ulcer (DFU) which often require extensive healing time and negatively impact patient quality of life and increase the risk of infection, amputation, and death1,2. Treatment of DFUs includes good wound care (GWC) such as debridement, moist dressings, and offloading areas of high pressure3-4. Treatment of complex DFUs often includes the application of cellular and/or tissue-based products (CPTs), otherwise known as skin substitutes3. This study aimed to assess the cost-effectiveness of commonly used CPTs in the management of patients with DFUs.

Methods: We developed an economic model to assess the clinical and economic outcomes of the different CPTs over one year considering outcomes of healing, infections, amputation, and mortality. We updated the AHRQ meta-analysis5 on CPTs for the clinical data. We assessed 6 CPTs (vCPM, BLCC, hFDS, dHACM, HSAM and vHAMA) which had RCT evidence, 2 weeks wash out period and were all compared with GWC. We then indirectly compared and ranked the CPTs in order of cost-effectiveness using GWC as the baseline. We conducted a probabilistic sensitivity analysis and costs are expressed in 2021 US dollars from a payer’s perspective.

Results: The estimated mean annual cost and (healed wounds) per 100 treated patients is $1.01m (91.4) for vCPM, $1.15m (90.3) for vHAMA, $1.59m (82.8) for dHACM, $1.73m (82.9) for hFDS, $1.80m (82.6) for hFDS, $1.99m (60.1) for GWC and $2.24m (86.6) for HSAM respectively. Using GWC as the baseline, vCPM is the dominant strategy over one year as it results in cheaper costs overall and better healing rates. Probabilistic sensitivity analysis demonstrated that vCPM has the highest probability of being cost-effective, 58% followed by vHAMA at 41% then hFDS, dHACM, HSAM and lastly BLCC using a $100,000/healed wound threshold.

Conclusions. All CPTs represent value for money when compared to GWC alone in the management of DFUs. However, vCPM appears to be the most cost-effective CPT over one year period followed by vHAMA, hFDS, dHACM, HSAM and BLCC. These results should be interpreted with caution as we currently lack direct evidence comparing all these CPTs.