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.
References
1. 1. Nuccio EJ, Lavery LA, Min S; Innovative Treatment of Chronic Diabetic Foot Ulcer in a Controlled Randomized Clinical Trial Produces Fewer Adverse Events, Faster Wound Closure, and Lower Costs; J Clin Diabetes Pract 2016, 1:33.<
2. Raspovic KM, Wukich DK, Naiman DQ, Lavery LA, Kirsner RS et al; Effectiveness of viable cryopreserved placental membranes for management of diabetic foot ulcers in a real world setting. Wound Repair and Regeneration 2018; 26(2):213-2204.<
3. Rice JB, Desai U, Cummings AK, Birnbaum HG, Skornicki M, Parsons NB. Burden of diabetic foot ulcers for Medicare and private insurers. Diabetes Care 2014;37:651–6582.<4
4. Samsell B, McLean J, Cazzell S, Dorsch K, Moyer PM, Moore M; Health economics for treatment of diabetic foot ulcers: a cost-effectiveness analysis of eight skin substitutes; J Wound Care North American Supplement; 2019, 28 (9); S14-265<
5. Snyder D, Sullivan N, Margolis BD, Schoelles K. Skin substitutes for treating chronic wounds. Technology Assessment Program technical brief. Agency for Healthcare Research and Quality (US), 2020
Trademark
Cryopreserved placental membrane with viable cells (vCPM) (Grafix® , Osiris Therapeutics, Inc., Columbia, MD, USA), Viable human amnion membrane allograft (vHAMA) AmnioBand® MTF Biologics, Edison NJ.Dehydrated human amnion chorion membrane (dHACM) (Epifix®, MiMedx Group Inc., Marietta, GA), Human fibroblast dermal substitute (hFDS) (Dermagraf®, Organogenesis Inc., Canton, MA), Bioengineered bilayered living cellular construct (BLCC) (Apligraf®, Organogenesis Inc., Canton, MA), Hypothermically stored amniotic membrane (HSAM) Affinity Organogenesis Inc., Canton, MA