Economic outcomes among Medicare patients receiving bioengineered cellular technologies for treatment of diabetic foot ulcers

Abstract

Objective: To assess the real-world medical services utilization and associated costs of Medicare patients with diabetic foot ulcers (DFUs) treated with Apligraf (bioengineered living cellular construct (BLCC)) or Dermagraft (human fibroblast-derived dermal substitute (HFDS)) compared with those receiving conventional care (CC). Methods:DFU patients were selected from Medicare de-identified administrative claims using ICD-9-CM codes. The analysis followed an 'intent-to-treat' design, with cohorts assigned based on use of (1) BLCC, (2) HFDS, or (3) CC (i.e., !1 claim for a DFU-related treatment procedure or podiatrist visit and no evidence of skin substitute use) for treatment of DFU in 2006-2012. Propensity score models were used to separately match BLCC and HFDS patients to CC patients with similar baseline demographics, wound severity, and physician experience measures. Medical resource use, lower-limb amputation rates, and total healthcare costs (2012 USD; from payer perspective) during the 18 months following treatment initiation were compared among the resulting matched samples. Results:Data for 502 matched BLCC-CC patient pairs and 222 matched HFDS-CC patient pairs were analyzed. Increased costs associated with outpatient service utilization relative to matched CC patients were offset by lower amputation rates (À27.6% BLCC, À22.2% HFDS), fewer days hospitalized (À33.3% BLCC, À42.4% HFDS), and fewer emergency department visits (À32.3% BLCC, À25.7% HFDS) among BLCC/ HFDS patients. Consequently, BLCC and HFDS patients had per-patient average healthcare costs during the 18-month follow-up period that were lower than their respective matched CC counterparts (À$5253 BLCC, À$6991 HFDS). Limitations:Findings relied on accuracy of diagnosis and procedure codes contained in the claims data, and did not account for outcomes and costs beyond 18 months after treatment initiation. Conclusion:These findings suggest that use of BLCC and HFDS for treatment of DFU may lower overall medical costs through reduced utilization of costly healthcare services.

In vitro assessment of a novel, hypothermically stored amniotic membrane for use in a chronic wound environment

“…In many cases, DFUs lead to amputations, which are associated with mortality rates between 30% and 50% at 1 year . DFUs are not only difficult to close, owing to the complex diabetic wound environment, but they are also expensive to treat, with the cost of treating a DFU estimated to run in excess of $18 000 per case . Improving healing rates and tissue quality of regenerated tissue in patients with these chronic wounds would not only improve patient quality of life but also reduce the overall burden to the health care system.…”

Bilayered skin-substitute technology for the treatment of diabetic foot ulcers: current insights

“…43,44 A comparative-effectiveness analysis showed greater healing rates and faster time to healing of BLCC compared with an active comparator, and supported its use in the realworld clinical setting. 45 An economic analysis suggests that BLCC may decrease DFU-associated complications and lower overall medical costs through reduced utilization of health care services. 46…”

“…In this analysis, BLCC was compared with a dehydrated human amnionchorion membrane (dHACM; Epifix, MiMedx Group Inc, Marietta, GA, USA) allograft, a collagenous membrane that contains no living cells. 45 Data were obtained from a wound care-specific electronic medical record database (Net Health; Pittsburgh, PA, USA) that included patients with DFUs receiving treatment in 2014 at 99 wound-care centers. The analysis considered DFUs between 1 and 25 cm 2 of ≤1-year duration and ≤20% area reduction in the 2 weeks prior to the first treatment.…”

“…Importantly, results of this comparative-effectiveness analysis were reasonably consistent with those observed in the randomized controlled clinical trials described earlier, and support the efficacy of BLCC in healing wounds in routine clinical practice. 45 Although the analysis was not designed to assess costs related to wound-care therapy and outcomes, results may suggest that the faster time to wound healing, higher incidence of wound healing, and lower number of applications with BLCC versus the comparator may have potential cost-saving implications. A recent economic analysis assessed the real-world medical resource utilization and costs of DFUs, comparing BLCC against standard-care therapy.…”

Amputation-free limb survival in diabetic foot lesions: A Review

“…Furthermore, dehydrated human amnion/chorion membrane (dHACM) preparations including EpiFix, MiMedx Group Inc., Marietta, GA have also been shown to be beneficial in the treatment of non-healing diabetic foot ulcers [32] . These newer technologies have been shown to reduce the overall costs for the treatment of diabetic foot ulcers [33] . Considerable in-roads have been made in the management of critical limb ischemia (CLI).…”