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

Guest, Julian F.; Weidlich, Diana; Singh, Heenal; Fontaine, Javier La; Garrett, Alan; Abularrage, Christopher J.; Waycaster, Curtis

doi:10.12968/jowc.2017.26.sup1.s12

Cited by 36 publications

(27 citation statements)

References 23 publications

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“…A Markov model was based on a randomized controlled trial of the treatment of patients with DFUs using tri-layer porcine small intestine submucosa (SIS; Oasis Ultra) as an adjunct to standard of care 33,34 . We do not know the severity or depth of these wounds.…”

Section: Discussionmentioning

confidence: 99%

Dehydrated human amnion and chorion allograft versus standard of care alone in treatment of Wagner 1 diabetic foot ulcers: a trial-based health economics study

Carter

2020

Journal of Medical Economics

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Aims: The aim of this health economics study was to estimate the cost-utility of an aseptically processed, dehydrated human amnion and chorion allograft (dHACA) plus standard of care (SOC) (group 1) versus SOC alone (group 2) based on a published randomized controlled trial in which patients who had an eligible Wagner 1 diabetic foot ulcer wound were randomized to either of these treatments. Materials and methods: A Markov microsimulation was used to project trial results out to a 1-year horizon time with a third-party payer perspective. The starting health state was an unhealed noninfected ulcer with other health states of healed ulcer, infected non-healed ulcer, cellulitis, osteomyelitis, and absorbing states of dead or amputation. All patients started with unhealed non-infected ulcers at cycle 0. Costs were incurred by patients for procedures at hospital outpatient wound care provider-based departments (PBDs) and hospitals (if complications occurred) and were calculated using time-based activity costing methods. Effectiveness units were quality-adjusted life years (QALYs) computed from literature utility values. One-way and probabilistic sensitivity analysis (PSA) were also conducted. Results: After 1 year, the calculated incremental cost-effectiveness ratio (ICER) for group 1 versus group 2 was-$4,373 with group 1 (dHACA) being dominant over group 2 (SOC). PSA demonstrated that group 1 had 69.2% lower cost values with increased positive incremental effectiveness for 94.9% of values. A willingness to pay (WTP) curve showed that about 92% of interventions were cost effective for group 1 when $50,000 was paid. Conclusions: The results of this study demonstrated that dHACA added to SOC compared to SOC alone was extremely cost-effective in the defined trial population.

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Section: Discussionmentioning

confidence: 99%

Dehydrated human amnion and chorion allograft versus standard of care alone in treatment of Wagner 1 diabetic foot ulcers: a trial-based health economics study

Carter

2020

Journal of Medical Economics

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“…Since decades, it is an established component for different chronic wounds such as diabetic ulcer, pressure ulcer, and chronic vascular ulcer. 16,[22][23][24] Beyond chronic wound applications, the ECM "OASIS" showed positive effects on surgical wound sites after "Mohs" surgery or at donor sites of split thickness skin grafts. It should serve as a provisional matrix.…”

Section: Discussionmentioning

confidence: 99%

“…Existing experiences of other disciplines indicate that higher expenses for the matrix might be equilibrated by a reduced number of dressings with subsequent lower personnel and material expenses. 23 Based on its retrospective character, another limitation was a low standardization according to documentation, different investigators who performed the scoring, a high range in follow-up periods, and missing long-term follow-ups.…”

Section: Discussionmentioning

confidence: 99%

Wound Care With a Porcine Extracellular Matrix After Surgical Treatment of Rhinophyma

et al. 2020

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Background Rhinophyma surgery is commonly associated with prolonged wound healing and the need for multiple wound dressings. Objectives To evaluate clinical outcome with a porcine extracellular matrix (ECM) after shave excision of rhinophyma compared with common wound care procedure. Materials and methods Retrospective analysis of patients with common dressings (CD) compared with patients with additional ECM (OASIS) application. Clinical findings were assessed prior to treatment and at follow-up visit using the Patient and Observer Scar Assessment Scale (POSAS), Vancouver Scar Scale (VSS), and Rhinophyma Severity Index (RHISI). Results Overall, 28 patients (67.5 ±9.0 years) with a mean wound area of 33.9 (±8.5) cm² were included. After a mean follow-up period of 132 (±73) days, scales of POSAS, VSS, and RHISI showed significant ( P< .0001) reductions of 47.0% (±11.1), 56.0% (±12.0), and 62.3% (±14.3), respectively. Subgroup analysis showed no significant differences of aforementioned parameters between the ECM group ( n= 17) and CD group ( n= 11). In contrast, the number of dressing changes were significantly ( P< .006) less in the ECM group (1.4 ±0.8) compared with CD group (4.1 ±2.6). The ECM group showed a significant ( P< .017) shorter time to re-epithelization (10.5 ±1.7 days) than the CD group (13.1 ±2.2 days). Conclusions The application of porcine ECM is practicable and reduces the number of dressing changes and time to re-epithelization clearly. Crusts are scaling off spontaneously without any aggressive action needed. Our findings indicate that ECM application is a promising approach for rhinophyma wound care.

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“…A Markov model was constructed to compare the costs and effects of Heberprot-P plus GWC to those of GWC alone over a 52-week period based on clinical trial data (Fernández-Montequín et al, 2009 ). Previous Markov models applied one-year time horizon in the economic evaluation of new technologies in diabetic foot ulcer (Redekop et al, 2003 ; Gilligan et al, 2015 ; Guest et al, 2017 ). According to the local methodological guidelines time horizon of economic evaluations should be long enough to take into account all important clinical outcomes and costs (Ministry of Health, 2011b ).…”

Section: Methodsmentioning

confidence: 99%

Cost-Utility Analysis of Heberprot-P as an Add-on Therapy to Good Wound Care for Patients in Slovakia with Advanced Diabetic Foot Ulcer

Tesař

Szilberhorn²,

Németh³

et al. 2017

Front. Pharmacol.

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Objectives: To explore whether Heberprot-P (an epidermal growth factor) is a cost-effective option for the treatment of advanced diabetic foot ulcer as an add-on therapy to good wound care (GWC) in Slovakia from the perspective of health care payers.Methods: A Markov model was constructed to compare the costs and effects of Heberprot-P plus GWC to those of GWC alone from the perspective of health care payers. The 52-week clinical trial period was extended to 5- and 10-year time horizons. Transition probabilities were calculated based on a previous clinical trial of Heberprot, utility values were derived from the scientific literature, and cost vectors were collected from the General Health Insurance Fund database in Slovakia. A one-way deterministic sensitivity analysis was employed to explore the influence of uncertainty for each input parameter on the incremental cost-effectiveness ratio (ICER).Results: Based on the ICER threshold of €30,030 per quality-adjusted life year (QALY) recommended by the Slovak Ministry of Health, Heberprot-P therapy plus GWC is not a cost-effective alternative to GWC alone over a 10-year time horizon. The ICER increases if a longer time horizon is applied, as the incremental costs are similar, but the aggregated utility gain from avoided amputation is lower. Based on the sensitivity analysis, the utility multiplier for the health state “no ulcer after small amputation” had the most impact on the ICER; however, the model was robust to changes in all input parameters.Conclusions: Heberprot-P, as an add-on therapy to GWC in the treatment of advanced diabetic foot ulcer, is not a cost-effective alternative to GWC alone. However, if the unit cost of Heberprot-P were to be reduced to <€273, its ICER would be <€30,030.

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

Cited by 36 publications

References 23 publications

Dehydrated human amnion and chorion allograft versus standard of care alone in treatment of Wagner 1 diabetic foot ulcers: a trial-based health economics study

Dehydrated human amnion and chorion allograft versus standard of care alone in treatment of Wagner 1 diabetic foot ulcers: a trial-based health economics study

Wound Care With a Porcine Extracellular Matrix After Surgical Treatment of Rhinophyma

Cost-Utility Analysis of Heberprot-P as an Add-on Therapy to Good Wound Care for Patients in Slovakia with Advanced Diabetic Foot Ulcer

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