Autologous Skin Cell Suspension for Full-Thickness Skin Defect Reconstruction: Current Evidence and Health Economic Expectations.

Despite differing etiologies, acute thermal burn injuries and full-thickness (FT) skin defects are associated with similar therapeutic challenges. When not amenable to primary or secondary closure, the conventional standard of care (SoC) treatment for these wound types is split-thickness skin grafting (STSG). This invasive procedure requires adequate availability of donor skin and is associated with donor site morbidity, high healthcare resource use (HCRU), and costs related to prolonged hospitalization. As such, treatment options that can facilitate effective healing and donor skin sparing have been highly anticipated. The RECELL® Autologous Cell Harvesting Device facilitates preparation of an autologous skin cell suspension (ASCS) for the treatment of acute thermal burns and FT skin defects. In initial clinical trials, the approach showed superior donor skin-sparing benefits and comparable wound healing to SoC STSG among patients with acute thermal burn injuries. These findings led to approval of RECELL for this indication by the US Food and Drug Administration (FDA) in 2018. Subsequent clinical evaluation in non-thermal FT skin wounds showed that RECELL, when used in combination with widely meshed STSG, provides donor skin-sparing advantages and comparable healing outcomes compared with SoC STSG. As a result, the device received FDA approval in June of 2023 for treatment of FT skin defects caused by traumatic avulsion or surgical excision or resection. Given that health economic advantages have been demonstrated for RECELL ± STSG versus STSG alone when used for burn therapy, it is prudent to examine similarities in the burn and FT skin defect treatment pathways to forecast the potential health economic advantages for RECELL when used in FT skin defects. This article discusses the parallels between the two indications, the clinical outcomes reported for RECELL, and the HCRU and cost benefits that may be anticipated with use of the device for non-thermal FT skin defects.

Analysis of real-world length of stay data and costs associated with use of autologous skin cell suspension for the treatment of small burns in U.S. centers.

BACKGROUND: Autologous skin cell suspension (ASCS) is a treatment for acute thermal burn injuries associated with significantly lower donor skin requirements than conventional split-thickness skin grafts (STSG). Projections using the BEACON model suggest that among patients with small burns (total body surface area [TBSA]<20 %), use of ASCS± STSG leads to a shorter length of stay (LOS) in hospital and cost savings compared with use of STSG alone. This study evaluated whether data from real-world clinical practice corroborate these findings. MATERIALS AND METHODS: Electronic medical record data were collected from January 2019 through August 2020 from 500 healthcare facilities in the United States. Adult patients receiving inpatient treatment with ASCS± STSG for small burns were identified and matched to patients receiving STSG using baseline characteristics. LOS was assumed to cost $7554/day and to account for 70 % of overall costs. Mean LOS and costs were calculated for the ASCS± STSG and STSG cohorts. RESULTS: A total of 151 ASCS± STSG and 2243 STSG cases were identified; 63.0 % of patients were male and the average age was 44.2 years. Sixty-three matches were made between cohorts. LOS was 18.5 days with ASCS± STSG and 20.6 days with STSG (difference: 2.1 days [10.2 %]). This difference led to bed cost savings of $15,587.62 per ASCS± STSG patient. Overall cost savings with ASCS± STSG were $22,268.03 per patient. CONCLUSIONS: Analysis of real-world data shows that treatment of small burn injuries with ASCS± STSG provides reduced LOS and substantial cost savings compared with STSG, supporting the validity of the BEACON model projections.

Length of Stay and Costs with Autologous Skin Cell Suspension Versus Split-Thickness Skin Grafts: Burn Care Data from US Centers.

INTRODUCTION: Autologous skin cell suspension (ASCS) significantly reduces donor skin requirements versus conventional split-thickness skin grafts (STSG) for thermal burn treatment. In analyses using the Burn-medical counter measure Effectiveness Assessment Cost Outcomes Nexus (BEACON) model, ASCS was associated with shorter hospital length of stay (LOS) and cost savings versus STSG. This study hypothesized that daily practice data from the USA would support these findings. METHODS: Electronic medical record data from 500 healthcare facilities (January 2019-August 2020) were used to match adult patients who received inpatient burn treatment with ASCS (± STSG) to patients treated with STSG alone on the basis of sex, age, percent total body surface area (TBSA), and comorbidities. Based on BEACON analyses, LOS was assumed to represent 70% of total costs and used as a proxy to assess the data. Mean LOS, costs, and the incremental revenue associated with inpatient capacity changes were calculated. RESULTS: A total of 151 ASCS and 2443 STSG patients were identified: 63.0% were male and average age was 44.5 years. Eight-one matches were made between cohorts. LOS was 21.7 days with ASCS and 25.0 days with STSG alone (difference 3.3 days [13.2%]). LOS was lower with ASCS than STSG in four of five TBSA intervals. The LOS difference led to hospital bed cost savings of $25,864 per ASCS patient; overall cost savings were $36,949 per patient. Similar cost savings were observed in TBSA groupings < 20% and ≥ 20%. The reduced LOS with ASCS translated into an increased capacity of 2.2 inpatients/bed annually, which increased hospital revenue by $92,283/burn unit bed annually. CONCLUSIONS: Real-world data show that ASCS (± STSG) is associated with reduced LOS and cost savings versus STSG alone across all burn sizes, supporting the validity of the BEACON analyses. ASCS use may also increase patient capacity and throughput, leading to increased hospital revenue.

Autologous skin cell suspension (ASCS) is a treatment for thermal skin burn injuries that can be used alone or in combination with split-thickness skin grafts (STSG), the conventional standard of care. Projections using the Burn-medical counter measure Effectiveness Assessment Cost Outcomes Nexus (BEACON) model indicate that ASCS leads to shorter hospital length of stay (LOS) and overall cost savings compared with STSG alone. These model findings are supported by benchmarking study data from a limited sample of US burn centers. The current study aimed to understand whether the BEACON projections are supported by daily clinical practice data from US healthcare facilities. Using electronic medical record data, we matched patients who received ASCS ± STSG from January 2019 to August 2020 to those receiving STSG alone on the basis of demographic and clinical factors. Data analysis showed that hospital LOS was shorter (3.3 days) with ASCS ± STSG than STSG alone, a difference associated with a hospital bed cost savings of $25,864 per ASCS patient. Overall cost savings, which included nursing time and other costs, were $36,949 per patient. Analysis of patients with burns comprising total body surface areas less than 20% or at least 20% showed cost savings in both groups. The reduced LOS with ASCS also translated into the ability to treat 2.2 more patients per hospital bed per year, which was projected to increase hospital earnings. These real-world findings support those of modeling analyses, indicating that use of ASCS ± STSG is associated with meaningful clinical and economic benefits compared with use of STSG alone.

Evaluating Real-World National and Regional Trends in Definitive Closure in U.S. Burn Care: A Survey of U.S. Burn Centers.

To better understand trends in burn treatment patterns related to definitive closure, this study sought to benchmark real-world survey data with national data contained within the National Burn Repository version 8.0 (NBR v8.0) across key burn center practice patterns, resource utilization, and clinical outcomes. A survey, administered to a representative sample of U.S. burn surgeons, collected information across several domains: burn center characteristics, patient characteristics including number of patients and burn size and depth, aggregate number of procedures, resource use such as autograft procedure time and dressing changes, and costs. Survey findings were aggregated by key outcomes (number of procedures, costs) nationally and regionally. Aggregated burn center data were also compared to the NBR to identify trends relative to current treatment patterns. Benchmarking survey results against the NBR v8.0 demonstrated shifts in burn center patient mix, with more severe cases being seen in the inpatient setting and less severe burns moving to the outpatient setting. An overall reduction in the number of autograft procedures was observed compared to NBR v8.0, and time efficiencies improved as the intervention time per TBSA decreases as TBSA increases. Both nationally and regionally, an increase in costs was observed. The results suggest resource use estimates from NBR v8.0 may be higher than current practices, thus highlighting the importance of improved and timely NBR reporting and further research on burn center standard of care practices. This study demonstrates significant variations in burn center characteristics, practice patterns, and resource utilization, thus increasing our understanding of burn center operations and behavior.

Cost-Effectiveness of the Use of Autologous Cell Harvesting Device Compared to Standard of Care for Treatment of Severe Burns in the United States.

INTRODUCTION: When introducing a new intervention into burn care, it is important to consider both clinical and economic impacts, as the financial burden of burns in the USA is significant. This study utilizes a health economic modeling approach to estimate cost-effectiveness and burn center budget-impact for the use of the RECELL® Autologous Cell Harvesting Device to prepare autologous skin cell suspension (ASCS) compared to standard of care (SOC) split-thickness skin graft (STSG) for the treatment of severe burn injuries requiring surgical intervention for definitive closure. METHODS: A hospital-perspective model using sequential decision trees depicts the acute burn care pathway (wound assessment, debridement/excision, temporary coverage, definitive closure) and predicts the relative differences between use of ASCS compared to SOC. Clinical inputs and ASCS impact on length of stay (LOS) were derived from clinical trials and real-world use data, American Burn Association National Burn Repository database analyses, and burn surgeon interviews. Hospital resource use and unit costs were derived from three US burn centers. A budget impact calculation leverages Monte Carlo simulation to estimate the overall impact to a burn center. RESULTS: ASCS treatment is cost-saving or cost-neutral (< 2% difference) and results in lower LOS compared to SOC across expected patient profiles and scenarios. In aggregate, ASCS treatment saves a burn center 14-17.3% annually. Results are sensitive to, but remain robust across, changing assumptions for relative impact of ASCS use on LOS, procedure time, and number of procedures. CONCLUSIONS: Use of ASCS compared to SOC reduces hospital costs and LOS of severe burns in the USA. FUNDING: AVITA Medical.