Dehydrated human amnion/chorion membrane to treat venous leg ulcers: a cost-effectiveness analysis.

OBJECTIVE: To evaluate the cost-effectiveness of dehydrated human amnion/chorion membrane (DHACM) in Medicare enrolees who developed a venous leg ulcer (VLU). METHOD: This economic evaluation used a four-state Markov model to simulate the disease progression of VLUs for patients receiving advanced treatment (AT) with DHACM or no advanced treatment (NAT) over a three-year time horizon from a US Medicare perspective. DHACM treatments were assessed when following parameters for use (FPFU), whereby applications were initiated 30-45 days after the initial VLU diagnosis claim, and reapplications occurred on a weekly to biweekly basis until completion of the treatment episode. The cohort was modelled on the claims of 530,220 Medicare enrolees who developed a VLU between 2015-2019. Direct medical costs, quality-adjusted life years (QALYs), and the net monetary benefit (NMB) at a willingness-to-pay threshold of $100,000/QALY were applied. Univariate and probabilistic sensitivity analyses (PSA) were performed to test the uncertainty of model results. RESULTS: DHACM applied FPFU dominated NAT, yielding a lower per-patient cost of $170 and an increase of 0.010 QALYs over three years. The resulting NMB was $1178 per patient in favour of DHACM FPFU over the same time horizon. The rate of VLU recurrence had a notable impact on model uncertainty. In the PSA, DHACM FPFU was cost-effective in 63.01% of simulations at the $100,000/QALY threshold. CONCLUSION: In this analysis, DHACM FPFU was the dominant strategy compared to NAT, as it was cost-saving and generated a greater number of QALYs over three years from the US Medicare perspective. A companion VLU Medicare outcomes analysis revealed that patients who received AT with a cellular, acellular and matrix-like product (CAMP) compared to patients who received NAT had the best outcomes. Given the added clinical benefits to patients at lower cost, providers should recommend DHACM FPFU to patients with VLU who qualify. Decision-makers for public insurers (e.g., Medicare and Medicaid) and commercial payers should establish preferential formulary placement for reimbursement of DHACM to reduce budget impact and improve the long-term health of their patient populations dealing with these chronic wounds. DECLARATION OF INTEREST: Support for this analysis was provided by MiMedx Group, Inc., US. JLD, and RAF are employees of MiMedx Group, Inc. WHT, BH, PS, BGC and WVP were consultants to MiMedx Group, Inc. VD, AO, MRK, JAN, NW and GAM served on the MiMedx Group, Inc. Advisory Board. MRK and JAN served on a speaker's bureau. WVP declares personal fees and equity holdings from Stage Analytics, US.

Treatment patterns and outcomes of Medicare enrolees who developed venous leg ulcers.

OBJECTIVE: To retrospectively evaluate the comorbidities, treatment patterns and outcomes of Medicare enrolees who developed venous leg ulcers (VLUs). METHOD: Medicare Limited Data Standard Analytic Hospital Inpatient and Outpatient Department Files were used to follow patients who received medical care for a VLU between 1 October 2015 and 2 October 2019. Patients diagnosed with chronic venous insufficiency (CVI) and a VLU were propensity matched into four groups based on their treatment regimen. Episode claims were used to document demographics, comorbidities and treatments of Medicare enrolees who developed VLUs, as well as important outcomes, such as time to ulcer closure, rates of complications and hospital utilisation rates. Outcomes were compared across key propensity-matched groups. RESULTS: In total, 42% of Medicare enrolees with CVI (n=1,225,278), developed at least one VLU during the study, and 79% had their episode claim completed within one year. However, 59% of patients developed another VLU during the study period. This analysis shows that only 38.4% of VLU episodes received documented VLU conservative care treatment. Propensity-matched episodes that received an advanced treatment or high-cost skin substitutes for a wound which had not progressed by 30 days demonstrated the best outcomes when their cellular, acellular, matrix-like product (CAMP) treatment was applied weekly or biweekly (following parameters for use). Complications such as rates of infection (33%) and emergency department visits (>50%) decreased among patients who received an advanced treatment (following parameters for use). CONCLUSION: Medicare enrolees with CVI have diverse comorbidities and many do not receive sufficient management, which contributes to high rates of VLUs and subsequent complications. Medicare patients at risk of a VLU who receive early identification and advanced CAMP treatment demonstrated improved quality of life and significantly reduced healthcare resource utilisation.

Skin Pigmentation Impacts the Clinical Diagnosis of Wound Infection: Imaging of Bacterial Burden to Overcome Diagnostic Limitations.

Underrepresentation of diverse skin tones in medical education and providers' implicit racial bias drives inequities in wound care, such as disproportionally poor outcomes for Black patients. Diagnostic indicators (e.g., erythema) can present differently depending on skin pigmentation. This post hoc analysis of 350 chronic wounds from a prospective 14-site clinical trial aimed to determine how the perception of clinical signs and symptoms of infection (CSS) differs by patient skin tone and if fluorescence-imaging can offer a more objective diagnostic solution. Participants were grouped by skin tone (low, medium, high) as measured by the Fitzpatrick Skin Phototype Classification (FSPC) scale. CSS and total bacterial load (TBL) were compared across FSPC groups, along with sensitivity to detect TBL >104 CFU/g using CSS alone and combined with fluorescence-imaging. Erythema was reported less often with increasing FSPC score (p = 0.05), from 13.4% (low), to 7.2% (medium), to 2.3% (high), despite comparable bacterial loads (median = 1.8 × 106 CFU/g). CSS sensitivity in the high group (2.9%) was 4.8-fold to 8.4-fold lower than the low (p = 0.003) and medium groups (p = 0.04). Fluorescence-imaging significantly improved the detection of high bacterial load in each group, peaking in the high group at 12-fold over CSS alone. These findings underscore the threat of pervasive racialized health inequities in wound care, where missed diagnosis of pathogenic bacteria and infection could delay treatment, increasing the risk of complications and poor outcomes. Fluorescence-imaging is poised to fill this gap, at least in part, serving as a more objective and equitable indicator of wound bacteria. Clinicaltrials.gov #NCT03540004 registered 16-05-2018.

Cost-effectiveness of dehydrated human amnion/chorion membrane allografts in lower extremity diabetic ulcer treatment.

OBJECTIVE: To evaluate the cost-effectiveness and budget impact of using standard care (no advanced treatment, NAT) compared with an advanced treatment (AT), dehydrated human amnion/chorion membrane (DHACM), when following parameters for use (FPFU) in treating lower extremity diabetic ulcers (LEDUs). METHOD: We analysed a retrospective cohort of Medicare patients (2015-2019) to generate four propensity-matched cohorts of LEDU episodes. Outcomes for DHACM and NAT, such as amputations, and healthcare utilisation were tracked from claims codes, analysed and used to build a hybrid economic model, combining a one-year decision tree and a four-year Markov model. The budget impact was evaluated in the difference in per member per month spending following completion of the decision tree. Likewise, the cost-effectiveness was analysed before and after the Markov model at a willingness to pay (WTP) threshold of $100,000 per quality adjusted life year (QALY). The analysis was conducted from the healthcare sector perspective. RESULTS: There were 10,900,127 patients with a diagnosis of diabetes, of whom 1,213,614 had an LEDU. Propensity-matched Group 1 was generated from the 19,910 episodes that received AT. Only 9.2% of episodes were FPFU and DHACM was identified as the most widely used AT product among Medicare episodes. Propensity-matched Group 4 was limited by the 590 episodes that used DHACM FPFU. Episodes treated with DHACM FPFU had statistically fewer amputations and healthcare utilisation. In year one, DHACM FPFU provided an additional 0.013 QALYs, while saving $3,670 per patient. At a WTP of $100,000 per QALY, the five-year net monetary benefit was $5003. CONCLUSION: The findings of this study showed that DHACM FPFU reduced costs and improved clinical benefits compared with NAT for LEDU Medicare patients. DHACM FPFU provided better clinical outcomes than NAT by reducing major amputations, ED visits, inpatient admissions and readmissions. These clinical gains were achieved at a lower cost, in years 1-5, and were likely to be cost-effective at any WTP threshold. Adoption of best practices identified in this retrospective analysis is expected to generate clinically significant decreases in amputations and hospital utilisation while saving money.

Observed impact of skin substitutes in lower extremity diabetic ulcers: lessons from the Medicare Database (2015-2018).

OBJECTIVE: To evaluate large propensity-matched cohorts to assess outcomes in patients receiving advanced treatment (AT) with skin substitutes for lower extremity diabetic ulcers (LEDUs) versus no AT (NAT) for the management of LEDUs. METHOD: The Medicare Limited Dataset (1 October 2015 through 2 October 2018) were used to retrospectively analyse people receiving care for a LEDU treated with AT or NAT (propensity-matched Group 1). Analysis included major and minor amputations, emergency department (ED) visits and hospital readmissions. In addition, AT following parameters for use (FPFU) was compared with AT not FPFU (propensity-matched Group 2). A paired t-test was used for comparisons of the two groups. For comparisons of three groups, the Kruskal-Wallis test was used. A Bonferroni correction was performed when multiple comparisons were calculated. RESULTS: There were 9,738,760 patients with a diagnosis of diabetes, of whom 909,813 had a LEDU. In propensity-matched Group 1 (12,676 episodes per cohort), AT patients had statistically fewer minor amputations (p=0.0367), major amputations (p<0.0001), ED visits (p<0.0001), and readmissions (p<0.0001) compared with NAT patients. In propensity-matched Group 2 (1131 episodes per cohort), AT FPFU patients had fewer minor amputations (p=0.002) than those in the AT not FPFU group. CONCLUSION: AT for the management of LEDUs was associated with significant reductions in major and minor amputation, ED use, and hospital readmission compared with LEDUs managed with NAT. Clinics should implement AT in accordance with the highlighted parameters for use to improve outcomes and reduce costs.