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

Abstract

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.

Specialty specific quality measures needed to improve outcomes in wound care

“…Once initiated, providers are not applying skin substitutes regularly enough (weekly or biweekly). Only 9.2% of providers applied AT FPFU, and the claims data confirms the value of using “weekly or biweekly applications” as a working guideline 5,6 …”

“…Given this perspective, quality measures need to be considered at each patient inflection point to drive increased compliance with best practises in order to redirect patients whose therapies fail. Since 2020, a series of Medicare studies have analysed outcomes and cost‐effective practices that were associated with reduced amputation rates among patients with DFUs 4‐6 . All wound care providers should take note of these findings and add their knowledge and support to developing quality measures that address amputation avoidance in diabetic patients.…”

“…Clinical guidelines related to LEDUs have long relied on the seminal Sheehan marker study, which identified that diabetic ulcers that have not progressed to at least 53% healing after 4 weeks of conservative care have only a 9% chance of proceeding to closure by 12 weeks 10 . It is therefore vital that patients move to advanced therapies within 30 to 45 days after initiation of failed conservative care; however, the Medicare claims data shows this is not happening regularly enough (average time to first skin substitute application >69 days) to benefit both the patient and the health care system 5,6 …”

“…CMS has the opportunity to review the evidence from their own data to encourage wound care specialty specific best practices from the top down. For instance, Medicare quality indicators could include the following quality measures: (1) DFUs that have failed 4 weeks of standard care should receive sharp debridement at weekly to biweekly intervals until the trajectory towards wound closure has been stabilised 4 ; (2) Advanced treatment should optimally be initiated within 30 to 45 days from the initial DFU claim if the ulcer does not respond to standard care 5,6 . (3) Once a skin substitute has been initiated, the AT should be applied at weekly to biweekly intervals until wound closure or improvement stops 5,6 .…”

“…Quality in health care is defined as “the degree to which health care services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge 11,12 . Recent compelling medical evidence supports the favourable clinical and economic impact of AT as a therapeutic class in the treatment of LEDUs 5,6 . It is important that quality measures incorporate best practises, including frequent debridement, AT applications that FPFU including the routine application of skin substitutes every 7 to 14 days after initiation until closure is achieved or improvement in the wound bed is no longer observed at subsequent visits.…”