Dehydrated Human Amnion/Chorion Membrane Allografts Found Cost Effective for LEDUs Advances

The increased prevalence of diabetes is estimated to affect more than 10% of the US population, and carried an annual cost of approximately $327 billion in 2017. Specifically, lower extremity diabetic ulcers (LEDUs) are a substantial financial burden for the US health care system and patients. Medicare spending on ulcers related to diabetes has reached nearly $20 billion annually. In addition, patients with an LEDU encounter challenges with mobility, infection risk, amputation, decreased quality of life, and a shortened lifespan. Research estimates that up to 85% of amputations are avoidable when a multispecialty team approach is enacted and appropriate, properly used advanced treatment (AT) modalities are integrated into the care plan. One AT modality is a skin substitute or cellular- and/or tissue-based product, such as the dehydrated human amnion/chorion membrane (DHACM) allograft. This particular allograft is comprised of cellular and acellular dermal substitutes that are predominantly derived from human placental tissues and animal tissues.

In a recent cost-effectiveness analysis, researchers evaluated the effect of employing standard of care over the DHACM when following parameters for use (FPFU) to treat LEDUs. The study results showed that when no advanced treatment (NAT) and DHACM FPFU were compared, the DHACM demonstrated clinical benefits for Medicare patients with an LEDU due to reductions in major amputations, emergency department visits, inpatient admissions, and hospital readmissions. Additionally, cost reductions were also derived.  

The researchers retrospectively analyzed a cohort of Medicare patients from 2015 to 2019 to generate 4 propensity-matched cohorts of LEDU episodes. The study design followed that of a previous study with some modifications, such as including an additional year of data (2019), an increased run-in period to better reflect the average Medicare episode, an updated definition of amputation and exclusion criteria, and a propensity model that factored in geographic and socioeconomic variables. (Importantly, the geographic and economic distributions were similar within their respective group to minimize differences in health care coverage.) Claims codes were used to track treatment outcomes for DHACM and NAT, such as amputations and health care utilization.

In evaluating the budget impact, researchers considered the difference in per member per month spending. That data was then analyzed by researchers and used to construct a hybrid economic model combining a 1-year decision tree and a 4-year Markov model. The cost-effectiveness was analyzed at a willingness to pay (WTP) threshold of $100 000 USD per quality-adjusted life year (QALY).

In years 1 through 5, clinical gains were achieved at a lower cost; researchers believed the DHACM FPFU was likely to be cost-effective at any WTP threshold. In noting these gains, research centered on 10 900 127 patients with a diabetes diagnosis, of whom 1 213 614 had an LEDU. Overall, LEDU episodes in which DHACM FPFU was used showed the shortest average treatment duration.

Propensity-matched Group 1 was generated from the 19 910 episodes that received AT. Only 9.2% of episodes were FPFU. In this group, the DHACM was identified as the most widely used AT product among a review of 16 735 episodes.

The propensity-matched Group 4 was limited by 590 episodes that used DHACM FPFU. Episodes treated with DHACM FPFU statistically resulted in a reduction in amputations and health care utilization.

According to the researchers, DHACM FPFU was likely to be cost-effective at any WTP threshold when compared with NAT, especially when the LEDU fails to close after 30 to 45 days of standard care. The DHACM FPFU provided an additional 0.013 QALYs, while saving $3670 per patient in year 1. The 5-year results showed an increase in 0.048 QALYs, saving $4777 per patient, and the net monetary benefit was $9624 at a WTP of $100 000 per QALY.

Given the multiple optimal clinical gains that DHACM FPFU provides at a lower cost, the therapeutic modality provides value and presents a beneficial treatment pathway for patients and payers. As the study validates that only 9.2% of LEDU episodes followed parameters for use, that providers delayed the first AT until approximately 80 days after diagnosis, and that AT reapplication did not occur regularly, the authors noted that educational improvements for all health care providers are necessary to guide appropriate AT FPFU.

“Improving policies supporting appropriate use of ATs, instead of limiting them, is also necessary and in years 1 to 5, post-treatment will be more cost effective,” they add. “Payers may want to consider linking proper usage to reimbursement to encourage the scheduling of regular visits,” the authors note. “This retrospective and cost-effectiveness analysis clearly demonstrated DHACM—when used according to defined parameters for use—could guide quality wound care practices that favorably impact patients’ QoL and reduce health care costs, while saving both limbs and lives.”

According to their study, adopting the best practices identified could generate clinically significant decreases in amputations and hospital costs, thus showing cost-effectiveness for both patients and US health care system.

–Carol Brzozowski

Reference

Tettelbach W, Armstrong D, Chang T, et al. Cost-effectiveness of dehydrated human amnion/chorion membrane allografts in lower extremity diabetic ulcer treatment. J Wound Care. 2022;31(Suppl 2):S10-S31. doi:10.12968/jowc.2022.31.Sup2.S10