Reducing Costs While Preserving Lives & Limbs in Medicare Patients; Cost-Effectiveness of Dehydrated Human Amnion Chorion Membrane Allografts in the Treatment of Lower Extremity Diabetic Ulcers

Objective: To evaluate the cost-effectiveness and budget impact of using standard care (No Advanced treatment, NAT) compared to an advanced Treatment (AT), like a Dehydrated Amnion/Chorion Membrane (DHACM) allograft, when Following Parameters for Use (FPFU) in treating Lower Extremity Diabetic Ulcers (LEDUs). FPFU is defined as the initiation of an AT within 30–45 days of a LEDU diagnosis and routine AT applications every 7–14 days during the episode of care.

Method: A retrospective analysis of Medicare data files from 2015-2019 was used to generate four propensity-matched cohorts of LEDU episodes.

Outcomes for DHACM and NAT such as amputations, and healthcare utilization were tracked from claims codes, analyzed, 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 analyzed before and after the Markov model at a willingness-to-pay 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 a LEDU. Propensity-matched Group 1 was generated from 19,910 episodes which received AT. Only 9.2% of episodes were FPFU while DHACM was identified as the most widely used AT product. 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 utilization. In year one, DHACM FPFU provided an additional 0.013 QALYs while saving $3,674 per patient. At a willingness-to-pay of $100,000 per QALY, the five-year Net Monetary Benefit was $9,726.

Conclusion: DHACM FPFU is an economically dominant strategy compared to NAT. DHACM FPFU provides better outcomes than NAT by reducing major amputations, ED visits, inpatient admissions, and readmissions. These gains are achieved at a lower cost, in years one through five and is likely to be cost-effective at any willingness-to-pay threshold. Adoption of best practices identified in this retrospective analysis is expected to generate clinically significant decreases in amputations and hospital utilization while saving money.