Dehydrated human amnion/chorion membrane to treat venous leg ulcers: a cost-effectiveness analysis
Abstract
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.
Approximately 1–3% of total healthcare expenditures are devoted to hard-to-heal wounds in high-income countries, and these rates are likely to increase as the population ages.1 In 2021, the US Medicare programme covered over 63.8 million lives, at a cost of $839 billion USD or 3.9% of the US gross domestic product (GDP), and is projected to increase to 6.5% of GDP by 2096.2 Hard-to-heal or chronic wounds, defined as wounds which have failed to close by 40–50% after four weeks of good standard care,3 affected about 10.5 million US Medicare beneficiaries in 2019 and cost projections for all wounds ranged from $22.5–67.0 billion USD.4 In the US, it has been estimated that 500,000–600,000 people experience a venous leg ulcer (VLU) annually,5 accounting for approximately 2% of total US healthcare costs.6 A retrospective analysis highlighted Medicare spending for wound care per beneficiary with the principal diagnosis of VLU increased from a mean value of $1206 USD in 2014 to $1803 USD in 2019.4 If medical resources and work absenteeism are taken into account, the annual US payor burden was estimated at $14.9 billion USD in 2014 for Medicare and private insurers, excluding generic payors.7
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