RestorixHealth, Los Angeles, CA, US.
College of Podiatric Medicine, Western University of Health Sciences, US.
J Wound Care. 2024 Mar 1;33(Sup3):S24-S38. doi: 10.12968/jowc.2024.33.Sup3.S24.
To evaluate the cost-effectiveness of dehydrated human amnion/chorion membrane (DHACM) in Medicare enrolees who developed a venous leg ulcer (VLU).
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.
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.
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.
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.
评估脱水人羊膜/绒毛膜（DHACM）在医疗保险参保者中治疗静脉性腿部溃疡（VLU）的成本效益。
本经济学评价采用四状态马尔可夫模型，从美国医疗保险的角度，模拟接受高级治疗（AT）的 DHACM 治疗或无高级治疗（NAT）的 VLU 患者在三年内的疾病进展。DHACM 治疗的评估依据是使用参数（FPFU），即应用在初始 VLU 诊断索赔后 30-45 天开始，并在每周至每两周一次的基础上重新应用，直至治疗结束。该队列基于 2015-2019 年间发生 VLU 的 530,220 名医疗保险参保者的索赔数据进行建模。直接医疗成本、质量调整生命年（QALYs）和意愿支付阈值为 100,000 美元/QALY 时的净货币收益（NMB）。进行了单变量和概率敏感性分析（PSA）以检验模型结果的不确定性。
DHACM 的 FPFU 应用优于 NAT，每例患者的成本降低了 170 美元，三年内 QALY 增加了 0.010。在相同时间内，DHACM FPFU 的 NMB 为每位患者 1178 美元。VLU 复发率对模型不确定性有显著影响。在 PSA 中，DHACM FPFU 在 100,000 美元/QALY 阈值下，63.01%的模拟结果具有成本效益。
在这项分析中，与 NAT 相比，DHACM FPFU 是一种更具成本效益的策略，因为它在三年内从美国医疗保险的角度来看既节省成本又增加了 QALYs。一项静脉性腿部溃疡医疗保险结果分析显示，与接受 NAT 的患者相比，接受含细胞、无细胞和基质样产品（CAMP）的 AT 治疗的患者具有更好的结果。鉴于为患者提供了更低成本的附加临床益处，提供者应向符合条件的 VLU 患者推荐 DHACM FPFU。公共保险公司（如 Medicare 和 Medicaid）和商业支付方的决策者应优先为 DHACM 的报销建立优惠目录，以降低预算影响并改善其治疗慢性伤口的患者群体的长期健康状况。
本分析得到 MiMedx 集团，Inc.，美国的支持。JLD 和 RAF 是 MiMedx 集团，Inc.的员工。WHT、BH、PS、BGC 和 WVP 是 MiMedx 集团，Inc.的顾问。VD、AO、MRK、JAN、NW 和 GAM 曾在 MiMedx 集团，Inc.的顾问委员会任职。MRK 和 JAN 曾在演讲者席任职。WVP 从美国的 Stage Analytics 公司获得个人酬金和股权。
