Strategic Solutions, Inc, Bozeman, MT, USA.
J Med Econ. 2020 Nov;23(11):1273-1283. doi: 10.1080/13696998.2020.1803888. Epub 2020 Aug 8.
The aim of this health economics study was to estimate the cost-utility of an aseptically processed, dehydrated human amnion and chorion allograft (dHACA) plus standard of care (SOC) (group 1) versus SOC alone (group 2) based on a published randomized controlled trial in which patients who had an eligible Wagner 1 diabetic foot ulcer wound were randomized to either of these treatments.
A Markov microsimulation was used to project trial results out to a 1-year horizon time with a third-party payer perspective. The starting health state was an unhealed non-infected ulcer with other health states of healed ulcer, infected non-healed ulcer, cellulitis, osteomyelitis, and absorbing states of dead or amputation. All patients started with unhealed non-infected ulcers at cycle 0. Costs were incurred by patients for procedures at hospital outpatient wound care provider-based departments (PBDs) and hospitals (if complications occurred) and were calculated using time-based activity costing methods. Effectiveness units were quality-adjusted life years (QALYs) computed from literature utility values. One-way and probabilistic sensitivity analysis (PSA) were also conducted.
After 1 year, the calculated incremental cost-effectiveness ratio (ICER) for group 1 versus group 2 was -$4,373 with group 1 (dHACA) being dominant over group 2 (SOC). PSA demonstrated that group 1 had 69.2% lower cost values with increased positive incremental effectiveness for 94.9% of values. A willingness to pay (WTP) curve showed that about 92% of interventions were cost effective for group 1 when $50,000 was paid.
The results of this study demonstrated that dHACA added to SOC compared to SOC alone was extremely cost-effective in the defined trial population.
本项健康经济学研究旨在评估经无菌处理、脱水的人羊膜和绒毛膜同种异体移植物（dHACA）联合标准治疗（SOC）（第 1 组）与单独 SOC（第 2 组）的成本-效用，其依据是一项已发表的随机对照试验，其中纳入的符合条件的 Wagner 1 型糖尿病足溃疡患者被随机分配至这两种治疗方案。
采用马尔可夫微模拟方法，基于一项 1 年时间的前瞻性试验结果，从第三方支付者的角度进行预测。起始健康状态为未愈合的无感染性溃疡，其他健康状态包括已愈合的溃疡、感染性未愈合的溃疡、蜂窝织炎、骨髓炎和吸收性的坏疽或截肢。所有患者在第 0 周期开始时均为未愈合的无感染性溃疡。患者在医院门诊伤口护理提供者科室（PBD）和医院（如果发生并发症）产生的费用通过基于时间的活动成本核算方法进行计算。采用文献效用值计算健康调整生命年（QALY）作为有效性单位。还进行了单因素敏感性分析（PSA）和概率敏感性分析（PSA）。
1 年后，第 1 组与第 2 组的增量成本效益比（ICER）计算值为-4373 美元，第 1 组（dHACA）的成本效益优于第 2 组（SOC）。PSA 显示，第 1 组的成本值降低了 69.2%，而增量有效性增加了 94.9%。意愿支付（WTP）曲线显示，当支付 5 万美元时，第 1 组约 92%的干预措施具有成本效益。
本研究结果表明，在定义的试验人群中，与 SOC 相比，dHACA 联合 SOC 的成本效益极高。
