Texas A&M University, College Station, Texas; Medical Decision Modeling Inc, Indianapolis, Indiana.
Medical Decision Modeling Inc, Indianapolis, Indiana.
Clin Ther. 2021 Nov;43(11):1877-1893.e4. doi: 10.1016/j.clinthera.2021.09.016. Epub 2021 Oct 4.
In the Phase III COV-BARRIER (Efficacy and Safety of Baricitinib for the Treatment of Hospitalised Adults With COVID-19) trial, treatment with baricitinib, an oral selective Janus kinase 1/2 inhibitor, in addition to standard of care (SOC), was associated with significantly reduced mortality over 28 days in hospitalized patients with coronavirus disease-2019 (COVID-19), with a safety profile similar to that of SOC alone. This study assessed the cost-effectiveness of baricitinib + SOC versus SOC alone (which included systemic corticosteroids and remdesivir) in hospitalized patients with COVID-19 in the United States.
An economic model was developed to simulate inpatients' stay, discharge to postacute care, and recovery. Costs modeled included payor costs, hospital costs, and indirect costs. Benefits modeled included life-years (LYs) gained, quality-adjusted life-years (QALYs) gained, deaths avoided, and use of mechanical ventilation avoided. The primary analysis was performed from a payor perspective over a lifetime horizon; a secondary analysis was performed from a hospital perspective. The base-case analysis modeled the numeric differences in treatment effectiveness observed in the COV-BARRIER trial. Scenario analyses were also performed in which the clinical benefit of baricitinib was limited to the statistically significant reduction in mortality demonstrated in the trial.
In the base-case payor perspective model, an incremental total cost of 17,276 US dollars (USD), total QALYs gained of 0.6703, and total LYs gained of 0.837 were found with baricitinib + SOC compared with SOC alone. With the addition of baricitinib, survival was increased by 5.1% and the use of mechanical ventilation was reduced by 1.6%. The base-case incremental cost-effectiveness ratios were 25,774 USD/QALY gained and 20,638 USD/LY gained; a "mortality-only" scenario analysis yielded similar results of 26,862 USD/QALY gained and 21,433 USD/LY gained. From the hospital perspective, combination treatment with baricitinib + SOC was more effective and less costly than was SOC alone in the base case, with an incremental cost of 38,964 USD per death avoided in the mortality-only scenario.
In hospitalized patients with COVID-19 in the United States, the addition of baricitinib to SOC was cost-effective. Cost-effectiveness was demonstrated from both the payor and the hospital perspectives. These findings were robust to sensitivity analysis and to conservative assumptions limiting the clinical benefits of baricitinib to the statistically significant reduction in mortality demonstrated in the COV-BARRIER trial.
在 III 期 COV-BARRIER（巴瑞替尼治疗住院 COVID-19 成人患者的疗效和安全性）试验中，与标准治疗（SOC）相比，加用口服选择性 Janus 激酶 1/2 抑制剂巴瑞替尼可显著降低住院 COVID-19 患者 28 天死亡率，安全性与 SOC 相当。本研究在美国评估了 COVID-19 住院患者中 SOC 联合巴瑞替尼与 SOC 单药（包括全身皮质类固醇和瑞德西韦）治疗的成本效益。
建立经济模型以模拟住院患者的住院时间、转至急性后护理和康复情况。模型中包括支付者成本、医院成本和间接成本。模型中获益包括获得的生命年（LY）、质量调整生命年（QALY）、避免的死亡和避免的机械通气。主要分析从支付者角度在终身时间范围内进行；次要分析从医院角度进行。基础案例分析采用 COV-BARRIER 试验中观察到的治疗效果的数值差异进行建模。还进行了情景分析，其中巴瑞替尼的临床获益仅限于试验中显示的死亡率统计学显著降低。
在基础案例支付者角度模型中，SOC 联合巴瑞替尼治疗比 SOC 单药治疗的总增量成本为 17276 美元（USD），总 QALY 增加 0.6703，总 LY 增加 0.837。加用巴瑞替尼可使生存率提高 5.1%，机械通气使用率降低 1.6%。基础案例增量成本-效果比为 25774 美元/QALY 增加和 20638 美元/LY 增加；“仅死亡率”情景分析结果类似，为 26862 美元/QALY 增加和 21433 美元/LY 增加。从医院角度来看，SOC 联合巴瑞替尼治疗比 SOC 单药治疗更有效且成本更低，在仅死亡率情景下，每避免一例死亡的增量成本为 38964 美元。
在美国 COVID-19 住院患者中，SOC 联合巴瑞替尼治疗具有成本效益。从支付者和医院角度均证明了成本效益。这些发现通过敏感性分析和对巴瑞替尼临床获益仅限于 COV-BARRIER 试验中显示的死亡率统计学显著降低的保守假设分析是稳健的。
