Abstract：
UNASSIGNED: The objective in this study was to assess the clinical and economic implications of the inclusion of rivaroxaban as a secondary prophylaxis in patients with chronic or symptomatic peripheral artery disease (PAD) in the United States (US).
UNASSIGNED: A cost-consequence model was adapted to evaluate the economic impact of rivaroxaban plus aspirin in a hypothetical 1-million-member health plan. The model inputs were taken from multiple sources: efficacy and safety of rivaroxaban + aspirin vs. aspirin alone were abstracted from COMPASS and VOYAGER randomized clinical trials; the prevalence of chronic and symptomatic PAD and incidence rates of clinical events (major adverse cardiac events [MACE], major adverse limb events [MALE], and major bleeding), were abstracted from the analysis of claims data; healthcare costs of clinical events and wholesale acquisition costs for rivaroxaban were abstracted from the literature and Red Book, respectively (2022 USD). One-way sensitivity analyses and subgroup analyses were also conducted.
UNASSIGNED: Over one year, with a 5% uptake of rivaroxaban, the model estimated rivaroxaban + aspirin to reduce 21 MACE/MALE events in the PAD patient population. The reduction in these clinical events offsets the increased risk of major bleeding (16 additional events), demonstrating a positive health benefit of the rivaroxaban addition. These benefits led to a $0.27 incremental cost per member per month (PMPM) to a US plan. The major driver of the incremental cost was the cost of rivaroxaban. In a subgroup of patients with the presence of any high-risk factor (heart failure, diabetes, renal insufficiency, or history of vascular disease affecting two or more vascular beds), the incremental PMPM cost was $0.13.
UNASSIGNED: Rivaroxaban + aspirin was found to provide positive net clinical benefit on the annual number of MACE/MALE avoided, with a modest increase in the PMPM cost.
UNASSIGNED: A cost-consequence model was adapted to evaluate the economic impact of rivaroxaban plus aspirin in a hypothetical 1-million-member health plan. The model inputs were taken from multiple sources: efficacy and safety of rivaroxaban + aspirin vs. aspirin alone were abstracted from COMPASS and VOYAGER randomized clinical trials; the prevalence of chronic and symptomatic PAD and incidence rates of clinical events (major adverse cardiac events [MACE], major adverse limb events [MALE], and major bleeding), were abstracted from the analysis of claims data; healthcare costs of clinical events and wholesale acquisition costs for rivaroxaban were abstracted from the literature and Red Book, respectively (2022 USD). One-way sensitivity analyses and subgroup analyses were also conducted.
UNASSIGNED: Over one year, with a 5% uptake of rivaroxaban, the model estimated rivaroxaban + aspirin to reduce 21 MACE/MALE events in the PAD patient population. The reduction in these clinical events offsets the increased risk of major bleeding (16 additional events), demonstrating a positive health benefit of the rivaroxaban addition. These benefits led to a $0.27 incremental cost per member per month (PMPM) to a US plan. The major driver of the incremental cost was the cost of rivaroxaban. In a subgroup of patients with the presence of any high-risk factor (heart failure, diabetes, renal insufficiency, or history of vascular disease affecting two or more vascular beds), the incremental PMPM cost was $0.13.
UNASSIGNED: Rivaroxaban + aspirin was found to provide positive net clinical benefit on the annual number of MACE/MALE avoided, with a modest increase in the PMPM cost.
摘要：
■本研究的目的是评估在美国（US）慢性或有症状的外周动脉疾病（PAD）患者中纳入利伐沙班作为二级预防的临床和经济意义。
■采用成本-后果模型来评估利伐沙班加阿司匹林在一个假设的100万成员健康计划中的经济影响。模型输入来自多个来源：利伐沙班+阿司匹林的疗效和安全性与从COMPASS和VOYAGER随机临床试验中提取单纯阿司匹林；慢性和有症状的PAD的患病率和临床事件的发生率（主要不良心脏事件[MACE]，主要肢体不良事件[男性]，和大出血)，从索赔数据分析中提取；从文献和红皮书中提取临床事件的医疗保健成本和利伐沙班的批发采购成本，分别（2022美元）。还进行了单向敏感性分析和亚组分析。
■超过一年，服用5%的利伐沙班，该模型估计利伐沙班+阿司匹林可减少PAD患者人群中的21起MACE/MALE事件.这些临床事件的减少抵消了大出血风险的增加（16个额外事件），证明利伐沙班的积极健康益处。这些好处导致美国计划每个成员每月增加0.27美元的成本(PMPM)。增加成本的主要驱动因素是利伐沙班的成本。在存在任何高风险因素（心力衰竭，糖尿病,肾功能不全,或影响两个或多个血管床的血管疾病病史)，增加的PMPM成本为0.13美元。
■利伐沙班+阿司匹林被发现对每年避免的MACE/男性数量提供正的净临床益处，PMPM成本略有增加。
■采用成本-后果模型来评估利伐沙班加阿司匹林在一个假设的100万成员健康计划中的经济影响。模型输入来自多个来源：利伐沙班+阿司匹林的疗效和安全性与从COMPASS和VOYAGER随机临床试验中提取单纯阿司匹林；慢性和有症状的PAD的患病率和临床事件的发生率（主要不良心脏事件[MACE]，主要肢体不良事件[男性]，和大出血)，从索赔数据分析中提取；从文献和红皮书中提取临床事件的医疗保健成本和利伐沙班的批发采购成本，分别（2022美元）。还进行了单向敏感性分析和亚组分析。
■超过一年，服用5%的利伐沙班，该模型估计利伐沙班+阿司匹林可减少PAD患者人群中的21起MACE/MALE事件.这些临床事件的减少抵消了大出血风险的增加（16个额外事件），证明利伐沙班的积极健康益处。这些好处导致美国计划每个成员每月增加0.27美元的成本(PMPM)。增加成本的主要驱动因素是利伐沙班的成本。在存在任何高风险因素（心力衰竭，糖尿病,肾功能不全,或影响两个或多个血管床的血管疾病病史)，增加的PMPM成本为0.13美元。
■利伐沙班+阿司匹林被发现对每年避免的MACE/男性数量提供正的净临床益处，PMPM成本略有增加。
