Is Aspirin a Cost-Effective Thromboprophylaxis Alternative for Orthopaedic Trauma Patients?

阿司匹林是骨科创伤患者经济有效的血栓预防替代方案吗？

• 批准号: 10784156
• 负责人: Joseph Frank Levy
• 金额: $ 9.93万
• 依托单位: UNIVERSITY OF MARYLAND BALTIMORE
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-30 至 2024-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10784156
• 关键词: Aspirin; Cost; Effective; Thromboprophylaxis; Alternative

ABSTRACT Orthopaedic trauma affects 1 million Americans annually and is a strong risk factor for venous thromboembolism (VTE) due to the initial injury, surgical intervention, and postoperative immobilization. The treatment of VTE, which includes deep vein thrombosis (DVT) and pulmonary embolism (PE), is associated with costly medical interventions, extended inpatient duration, hospital readmission, and high fatality rates. Currently, all major clinical guidelines recommend a multiweek course of low-molecular-weight heparin (LMWH, enoxaparin) to prevent VTE after orthopaedic trauma. However, our study team recently published a trial in the New England Journal of Medicine that compared thromboprophylaxis with LMWH versus aspirin in over 12,000 patients who sustained orthopaedic trauma. We found that aspirin was noninferior to LMWH in preventing fatal events and similar in its protection against PE and major bleeding events. In contrast, LMWH provided better protection against DVT. Given the substantially lower cost of aspirin for thromboprophylaxis compared to LMWH, determining if LMWH or aspirin is more cost-effective is of tremendous interest to patients, clinicians, payers, and policymakers. In this proposed study, we aim to 1) generate evidence on the comparative costs and effects of LMWH versus aspirin for the prevention of VTE after orthopaedic trauma and 2) determine the cost-effectiveness of LMWH versus aspirin for thromboprophylaxis in orthopaedic trauma patients. We will combine clinical trial data of over 12,000 patients with Truven MarketScan and federal drug pricing data to estimate intervention and treatment costs. In addition, we will estimate health state utilities (HSU) of discrete health states associated with our study outcomes (death, PE, DVT, bleeding) through a systematic literature review of clinical studies with health-related quality of life data. With these data, we will perform a cost-utility analysis (CUA), based on a de novo Markov model, from the US healthcare sector payers’ perspectives. In addition to a base model, we will explore heterogeneity through subgroup estimates based on policy-relevant indicators (age, insurance status, VTE risk, and race). In all models, we will compute the total costs and QALYs expected from each treatment and subgroup. With these, incremental cost-effectiveness ratios (ICERs) of LMWH compared to aspirin using total costs and QALYs accumulated from each treatment. In the base case, we will compare the computed ICER to a standard willingness to pay (WTP) threshold of $100,000 per QALY to assess cost-effectiveness. We will also estimate the value-based prices of LMWH to discern the difference between current market prices and value-based prices at various WTP thresholds. The proposed research is directly relevant to improving patient safety and making healthcare more affordable.

摘要 骨科创伤每年影响100万美国人，是静脉疾病的强烈风险因素 血栓栓塞症(VTE)源于最初的损伤、手术干预和术后制动。这个 VTE的治疗，包括深静脉血栓形成(DVT)和肺栓塞(PE)，是相关的 由于昂贵的医疗干预、延长的住院时间、再次住院和高死亡率。 目前，所有主要的临床指南都建议使用多周疗程的低分子肝素 (低分子肝素，依诺肝素)预防骨科创伤后静脉血栓形成。然而，我们的研究小组最近发表了一份 在《新英格兰医学杂志》上发表的一项比较低分子肝素和阿司匹林预防血栓的试验 超过12,000名遭受骨科创伤的患者。我们发现阿司匹林并不逊色于低分子肝素 防止致命事件，以及在防止PE和重大出血事件方面的类似保护。相比之下，LMWH 提供更好的预防DVT的保护。鉴于阿司匹林用于血栓预防的成本大大降低 与低分子肝素相比，确定低分子肝素和阿司匹林哪一个更具成本效益是非常有意义的 患者、临床医生、付款人和政策制定者。在这项拟议的研究中，我们的目标是1)产生关于 低分子肝素与阿司匹林预防骨科术后静脉血栓形成的成本和效果比较 创伤和2)确定低分子肝素与阿司匹林预防血栓的成本-效果 骨科创伤患者。我们将结合超过12,000名患者的临床试验数据使用Truven MarketScan和联邦药品定价数据，以估计干预和治疗成本。此外，我们还将 估计与我们的研究结果相关的离散健康状态(死亡、PE、 DVT，出血)通过系统的文献回顾与健康相关的生活质量数据的临床研究。 有了这些数据，我们将基于来自美国的新马尔可夫模型进行成本效用分析(CUA 医疗保健行业支付者的观点。除了基本模型之外，我们还将通过以下方式探索异构性 根据与政策相关的指标(年龄、保险状况、VTE风险和种族)进行的分组估计。总而言之， 模型中，我们将计算每个治疗和分组预期的总成本和QALY。有了这些， 使用总成本和QALY比较低分子肝素与阿司匹林的增量成本-效果比 从每种处理中积累的。在基本情况下，我们将计算的ICER与标准ICER进行比较 支付意愿(WTP)阈值为每QALY 100,000美元，以评估成本效益。我们还将估计 以价值为基础的低含水率价格，以区分当前市场价格和基于价值的价格之间的差异 不同WTP门槛的价格。拟议的研究直接与改善患者安全和 让医疗保健更容易负担得起。