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

摘要 骨科创伤每年影响100万美国人，是静脉血栓形成的一个重要风险因素。 血栓栓塞（VTE）由于初始损伤，手术干预，术后固定。的 包括深静脉血栓形成（DVT）和肺栓塞（PE）在内的VTE的治疗与 昂贵的医疗干预、延长的住院时间、再入院和高死亡率。 目前，所有主要的临床指南都推荐使用低分子量肝素的多周疗程 (LMWH依诺肝素）预防骨科创伤后VTE。然而，我们的研究小组最近发表了一份 新英格兰医学杂志上的一项试验比较了低分子肝素与阿司匹林预防血栓形成的作用， 超过12，000名骨科创伤患者。我们发现阿司匹林在以下方面不劣于LMWH： 预防致死性事件，并在预防PE和大出血事件方面具有相似的保护作用。相反，LMWH 更好地保护DVT。由于阿司匹林用于血栓预防的成本较低， 与LMWH相比，确定LMWH或阿司匹林是否更具成本效益， 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）生成关于 LMWH与阿司匹林预防骨科术后静脉血栓栓塞的成本和效果比较 创伤和2）确定低分子肝素与阿司匹林预防血栓形成的成本效益， 骨科创伤患者。我们将联合收割机与Truven结合， MarketScan和联邦药物定价数据，以估计干预和治疗费用。此外，我们将 估计与我们的研究结果（死亡，PE， DVT，出血），通过对具有健康相关生活质量数据的临床研究进行系统性文献综述。 有了这些数据，我们将进行成本效用分析（CUA），基于从头马尔可夫模型，从美国 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质性： 基于政策相关指标（年龄、保险状况、VTE风险和种族）的亚组估计值。在所有 模型，我们将计算每个治疗和亚组的总成本和预期QOLS。有了这些， 使用总成本和QORs，LMWH与阿司匹林相比的增量成本-效果比（ICER） 从每次治疗中积累。在基本情况下，我们将比较计算的ICER与标准 支付意愿（WTP）阈值为每QALY 10万美元，以评估成本效益。我们还将估计 LMWH基于价值的价格，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阈值的价格。拟议的研究与改善患者安全直接相关， 使医疗保健更加实惠。

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.