Department of Operations, Faculty of Economics and Business, University of Groningen, Groningen, The Netherlands.
Health Technology Assessment, Department of Epidemiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Eur Stroke J. 2023 Sep;8(3):638-646. doi: 10.1177/23969873231174943. Epub 2023 May 19.
Alteplase is widely used as an intravenous thrombolytic drug in acute ischemic stroke (AIS). Recently however, tenecteplase, a modified form of tissue plasminogen activator, has been shown to increase early recanalization rate and has proven to be non-inferior with a similar safety profile compared to alteplase. This study aims to evaluate the cost-effectiveness of 0.25 mg/kg tenecteplase versus 0.9 mg/kg alteplase for intravenous thrombolysis in AIS patients from the Dutch healthcare payer perspective.
A Markov decision-analytic model was constructed to assess total costs, total quality-adjusted life year (QALY), an incremental cost-effectiveness ratio, and incremental net monetary benefit (INMB) of two treatments at willingness-to-pay (WTP) thresholds of €50,000/QALY and €80,000/QALY over a 10-year time horizon. One-way sensitivity analysis, probabilistic sensitivity analysis, and scenario analysis were conducted to test the robustness of results. Clinical data were obtained from large randomized controlled trials and real-world data.
Treatment with tenecteplase saved €21 per patient while gaining 0.05 QALYs, resulting in INMB of €2381, clearly rendering tenecteplase cost-effective compared to alteplase. Importantly, tenecteplase remained the cost-effective alternative in all scenarios, including AIS patients due to large vessel occlusion (LVO). Probabilistic sensitivity analysis proved tenecteplase to be cost-effective with a 71.0% probability at a WTP threshold of €50,000/QALY.
Tenecteplase treatment was cost-effective for all AIS patients (including AIS patients with LVO) compared to alteplase. The finding supports the broader use of tenecteplase in acute stroke care, as health outcomes improve at acceptable costs while having practical advantages, and a similar safety profile.
阿替普酶广泛应用于急性缺血性脑卒中(AIS)的静脉溶栓治疗。然而,近年来组织型纤溶酶原激活剂(t-PA)的改良型药物替奈普酶已被证明能提高早期再通率,且在与阿替普酶比较时,其疗效非劣效,安全性相似。本研究旨在从荷兰医疗保健支付方的角度,评估 0.25mg/kg 替奈普酶与 0.9mg/kg 阿替普酶用于 AIS 患者静脉溶栓的成本效果。
构建了一个马尔可夫决策分析模型,以评估两种治疗方案在 10 年时间范围内,在支付意愿(WTP)阈值为 50000 欧元/QALY 和 80000 欧元/QALY 时的总成本、总质量调整生命年(QALY)、增量成本效果比和增量净货币效益(INMB)。进行了单因素敏感性分析、概率敏感性分析和情景分析,以检验结果的稳健性。临床数据来源于大型随机对照试验和真实世界数据。
替奈普酶治疗可使每位患者节省 21 欧元,同时获得 0.05 个 QALY,使 INMB 达到 2381 欧元,明显使替奈普酶的成本效果优于阿替普酶。重要的是,在包括大血管闭塞(LVO)的 AIS 患者在内的所有情况下,替奈普酶都是更具成本效益的选择。在 WTP 阈值为 50000 欧元/QALY 时,概率敏感性分析证明替奈普酶具有 71.0%的成本效果概率。
与阿替普酶相比,替奈普酶治疗对所有 AIS 患者(包括 LVO 的 AIS 患者)均具有成本效果。该结果支持更广泛地将替奈普酶应用于急性脑卒中治疗,因为在可接受的成本下提高了健康结果,同时具有实际优势和相似的安全性。