de Jong Lisa Aniek, Gout-Zwart Judith J, van den Bosch Marina, Koops Mike, Postma Maarten J
a Unit of PharmacoTherapy, -Epidemiology & -Economics , University of Groningen, Groningen Research Institute of Pharmacy (GRIP) , Groningen , the Netherlands.
b Department of Nephrology , University of Groningen, University Medical Center Groningen (UMCG) , the Netherlands.
J Med Econ. 2019 Apr;22(4):306-318. doi: 10.1080/13696998.2018.1563404. Epub 2019 Jan 15.
Non-vitamin K antagonist oral anticoagulants (NOACs) have been included in international guidelines as important alternatives to vitamin K antagonists (VKAs) for the treatment of venous thromboembolism (VTE) and stroke prevention in non-valvular atrial fibrillation (NVAF). Meanwhile, in the Netherlands, NOACs are widely used next to VKAs. The objective of this study is to estimate the cost-effectiveness of treatment with rivaroxaban compared to VKAs in NVAF and VTE patients in the Netherlands, using data from international prospective observational phase IV studies.
Two models were developed to represent NVAF and VTE patients, populated with patients from the XANTUS (NCT01606995) and XALIA (NCT01619007) international prospective observational studies. The 1-year cost-effectiveness of rivaroxaban use, compared to VKAs, was explored in a population consisting of NVAF and VTE patients (base case) as well as for four scenarios with sub-populations: NVAF patients only, VTE patients only, NVAF patients with unstable international normalized ratio (INR), and NVAF patients using an INR self-measuring device.
In the base case, rivaroxaban saved €72,350 and gained 21 quality-adjusted life-years (QALYs) in a simulation of 2,000 patients over the use of VKAs. Ergo, rivaroxaban was dominant over VKAs. The probabilistic sensitivity analysis showed a probability of 85% for rivaroxaban being dominant and 100% at a willingness-to-pay threshold of €20,000/QALY. Rivaroxaban appeared to be dominant in all scenarios as well, except for the NVAF-patients-only scenario where the incremental cost-effectiveness ratio (ICER) was €157/QALY.
In patients with NVAF or VTE, rivaroxaban treatment is likely to be cost-effective and a potentially cost-saving alternative to VKA in the Netherlands.
非维生素K拮抗剂口服抗凝药（NOACs）已被纳入国际指南，作为维生素K拮抗剂（VKAs）的重要替代药物，用于治疗静脉血栓栓塞症（VTE）和预防非瓣膜性心房颤动（NVAF）患者的中风。与此同时，在荷兰，除VKAs外，NOACs也被广泛使用。本研究的目的是利用国际前瞻性观察性IV期研究的数据，评估在荷兰NVAF和VTE患者中，利伐沙班与VKAs相比治疗的成本效益。
开发了两个模型来代表NVAF和VTE患者，数据来自XANTUS（NCT01606995）和XALIA（NCT01619007）国际前瞻性观察性研究。在由NVAF和VTE患者组成的人群（基础病例）以及四个亚人群情景中，探讨了与VKAs相比，使用利伐沙班的1年成本效益：仅NVAF患者、仅VTE患者、国际标准化比值（INR）不稳定的NVAF患者以及使用INR自我测量装置的NVAF患者。
在基础病例中，在对2000名患者的模拟中，与使用VKAs相比，利伐沙班节省了72350欧元，并获得了21个质量调整生命年（QALYs）。因此，利伐沙班优于VKAs。概率敏感性分析显示，利伐沙班占优的概率为85%，在支付意愿阈值为20000欧元/QALY时占优概率为100%。利伐沙班在所有情景中似乎也占优，除了仅NVAF患者情景，其增量成本效益比（ICER）为157欧元/QALY。
在NVAF或VTE患者中，在荷兰，利伐沙班治疗可能具有成本效益，并且是VKA的一种潜在节省成本的替代方案。
