Bayer Plc, Reading, England, United Kingdom.
Bayer AG, Berlin, Germany.
PLoS One. 2020 Jan 24;15(1):e0225301. doi: 10.1371/journal.pone.0225301. eCollection 2020.
The objective was to assess the real-world cost-effectiveness of rivaroxaban, versus vitamin K antagonists (VKAs), for stroke prevention in patients with atrial fibrillation (AF) from a French national health insurance perspective.
A Markov model was developed with a lifetime horizon and cycle length of 3 months. All inputs were drawn from real-world evidence (RWE) studies: data on baseline patient characteristics at model entry were obtained from a French RWE study, clinical event rates as well as persistence rates for the VKA treatment arm were estimated from a variety of RWE studies, and a meta-analysis provided comparative effectiveness for rivaroxaban compared to VKA. Model outcomes included costs (drug costs, clinical event costs, and VKA monitoring costs), quality-adjusted life-years (QALY) and life-years (LY) gained, incremental cost per QALY, and incremental cost per LY. Sensitivity analyses were performed to test the robustness of the model and to better understand the results drivers.
In the base-case analysis, the incremental total cost was €714 and the total incremental QALYs and LYs were 0.12 and 0.16, respectively. The resulting incremental cost/QALY and incremental cost/LY were €6,006 and €4,586, respectively. The results were more sensitive to the inclusion of treatment-specific utility decrements and clinical event rates.
Although there is no official willingness-to-pay threshold in France, these results suggest that rivaroxaban is likely to be cost-effective compared to VKA in French patients with AF from a national insurance perspective.
从法国国家健康保险的角度出发,评估利伐沙班相较于维生素 K 拮抗剂(VKA)用于预防房颤(AF)患者卒中的真实世界成本效益。
采用Markov 模型进行研究,模型的时间范围为终生,时间周期为 3 个月。所有输入均来自真实世界证据(RWE)研究:模型初始时的基线患者特征数据来自一项法国 RWE 研究,VKA 治疗组的临床事件发生率和持续率由多项 RWE 研究进行估算,比较利伐沙班与 VKA 的疗效的是一项荟萃分析。模型结果包括成本(药物成本、临床事件成本和 VKA 监测成本)、质量调整生命年(QALY)和生命年(LY)的增加、增量成本每 QALY 和增量成本每 LY。进行了敏感性分析以检验模型的稳健性,并深入了解结果驱动因素。
在基础案例分析中,增量总成本为 714 欧元,增量总 QALY 和 LY 分别为 0.12 和 0.16。增量成本/QALY 和增量成本/LY 分别为 6006 欧元和 4586 欧元。结果对特定治疗方法的效用降低和临床事件发生率的纳入更为敏感。
尽管法国没有官方的意愿支付阈值,但这些结果表明,从国家保险的角度来看,利伐沙班相较于 VKA 用于法国 AF 患者,可能具有成本效益。