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利伐沙班与华法林用于肯尼亚西部静脉血栓栓塞管理的成本效益分析

A Cost-Effectiveness Analysis of Rivaroxaban Compared to Warfarin for the Management of Venous Thromboembolism in Western Kenya.

作者信息

O'Neill Emily T, Huang Andrew W, Wilson-Barthes Marta, Manji Imran, Kigen Gabriel, Busakhala Naftali, Nyanje Samuel, Galárraga Omar, Pastakia Sonak D

机构信息

Department of Health Services Policy and Practice, Brown University School of Public Health, 121 S. Main Street, Providence, RI, 02903, USA.

Center for Global Public Health, Brown University School of Public Health, 121 S. Main Street, Providence, RI, 02903, USA.

出版信息

Clin Drug Investig. 2025 Jun 28. doi: 10.1007/s40261-025-01454-7.

Abstract

BACKGROUND AND OBJECTIVE

Access to direct oral anticoagulants (DOACs) in sub-Saharan Africa is limited due to prohibitive upfront costs, making warfarin the standard of care for many patients, especially those relying on public-sector healthcare. This study evaluated the cost-effectiveness of using the DOAC, rivaroxaban, compared to warfarin for treating venous thromboembolism (VTE), a cardiovascular disorder caused by blood clots in the veins, in western Kenya.

METHODS

We developed a discrete-time individual state-transition Markov model to simulate a VTE patient's quality-adjusted life-years (QALYs) and annual treatment costs under a rivaroxaban or warfarin therapy strategy. Transition state probabilities were derived from real-world event-rate data observed in patients treated with rivaroxaban (n = 160) or warfarin (n = 116) for VTE at Moi Teaching and Referral Hospital in western Kenya. Base-case parameter values were obtained from cohort event rates, local costs, and literature-derived utility values. Cost-effectiveness was assessed over a 1-year time horizon using an incremental cost-effectiveness ratio (ICER) threshold of (US)$6020.40 per QALY gained (equivalent to three times Kenya's 2021 per capita GDP). Deterministic and probabilistic sensitivity analyses were conducted to assess parameter and model uncertainty.

RESULTS

After 12 months, total mean treatment costs per patient were $216.00 and $173.00 using warfarin and rivaroxaban, respectively. In the base-case analysis, rivaroxaban therapy resulted in an additional 0.023 QALYs per patient compared to warfarin, with an ICER of $- 1862.00 per QALY gained. Based on probabilistic sensitivity analysis with Monte Carlo simulation, when costs, utility values, and event rates were varied, rivaroxaban was cost-effective compared to warfarin in 84.1% of all simulations at a willingness-to-pay threshold of $6020.40 per QALY. One-way sensitivity analyses and scenario analyses were stable with rivaroxaban therapy, resulting in fewer costs and higher QALYs.

CONCLUSIONS

In this study, rivaroxaban is a clinically and economically superior alternative to warfarin. This research may catalyze further discussions with policymakers and industry partners to scale up the appropriate use of rivaroxaban in resource-constrained settings.

摘要

背景与目的

由于前期成本过高,撒哈拉以南非洲地区获得直接口服抗凝剂(DOACs)的机会有限,这使得华法林成为许多患者(尤其是依赖公共部门医疗保健的患者)的标准治疗药物。本研究评估了在肯尼亚西部,使用DOAC利伐沙班与华法林治疗静脉血栓栓塞症(VTE,一种由静脉血栓引起的心血管疾病)的成本效益。

方法

我们开发了一个离散时间个体状态转换马尔可夫模型,以模拟在利伐沙班或华法林治疗策略下VTE患者的质量调整生命年(QALYs)和年度治疗成本。转换状态概率来自于在肯尼亚西部莫伊教学与转诊医院接受利伐沙班(n = 160)或华法林(n = 116)治疗VTE的患者中观察到的实际事件发生率数据。基础案例参数值来自队列事件发生率、当地成本和文献得出的效用值。使用每获得一个QALY增加成本效益比(ICER)阈值为6020.40美元(相当于肯尼亚2021年人均国内生产总值的三倍),在1年的时间范围内评估成本效益。进行确定性和概率敏感性分析以评估参数和模型的不确定性。

结果

12个月后,使用华法林和利伐沙班时每位患者的总平均治疗成本分别为216.00美元和173.00美元。在基础案例分析中,与华法林相比,利伐沙班治疗使每位患者额外获得0.023个QALYs,ICER为每获得一个QALY - 1862.00美元。基于蒙特卡洛模拟的概率敏感性分析,当成本、效用值和事件发生率变化时,在每QALY支付意愿阈值为6020.40美元的情况下,在所有模拟中有84.1%的情况利伐沙班比华法林更具成本效益。单向敏感性分析和情景分析显示利伐沙班治疗稳定,成本更低且QALYs更高。

结论

在本研究中,利伐沙班在临床和经济上是优于华法林的替代药物。这项研究可能会促使与政策制定者和行业伙伴进行进一步讨论,以在资源有限的环境中扩大利伐沙班的合理使用。

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