Vilain Katherine A, Yang Ming Chin, Hui Tan Elise Chia, Wang Kaijun, Li Haiyan, Hsu Wan Hsuan, Giugliano Robert P, Cohen David J, Magnuson Elizabeth A
Saint Luke's Mid America Heart Institute, Kansas City, MO, USA.
Institute of Health Policy and Management, College of Public Health, National Taiwan University, Taipei, Taiwan.
Value Health Reg Issues. 2017 May;12:74-83. doi: 10.1016/j.vhri.2017.03.011. Epub 2017 May 17.
Novel anticoagulants, such as factor Xa inhibitors, have entered clinical practice as alternatives to warfarin for the prevention of stroke and systemic embolic event (SEE) in patients with atrial fibrillation (AF). It is not known whether edoxaban, the fourth-to-market factor Xa inhibitor approved for this indication, will be cost-effective in Taiwan, where the cost of warfarin monitoring is prohibitive.
A Markov model projecting lifetime results of edoxaban 60 mg/30 mg dose-reduced versus warfarin in patients with nonvalvular AF, based on the ENGAGE AF - TIMI 48 trial, found edoxaban to be of high value relative to warfarin, from the perspective of the US health care system. We applied Taiwan-specific cost inputs to this model structure to assess the relative cost-effectiveness of edoxaban versus warfarin from the perspective of the Taiwanese health care system. Event rates and hazard ratios from the ENGAGE AF - TIMI 48 East Asian subpopulation were explored in sensitivity analyses.
Edoxaban was found to be highly cost-effective compared with warfarin, based on guidelines proposed by the World Health Organization (WHO), with a base case incremental cost-effectiveness ratio of $12,902 per quality-adjusted life year gained. These results were robust to variation of key model parameters, including assumptions regarding the cost and quality-of-life impact of stroke and bleeding events, and assuming East Asian-specific (as opposed to full-trial-population) rates for combinations of ischemic stroke, SEE, and major bleeding.
Despite its higher acquisition cost, edoxaban is an economically attractive alternative to warfarin for the prevention of stroke and SEE in patients with AF in Taiwan.
新型抗凝剂，如Xa因子抑制剂，已进入临床实践，可作为华法林的替代药物，用于预防心房颤动（AF）患者的中风和全身性栓塞事件（SEE）。目前尚不清楚已获批用于该适应症的第四种上市Xa因子抑制剂依度沙班在台湾是否具有成本效益，因为在台湾，华法林监测成本过高。
基于ENGAGE AF - TIMI 48试验，采用马尔可夫模型预测非瓣膜性AF患者中依度沙班60 mg/30 mg剂量减少方案与华法林的终生结果，从美国医疗保健系统的角度来看，依度沙班相对于华法林具有较高价值。我们将台湾特定的成本投入应用于该模型结构，从台湾医疗保健系统的角度评估依度沙班与华法林的相对成本效益。在敏感性分析中探讨了ENGAGE AF - TIMI 48东亚亚组的事件发生率和风险比。
根据世界卫生组织（WHO）提出的指南，与华法林相比，依度沙班具有很高的成本效益，基本情况增量成本效益比为每获得一个质量调整生命年12,902美元。这些结果对于关键模型参数的变化具有稳健性，包括关于中风和出血事件的成本及生活质量影响的假设，以及假设东亚特定（而非整个试验人群）的缺血性中风、SEE和大出血组合发生率。
尽管依度沙班的采购成本较高，但在台湾，对于预防AF患者的中风和SEE而言，依度沙班是华法林在经济上具有吸引力的替代药物。
