阿哌沙班与华法林用于非瓣膜性房颤患者卒中防治的成本效果分析

Cost-effectiveness of Apixaban vs Warfarin for Secondary Stroke Prevention of Atrial Fibrillation

关键词:  阿哌沙班  华法林  非瓣膜性房颤  抗凝  药物经济学

Key words:  apixaban  warfarin  atrial fibrillation  anticoagulation  pharmacoeconomics

摘要:

目的 评估中国非瓣膜性房颤患者使用阿哌沙班或华法林预防卒中的成本效果。方法 基于全球性临床试验ARISTOTLE的研究数据及中国目前医疗成本，建立1年期决策树及长期外推Markov模型的方法，通过计算新型口服抗凝药物阿哌沙班(5 mg bid)及华法林(INR控制在2.0~3.0)的质量调整生命年(quality-adjusted life-years QALYs)及治疗成本，对阿哌沙班用于中国房颤患者卒中预防的成本效果进行了分析和研究。结果 阿哌沙班和华法林的总成本分别为271 826元和40 126元，阿哌沙班组患者可获得的QALYs为6.256，华法林组患者的QALYs为5.614。阿哌沙班较华法林的增量成本效果比(incremental cost-effectiveness ratio，ICER)为360 903元/QALY。ICER>3倍中国人均GDP，但<3倍部分城市人均GDP。敏感度分析显示该成本效果分析结果稳定可靠。结论 在中国目前整体经济形势下，与华法林相比，将阿哌沙班预防非瓣膜性房颤患者卒中预防不具备成本效果优势。目前仅在中国经济发达的某些城市，可推荐阿哌沙班替代华法林成为房颤卒中治疗药物。

Abstract:

OBJECTIVE To compare the cost-effectiveness of apixaban vs warfarin for secondary stroke prevention in patients with atrial fibrillation in China. METHODS Using standard methods, a decision tree and a Markov decision model were created based on the estimated cost of apixaban and data from the Apixaban for Reduction in Stroke in Atrial Fibrillation (ARISTOTLE) trial. The cost and quality-adjusted life expectancy were quantified resulting from apixaban 5 mg twice daily compared with those from warfarin therapy targeted to an international normalized ratio of 2–3. RESULTS Warfarin therapy resulted in a quality-adjusted life expectancy of 5.614 years at a cost of 40 126 yuan. In comparison, treatment with apixaban led to a quality-adjusted life expectancy of 6.256 years at a cost of 271 826 yuan. Therefore, apixaban provided a gain of 0.642 quality-adjusted life-years (QALYs) at an additional cost of 231?700 yuan, resulting in an incremental cost-effectiveness ratio of 360 903 yuan per QALY, which was >3 times per capita GDP. The findings were robust in univariate sensitivity analyses varying model inputs across plausible ranges. CONCLUSION Under the current economic situation in China, apixaban appears to have no cost-effectiveness relative to warfarin for stroke prevention in patients with atrial fibrillation. It is only recommend in some cities with highly developed economics.