新型抗凝药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

目的:评估中国非瓣膜性房颤患者使用新型抗凝药预防卒中的成本效果,为中国房颤患者抗凝治疗药物的合理选用提供理论依据。方法:基于全球性临床试验ARISTOTLE、RE-LY及ROCKET-AF的研究数据及我国目前医疗成本,建立一年期决策树及长期外推Markov模型的方法,通过分别计算3种新型口服抗凝药物阿哌沙班(5 mg bid)、达比加群(150 mg bid、110 mg bid)、利伐沙班(20 mg qd)和华法林的调整质量生命年(QLAYs)及治疗成本,对新型抗凝药物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:NOACs治疗的总成本为163586~582710元,使用NOACs患者可获得的质量调整生命年为6.812~7.010。以华法林为参考的增效成本效果分析显示,成本效果比(ICER)为177271~739480元/QLAY,ICER_利伐沙班> ICER_阿哌沙班> ICER_{达比加群150 mg}> ICER_{达比加群110 mg}。3种抗凝药物与华法林比较的ICER均大于我国人均国民生产总值(GDP)的3倍,但小于部分城市人均GDP的3倍。一维敏感度分析显示该成本效果分析结果稳定可靠。结论:目前在我国,与华法林相比,使用新型抗凝药物预防非瓣膜性房颤患者卒中不具备成本效果优势。目前仅在我国经济发达的某些城市,可推荐阿哌沙班或达比加群用于房颤卒中的治疗。

Cost-effectiveness of novel oral anticoagulants versus warfarin for stroke prevention in patients with non-valvular atrial fibrillation

OBJECTIVE To compare cost-effectiveness of three novel oral anticoagulants versus warfarin for secondary stroke prevention in patients with non valvular atrial fibrillation (AF) in China.METHODS One year decision tree and a long term extrapolative Markov model was established based on estimated costs of three novel oral anticoagulants (NOACs) and data from NOACs for reduction in stroke in atrial fibrillation (ARISTOTLE,RE-LY and ROCKET-AF trials).By quantifying costs and quality-adjusted life years (QALYs) from apixaban 5 mg bid,dabigatran 150 mg bid,dabigatran 110 mg bid and rivaroxaban 20 mg qd compared with those from warfarin therapy targeted to an international normalized ratio of 2-3.RESULTS NOACs therapy resulted in a quality-adjusted life-years (QALYs) of 6.812-7.010 years at a cost of 163586-582710 yuan.In comparison with warfarin therapy,all three NOACs provided the gain of QALYs at an additional cost,resulting in an incremental cost-effectiveness ratio of 177271-739480 yuan per QALY.ICER for all three NOACs were found to be more than 3 times per capita GDP but less than some urban per capita GDP in China.One dimensional sensitivity analysis showed that this cost-effectiveness analysis was stable and reliable.CONCLUSION Under current economic situations in China,apixaban shows no superior cost-effectiveness to warfarin for stroke prevention in patients with AF.Apixaban and dabigatran can be recommend in some cities with highly developed economics for stroke prevention.