OBJECTIVES: Warfarin has been the standard oral anticoagulant for stroke prevention in patients with atrial fibrillation (AF). However, it has an increased risk of bleeding and a narrow therapeutic range which required frequent monitoring of the International Normalized Ratio (INR) and dose adjustments. Dabigatran, a novel oral anticoagulant, has demonstrated to be at least as effective and as safe as warfarin, and shown to be cost-effective in Canada and UK. Recently, dabigatran received approval in China. In this study, we aim to assess the potential cost-effectiveness of dabigatran for the prevention of stroke and systemic embolism among patients with AF as compared to warfarin as a first-line therapy, from the payer perspective in China. METHODS: An individual level simulation model was developed to simulate the clinical events and outcomes under different treatment pathways over a patient’s remaining lifetime. The model explicitly incorporated an INR control component to account for heterogeneous use of warfarin in different populations and in settings. Input data were derived from the published literature, NICE STA reports, and expert inputs. Patient baseline profiles were based on China Registry of AF (CRAF), a multicenter, cross-sectional study of 3551 AF patients in mainland China. RESULTS: Comparing to warfarin first-line use among patients eligible for anticoagulants, dabigatran was associated with 0.40 fewer ischemic stroke, 0.11 fewer systemic embolism, 0.19 fewer hemorrhagic stroke, 0.30 fewer intracranial hemorrhage, 1.33 more extra-cranial hemorrhage and 0.38 more acute myocardial infarction, per 100 patient-year. Predicted incremental costs and QALYs are US$ 13527.88 and 0.23, respectively, resulting an ICER of US$ 59546.08 per QALY gained. The result was sensitive to the cost of dabigatran cost, warfarin-related cost, and INR control assumptions. CONCLUSIONS: The cost-effectiveness of new anticoagulation therapy should be considered when making treatment recommendations. Further economic evaluation of appropriate use of dabigatran in China setting is needed.