Objective: To analyze the cost-effectiveness and cost-utility of dabigatran compared with warfarin in patients with nonvalvular atrial fibrillation with moderate to high risk of ischemic stroke or systemic embolism and eligible for treatment with anticoagulants. Methods: Markov-based economic analysis was performed to estimate treatment costs and outcomes. Epidemiological and efficacy data were determined after a critical revision of the medical literature. Unit costs were taken from Brazilian official databases. Only direct medical costs were covered. Costs and benefits were discounted at a rate of 5% per year. Outcomes were expressed as life-year (LY) and quality-adjusted life-year (QALY). Results: Dabigatran use is cost-effective in terms of LY and QALY considering a willingness-to-pay threshold of 3 times gross domestic product per capita of 2010 (Brazilian real 57,048/US $24,275.74) per LY and QALY saved in both analyzed perspectives (private and public health care systems). Conclusions: Dabigatran use improves patient survival and quality of life compared with warfarin. This represents the best therapeutic option in terms of cost and effectiveness in the prevention of ischemic stroke and systemic embolism in patients with nonvalvular atrial fibrillation. © 2015 International Society for Pharmacoeconomics and Outcomes Research (ISPOR).