OBJECTIVES: Dabigatran was proven to have similar effect on the recurrence of venous thromboembolism (VTE) and a lower risk of bleeding compared to vitamin K antagonists (VKAs). This study aims to assess the cost-effectiveness (CE) of dabigatran for the treatment and secondary prevention in high risk patients of VTE compared to VKAs in the Dutch setting. METHODS: Previously published Markov model was modified and updated to assess the CE of dabigatran and VKAs for the treatment and secondary prevention in high risk patients of VTE from a societal perspective in the base-case analysis. The model was populated with efficacy and safety data from major dabigatran trials (i.e. RE-COVER, RECOVER II, RE-MEDY and RE-SONATE), Dutch specific costs, and utilities derived from dabigatran trials or other published literature. Univariate, probabilistic sensitivity and a number of scenario analyses on the impact of various decision-analytic settings (e.g. the perspective of analysis, use of anticoagulants only for treatment or only for secondary prevention) were tested on the incremental cost-effectiveness ratio (ICER). RESULTS: In the base-case, patients on dabigatran gained an additional 0.583 discounted quality adjusted life years (QALYs) over a lifetime and savings of €1,996. Results of univariate sensitivity analysis were quite robust. The probability that dabigatran is cost-effective at a willingness-to-pay threshold of €20,000/QALY was 100%. Except for the scenario comparing dabigatran to VKAs from the healthcare provider perspective and the one comparing dabigatran to placebo for the prevention of recurrent VTE in patients who are at equipoise for anticoagulation treatment where the ICERs for dabigatran compared to VKAs of €1,005 and €33,305 per QALY gained, respectively were estimated, other scenarios showed dabigatran was cost-saving. CONCLUSIONS: From a societal perspective, dabigatran is likely to be a cost-effective or even cost-saving strategy for treatment and secondary prevention of VTE compared to VKAs in the Netherlands.