OBJECTIVES : Catheter ablation of atrial fibrillation (AF) is a well-established procedure for recurrent AF prevention. As the most important complications associated with these patients are cerebrovascular events, international guidelines recommend uninterrupted anticoagulant treatment for at least 8 weeks after intervention. In addition, RE-CIRCUIT trial shows that dabigatran has a lower bleeding rate than a vitamin K antagonist (VKA) in AF patients undergoing ablation. Despite this evidence, reimbursement conditions in Spain do not recognize ablation as an option for initiating treatment with dabigatran. The aim of this study was to assess the impact of dabigatran vs. VKA for catheter ablation in AF patients in the Spanish National Health System (NHS).

METHODS: A budget impact model was conducted to estimate the impact of treating 10% of patients with dabigatran 150 mg vs. treating all patients with VKA for three months. Number of ablations in AF patients in public hospitals was obtained from the Spanish Society of Cardiology’s registry, and projected to 2019. Only drug acquisition and VKA-monitoring costs were considered. The model did not consider the potential cost-savings from bleeding events reduction observed with dabigatran in the RE-CIRCUIT trial. Furthermore, a sensitivity analysis was performed to analyze the impact of potential dabigatran increase (30% and 50%).

RESULTS: In the base case scenario, the model showed an impact of €8,805 in one year (€6.55 per patient): €22,927 pharmacological costs and a reduction of €14,121 VKA-monitoring cost. In the sensitivity analysis, impact was €19.66 per patient with 30% of dabigatran utilization and €32.77 with 50%.

CONCLUSIONS: The pharmacological impact of treating with dabigatran would only represent 0.01% of direct oral anticoagulant total national expenditure. Considering bleeding rates reduction and low economic impact of dabigatran vs VKA, using dabigatran in these patients should be considered.