OBJECTIVES: Coronary artery disease (CAD) co-exists in 20–30% of atrial fibrillation (AF) patients. Percutaneous coronary intervention (PCI) with stents is currently the most commonly performed coronary revascularization in CAD. Given the high thrombotic risk in these patients, one-year antithrombotic treatment is indicated after intervention. International guidelines recognize utilization of dual therapy (DT) – dabigatran plus P2Y12 inhibitor – vs. triple therapy (TT) – vitamin K antagonist (VKA) plus clopidogrel and AAS – in high bleeding risk patients, because of the reduced bleeding rate observed in dabigatran in the REDUAL-PCI trial. Despite this evidence, reimbursement conditions in Spain do not recognize PCI as an option for initiating treatment with dabigatran in DT. The aim was to assess the impact of dabigatran DT vs. TT with VKA in the Spanish National Health System (NHS).

METHODS: A budget impact model was conducted to estimate the impact of treating 10% of patients with DT (dabigatran 150mg or 110mg plus clopidogrel) vs. using TT in all patients (VKA plus clopidogrel and aspirin up to 6 months) for one year. Only drug acquisition and VKA-monitoring costs were considered. The model did not consider potential cost-savings from bleeding events reduction observed in REDUAL-PCI trial. Furthermore, a sensitivity analysis was performed to analyze potential impact of DT increase (30% and 50%).

RESULTS: In the base case scenario, the model showed an impact of €97,673 in one year (€26.36 per patient): €255,625 pharmacological costs and a reduction of €157,952 in VKA-monitoring cost. In the sensitivity analysis, impact was €79.07 per patient with 30% DT penetration and €131.79 with 50%.

CONCLUSIONS: The pharmacological impact of treating with dabigatran would only represent 0.10% of direct oral anticoagulant total national expenditure. Considering guidelines recommendation, bleeding rates reduction and low economic impact of DT with dabigatran vs TT, using DT in these patients should be considered.