[Dabigatran versus acenocumarol for the prevention of stroke in atrial fibrillation: budget impact analysis in one health department in Spain].

BACKGROUND To Estimate, in the context of a Health Department of the Valencia Health Agency, the budgetary impact of the widespread use of dabigatran at doses of 110 and 150 mg in patients with non-valvular atrial fibrillation (AF), regarding the current scenario with acenocoumarol therapy. METHODS Budget impact analysis of three scenarios of oral anticoagulation use in AF: a) current treatment with acenocoumarol, b) widespread replacement of acenocoumarol for Dabigatran 110 mg and, c) idem at doses of 150 mg. The analysis was conducted from the perspective of the Valencia Health Agency with a time horizon of one year (2009). The effectiveness and adverse effects were extrapolated from the RE-LY study, while prevalence and cost data correspond to the Health Department estimates in 2009. RESULTS We included 5889 patients (2.4% of the population > 18 years) diagnosed with AF, of which 3726 (63.2%) were treated with acenocoumarol. The total costs of each scenario were € 1,119,412 (€ 300 patient/year) for acenocoumarol, € 4,985,095 (€ 1,337 patient/year) for dabigatran 110 and € 4,981,226 (€ 1,336 patient/year) for dabigatran 150, with a budget impact of 1,037 euros/year per patient shifted from acenocumarol to dabigatran-150. CONCLUSIONS The high budgetary impact of moving to a scenario of widespread substitution of warfarin for Dabigatran supports the restriction of this therapeutic strategy to subgroups of patients at high risk or difficult control.