Analisi di costo efficacia dei nuovi anticoagulanti orali nella prevenzione dell’ictus in pazienti con fibrillazione atriale non valvolare in Italia

Oral dabigatran etexilate is indicated for the prevention of systemic thromboembolic events in patients with non-valvular atrial fibrillation (NVAF). Based on the RE-LY study we investigated the cost-effectiveness of dabigatran etexilate versus warfarin and versus others new oral anticoagulants (rivaroxaban and apixaban) in the Italian setting. A Markov decision model with a 3-month cycles and a lifetime horizon were adopted. Efficacy and quality of life were estimated from clincal trials and published literature. The cost-effectiveness analysis was performed form the perspective of the Italian National Health Service. We considered Quality-Adjusted Life-Years (QALYs) and direct medical costs. Benefits and costs were discounted (3%). Costs were assessed in 2014 Euros. A sensitivity analyses on key clinical and economic parameters was performed. The incremental cost-effectiveness ratio (ICER) of dabigatran was €6,800/QALY versus warfarin and €5,787/QALY versus apixaban. Compared with rivaroxaban, dabigatran was the dominant strategy. Sensitivity analysis confirmed the base case results. This economic evaluation, based on estimates derived from different trials, suggested that dabigatran is cost-effective versus warfarin and apixaban and dominant versus rivaroxaban in treatment for the prevention of systemic thromboembolic events in patients with NVAF in the Italian healthcare setting.