[Economic evaluation of dabigatran for stroke prevention in patients with non-valvular atrial fibrillation]

Abstract

Introduction and objectives: To estimate the cost-effectiveness and cost-utility of dabigatran in the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation in Portugal.

Methodology: A Markov model was used to simulate patients' clinical course, estimating the occurrence of ischemic and hemorrhagic stroke, transient ischemic attack, systemic embolism, myocardial infarction, and intra- and extracranial hemorrhage. The clinical parameters are based on the results of the RE-LY trial, which compared dabigatran with warfarin, and on a meta-analysis that estimated the risk of each event in patients treated with aspirin or with no antithrombotic therapy.

Results: Dabigatran provides an increase of 0.331 life years and 0.354 quality-adjusted life years for each patient. From a societal perspective, these clinical gains entail an additional expenditure of 2978 euros. Thus, the incremental cost is 9006 euros per life year gained and 8409 euros per quality-adjusted life year.

Conclusions: The results show that dabigatran reduces the number of events, especially the most severe such as ischemic and hemorrhagic stroke, as well as their long-term sequelae. The expense of dabigatran is partially offset by lower event-related costs and by the fact that INR monitoring is unnecessary. It can thus be concluded that the use of dabigatran in clinical practice in Portugal is cost-effective.

Keywords: AASÁ; AIT; AV; AVAQ; AVC; AVCH; AVCI; Acidente Isquémico Transitório; Acidente Vascular Cerebral; Acidente Vascular Cerebral Hemorrágico; Acidente Vascular Cerebral Isquémico; Acidente vascular cerebral; Anos de Vida; Anos de Vida Ajustados pela Qualidade; Atrial fibrillation; Cost-effectiveness; Custo-efetividade; Dabigatran; Dabigatrano; Duas vezes por dia; EAM; ES; Embolia Sistémica; Enfarte Agudo do Miocárdio; FA; Fibrilhação Auricular; Fibrilhação auricular; HI; Hemorragia Intracraniana; INR; IVA; Imposto sobre o Valor Acrescentado; International Normalized Ratio; Portugal; Prevention; Prevenção; RCEI; Rácio Custo Efetividade Incremental; Stroke; Uma vez por dia; bid; cido Acetilsalicilico; qd.