OBJECTIVES: In addition to demonstrating the efficacy of new drugs, it is necessary to assess their effectiveness in routine clinical practice using patient-level data. We designed a retrospective cohort study to assess the cost-effectiveness of direct oral anticoagulants (DOACs) compared with acenocoumarol in new DOAC users with non-valvular atrial fibrillation (NVAF) with up to 7 years of follow-up.

METHODS: Patients registered with the Basque Health Service who started oral anticoagulant treatment between 2013 and 2016 were included in the study and followed up until the end of 2019. Data were extracted from an electronic health record management system. Effectiveness was expressed as life years gained and adjusted for health-related quality of life (ie, quality-adjusted life years, QALYs). Propensity score methods (specifically IPTW, entropy balance and GBM) were used to limit the effect of covariates on the results. Resource unit costs were obtained from the cost accounting system of the Basque Health Service.

RESULTS: A total of 10,843 new users of oral anticoagulants were included with a mean follow-up of 4.1 years. The incremental cost-effectiveness ratio of DOACs compared with acenocoumarol ranged from €1,732 to €2,556/QALY, while the incremental net benefit for different willingness-to-pay thresholds was negative only for values below €3,000/QALY. In this study, dabigatran and rivaroxaban appear to be more efficient drugs than apixaban, both in terms of life years gained and QALYs, in all the different types of analyses performed.

CONCLUSIONS: Based on the analysis of data from clinical practice and the similarity of results using different techniques to adjust for the bias associated with observational studies, we conclude that DOACs would be an efficient alternative to acenocoumarol in the treatment of patients with NVAF in Spain.