OBJECTIVES: Patients with atrial fibrillation (AF) face higher risks of strokes and systemic thromboembolism (SE) traditionally managed with vitamin K antagonists (VKA), inducing major bleeding (MB) risk. In 2013, the French Health Technology Assessment (HAS) requested a nationwide study comparing the effectiveness of DOACs (apixaban, dabigatran, rivaroxaban) and VKAs in matched cohorts of over 400,000 AF patients. The study found that DOACs were more effective and safer, with lower total costs than VKAs. This analysis aims to evaluate the budget impact of DOACs over 10 years in France, specifically in decreasing strokes/STE and MB in AF patients.

METHODS: A retrospective budget impact model from 2014 to 2023 was developed, comparing scenarios with and without DOACs, using clinical and costs data from NAXOS-study. Based on HAS estimates, DOAC-eligible population grew from 725,000 to 1.4 million patients between 2014-2023.

From the public MEDICAM drugs database, the market shares showed VKA use decreased from 67% to 11% over 10 years, while DOAC use considerably increased, specifically apixaban (2% to 55%). Costs included treatment acquisition, strokes/SE, MB, and international normalized ratio testing (INRt) for VKAs.

RESULTS: Introduction of DOACs increased AF patients’ treatment costs from €194 million in 2014 to €821 million in 2023, totaling €5.19 billion over 10 years. However, DOACs led to substantial savings in strokes/SE care (-€120 million in 2014 to -€734 million in 2023), totaling -€4.24 billion. Similar savings were observed for MB and INRt, contributing to -€3.22 billion and -€1.13 billion, respectively.

Overall, DOACs introduction saved from €61 million to National insurance in 2013 to €654 million in 2023, totaling -€3.40 billion over 10 years, with apixaban contributing 55% of the savings.

CONCLUSIONS: Considering AF-associated costs only, the introduction of DOACs has led to substantial savings over 10 years, demonstrating long-term economic value of an innovative therapeutic class introduction.