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Randomized Controlled Trial Comparative Study
Cost-effectiveness of direct oral anticoagulants versus vitamin K antagonist in atrial fibrillation: A study protocol using Real-World Data from Catalonia (FantasTIC Study).
- Zojaina Hernández Rojas, Maria Rosa Dalmau Llorca, Carina Aguilar Martín, Alessandra Queiroga Gonçalves, Marc Casajuana, José Fernández-Sáez, Dolores Rodríguez Cumplido, Emma Forcadell Drago, Noèlia Carrasco-Querol, Josep Maria Pepió Vilaubí, and Josep M Alegret.
- Equip d'Atenció Primària Tortosa Est, Institut Català de la Salut, Tortosa, Tarragona, Spain.
- Medicine (Baltimore). 2020 Sep 4; 99 (36): e22054e22054.
BackgroundAnticoagulant therapy is used for stroke prevention and proved to be effective and safe in the long term. The study aims to analyse the cost-effectiveness relationship of using of direct-acting oral anticoagulants vs vitamin K antagonists to prevent ischaemic stroke in patients with nonvalvular atrial fibrillation, including all the active ingredients marketed in Spain, prescribed for 2 years in the Primary Care service of the Institut Català de la Salut.MethodsPopulation-based cohort study, in which the cost of the 2 treatment groups will be evaluated. Direct costs (pharmacy, primary care, emergency and hospitalization) and indirect costs (lost productivity) will be included from a social perspective. Effectiveness (assessed as the occurrence of a health event, the 1 of primary interest being stroke) will be determined, with a 2-year time horizon and a 3% discount rate. The average cost of the 2 groups of drugs will be compared using a regression model to determine the factors with the greatest influence on determining costs. We will carry out a univariate ('one-way') deterministic sensitivity analysis.DiscussionWe hope to provide relevant information about direct and indirect costs of oral anticoagulants, which, together with aspects of effectiveness and safety, could help shape the consensual decision-making of evaluating bodies.
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