Nationwide extrapolation of economic benefit of therapeutic innovation: a 10-year retrospective budget impact of direct oral anticoagulants introduction in France.

Objectives: Patients with atrial fibrillation (AF) face increased risks of strokes and systemic thromboembolism (SE), traditionally managed with vitamin K antagonists (VKAs), which are associated with major bleeding (MB) risks. The nationwide real-life data-based NAXOS study, comparing Direct Oral A...

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Publicado en:Journal of Medical Economics Vol. 28; no. 1; pp. 859 - 871
Autores principales: Guilmet, C., Lesage, H., Cotté, F. E., Moreau, R., Marant Micallef, C., Née, M., Guitard-Dehoux, D., Belhassen, M., Danchin, N.
Formato: Journal Article
Publicado: Taylor & Francis Ltd Dec2025
Acceso en línea:Ver este registro en EBSCOhost
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      dt: Dec2025
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      pub: Taylor & Francis Ltd
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        10.1080/13696998.2025.2514381
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        atl: Nationwide extrapolation of economic benefit of therapeutic innovation: a 10-year retrospective budget impact of direct oral anticoagulants introduction in France.
      aug:
        au:
          Guilmet, C.
          Lesage, H.
          Cotté, F. E.
          Moreau, R.
          Marant Micallef, C.
          Née, M.
          Guitard-Dehoux, D.
          Belhassen, M.
          Danchin, N.
        affil: Bristol-Myers Squibb, Rueil-Malmaison, France
      sug:
      ab: Objectives: Patients with atrial fibrillation (AF) face increased risks of strokes and systemic thromboembolism (SE), traditionally managed with vitamin K antagonists (VKAs), which are associated with major bleeding (MB) risks. The nationwide real-life data-based NAXOS study, comparing Direct Oral Anticoagulants (DOACs: apixaban, dabigatran, rivaroxaban) to VKAs in over 400,000 AF patients in France, showed that DOACs are more effective, safer, and associated with lower total costs. This study evaluates the 10-year budget impact of DOACs in France, focusing on reductions in strokes/SE, MB, and monitoring costs (INRt). Methods: A retrospective budget impact model from 2014 to 2023 compared scenarios with and without DOACs, using clinical and cost data from the NAXOS study. The target population of DOAC-eligible patients ranged from 725,000 in 2014 to 1.4 million in 2023. Market shares trends were derived from the public national drugs database, indicating that VKAs' use decreased from 67% to 11%, while DOACs, especially apixaban, rose sharply (2% to 55%) over the same period. Costs included treatment acquisition, strokes/SE, MB, and international normalized ratio testing (INRt) for VKAs. Results: Over a 10-year horizon, the introduction of DOACs is estimated to have prevented 73,009 strokes, 97,234 major bleeding, and 19,567 stroke-related deaths among patients with NVAF. DOAC introduction increased treatment costs by €5.15 billion over 10 years, and reduced costs for strokes/SE (-€4.24 billion), MB (-€3.22 billion), and INRt (-€1.14 billion), leading to €3.45 billion of savings for National Insurance over 10 years, with apixaban contributing 55% of savings. Limitations: This analysis may not account for all contextual variables, such as indirect costs related to productivity losses. Conclusion: Over 10 years, the introduction of DOACs in France has generated substantial savings in AF-related costs, highlighting their clinical and economic benefits and the importance for authorities to valorise the external effects of therapeutic innovations.
      pubtype: Academic Journal
      doctype: Journal Article
      ougenre: Article
    language: English
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