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...
| Publicado en: | Journal of Medical Economics Vol. 28; no. 1; pp. 859 - 871 |
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| Autores principales: | , , , , , , , , |
| Formato: | Journal Article |
| Publicado: |
Taylor & Francis Ltd
Dec2025
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=190436910&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 190436910 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 13696998 3K1U jtl: Journal of Medical Economics issn: 13696998 maglogo: N pubinfo: dt: Dec2025 vid: 28 iid: 1 pid: 377 pub: Taylor & Francis Ltd place: Philadelphia, Pennsylvania artinfo: ui: 190436910 10.1080/13696998.2025.2514381 190436910 ppf: 859 ppct: 12 formats: tig: 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 refInfo: holdings: @attributes: islocal: N |
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