Journal of medical economics · 2025
Nationwide extrapolation of economic benefit of therapeutic innovation: a 10-year retrospective budget impact of direct oral anticoagulants introduction in France.
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Guilmet C, Lesage H, Cotté F E, Moreau R, Marant Micallef C, Née M, Guitard-Dehoux D, Belhassen M, Danchin N
Аннотация
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.
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.