¿El uso de edoxabán sería coste-efectivo para la prevención del ictus y la embolia sistémica en pacientes con fibrilación auricular no valvular en España? / Would the use of edoxaban be cost-effective for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation in Spain?

Introducción y objetivos: Analizar el coste-efectividad del edoxabán frente al acenocumarol en la prevención del ictus y la embolia sistémica en pacientes con fibrilación auricular no valvular (FANV) en España. Métodos: Modelo de Markov, adaptado a España desde la perspectiva del Sistema Nacional de Salud, que simula la evolución de una cohorte hipotética de pacientes con FANV a lo largo de toda su vida a partir de diferentes estados de salud: ictus, hemorragias y otras complicaciones cardiovasculares. Los datos de eficacia y seguridad se obtuvieron a partir de la evidencia clínica disponible (principalmente del estudio en fase III ENGAGE AF-TIMI 48). Los costes del tratamiento de la FANV y sus complicaciones se obtuvieron de fuentes españolas. Resultados: El edoxabán resultó en 0,34 años de vida ajustados por calidad (AVAC) adicionales en comparación con el acenocumarol. El coste incremental con el edoxabán fue de 3.916 euros, derivado principalmente de un mayor coste farmacológico, que se compensa parcialmente por los menores costes de la monitorización del tratamiento y del tratamiento de eventos y complicaciones de la FANV. Se obtuvo un coste por AVAC de 11.518 euros, dentro de los umbrales comúnmente considerados coste-efectivos en España (25.000-30.000 euros/AVAC). Los diferentes análisis de sensibilidad realizados confirmaron la robustez de los resultados. Conclusiones: El edoxabán es una alternativa coste-efectiva frente al acenocumarol en la prevención del ictus y la embolia sistémica en pacientes con FANV en España

Introduction and objectives: To assess the cost-effectiveness of edoxaban versus acenocoumarol in the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF) in Spain. Methods: Markov model, adapted to the Spanish setting from the perspective of the National Health System, stimulating the progression of a hypothetical cohort of patients with NVAF throughout their lifetime, with different health states: stroke, hemorrhage, and other cardiovascular complications. Efficacy and safety data were obtained from the available clinical evidence (mainly from the phase III ENGAGE AF-TIMI 48 study). The costs of managing NVAF and its complications were obtained from Spanish sources. Results: Edoxaban use led to 0.34 additional quality-adjusted life years (QALY) compared with acenocoumarol. The incremental cost with edoxaban was €3916, mainly because of higher pharmacological costs, which were partially offset by lower costs of treatment monitoring and managing NVAF events and complications. The cost per QALY was €11 518, within the thresholds commonly considered cost-effective in Spain (€25 000-€30 000/QALY). The robustness of the results was confirmed by various sensitivity analyses. Conclusions: Edoxaban is a cost-effective alternative to acenocoumarol in the prevention of stroke and systemic embolism in patients with NVAF in Spain

Would the Use of Edoxaban Be Cost-effective for the Prevention of Stroke and Systemic Embolism in Patients With Nonvalvular Atrial Fibrillation in Spain?

INTRODUCTION AND OBJECTIVES: To assess the cost-effectiveness of edoxaban vs acenocoumarol in the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF) in Spain. METHODS: Markov model, adapted to the Spanish setting from the perspective of the National Health System, stimulating the progression of a hypothetical cohort of patients with NVAF throughout their lifetime, with different health states: stroke, haemorrhage, and other cardiovascular complications. Efficacy and safety data were obtained from the available clinical evidence (mainly from the phase III ENGAGE AF-TIMI 48 study). The costs of managing NVAF and its complications were obtained from Spanish sources. RESULTS: Edoxaban use led to 0.34 additional quality-adjusted life years (QALY) compared with acenocoumarol. The incremental cost with edoxaban was 3916€, mainly because of higher pharmacological costs, which were partially offset by lower costs of treatment monitoring and managing NVAF events and complications. The cost per QALY was 11 518€, within the thresholds commonly considered cost-effective in Spain (25 000-30 000 €/QALY). The robustness of the results was confirmed by various sensitivity analyses. CONCLUSIONS: Edoxaban is a cost-effective alternative to acenocoumarol in the prevention of stroke and systemic embolism in patients with NVAF in Spain.