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Vol. 72. Issue 5.
Pages 398-406 (May 2019)
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Vol. 72. Issue 5.
Pages 398-406 (May 2019)
Original article
DOI: 10.1016/j.rec.2018.03.024
Would the Use of Edoxaban Be Cost-effective for the Prevention of Stroke and Systemic Embolism in Patients With Nonvalvular Atrial Fibrillation in Spain?
¿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?
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Iñaki Lekuonaa, Manuel Anguitab, José Luis Zamoranoc, José Manuel Rodríguezd, Paloma Barja de Soroae, Ferran Pérez-Alcántaraf,
Corresponding author
ferran.perez@oblikue.com

Corresponding author: Oblikue Consulting S.L., Avda. Diagonal 514, 3.°-3.a, 08006 Barcelona, Spain.
a Servicio de Cardiología, Hospital de Galdakao, Usansolo, Vizcaya, Spain
b Servicio de Cardiología, Hospital Reina Sofía, Córdoba, Spain
c Servicio de Cardiología, Hospital Universitario Ramón y Cajal, Madrid, Spain
d Market Access Department, Daiichi Sankyo Europe GmbH, Munich, Germany
e Departamento de Acceso, Daiichi Sankyo España S.A., Madrid, Spain
f Oblikue Consulting S.L., Barcelona, Spain
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Figures (3)
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Tables (8)
Table 1. Monthly Transition Probabilities and Age Adjustment Factors
Table 2. Treatment Switches Due to Interruption
Table 3. Probability of Mortality Due to an Acute Event and After Surviving an Acute Event
Table 4. Utilities Used in Model
Table 5. Costs Associated With Health States in the Model
Table 6. Base-Case Results
Table 7. Analysis of Scenarios
Table 8. Minimum Treatment Time Needed for Edoxaban to Be a Cost-Effective Alternative to Vitamin K Antagonists
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Abstract
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.

Keywords:
Cost-effectiveness analysis
Edoxaban
Nonvalvular atrial fibrillation
Stroke prevention
Systemic embolism prevention
Spain
Abbreviations:
AF
DOAC
NVAF
VKA
Resumen
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.

Palabras clave:
Análisis de coste-efectividad
Edoxabán
Fibrilación auricular no valvular
Prevención de ictus
Prevención de embolia sistémica
España

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