RESUMO
OBJECTIVE: To assess the cost-effectiveness of apixaban versus acetylsalicylic acid (ASA) in stroke prevention in patients with non-valvular atrial fibrillation (NVAF) with contraindications of vitamin K antagonists in Spain. METHODS: A Markov model was adapted, simulating the patient's lifetime. The safety and efficacy of the drugs were obtained from AVERROES clinical trial. The analysis was done from the Spanish National Health System (NHS) and societal perspective. The cost of drugs was calculated according to the recommended doses. The cost of NVAF complications and disease management was obtained from Spanish sources. RESULTS: In a cohort of 1,000 patients with NVAF, during their lifetime numerous complications could be avoided with apixaban versus ASA (48 ischemic strokes, 10 systemic embolism and 53 related deaths). In each patient treated with apixaban more life-years (0.303 LYG) and more quality-adjusted life-years (0.277 QALYs) could be gained. Apixaban would generate more costs per patient for the NHS (1,742 per patient) but savings would result from the social perspective (2,887 saved per patient). The cost per LYG and QALY gained would be of 5,749 and 6,289 for the NHS. Apixaban would be dominant (more effective with less costs than ASA) from the societal perspective. The results were stable in both deterministic and probabilistic sensitivity analyses. CONCLUSIONS: According to this model, when costs and estimated lifetime outcomes achieved with apixaban are compared with those of ASA, apixaban was assessed to be a cost-effective treatment for the prevention of stroke in patients with NVAF in Spain.
Assuntos
Aspirina/economia , Aspirina/uso terapêutico , Pirazóis/economia , Pirazóis/uso terapêutico , Piridonas/economia , Piridonas/uso terapêutico , Acidente Vascular Cerebral/prevenção & controle , Idoso , Fibrilação Atrial/complicações , Análise Custo-Benefício , Feminino , Humanos , Masculino , Cadeias de Markov , Espanha , Acidente Vascular Cerebral/etiologiaRESUMO
INTRODUCTION AND OBJECTIVES: Cost-effectiveness analysis of apixaban (5 mg twice daily) vs acenocoumarol (5mg/day) in the prevention of stroke in patients with nonvalvular atrial fibrillation in Spain. METHODS: Markov model covering the patient's entire lifespan with 10 health states. Data on the efficacy and safety of the drugs were provided by the ARISTOTLE trial. Warfarin and acenocoumarol were assumed to have therapeutic equivalence. PERSPECTIVES: The Spanish National Health System and society. Information on the cost of the drugs, complications, and the management of the disease was obtained from Spanish sources. RESULTS: In a cohort of 1000 patients with nonvalvular atrial fibrillation, administration of apixaban rather than acenocoumarol would avoid 18 strokes, 71 hemorrhages (28 intracranial or major), 2 myocardial infarctions, 1 systemic embolism, and 23 related deaths. Apixaban would prolong life (by 0.187 years) and result in more quality-adjusted life years (by 0.194 years) per patient. With apixaban, the incremental costs for the Spanish National Health System and for society would be 2,488 and 1,826 per patient, respectively. Consequently, the costs per life year gained would be 13,305 and 9,765 and the costs per quality-adjusted life year gained would be 12,825 and 9,412 for the Spanish National Health System and for society, respectively. The stability of the baseline case was confirmed by sensitivity analyses. CONCLUSIONS: According to this analysis, apixaban may be cost-effective in the prevention of stroke in patients with nonvalvular atrial fibrillation compared with acenocoumarol.
Assuntos
Fibrilação Atrial/complicações , Custos de Medicamentos , Modelos Econômicos , Pirazóis/uso terapêutico , Piridonas/uso terapêutico , Acidente Vascular Cerebral/prevenção & controle , Acenocumarol , Idoso de 80 Anos ou mais , Anticoagulantes/uso terapêutico , Fibrilação Atrial/economia , Análise Custo-Benefício , Feminino , Humanos , Incidência , Masculino , Fatores de Risco , Espanha/epidemiologia , Acidente Vascular Cerebral/epidemiologia , Acidente Vascular Cerebral/etiologiaRESUMO
OBJETIVO: Evaluar el coste-utilidad de apixabán frente al ácido acetilsalicílico (AAS) en la prevención del ictus en pacientes con fibrilación auricular no valvular (FANV) con contraindicación de antagonistas de la vitamina K en España. MÉTODOS: Se adaptó un modelo de Markov, simulando toda la vida del paciente. Los datos de eficacia y seguridad provienen del ensayo clínico AVERROES. Perspectivas del análisis: Sistema Nacional de Salud (SNS) y sociedad. El coste de los medicamentos se calculó según las dosis recomendadas. Los costes de las complicaciones y el manejo de la FANV proceden de fuentes españolas. RESULTADOS: Si una cohorte de 1.000 pacientes con FANV fuese tratada durante toda su vida con apixabán en lugar de AAS, se evitarían 48 ictus isquémicos, 10 embolismos sistémicos y 53 muertes relacionadas. Cada paciente tratado con apixabán obtendría más años de vida ganados (0,303 AVG) y más años de vida ajustados por calidad (0,277 AVAC ganados). Los costes para el SNS serían superiores con apixabán (1.742 € más por paciente), pero la inclusión de los costes informales generaría 2.887 € de ahorro por paciente. El resultado sería un coste por AVG y AVAC ganado de 5.749 € y 6.289 € respectivamente para el SNS, siendo apixabán dominante (más eficaz con menos costes que AAS) desde la perspectiva de la sociedad. Los análisis de sensibilidad confirmaron la estabilidad del caso base. CONCLUSIONES: Según el presente modelo, apixabán sería un tratamiento coste-efectivo en comparación con AAS en la prevención del ictus en pacientes con FANV en España
OBJECTIVE: To assess the cost-effectiveness of apixaban versus acetylsalicylic acid (ASA) in stroke prevention in patients with non-valvular atrial fibrillation (NVAF) with contraindications of vitamin K antagonists in Spain. METHODS: A Markov model was adapted, simulating the patient's lifetime. The safety and efficacy of the drugs were obtained from AVERROES clinical trial. The analysis was done from the Spanish National Health System (NHS) and societal perspective. The cost of drugs was calculated according to the recommended doses. The cost of NVAF complications and disease management was obtained from Spanish sources. RESULTS: In a cohort of 1,000 patients with NVAF, during their lifetime numerous complications could be avoided with apixaban versus ASA (48 ischemic strokes, 10 systemic embolism and 53 related deaths). In each patient treated with apixaban more life-years (0.303 LYG) and more quality-adjusted life-years (0.277 QALYs) could be gained. Apixaban would generate more costs per patient for the NHS (€ 1,742 per patient) but savings would result from the social perspective (€ 2,887 saved per patient). The cost per LYG and QALY gained would be of € 5,749 and € 6,289 for the NHS. Apixaban would be dominant (more effective with less costs than ASA) from the societal perspective. The results were stable in both deterministic and probabilistic sensitivity analyses. CONCLUSIONS: According to this model, when costs and estimated lifetime outcomes achieved with apixaban are compared with those of ASA, apixaban was assessed to be a cost-effective treatment for the prevention of stroke in patients with NVAF in Spain
Assuntos
Humanos , Masculino , Feminino , Acidente Vascular Cerebral/tratamento farmacológico , Acidente Vascular Cerebral/economia , Análise Custo-Eficiência , Fibrilação Atrial/economia , Fibrilação Atrial/epidemiologia , Aspirina/economia , Aspirina/uso terapêutico , Anticoagulantes/economia , Anticoagulantes/uso terapêutico , Custos de Medicamentos/normas , Efeitos Psicossociais da Doença , 50303 , Acidente Vascular Cerebral/prevenção & controle , Atenção Primária à Saúde/organização & administração , Atenção Primária à Saúde/normasRESUMO
Introducción y objetivos. Análisis de coste-efectividad de apixabán (5 mg dos veces al día) frente a acenocumarol (5 mg/día) en la prevención del ictus en pacientes con fibrilación auricular no valvular en España. Métodos. Modelo de Markov durante toda la vida del paciente con 10 estados de salud. Los datos de eficacia y seguridad de los fármacos proceden del ensayo clínico ARISTOTLE. Se asumió la equivalencia terapéutica de warfarina y acenocumarol. Perspectivas: Sistema Nacional de Salud y la sociedad. El coste de los medicamentos, las complicaciones y el manejo de la enfermedad se obtuvieron de fuentes españolas. Resultados. En una cohorte de 1.000 pacientes con fibrilación auricular no valvular, con apixabán se evitarían frente a acenocumarol: 18 ictus, 71 hemorragias (28 intracraneales o mayores), 2 infartos de miocardio, 1 embolia sistémica y 23 muertes relacionadas. Con apixabán se obtendrían más años de vida (0,187) y más años de vida ajustados por calidad (0,194) por paciente. Los costes incrementales con apixabán para el Sistema Nacional de Salud y la sociedad serían de 2.488 y 1.826 euros por paciente. En consecuencia, se obtendría unos costes por año de vida ganado de 13.305 y 9.765 euros, y unos costes por año de vida ajustado por calidad ganado de 12.825 y 9.412 euros para el Sistema Nacional de Salud y la sociedad respectivamente. Los análisis de sensibilidad confirmaron la estabilidad del caso base. Conclusiones. Según este análisis, apixabán puede ser coste-efectivo en la prevención del ictus en pacientes con fibrilación auricular no valvular frente a acenocumarol (AU)
Introduction and objectives. Cost-effectiveness analysis of apixaban (5 mg twice daily) vs acenocoumarol (5 mg/day) in the prevention of stroke in patients with nonvalvular atrial fibrillation in Spain. Methods. Markov model covering the patient's entire lifespan with 10 health states. Data on the efficacy and safety of the drugs were provided by the ARISTOTLE trial. Warfarin and acenocoumarol were assumed to have therapeutic equivalence. Perspectives: The Spanish National Health System and society. Information on the cost of the drugs, complications, and the management of the disease was obtained from Spanish sources. Results. In a cohort of 1000 patients with nonvalvular atrial fibrillation, administration of apixaban rather than acenocoumarol would avoid 18 strokes, 71 hemorrhages (28 intracranial or major), 2 myocardial infarctions, 1 systemic embolism, and 23 related deaths. Apixaban would prolong life (by 0.187 years) and result in more quality-adjusted life years (by 0.194 years) per patient. With apixaban, the incremental costs for the Spanish National Health System and for society would be Euros 2488 and Euros 1826 per patient, respectively. Consequently, the costs per life year gained would be Euros 13 305 and Euros 9765 and the costs per quality-adjusted life year gained would be Euros 12 825 and Euros 9412 for the Spanish National Health System and for society, respectively. The stability of the baseline case was confirmed by sensitivity analyses. Conclusions. According to this analysis, apixaban may be cost-effective in the prevention of stroke in patients with nonvalvular atrial fibrillation compared with acenocoumarol (AU)