Análisis coste-utilidad de apixabán frente al ácido acetilsalicílico en la prevención del ictus en pacientes con fibrilación auricular no valvular en España / Cost-effectiveness analysis of apixaban versus acetylsalicylic acid in the prevention of stroke in patients with non-valvular atrial fibrillation in Spain

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

[Cost-effectiveness analysis of apixaban versus acetylsalicylic acid in the prevention of stroke in patients with non-valvular atrial fibrillation in Spain]. / Análisis coste-utilidad de apixabán frente al ácido acetilsalicílico en la prevención del ictus en pacientes con fibrilación auricular no valvular 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.

Análisis de coste-efectividad de dapagliflozina en comparación con los inhibidores de la DPP4 y otros antidiabéticos orales en el tratamiento de la diabetes mellitus tipo 2 en España / Cost-effectiveness analysis of dapagliflozin compared to DPP4 inhibitors and other oral antidiabetic drugs in the treatment of type-2 diabetes mellitus in Spain

OBJETIVO: Evaluar la eficiencia de la terapia combinada de metformina y dapagliflozina, un nuevo antidiabético oral con un mecanismo de acción independiente de la insulina, en el tratamiento de la diabetes mellitus tipo 2 (DM2) en comparación con inhibidores de DPP4, sulfonilureas y tiazolidindionas, combinados también con metformina. DISEÑO: Análisis de coste-efectividad utilizando un modelo de simulación de eventos discretos a partir de los resultados de los ensayos clínicos disponibles y considerando un horizonte temporal de toda la vida del paciente. Emplazamiento: Perspectiva del Sistema Nacional de Salud. PARTICIPANTES: El modelo simuló la historia natural de 30.000 pacientes con DM2 para cada opción comparada. MEDICIONES PRINCIPALES: Años de vida ajustados por calidad (AVAC) y consecuencias económicas del manejo de la enfermedad y sus complicaciones. Se consideraron los costes directos (actualizados a euros de 2013) y se aplicó un descuento del 3% tanto para costes como para resultados en salud. RESULTADOS: El análisis principal comparó dapagliflozina con los inhibidores de DPP4, resultando dapagliflozina como una opción de tratamiento que aportaría una ligera mayor efectividad (0,019 AVAC) con menores costes totales asociados (−42 Euros). En los análisis adicionales, dapagliflozina fue una opción coste-efectiva en comparación con sulfonilureas y tiazolidindionas con razones de coste por AVAC ganado de 3.560 Euros y 2.007 Euros, respectivamente. Los análisis de sensibilidad univariantes y probabilístico confirmaron la solidez de los RESULTADOS: CONCLUSIONES: Los resultados del análisis realizado sugieren que dapagliflozina, en combinación con metformina, sería una alternativa coste-efectiva en el contexto español para el tratamiento de la DM2

OBJECTIVE: To assess the efficiency of the combined therapy with metformin and dapagliflozin, a new oral anti-diabetic drug with an insulin-independent mechanism of action, in the treatment of type-2 diabetes mellitus (T2DM) compared to DPP4 inhibitors, sulphonylureas and thiazolidindiones, also combined with metformin. DESIGN: Cost-effectiveness analysis using a discrete event simulation model based on the results of the available clinical trials and considering patient's entire life as time horizon. SETTING: National Health System perspective. PARTICIPANTS: The model simulated the natural history of 30,000 patients with T2DM for each of the options compared. MAIN MEASUREMENTS: Quality-adjusted life-years (QALY) and economic consequences of managing the disease and its complications. The analysis considered direct costs updated to 2013. A discount rate of 3% was applied to costs and health outcomes. RESULTS: In the main analysis comparing dapagliflozin with DPP4 inhibitors, dapagliflozin resulted in a treatment option that would provide a slightly higher effectiveness (0.019 QALY) and lower overall associated costs (- 42 Euros). In the additional analyses, dapagliflozin was a cost-effective option compared with sulphonylureas and thiazolidinediones resulting in a cost per QALY gained of 3,560 Euros and 2,007 Euros, respectively. The univariate and probabilistic sensitivity analyses confirmed the robustness of the RESULTS: CONCLUSIONS: The results of the analyses performed suggested that dapagliflozin, in combination with metformin, would be a cost-effective alternative in the Spanish context for the treatment of T2DM

Análisis coste-efectividad de apixabán frente a acenocumarol en la prevención del ictus en pacientes con fibrilación auricular no valvular en España / Cost-effectiveness analysis comparing apixaban and acenocoumarol in the prevention of stroke in patients with nonvalvular atrial fibrillation in Spain

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)

[Cost-effectiveness analysis of dapagliflozin compared to DPP4 inhibitors and other oral antidiabetic drugs in the treatment of type-2 diabetes mellitus in Spain]. / Análisis de coste-efectividad de dapagliflozina en comparación con los inhibidores de la DPP4 y otros antidiabéticos orales en el tratamiento de la diabetes mellitus tipo 2 en España.

OBJECTIVE: To assess the efficiency of the combined therapy with metformin and dapagliflozin, a new oral anti-diabetic drug with an insulin-independent mechanism of action, in the treatment of type-2 diabetes mellitus (T2DM) compared to DPP4 inhibitors, sulphonylureas and thiazolidindiones, also combined with metformin. DESIGN: Cost-effectiveness analysis using a discrete event simulation model based on the results of the available clinical trials and considering patient's entire life as time horizon. SETTING: National Health System perspective. PARTICIPANTS: The model simulated the natural history of 30,000 patients with T2DM for each of the options compared. MAIN MEASUREMENTS: Quality-adjusted life-years (QALY) and economic consequences of managing the disease and its complications. The analysis considered direct costs updated to 2013. A discount rate of 3% was applied to costs and health outcomes. RESULTS: In the main analysis comparing dapagliflozin with DPP4 inhibitors, dapagliflozin resulted in a treatment option that would provide a slightly higher effectiveness (0.019 QALY) and lower overall associated costs (-€42). In the additional analyses, dapagliflozin was a cost-effective option compared with sulphonylureas and thiazolidinediones resulting in a cost per QALY gained of €3,560 and €2,007, respectively. The univariate and probabilistic sensitivity analyses confirmed the robustness of the results. CONCLUSIONS: The results of the analyses performed suggested that dapagliflozin, in combination with metformin, would be a cost-effective alternative in the Spanish context for the treatment of T2DM.

Cost-effectiveness Analysis Comparing Apixaban and Acenocoumarol in the Prevention of Stroke in Patients With Nonvalvular Atrial Fibrillation in Spain.

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.

Impacto presupuestario para el Sistema Nacional de Salud de la prevención del tromboembolismo venoso con Apixaban en pacientes sometidos a artroplastia total de rodilla o cadera / Budgetary impact for the National Health System of Apixaban prophylaxis of venous thromboembolism in patients undergoing total knee or hip replacement

Fundamentos: Debido al elevado coste sanitario del tromboembolismo venoso (TEV) es necesario realizar análisis económicos que determinen la eficiencia de sus diferentes tratamientos farmacológicos. El objetivo del trabajo es estimar el impacto presupuestario para el Sistema Nacional de Salud (SNS) de la prevención del tromboembolismo venoso (TEV) con apixaban en artroplastia total de cadera (ATC) o rodilla (ATR). Métodos: Se consideraron los costes de los diferentes fármacos para la prevención del TEV (apixaban, dabigatrán, enoxaparina, fondaparinux, otras heparinas, rivaroxaban y warfarina) y los de las complicaciones del TEV a corto plazo (90 días) y a 5 años (trombosis venosa profunda, embolismo pulmonar, sangrados y síndrome postrombótico). La eficacia de la prevención se estimó mediante un metaanálisis. Las tasas de TEV y muerte con apixaban fueron inferiores en ATC y ATR a las observadas con enoxaparina (-3,5% y -10,0%, respectivamente) y tuvo menos acontecimientos hemorrágicos (-0,7% y -1,6%, respectivamente). Los datos poblacionales y los costes se obtuvieron de fuentes españolas. Horizonte temporal: 5 años. Todos los costes se descontaron anualmente un 3,5%. Se estimó que a los cinco años de su comercialización el consumo de apixaban supondría el 23% de la prevención del TEV y el de enoxaparina descendería del 60% hasta el 33%. Resultados: La introducción de apixaban para la prevención del TEV produciría un ahorro para el SNS de 547.422 euros en un periodo de 5 años. En el caso de considerar sin coste la administración ambulatoria de las heparinas, el ahorro quinquenal para el SNS ascendería a 270.068 euros. Conclusiones: La introducción de apixaban podría reducir la tasa de TEV y sangrados en comparación con enoxaparina, reduciéndose el gasto del SNS en la prevención del TEV(AU)

Background: Due to high health care costs of venous thromboembolism (VTE), economic analyses are needed to determine the efficiency of different drug treatments. Consequently, a study was conducted to estimate the budgetary impact for the National Health System (NHS) with apixaban for prevention of venous thromboembolism (VTE) in total hip (THR) or knee (TKR) replacement. Methods: Cost considered: the drugs for the prevention of VTE (apixaban, dabigatran, enoxaparin, fondaparinux, other heparins, rivaroxaban and warfarin) and the complications of VTE in the short term and in 5 years (deep vein thrombosis, pulmonary embolism, bleedings and the post-thrombotic syndrome). The effectiveness of prophylaxis was estimated using a meta-analysis. The VTE rates and death with apixaban are lower in THR and TKR than enoxaparin (-3.5% and -10.0%, respectively) with less bleeding events (-0.7% and -1.6%, respectively). Population data and unit costs were obtained from Spanish sources. Time horizon: 5 years. All costs were discounted by 3.5% annually. Five years after commercialization, the use of apixaban was estimated to account for 23% of the prophylaxis of VTE and the use of enoxaparin decrease from the 60% to 33%. Results: Apixaban's introduction for the prophylaxis of VTE would have a significant impact for the NHS, resulting in a saving of euros 547,422 over a period of 5 years. In the case of outpatient administration of heparin did not have a cost, the savings for the NHS five years amount to euros 270,068. Conclusions: According to this study, the introduction of apixaban may reduce the rate of VTE and bleeding compared with enoxaparin, decreasing the expenditure of NHS in VTE prophylaxis(AU)

[Budgetary impact for the National Health System of apixaban prophylaxis of venous thromboembolism in patients undergoing total knee or hip replacement]. / Impacto presupuestario para el Sistema Nacional de Salud de la prevención del trombolismo venoso con apixaban en pacientes sometidos a artroplastia total de rodilla o cadera.

BACKGROUND: Due to high health care costs of venous thromboembolism (VTE), economic analyses are needed to determine the efficiency of different drug treatments. Consequently, a study was conducted to estimate the budgetary impact for the National Health System (NHS) with apixaban for prevention of venous thromboembolism (VTE) in total hip (THR) or knee (TKR) replacement. METHODS: Cost considered: the drugs for the prevention of VTE (apixaban, dabigatran, enoxaparin, fondaparinux, other heparins, rivaroxaban and warfarin) and the complications of VTE in the short term and in 5 years (deep vein thrombosis, pulmonary embolism, bleedings and the post-thrombotic syndrome). The effectiveness of prophylaxis was estimated using a meta-analysis. The VTE rates and death with apixaban are lower in THR and TKR than enoxaparin (-3.5% and -10.0%, respectively) with less bleeding events (-0.7% and -1.6%, respectively). Population data and unit costs were obtained from Spanish sources. TIME HORIZON: 5 years. All costs were discounted by 3.5% annually. Five years after commercialization, the use of apixaban was estimated to account for 23% of the prophylaxis of VTE and the use of enoxaparin decrease from the 60% to 33%. RESULTS: Apixaban´s introduction for the prophylaxis of VTE would have a significant impact for the NHS, resulting in a saving of 547,422 Euro over a period of 5 years. In the case of outpatient administration of heparin did not have a cost, the savings for the NHS five years amount to 270,068 Euro. CONCLUSIONS: According to this study, the introduction of apixaban may reduce the rate of VTE and bleeding compared with enoxaparin, decreasing the expenditure of NHS in VTE prophylaxis.