Introduction: The prevalence of Hepatitis C (HCV) in Spain is 2,5%, with a high morbimortality rate. Triple therapy based on telaprevir plus peginterferon/ribavirin ([T/PR]) has demonstrated to be an effective approach in treatment-naïve G1-HCV patients. This analysis evaluated, through a Markov model, the incremental cost-effectiveness ratio of triple therapy compared to peginterferon/ ribavirin ([PR]) alone in naïve patients depending on fibrosis stage, from the Spanish Healthcare Authorities perspective.
Methods: Efficacy results and adverse events incidence were based on the combined results of ADVANCE and OPTIMIZE studies. Adverse events and disease-related costs (€, 2014) were built up from panel expert opinion except from transplant and post-transplant costs, taken from published data. Drug costs were obtained from national databases and adjusted for the mandatory deduction. Outcomes and costs were both discounted at 3%/year.
Results: The analysis shows higher costs and improved outcomes associated with [TR/PR] relative to [PR] alone, resulting in an incremental cost-effectiveness ratio (ICER) of €18,288/ QALY for all the cohort, €14,152QALY for moderate fibrosis, €11,364QALY for bridging fibrosis, €15,929/QALY for cirrhosis. Over a lifetime period, the use of [T/PR] could avoid 12 cirrhosis and 4 liver transplants per 1,000 patients compared to [PR] alone. The probabilistic analysis, following 10,000 Montecarlo simulations, demonstrated the probability of an ICER below a €30,000/QALY gained threshold of 69%. At a willingness- to-pay of €30,000/QALY, [T/PR] could be considered as an efficient option compared with [PR] alone for treatment-naïve genotype 1 HCV patients, over a lifetime horizon.
Introduccion: En España, con una prevalencia del 2,5%, la hepatitis C (VHC) se asocia a una elevada morbi-mortalidad. El tratamiento combinado de telaprevir y peginterferon/ribavirina ([T/PR]) es eficaz en pacientes con VHC-G1. El objetivo primario de este estudio fue evaluar la relación coste-utilidad (RCUI) de [T/PR] versus peginterferon alfa 2a/ribavirina ([PR]) en pacientes naïve VHC-G1, según el grado de fibrosis y bajo la perspectiva del sistema sanitario español.
Metodología: La eficacia y la incidencia de efectos adversos (EAs) se obtuvieron de los estudios ADVANCE y OPTIMIZE. La estimación de los costes de monitorización, de manejo de EAs y de la enfermedad por estados de salud (€, 2014) fueron proporcionados por el panel de expertos, según bases de costes nacionales, excepto el coste de trasplante y post-trasplante obtenido de publicaciones. Se aplicó la deducción obligatoria a los costes farmacológicos (precio de venta del laboratorio). La tasa de descuento considerada para los costes y beneficios fue 3% anual.
Resultados: [T/PR] proporcionó mejores resultados en salud (0,96 Años de Vida Ajustados por Calidad, AVAC) y mayor coste (17.495€) comparado con [PR], resultando una RCUI de [T/PR] versus [PR] de 18.288€/AVAC para toda la cohorte, 14.152€/AVAC para fibrosis moderada, 11.364€/AVAC para fibrosis en puentes y 15.929€/AVAC para cirrosis. Considerando toda la vida del paciente, [T/PR] podría evitar 12 cirrosis y 4 trasplantes cada 1.000 pacientes. Con una RCUI inferior a 30.000€/AVAC en el 69% de las simulaciones del análisis probabilístico [T/PR] sería eficiente versus [PR] en pacientes naïve, independientemente del grado de fibrosis.
Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.