[Cost-utility analysis of triple therapy with telaprevir in treatment-naïve hepatitis C patients]

Farm Hosp. 2014 Sep 16;38(5):418-29. doi: 10.7399/fh.2014.38.5.7640.
[Article in Spanish]

Abstract

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.

Publication types

  • Comparative Study

MeSH terms

  • Anemia / chemically induced
  • Antiviral Agents / adverse effects
  • Antiviral Agents / economics
  • Antiviral Agents / therapeutic use*
  • Carcinoma, Hepatocellular / etiology
  • Carcinoma, Hepatocellular / surgery
  • Cost-Benefit Analysis
  • Drug Eruptions / etiology
  • Drug Therapy, Combination / economics
  • Gastrointestinal Diseases / chemically induced
  • Hepacivirus / drug effects
  • Hepacivirus / genetics
  • Hepatitis C / complications
  • Hepatitis C / drug therapy*
  • Hepatitis C / economics
  • Hepatitis C / epidemiology
  • Hepatitis C / virology
  • Humans
  • Interferon-alpha / adverse effects
  • Interferon-alpha / economics
  • Interferon-alpha / therapeutic use*
  • Liver Cirrhosis / etiology
  • Liver Cirrhosis / prevention & control
  • Liver Neoplasms / etiology
  • Liver Neoplasms / surgery
  • Liver Transplantation
  • Markov Chains
  • Oligopeptides / adverse effects
  • Oligopeptides / economics
  • Oligopeptides / therapeutic use*
  • Polyethylene Glycols / adverse effects
  • Polyethylene Glycols / economics
  • Polyethylene Glycols / therapeutic use*
  • Prevalence
  • Quality-Adjusted Life Years
  • Recombinant Proteins / adverse effects
  • Recombinant Proteins / economics
  • Recombinant Proteins / therapeutic use
  • Ribavirin / adverse effects
  • Ribavirin / economics
  • Ribavirin / therapeutic use*
  • Severity of Illness Index
  • Spain / epidemiology

Substances

  • Antiviral Agents
  • Interferon-alpha
  • Oligopeptides
  • Recombinant Proteins
  • Polyethylene Glycols
  • Ribavirin
  • telaprevir
  • peginterferon alfa-2a