Resumen
Objetivo
Estimar la relación coste-efectividad de la terapia adyuvante con trastuzumab frente a la ausencia de intervención, en el tratamiento de cáncer de mama precoz (CMP) con sobreexpresión del gen HER2, en pacientes españolas.
Métodos
Se utilizó un modelo de Markov que estima la evolución de una cohorte de 1.000 pacientes con CMP en un horizonte temporal de 10 años. Las intervenciones analizadas fueron: tratamiento con trastuzumab durante un año (8 mg/kg como dosis inicial y 6 mg/kg como dosis de mantenimiento cada tres semanas) frente a la ausencia de intervención (seguimiento y observación). El análisis se ha realizado desde la perspectiva del Sistema Nacional de Salud español (SNS). Las pautas de tratamiento y el consumo de recursos se estimaron mediante un panel de expertos y un estudio observacional, retrospectivo de revisión de 31 historias clínicas. La efectividad se midió en años de vida ganados (AVG) y en años de vida ajustados por calidad (AVAC). Se realizó un análisis de sensibilidad probabilístico y un análisis de escenarios considerando un horizonte temporal de 45 años y el seguimiento de las pacientes hasta su fallecimiento.
Resultados
La utilización de trastuzumab en el CMP evita 195 recurrencias locales, 755,8 recurrencias a distancia y 114,7 muertes. Las pacientes en tratamiento con trastuzumab obtienen un incremento de 0,41 AVG y 0,60 AVAC, con un coste incremental de 6.511 € y una razón coste-efectividad incremental de 10.771 €/AVAC a 10 años frente a la ausencia de intervención. El análisis de sensibilidad confirmó la robustez de los resultados.
Conclusiones
El uso de trastuzumab como terapia adyuvante en el tratamiento del CMP aumenta la esperanza de vida y los AVAC frente a la ausencia de intervención y puede ser considerado una estrategia eficiente para el SNS español.
Abstract
Aims
To estimate cost-effectiveness of adjuvant therapy with trastuzumab versus no intervention, in patients with HER2-overexpressing early breast cancer (EBC) in Spain.
Methods
A Markov model was used to estimate the course in a cohort of 1000 EBC patients, with a 10-year time horizon. The following interventions were analyzed: 1-year trastuzumab therapy (starting dose 8 mg/kg; maintenance dose 6 mg/kg every 3 weeks) versus no intervention (follow-up and observation). Spanish National Health Service (NHS) perspective was used for analyses. Therapy regimen and resources use data were derived from an expert panel and an observational study based on a retrospective review of medical records from 31 patients. Effectiveness was measured with life years gained (LYG) and quality-adjusted life years (QALY). A probabilistic sensitivity analysis and a scenario analysis were carried out, with a 45-year time horizon and a follow-up until patient’s death.
Results
Trastuzumab use in EBC avoids 195 local recurrences, 755.8 distant recurrences and 114.7 deaths. Patients receiving trastuzumab show a 0.41 LYG gain and a 0.60 QALY gain, with a 6,511 € incremental cost; incremental cost-effectiveness ratio versus no-intervention after 10 years is 10,771 €/QALY. The sensitivity analysis confirmed that results were robust.
Conclusions
Adjuvant use of trastuzumab in EBC increases life expectancy and QALY compared to no-intervention, and can be considered an efficient strategy from a Spanish NHS perspective.
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La investigación ha sido patrocinada por Roche Farma. No obstante el análisis ha sido realizado por los autores de forma independiente, y no hay conflictos de intereses de los autores.
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Lindner, L., Vieta, A., Rodríguez, C. et al. Análisis coste-efectividad de la terapia adyuvante con trastuzumab para el tratamiento de cáncer de mama en estadios iniciales. PharmacoEcon Span Res Artic 10, 27–35 (2013). https://doi.org/10.1007/s40277-013-0003-x
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DOI: https://doi.org/10.1007/s40277-013-0003-x