Coste-efectividad de la terapia de combinación dutasterida/tamsulosina: un análisis basado en el ensayo clínico CONDUCT

  • Bernardino Miñana López
  • Francisco José Brenes
  • José María Molero
  • Antonio Fernández-Pro
  • José Manuel Cozar
  • Alicia Huerta
  • Laura Amanda Vallejo-Aparicio
Artículo de Investigación Original

Resumen

Objetivo

Estimar la ratio coste-efectividad incremental (RCEI) de la combinación dutasterida/tamsulosina (DUT/TAM) como tratamiento de inicio frente a la práctica clínica de espera vigilada (EV) más escalado a tamsulosina (EV + TAM), en pacientes con hiperplasia benigna de próstata (HBP) moderada en riesgo de progresión, desde la perspectiva del Sistema Nacional de Salud (SNS).

Métodos

Se modificó un modelo de Markov previamente publicado para incorporar los resultados del estudio CONDUCT. Consta de 9 estados de salud basados en el nivel de síntomas y en la ocurrencia de eventos de progresión y cirugías, en dos horizontes temporales, dos años (duración CONDUCT) y toda la vida del paciente. La efectividad se midió como años de vida ajustados por calidad (AVAC), obteniendo las utilidades de la literatura. El uso de recursos se basó en la práctica clínica habitual española y los costes unitarios directos se obtuvieron de datos españoles publicados (euros de 2015). Se aplicó una tasa de descuento del 3% tanto a costes como a efectos. Para verificar la robustez de los resultados del caso-base se realizaron análisis de sensibilidad determinísticos y probabilísticos.

Resultados

Los RCEI del caso-base fueron 17.434 €/AVAC (dos años) y 21.234 €/AVAC (toda la vida). Los resultados de los análisis determinísticos oscilaron entre 13.945 €/AVAC–20.924 €/AVAC (dos años), y 13.749 €/AVAC–25.518 €/AVAC (toda la vida). Para una disponibilidad a pagar de 30.000 €/AVAC, DUT/TAM fue coste-efectivo con una probabilidad del 90%.

Conclusión

DUT/TAM puede ser considerado una alternativa coste-efectiva como tratamiento de inicio en pacientes con HBP moderada en riesgo de progresión dentro del SNS, comparado con la práctica clínica de EV + TAM.

Palabras clave

Coste-efectividad Dutasterida/tamsulosina Modelo económico Hiperplasia benigna de próstata 

Abstract

Objectives

To estimate the Incremental Cost-Effectiveness Ratio (ICER) of dutasteride/tamsulosin combination therapy (DUT/TAM) vs. Watchful Waiting (WW) plus escalation to tamsulosin (WW + TAM) clinical practice, in naïve moderate Benign Prostatic Hyperplasia (BPH) patients at risk of progression, from the Spanish National Healthcare System (NHS) perspective.

Methods

A previously published Markov model was modified to incorporate results from CONDUCT trial. Model structure has 9 health-states based on patient’s symptoms level, progression events and surgery occurrence, with two time-horizons, 2-year (CONDUCT study duration) and lifetime. Effectiveness was measured as Quality-Adjusted-Life-Years (QALYs), and utility data was obtained from a literature review. Resource use was based on Spanish common clinical practice and unit direct costs were obtained from Spanish published data (€2015). A discount rate of 3% was applied for both costs and outcomes. Deterministic and Probabilistic-Sensitivity-Analyses were conducted to verify the robustness of the base-case results.

Results

In the base-case ICERs were €17,434/QALY and €21,234/QALY from 2-year and lifetime-horizon respectively. Deterministic results ranged from €13,945–€20,924/QALY (2 years), and from €13,749/QALY–€25,518/QALY (lifetime). The probability of DUT/TAM being cost-effective was 90% at a willingness to pay of €30,000/QALY.

Conclusion

DUT/TAM could be considered as a cost-effective alternative within the Spanish NHS as an initial treatment for BPH naïve moderate patients at risk of progression, compared with WW + TAM clinical practice.

Keywords

Cost-effectiveness Dutasteride/tamsulosin Economic model Benign prostatic hyperplasia 

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Copyright information

© Springer International Publishing Switzerland 2017

Authors and Affiliations

  • Bernardino Miñana López
    • 1
  • Francisco José Brenes
    • 2
  • José María Molero
    • 3
  • Antonio Fernández-Pro
    • 4
  • José Manuel Cozar
    • 5
  • Alicia Huerta
    • 6
  • Laura Amanda Vallejo-Aparicio
    • 6
  1. 1.Servicio de UrologíaHospital General Universitario J.M. Morales MeseguerMurciaEspaña
  2. 2.CAP Badalona-6 Llefià BadalonaBarcelonaEspaña
  3. 3.Centro de Salud San AndrésMadridEspaña
  4. 4.Centro de Salud de MenasalbasToledoEspaña
  5. 5.Hospital Universitario Virgen de las NievesGranadaEspaña
  6. 6.Departamento Evaluación del MedicamentoGSK EspañaMadridEspaña

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