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Coste-efectividad de roflumilast en el tratamiento de pacientes con enfermedad pulmonar obstructiva crónica en España

  • Artículo de Investigación Original
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PharmacoEconomics Spanish Research Articles

Resumen

Objetivo: Estimar la relación de coste-efectividad de roflumilast frente al tratamiento farmacológico más prescrito en España en pacientes adultos con enfermedad pulmonar obstructiva crónica (EPOC) grave con historia de exacerbaciones frecuentes.

Metodología: Se utilizó un modelo de Markov para estimar la relación de costeefectividad de roflumilast más un broncodilatador antagonista de los receptores muscarínicos de acción prolongada (roflumilast+LAMA) frente a un LAMA más un agonista beta-2 de acción prolongada asociado a un corticoide inhalado (LAMA+LABA/CI). Se utilizó la perspectiva del Sistema Nacional de Salud (SNS) español y un horizonte temporal de la esperanza de vida de los pacientes. Los resultados de salud evaluados fueron los siguientes: episodios de exacerbación evitados, años de vida ajustados por calidad (AVAC) y años de vida ganados (AVG). La incertidumbre en los parámetros del modelo se examinó en un análisis de sensibilidad.

Resultados: Durante el periodo correspondiente a la esperanza de vida de los pacientes, roflumilast+LAMA supuso un coste 3.510 € menor que el de LAMA+LABA/CI. Se estimó que un paciente tratado con roflumilast+LAMA tendría 1,24 exacerbaciones menos, 0,142 AVAC más y 0,16 AVG más que un paciente en tratamiento con LAMA+LABA/CI. El análisis de sensibilidad confirmó la robustez de los resultados.

Conclusiones: La combinación de roflumilast+LAMA es la opción dominante (menor coste y mayor efectividad) en España para el tratamiento de pacientes con EPOC grave asociada a bronquitis crónica con historia de exacerbaciones frecuentes, al compararla con LAMA+LABA/CI.

Abstract

Objective: To estimate the cost-effectiveness of roflumilast versus the most prescribed drug combination in Spain in the treatment of adult patients with severe chronic obstructive pulmonary disease (COPD) with a history of frequent exacerbations.

Methods: A Markov model was constructed to estimate the lifetime cost-effectiveness of roflumilast plus a long-acting muscarinic antagonist (roflumilast+LAMA) versus the combination of LAMA with a long-acting beta agonist and an inhaled corticosteroid (LAMA+LABA/ICS). Outcomes were expressed as the incremental cost per exacerbation avoided from the Spanish National Health System perspective using a life-time horizon (30 years). Other health outcomes in the model include quality-adjusted life year (QALY) gained and life years (LY) gained. The key inputs are based on roflumilast pivotal clinical trials and published epidemiological and population data. Uncertainty in the model’s parameters was examined by sensitivity analysis.

Results: The results of the economic analysis have demonstrated that, over the lifetime of patients with severe COPD and associated chronic bronchitis with a history of frequent exacerbations, the roflumilast+LAMA strategy will cost € 3,510 less than using LAMA+LABA/ICS. Over a lifetime, a patient treated with a roflumilast+LAMA is estimated to have 1.24 exacerbations less, 0.142 more QALYs and 0.16 more LY that a patient treated with LAMA+LABA/ICS. The roflumilast treatment arm appears to be the dominating option. Sensitivity analyses showed that the variable that has the most significant impact on the ICER results is the relative risk for exacerbations.

Conclusions: Roflumilast+LAMA offers a cost-effective option for the maintenance treatment of severe COPD associated with chronic bronchitis in patients with a history of frequent exacerbations, compared with LAMA+LABA/ICS.

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Authors and Affiliations

  1. Health Economics & Outcomes Research, IMS Health, Dr. Ferrán, 25-27, 08034, Barcelona, España

    Leandro Lindner

  2. Servicio de Neumología, Hospital de La Princesa, Madrid, España

    Julio Ancochea

  3. Nycomed Pharma S.A., Madrid, España

    Jesús Aparicio & Leticia Camíns

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Lindner, L., Ancochea, J., Aparicio, J. et al. Coste-efectividad de roflumilast en el tratamiento de pacientes con enfermedad pulmonar obstructiva crónica en España. Pharmacoecon. Span. Res. Artic. 9, 95–108 (2012). https://doi.org/10.1007/BF03320879

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