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Análisis económico de oxicodona LP/ naloxona LP en el manejo del dolor intenso y el estreñimiento asociado al tratamiento con opioides en España

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PharmacoEconomics Spanish Research Articles

Resumen

Introducción: El dolor es todavía un grave problema de salud. Los opioides están recomendados en el manejo del dolor, pero su eficacia analgésica se asocia a algunos efectos adversos. El estreñimiento inducido por opioides (EIO) es el efecto adverso más frecuente, con un profundo impacto en la calidad de vida. El objetivo de este estudio fue estimar las consecuencias clínicas y económicas del uso de oxicodona de liberación prolongada (LP)/naloxona LP comparado con el de oxicodona LP, en pacientes con dolor crónico y EIO.

Métodos: Se construyó un modelo farmacoeconómico para describir las consecuencias clínicas y económicas para cada opción terapéutica. El modelo está basado en resultados de los ensayos clínicos, información sobre el manejo del EIO obtenida de un panel de 10 expertos clínicos españoles y costes representativos del Sistema Nacional de Salud (SNS). El estudio se realizó desde la perspectiva del SNS.

Resultados: El análisis de costes desagregados muestra que el mayor coste de adquisición de oxicodona LP/naloxona LP casi se compensa con el menor uso de recursos sanitarios asociados al manejo del EIO. Oxicodona LP/naloxona LP se asoció a mayor ganancia en años de vida ajustados por calidad y a razones de coste por AVAC ganado de entre 4.904 € y 6.723 € dependiendo del horizonte temporal del análisis. Los análisis de sensibilidad univariante y probabilístico confirmaron la solidez de estos resultados.

Conclusiones: La utilización de oxicodona LP/naloxona LP para el tratamiento del dolor intenso en España se asocia a razones de coste-efectividad muy por debajo del umbral para considerar una intervención sanitaria eficiente en España.

Abstract

Introduction: Pain is still a major health problem. Although opioids are recommended for treatment of moderate-to-severe pain, their efficacy is commonly associated to a number of adverse events. Opioid induced constipation (OIC) is the most frequent adverse event and has an important impact on patient’s quality of life. The aim of this study was to estimate the clinical and economic consequences of prolonged-release (PR) oxycodone/naloxone compared to PR oxycodone, in patients with chronic pain and OIC.

Methods: A pharmacoeconomic model was built to describe both the economic and clinical outcomes associated to each compared therapeutic option. The model was based on clinical trial results, expert opinion on the management of OIC and local unit costs for the National Health System (NHS).

Results: The cost analysis showed that the higher acquisition cost of oxycodone/naloxone was almost offset by the decrease in resource use to manage OIC. PR oxycodone/naloxone was associated with higher quality adjusted life years and incremental cost per QALY gained ratios between 4.904 € and 6.723 € depending on time horizon. Univariate and probabilistic sensitivity analyses confirmed the robustness of these results.

Conclusions: Use of PR oxycodone/naloxone to treat severe pain in Spain is associated to an incremental cost-effectiveness ratio far below the efficiency threshold commonly cited in Spain.

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Authors and Affiliations

  1. Unidad de Dolor, Hospital Universitario Virgen de las Nieves, Granada, España

    Gálvez Rafael

  2. Servicio de Oncología Médica, Hospital Universitario Puerta de Hierro Majadahonda, Madrid, España

    Provencio Mariano

  3. Servicio de Oncología Médica, Hospital Universitario Marqués de Valdecilla, Santander, España

    Sanz-Ortiz Jaime

  4. Unidad de Dolor, Hospital Universitario Vall d’Hebron, Barcelona, España

    Ribera Ma Victoria

  5. Servicio de Oncología Médica, Hospital Universitario Central de Asturias, Oviedo, España

    Esteban Emilio

  6. Unidad de Dolor, Hospital Universitario Puerta del Mar, Cádiz, España

    Collado Francisco

  7. Centro Regional de Cuidados Paliativos y Tratamiento del Dolor, Hospital Los Montalvos, Salamanca, España

    Vara Francisco

  8. Unidad de Dolor, Complejo Hospitalario de Pontevedra, Pontevedra, España

    Díaz Pilar

  9. Dirección Asistencial, Hospital Centro de Cuidados Laguna, Madrid, España

    Rocafort Javier

  10. Servicio de Oncología Médica Complejo Hospitalario Regional Carlos Haya, Málaga, España

    Cobo Manuel

  11. Departamento Médico, Mundipharma Pharmaceuticals S.L., Madrid, España

    Traseira Susana

  12. S.L., C/Josep Irla i Bosch, 5–7 Primera Planta, 08034, Barcelona, España

    Brosa Max (Oblikue Consulting)

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  1. Gálvez Rafael
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  2. Provencio Mariano
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  3. Sanz-Ortiz Jaime
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  4. Ribera Ma Victoria
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  6. Collado Francisco
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  7. Vara Francisco
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  8. Díaz Pilar
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  9. Rocafort Javier
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  10. Cobo Manuel
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  11. Traseira Susana
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  12. Brosa Max
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Corresponding author

Correspondence to Brosa Max.

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Estudio financiado por Mundipharma Pharmaceuticals S.L.

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Rafael, G., Mariano, P., Jaime, SO. et al. Análisis económico de oxicodona LP/ naloxona LP en el manejo del dolor intenso y el estreñimiento asociado al tratamiento con opioides en España. Pharmacoecon. Span. Res. Artic. 9, 23–34 (2012). https://doi.org/10.1007/BF03320871

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