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Eficiencia de los fármacos de origen biotecnológico en el marco terapéutico actual, según los estudios farmacoeconómicos disponibles

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PharmacoEconomics Spanish Research Articles

Resumen

Objetivo: El objetivo de este estudio consiste en identificar y describir la información disponible en la literatura científica relativa al análisis de fármacos biotecnológicos, así como definir un baremo coste-beneficio que permita una clasificación de los fármacos biotecnológicos en función de su eficiencia.

Métodos: Se realizó una búsqueda en MEDLINE (PubMed), mediante el cruce de los términos life, year, y saved, de los estudios farmacoeconómicos que evaluaran los fármacos biotecnológicos expresando los resultados en años de vida ganados (AVG) o años de vida ajustados por calidad de vida (AVAC). Se analizaron dichos resultados adoptando un valor umbral límite de 30.000 € — 45.000 €/AVG y/o AVAC y caracterizando el impacto farmacoeconómico de cada fármaco en cada cuadro clínico.

Resultados: Se encontraron 42 estudios, que hacían referencia a 17 de los 77 fármacos biotecnológicos buscados, de los cuales 11 eran vacunas. Los estudios fueron mayoritariamente estadounidenses, con un 50%; se realizaron en un 40% en población pediátrica; en el 67% sólo se recogían costes directos; y en la mayoría se aplicaban una tasa de descuento del 3%–5%. De las 64 situaciones clínicas evaluadas a través de los estudios se observó cómo en una situación el fármaco reduce costes (< 0 €/AVG), en 51 es altamente coste-efectivo (0–30.000 €/AVG), en uno es coste-efectivo (30.000–45.000 €/AVG) y en 11 casos es dudosamente coste-efectivo (> 45.000 €/AVG).

Conclusiones: No obstante la favorable calificación global obtenida, en términos de coste-efectividad, de los fármacos biotecnológicos, el número de estudios farmacoeconómicos y la cantidad de fármacos evaluados es baja, lo cual dificulta su adecuada categorización. La inexistencia de datos universales impide una adecuada toma de decisión respecto del posicionamiento de los fármacos biotecnológicos en el contexto terapéutico de nuestro sistema de salud, por lo que la necesidad de que se realicen más estudios farmacoeconómicos que evalúen dichos fármacos según costes/AVG o AVAC es esencial.

Abstract

Objective: The aim of this study was to identify and describe the information available in scientific literature of biotechnological drug analysis, as well as to define a cost-benefit scale which allows a classification of biotechnological drugs based on their efficiency.

Methods: A search was conducted in MEDLINE (PubMed), crossing the terms “life”, “year”, and “saved”, of the pharmacoeconomics studies which evaluated biotechnological drugs expressing the results in life years saved (LYS) or quality adjusted life years saved (QALY). These results were analyzed adopting a threshold limit value of 30000€-45000€/LYS and/or QALY and characterizing the pharmacoeconomic impact of each drug in each clinical situation.

Results: Forty-two studies were found. They referred to 17 of 77 searched biotechnological drugs, of which 11 were vaccines. The majority (50%) of the studies were American and the 40% were carried out in pediatric population. In 67% of the studies the direct costs were only considered and in the majority of them a 3–5% discount rate was employed. Of the 64 evaluated clinical situations through the studies, it was observed as in 1 situation the drug reduces costs (< 0€/LYS), in 51 is highly cost-effective (0–30000€/LYS), in 1 is cost-effective (30000 - 45000€/LYS) and in 11 cases is doubtfully cost-effective (>45000€/LYS).

Conclusions: Despite the favorable global qualification of biotechnological drugs obtained in terms of cost-effectiveness, the number of pharmacoeconomics studies and the amount of evaluated drugs are low, which makes a suitable categorization difficult. The nonexistence of universal data prevents a suitable decision with regards to the place of biotechnological drugs in the therapeutic setting of our National Health System. This is the reason why furhter pharmacoeconomic studies are required to evaluate these drugs on the basis of costs/LYS or QALY.

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Authors and Affiliations

  1. Farmacéutico Residente II, Servicio de Farmacia, Hospital Universitari Vall d’Hebron, Barcelona, España

    Juan Luís Saucedo Figueredo

  2. Farmacéutica Adjunta, Servicio de Farmacia, Hospital Universitari Vall d’Hebron, Barcelona, España

    Susana Clemente Bautista

  3. Farmacéutico Adjunto, Servicio de Farmacia, Hospital Universitari Vall d’Hebron, Po Vall d’Hebron 119-129, Barcelona, 08035, España

    Luís Mendarte Barrenechea & José Bruno Montoro Ronsano

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  1. Juan Luís Saucedo Figueredo
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  4. José Bruno Montoro Ronsano
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Correspondence to José Bruno Montoro Ronsano.

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Figueredo, J.L.S., Bautista, S.C., Barrenechea, L.M. et al. Eficiencia de los fármacos de origen biotecnológico en el marco terapéutico actual, según los estudios farmacoeconómicos disponibles. Pharmacoecon. Span. Res. Artic. 5, 119–133 (2008). https://doi.org/10.1007/BF03321472

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