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OFF-LABEL USE OF BEVACIZUMAB IN ONCOLOGY PATIENTS. INFLUENCE ON EFFECTIVENESS, SECURITY AND COSTS

JUAN FRANCISCO MARIN POZO ^1*, JUAN MANUEL DUARTE PEREZ ², PEDRO SANCHEZ ROVIRA ³

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We evaluated the prevalence of data on the off-label use (OFLU) of bevacizumab for oncology patients and we analysed the influence on health outcomes and economic costs in the context of general clinical practice. We collected data on the oncology prescriptions of patients in a regional hospital of southern Spain (years 2006 - 2012). We collected progression free survival (PFS), overall survival (OS), duration of treatment and costs as outcome variables. The analysis comprised 240 prescriptions, 57.1% were on-label use (ONLU) versus 42.9% OFLU. The median of the treatment duration, PFS and OS at ONLU/OFLU was 6.1/5.4 months, 7.2/6.5 months and 12.9/12.6 months, respectively. The sensitivity analysis showed a statistically significant difference for PFS and OS in favour of ONLU prescriptions. Patients with ONLU prescriptions had a frequency of adverse effects of 71.5% while patients with OFLU prescriptions 60.2%. The cost of bevacizumab for the ONLU treatments was 2,850,370.42 € and 3,586,419.60 € for the OFLU treatments. The results of efficacy and safety do not vary significantly between ONLU and OFLU prescriptions, but do vary in the sensitivity analysis. The consumption of bevacizumab increases significantly with bevacizumab OFLU.