OFF-LABEL USE OF BEVACIZUMAB IN ONCOLOGY PATIENTS.
INFLUENCE ON EFFECTIVENESS, SECURITY AND COSTS
JUAN FRANCISCO MARIN POZO1*, JUAN MANUEL DUARTE PEREZ2, PEDRO SANCHEZ ROVIRA3
1Board Certified Oncology Pharmacist (BCOP), Hospital Pharmacy Department, Complejo Hospitalario de Jaén, Spain
2Faculty of Pharmacy, University of Granada, Spain
3Medical Oncology Specialist, Medical Oncology Department, Complejo Hospitalario de Jaén, Spain
*corresponding author: jfmarinpozo@yahoo.es
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Abstract:
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.

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