Monoclonal antibodies: Indications, budget impact and use

Abstract

Objectives: This study aims to compile a list of monoclonal antibodies and their indications in the European Union, and to examine the budget impact and use of monoclonal antibodies in a Belgian university hospital. Methods: Information about monoclonal antibodies was extracted from the European Public Assessment Reports published by the European Medicines Agency. The Belgian Centre for Pharmacotherapeutic Information was accessed to explore which monoclonal antibodies were marketed in Belgium. Annual data about the budget impact and the number of patients using monoclonal antibodies in University Hospitals Leuven were extracted from pharmacy databases from 2004 to 2008. A qualitative questionnaire was sent to hospital physicians to elicit approved and off-label use of monoclonal antibodies. Key findings: In March 2010, 39 monoclonal antibodies (17 of which are orphan drugs) were registered in the European Union. Around 40% of these were marketed in Belgium. Six monoclonal antibodies were revoked for commercial reasons. The proportion of the hospital drug budget spent on monoclonal antibodies has more than doubled from 8% in 2004 to 17% in 2008. The monoclonal antibody budget was made up of infliximab (41% of budget), trastuzumab (20%), rituximab (10%), cetuximab (9%), ranibizumab (9%) and others (11%) in 2008. Although monoclonal antibodies tend to be used in their registered indications in University Hospitals Leuven, a number of cases of off-label use were documented. Conclusions: The monoclonal antibody market is expected to continue to evolve with the registration of new antibodies, expansion of indications and increased utilisation. © 2010 The Authors JPHSR. © 2010 Royal Pharmaceutical Society.