Cost and role of non-evidence-based indications of antineoplastic medicines in São Paulo, Brazil

A growing demand for costly antineoplastics has burdened financing of the Brazilian Public Health System (SUS). We aim to contribute to the enhancement of quality oncological pharmaceutical services in SUS, through production of independent information to warrant adoption of this technology. The medicines were evaluated in relation to evidence of efficacy and safety, based on the Micromedex^® classification and on meta-analyses, systematic reviews and randomized controlled clinical trials. Indications mentioned by Micromedex^® were confronted to those approved by regulatory agencies in Brazil, the United States and Europe. In the State of São Paulo, only seven medicines - bevacizumab, capecitabine, cetuximab, erlotinib, rituximab, imatinib and temozolomide - generated costs in excess of 21 million US dollars in 2006 and 2007. They were used by 1220 patients, at an average cost of 17,231.33 USD per patient. The majority of uses for these were unsubstantiated by evidence from the selected studies. In São Paulo, SUS spent 3,541,715.00 USD in medicines for non-evidence-based indications, while simultaneously risking indirect costs for the health system from possible adverse effects. This is contrary to the prominent role that Health Technology Assessment has played in SUS, supporting decisions on adoption of technologies and contributing to the overall planning, management and evaluation of programs and services.