Rational use of anticancer drugs and patient lawsuits in the state of Sao Paulo, Southeastern Brazil

OBJECTIVE: To assess the rationality of legal suits and administrative requests requiring anticancer drugs filed against and submitted to the Sao Paulo State Department of Health, in view of scientific evidence on efficacy and safety. METHODS: A descriptive cross-sectional study was carried out based on information on lawsuits filed by cancer patients requiring anticancer drugs were furnished by the Department of Health. These drugs are among those having the greatest financial impact on the Brazilian Health System in 2006 and 2007. The drugs were assessed according to clinical evidence on efficacy and safety, based on Micromedex (R) categorization, on systematic reviews and meta-analyses. Indications present in the legal documentation were compared to the indications approved by regulatory agencies. RESULTS: Bevacizumab, capecitabine, cetuximab, erlotinib, rituximab, imatinib, and temozolomide accounted for expenses over R$ 40 million to meet 1220 requests and lawsuits, at an average cost of R$ 33,500 per patient. Selected studies do not recommend all the indications for the prescribed drugs. Approximately 17% of requests and lawsuits did not provide evidence for the required indication, and these amounted to inappropriate expenses of, at least, R$ 6.8 million. CONCLUSIONS: The results reinforce the need for technical expertise in dealing with legal suits and for capacity-building of health professionals in approaching the scientific literature, in order to appropriately select drugs and to ensure the best therapeutic decision for each clinical condition, and thus guarantee access to sale and effective health technologies and, therefore, to enhance the quality of the Brazilian pharmaceutical services model in oncology.