The lawsuits to antineoplastic drugs: the tip of an iceberg?

The lawsuits with antineoplastic drugs generate high costs for governments and require careful analysis to ensure efficient and adequate health results. This study analyzed cases conducted by federal entities to a reference institute for the treatment of cancer for technical opinion. Data were collected from copies of the cases examined from July 1 to December 31, 2013. It was analyzed: therapeutic subgroups, presence in essential drug list, drug registry, off-label use, indications of clinical practice guidelines, drug incorporation in Brazilian Health System and estimated value of court cases. 158 cases were examined, with a total of 164 requests of 35 antineoplastic drugs. Most of the medications were protein kinase inhibitors (31.4%), ten (28.6%) were included in the essential drugs list, three did not contain sanitary registration, ten had indication of off-label use, 56.7% were described in clinical practice guidelines and four drugs were recommended for incorporation. The total estimated amount of the court cases was R$ 18,110,504.89. It was identified that the technical and sanitary instruments currently available to support the decisions seem to be insufficient and that there is need to establish strategies to minimize inconsistencies that compromise the comprehensiveness of care.