Uso racional de medicamentos antineoplásicos e ações judiciais no Estado de São Paulo

Abstract

OBJECTIVE:To assess the rationality of legal suits and administrative requests requiring anticancer drugs fi led against and submitted to the São Paulo State Department of Health, in view of scientifi c evidence on effi cacy and safety. METHODS:A descriptive cross-sectional study was carried out based on information on lawsuits fi led by cancer patients requiring anticancer drugs were furnished by the Department of Health. These drugs are among those having the greatest fi nancial impact on the Brazilian Health System in 2006 and 2007. The drugs were assessed according to clinical evidence on effi cacy and safety, based on Micromedex ® 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 scientifi c literature, in order to appropriately select drugs and to ensure the best therapeutic decision for each clinical condition, and thus guarantee access to safe and effective health technologies and, therefore, to enhance the quality of the Brazilian pharmaceutical services model in oncology.

Studies published in indexed journals on lawsuits for medicines in Brazil: a systematic review

“…The first year of the publications included in the review was 2005, and there was a peak in the years 2010 and 2011. The data refer to studies done in the states of Pernambuco 5 , Rio Grande do Sul 2,6 , Minas Gerais 7,8 , Rio de Janeiro 9,10,11,12 , and São Paulo 13,14,15,16,17 , besides one article that collected data directly from the Ministry of Health in Brasilia 18 . The studies that examined the most lawsuits (between 2,000 and 2,927 cases) were done in the states of São Paulo, Rio de Janeiro, and Santa Catarina 7,12,14,16,19 .…”

“…In one study, free legal aid was provided to all the plaintiffs 6 . According to two studies, a small number of attorneys and physicians were involved in a large number of lawsuits 7,17 . For example, one study found that in one of the law firms representing plaintiffs (165 suits), 43.6% involved the same physician prescribing adalimumab (for treatment of rheumatoid arthritis), suggesting a possible association between the manufacturing laboratory, prescribers, and attorneys 7 .…”

“…Characteristics of the claims examined in the articles Table 4 shows the characteristics of the type of drug involved in the claim, type of health care service (public versus private), supply of the drug to the patient, presence of the drug on standard government lists, and registration of the drug in Brazil. Two articles dealt specifically with lawsuits for rare diseases 6,18 , and one focused on claims filed by cancer patients 17 . Of the five studies that examined more than 2,000 lawsuits, only one verified whether the origin of the supply was from the public or private sector, and whether the drugs were registered with the Brazilian National Health Surveillance Agency (ANVISA) 14 , and three studies analyzed whether the drugs claimed through lawsuits were part of official government lists 12,14,19 .…”

“…Ten studies analyzed the plaintiffs' legal representation 2,6,7,8,9,10,14,16,17,20 , of which three 7,14,16 examined more than two thousand lawsuits, whose plaintiffs were represented predominantly by private attorneys. These studies were done in São Paulo, Rio de Janeiro, and Minas Gerais, states with large populations, and two of the three Table 2 Characterization of types of documents and agencies used as data sources.…”

“…Another factor to consider in relation to the prevalence of chronic diseases is the change in the population's epidemiological profile related to aging and socioeconomic conditions 14 . Data on the therapeutic indications for the medicines were analyzed by nine of the 17 articles included in the review 2,6,7,10,11,15,17,18,20 and show that in most cases the prescribed drugs can be classified as medium to high cost, while four studies were designed to clarify points on rare diseases. Thus, it is not possible to infer that the high cost of lawsuits is due to the lack of organization in primary care.…”