A quantidade de decisões judiciais para o fornecimento de tecnologias em saúde e, em especial medicamentos, segue uma trajetória crescente desde a Constituição Federal de 1988, trazendo dificuldades à gestão do SUS. A Lei 12.401/2011, ao instituir a Comissão Nacional de Incorporação de Tecnologias no SUS - CONITEC com a finalidade de assessorar tecnicamente o Ministério da Saúde trouxe um componente importante a essa questão, na medida em que disciplinou o processo de avaliação e incorporação de tecnologias em saúde, propiciando a tomada de decisão baseada em evidências científicas, com o estabelecimento de prazos processuais e mecanismos para a participação social. No âmbito de sua atuação, a CONITEC, por meio de sua Secretaria-Executiva, tem estabelecido canais de comunicação com os operadores do Direito e com a sociedade, visando a apresentar esclarecimentos e informações para que as respectivas ações e decisões sejam tomadas com o maior conhecimento possível acerca das tecnologias em saúde disponibilizadas pelo SUS. Este artigo apresenta um estudo de caso descritivo e analítico, que utilizou como fonte de dados 889 respostas e 260 informações técnicas enviadas no período de 2012 a 2015 e os indicativos da sua contribuição para a prevenção da judicialização da saúde.

INTRODUCTION:The Unified Health System (SUS) is based on the principle of health as a citizen's right and the state's duty, which must be guaranteed based on public policies. Although there are several legislations, lists of medicines and clinical guidelines, Brazilians who have been prescribed expensive technologies that are not part of the essential drug lists ask judges to issue court orders obliging public health managers to purchase these drugs or to provide elective medical procedures immediately. Due to the health technical inexperience from judges, prosecutors and public lawyers, a partnership has arisen for the National Committee for Health Technology Incorporation (CONITEC) to provide technical assistance to help their decision-making process. Thus the purpose of this study is to describe CONITEC's experiences in communicating with stakeholders in this process.METHODS:A case study method was used and information about the rapid reports developed by CONITEC's Executive Secretariat in response to the applicants in the period of 2012 to 2016, was retrieved from CONITEC database.RESULTS:Rapid reports (2,773) about health technologies incorporation such as medicines, procedures or medical devices were produced by CONITEC during this period. Most requests covering topics as treatments for diabetes, arterial hypertension, osteoporosis, oncology and epilepsy; diseases for which there are several treatment options in SUS. The data analysis indicated that CONITEC contributed to the evidence based decision-making. On one hand, the Prosecutor's Office has been increasingly requesting information before starting lawsuits and Judiciary Power has increasingly used evidence-based technical information before deciding on the concession of injunctions; on the other hand, from 2012 to 2016 the number of requests decreased for information to State defense in lawsuits that has been already established.CONCLUSIONS:There is a growing interest in technical knowledge for fair decision making that respects the current organization of the evidence-based health system.

Introduction:Eculizumab is a monoclonal antibody indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) or with atypical hemolytic uremic syndrome (aHUS). In Brazil in recent years eculizumab was the most expensive drug requested through court orders, obliging public health managers to import it from the USA. From 2012 to 2016, approximately BRL 424 million (USD 112 million) was spent on eculizumab. The purpose of this study was to assess the regulatory situation and the scientific evidence on the safety and efficacy of eculizumab.Methods:A literature search was conducted in PubMed, The Cochrane Library, and the Centre for Reviews and Dissemination databases on September 2017. The websites of regulatory agencies were also searched.Results:In 2007, the use of eculizumab was approved by the United States Food and Drug Administration and the European Medicines Agency. In Brazil, despite the provision of eculizumab through judicial proceedings since 2009, the manufacturer of eculizumab only requested a licence for it in 2017, after several meetings with the government when the company agreed to provide the drug at approximately half the price of the imported product. The efficacy of eculizumab in PNH patients was assessed in one randomized, placebo controlled study, one single arm study, and one long-term extension study. The drug reduced hemolysis and the need for transfusion, although the studies had methodological problems. The efficacy of eculizumab in the treatment of aHUS was assessed in four prospective, controlled open-label studies, two long-term extension studies, and one retrospective study. Eculizumab normalized platelet counts and reduced the need for plasmapheresis, although the studies had no control group. Eculizumab was well tolerated, with no meningococcal infections occurring after patients were immunized.Conclusions:Some companies have no interest in licensing their products in Brazil because their provision by judicial proceedings is more lucrative. This situation promotes litigation and irrational prescription of drugs, and also obligates the Brazilian government to import expensive health products.