Evolution number of litigation cases and expenditure with monoclonal antibodies (MoAbs) (Bevacizumab, Cetuximab and Panitumumab) and tirosine kinase inhibitor (Regorafenib) for the treatment of cancer in Minas Gerais-Brazil : A preliminary analysis from 2009 to 2016

Introduction: The last decade was marked by the widespread use of molecular biological agents in combination with 5-FU / oxaliplatin or irinotecan-containing regimens in the treatment of cancer. Such biological medicines have significantly increased the costs of oncological treatment, leading to concerns about the future sustainability of drug policy and, as a consequence, health systems with universal access to health care. In the case of Brazil, the tree MoAbs BEVACIZUMAB(BEVA), CETUXIMAB(CETUX), PANITUMUMAB(PANIT) and one tirosin kinase inhibitor REGORAFENIB(REGORA) compared in this study can only be used by the patient when there is a litigation against the State, since they are not incorporated into the Single System of Health-SUS. Objectives: To evaluate the evolution number of litigation cases and expenditure with monoclonal antibodies(MoAbs) (Bevacizumab, Cetuximab and Panitumumab) and tirosin kinase inhibitor (Regorafenib) for the treatment of cancer in Minas Gerais-Brazil. Method: Retrospective descriptive study whose judicial information was extracted from the database of the Minas Gerais State Secretariat - SES-MG. The judicial actions were filed against the State of Minas Gerais for Cancer treatment and refer to the period from January 2009 to December 2016. The study was cut from the judicialized MoAbs (BEVA, CETUX, PANIT) and tirosin kinase inhibitor (REGORA) for the treatment of Colorectal Cancer (CCR). The cost of the treatments was calculated based on the prices of the Câmara de Regulação do Mercado de Medicamentos (CMED) ANVISA, taking into account the official dollar exchange rate of the Central Bank on January 31, 2018 and there is no adjustment for inflation. Results and discussion: Preliminary results showed that in the period between 2009 and 2016, 1024 lawsuits were filed against the State of Minas Gerais for cancer treatment, making 766 for BEVA, 206 for CETUX, 35 for PANIT and 17 for REGORA . The total cost obtained considering a 6-month overall survival for each patient was $ 22,260,536. In Brazil, the growing number of litigation and drug costs (BEVA, CETUX, PANIT and REGORA) per year is worrying, considering the increase of 5.100% for judicial actions and 1899% for treatment costs in the period 2009 to 2016 (TABLE 1). Conclusion: The exponential increase in lawsuits against the State of Minas Gerais demonstrates the growing pressure on the resources available to attend a reduced number of patients, who are available to judicialize treatments outside universal health coverage, which is already guaranteed right by the Brazilian constitution

Judicialização do acesso a medicamentos no Estado de Minas Gerais, Brasil

OBJETIVO: Analisar o perfil dos requerentes e dos medicamentos pleiteados em ações judiciais. MÉTODOS: Estudo descritivo sobre 827 processos judiciais com 1.777 pedidos de medicamentos de 2005 a 2006 no Estado de Minas Gerais. Avaliaram-se os tipos de atendimento no sistema de saúde e a representação dos autores junto ao Poder Judiciário. Os medicamentos foram descritos segundo registro na Agência Nacional de Vigilância Sanitária, essencialidade, inclusão programática no Sistema Único de Saúde e evidências de eficácia. RESULTADOS: Mais de 70% dos autores foram atendidos no sistema privado de saúde e 60,3% foram representados por advogados particulares. O diagnóstico mais freqüente foi o de artrite reumatóide (23,1%) e os imunossupressores foram os medicamentos mais solicitados (principalmente adalimumabe e etanercepte). Aproximadamente 5% dos medicamentos pleiteados não eram registrados na Agência, 19,6% estavam presentes na Relação Nacional de Medicamentos Essenciais, 24,3% compunham o Programa de Medicamentos de Alto Custo e 53,9% apresentavam evidência consistente de eficácia. Dentre os medicamentos não disponíveis no sistema público, 79,0% apresentavam alternativa terapêutica nos programas de assistência farmacêutica. CONCLUSÕES: O fenômeno da judicialização na saúde pode indicar falhas do sistema público de saúde, uma vez que há solicitações de medicamentos constantes de suas listas. Todavia, constitui um obstáculo para a prática do uso racional de medicamentos e para a consolidação das premissas da Política Nacional de Medicamentos, principalmente quando são solicitados medicamentos sem comprovação de eficácia e não padronizados pelo Sistema Único de Saúde.OBJECTIVE: To analyze the profile of claimants and medicines demanded in lawsuits. METHODS: Descriptive study that examined 827 lawsuits with 1,777 demands of access to medicines in the period between July 2005 and June 2006 in the state of Minas Gerais, Southeastern Brazil. There were examined the type of health care provided to claimants and their attorneyship. The medicines were described based on the following: drug registration at the National Health Surveillance Agency (Anvisa); wheter they were essential medicines; supply in the Brazilian Health System programs; and evidence of drug efficacy. RESULTS: More than 70% of the claimants were provided care in the private health system and 60.3% hired private lawyers. The most common diagnosis of claimants was rheumatoid arthritis (23.1%) and the immunosuppressant agents were the most frequent demand medicines (mainly adalimumab and etanercept). Approximately 5% of the medicines demanded were not registered at Anvisa, 19.6% were included in the Brazilian List of Essential Medicine, 24.3% were included in the High-Cost Drug Program and 53.9% showed consistent evidence of efficacy. Among the medicines that were not available in Brazilian Health System, 79.0% had therapeutic alternatives in drug programs. CONCLUSIONS: The phenomenon of judicialization of health in Brazil can point out failures in the public health system as some medicines demanded are included in its lists. However, it is a barrier for rational drug use and application of the National Drug Policy guidelines, especially when there are demanded medicines with no evidence of efficacy and that are not included in Brazilian Health System standards.OBJETIVO: Analizar el perfil de los requirentes y de los medicamentos pleiteados en acciones judiciales. MÉTODOS: Estudio descriptivo sobre 827 procesos judiciales con 1.777 pedidos de medicamentos de 2005 a 2006 en el Estado de Minas Gerais, Sureste de Brasil. Se evaluaron los tipos de asistencia en el sistema de salud y la representación de los autores junto al Poder Judicial. Los medicamentos fueron descritos según registro en la Agencia Nacional de Vigilancia Sanitaria, esencialidad, inclusión programática en el Sistema Único de Salud y evidencias de eficiencia. RESULTADOS: Más de 70% de los autores fueron atendidos en el sistema privado de salud y 60,3% fueron representados por abogados particulares. El diagnóstico más frecuente fue el de artritis reumatoidea (23,1%) y los inmunosupresores fueron los más solicitados (principalmente adalimumabe y etanercepte). Aproximadamente 5% de los medicamentos pleiteados no eran registrados en la Agencia, 19,6% estaban presentes en la Relación Nacional de Medicamentos Esenciales, 24,3% componían el Programa de Medicamentos de Alto Costo y 53,9% presentaban evidencia consistente de eficiencia. Entre los medicamentos no disponibles en el sistema público, 79,0% presentaban alternativa terapéutica en los programas de asistencia farmacéutica. CONCLUSIONES: El fenómeno de la judicialización en la salud puede indicar fallas del sistema público de salud, dado que hay solicitudes de medicamentos constantes de sus listas. Aún constituye un obstáculo para la práctica del uso racional de medicamentos y para la consolidación de las premisas de la Política Nacional de Medicamentos, principalmente cuando son solicitados medicamentos sin comprobación de eficiencia y no estandarizados por el Sistema Único de Salud