Drug approval with agnostic indication is already a reality in Brazil: what does it mean for judicialization?

• Autor(a) principal: de Paula, Ellen Alves
• Data de Publicação: 2019
• Outros Autores: Silva, Rafael Augusto Mantovani, de Siqueira, Paula Sue Facundo, de Melo, Daniela Oliveira
• Tipo de documento: Artigo
• Idioma: por
• Título da fonte: Cadernos Ibero-Americanos de Direito Sanitário (Online)
• Texto Completo: https://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/572
• topic: Health's Judicialization. Pharmaceutical Services. Access to Essential Medicines and Health Technologies. Brazilian Health Surveillance Agency.; Judicialización de la salud. Servicios farmacéuticos. Acceso a medicamentos esenciales y tecnologías sanitarias. Agencia Nacional de Vigilancia Sanitaria.; Judicialização da Saúde. Assistência Farmacêutica. Acesso a Medicamentos Essenciais e Tecnologias em Saúde. Agência Nacional de Vigilância Sanitária

Objective: to describe the regulatory aspects of larotrectinib, the first approved drug with indication for tumor-agnosis in Brazil, and its likely impacts on judicialization in the country. Methods: this is a descriptive exploratory study. Results and discussion: larotrectinib was approved in Brazil about 225 days after FDA approval. Its approval brings new elements to the discussion of judicialization in health, since few patients will benefit from this therapy. The prevalence of fusion of the NTRK receptor (larotrectinib target mutation) gene is known to be 0.31% of adult tumors and 0.34% of pediatric patient tumors. In addition, pharmacogenetic tests are required to confirm this mutation. Conclusion: with the registration of drugs with tumor-agnostic indication becoming a reality in Brazil, the need for presentation and interpretation of pharmacogenetic tests is increasing. However, this is not a reality in the Unified Health System and, therefore, these drugs tend to benefit only those who have access to pharmacogenetic tests, have the specific mutation for treatment, thus promoting legal demands and thus restricting their access to large majority of the population.