Da aprovação regulatória ao acessoanálise do cenário em transformação das terapias CAR-T no Brasil até o primeiro trimestre de 2026

Resumo

CAR-T cell therapies represent one of the most significant recent innovations in hematology. However, their incorporation into healthcare systems involves regulatory, operational, organizational, and access-related challenges that extend beyond product approval. In this context, this study sought to answer the following research question: What is the current status of CAR-T cell therapies in Brazil, and which factors influence their implementation and access in the country? The objective of this study was to analyze the Brazilian CAR-T cell therapy landscape, considering aspects related to clinical development, regulatory pathways, healthcare infrastructure, patient access, and national initiatives aimed at the development and use of these therapies. A qualitative research approach was adopted, combining a literature review, documentary analysis of national and international public sources, and exploratory consultations with stakeholders involved in the advanced therapy ecosystem in Brazil. The findings indicate that Brazil has achieved important regulatory advances, including the publication of specific regulations for advanced therapy medicinal products and the approval of the first commercial CAR-T therapies. Nevertheless, significant challenges remain regarding the geographic distribution of qualified treatment centers, the complexity of the patient care pathway, the sustainability of access models, and the integration of public, private, and academic initiatives. The study also identified ongoing efforts aimed at the development of domestic CAR-T platforms and the expansion of national technological capabilities, although substantial barriers to large-scale implementation persist. The study concludes that the evolution of CAR-T therapies in Brazil depends not only on scientific and regulatory progress but also on the healthcare system’s capacity to organize specialized care networks, coordinate service delivery, and develop sustainable strategies to expand patient access. By consolidating and systematizing information that is currently fragmented across multiple sources, this study provides relevant insights for healthcare managers, policymakers, and other stakeholders involved in the implementation of advanced therapies in Brazil.

Ficha do documento

Tipo

Dissertação

Ano

2026

Instituição

Fundação Getulio Vargas

Fonte

Repositório da FGV

Idioma

Português

Acesso

Acesso aberto

Identificador

oai:repositorio.fgv.br:10438/40863

Temas

TecnologiaSaúde

Palavras-chave

Terapias CAR-TTerapias avançadasHematologiaInovação em saúdeIncorporação de tecnologiasCAR-T therapiesAdvanced therapy medicinal productsHematologyHealthcare innovationTechnology adoptionAdministração de empresasAcesso aos serviços de saúdeAdministração dos serviços de saúde - BrasilCâncer - TratamentoODS 3: Saúde e bem-estar