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Consulta Pública para Incorporação de Novo Medicamento para Leucemia Mieloide Aguda (LMA) no SUS Está Aberta no Site da CONITEC Até 22 de Abril


News provided by

AbbVie Brasil

Apr 20, 2020, 13:16 ET

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  • Consulta pública, aberta à participação de toda população, avalia a incorporação de novo tratamento para leucemia mieloide aguda (LMA) no Sistema Único de Saúde (SUS). O link para participar está disponível no site da CONITEC 

SÃO PAULO, 20 de abril de 2020 /PRNewswire/ -- A Comissão Nacional de Incorporação de Tecnologias no Sistema Único de Saúde (CONITEC) está com consulta pública aberta para receber contribuições da população para avaliação da incorporação pelo SUS de venetoclax em combinação com azacitidina para o tratamento de pacientes recém diagnosticados com LMA (Leucemia Mieloide Aguda) e que são inelegíveis para quimioterapia intensiva, a critério do médico. Venetoclax, como tratamento para LMA, foi aprovado em janeiro de 2019 pela Agência Nacional de Vigilância Sanitária (ANVISA). A consulta pública estará disponível para contribuições da população até 22 de abril de 2020.

LMA é a forma mais comum de leucemia aguda em adultos1,2. Nesta doença, a medula óssea passa a produzir formas anormais e imaturas das células do sangue (brancas e vermelhas) e de plaquetas, que se tornam ineficientes em suas funções. Trata-se de um tipo de câncer agressivo com alta taxa de mortalidade 1,2 e apenas 27% dos pacientes sobrevivem após 5 anos ou mais, a partir do diagnóstico. Cerca de 50% dos pacientes são inelegíveis para o tratamento com quimioterapia intensiva. Para esses pacientes não existem alternativas inovadoras disponíveis há décadas.3

A consulta pública é um instrumento que permite que a população participe do processo de decisão do Ministério da Saúde sobre incorporação de novos medicamentos. Para participar da consulta pública, os interessados devem acessar o site da CONITEC, localizar a consulta pública de número 17 ("Venetoclax em Combinação com Azacitidina Para Pacientes Recém Diagnosticados com LMA") e clicar em "Contribuições". São duas opções - uma direciona para o formulário usado para submissão de informação técnica (evidência clinica/avaliação financeira, impacto no orçamento) e outra para a opinião, experiência (cuidadores, experiência com o medicamento ou a doença).  Neste formulário para opiniões/experiências, no item 6, a opção DISCORDO da recomendação preliminar da CONITEC é a FAVOR DA INCORPORAÇÃO deste novo medicamento no sistema público.  A opção Eu Concordo é a favor da não incorporação deste novo medicamento.

Qualquer pessoa acima de 18 anos pode submeter sua opinião sobre a incorporação no SUS do novo medicamento para LMA.

Venetoclax é o primeiro de uma nova classe de medicamentos e seletivamente inibe a proteína BCL-2. Em alguns tipos de câncer no sangue ou outros, a proteína BCL-2 impede a morte natural das células, ou seu processo de auto destruição, chamado de apoptose. Venetoclax age para restaurar o processo de apoptose e é um tratamento de uso oral e livre de quimioterapia.

Venetoclax está sendo desenvolvido pela AbbVie e Roche. É comercializado conjuntamente pela AbbVie e Genentech, uma empresa do grupo Roche, nos Estados Unidos; e pela AbbVie, fora dos Estados Unidos. Juntas, as companhias têm o compromisso de pesquisar a proteína BCL-2 e estudar venetoclax em estudos clínicos de vários tipos de câncer. Venetoclax está aprovado em 50 países, incluindo Brasil.

Sobre a AbbVie

A AbbVie é uma companhia biofarmacêutica global baseada em pesquisa e desenvolvimento, que tem o compromisso de desenvolver terapias avançadas inovadoras para algumas das mais complexas e críticas condições de saúde do mundo. A missão da companhia é usar seu conhecimento, equipe dedicada e foco em inovação para aprimorar, de forma notável, tratamentos em quatro áreas terapêuticas principais: imunologia, oncologia, virologia e neurociência. Em mais de 75 países, os colaboradores da AbbVie trabalham diariamente para desenvolver soluções em saúde para pessoas ao redor do mundo. Para mais informação sobre a AbbVie, acesse www.abbvie.com. Siga @abbvie no Twitter, Facebook, LinkedIn ou Instagram.

No Brasil, a AbbVie começou a operar no início de 2014. Suas unidades de negócios locais incluem imunologia, neonatologia, virologia e oncologia e, entre suas diferentes áreas de atuação, conduz mais de 50 estudos e projetos clínicos, envolvendo mais de 200 equipes e centros de pesquisa brasileiros. Para mais informações, acesse www.abbvie.com.br

Referências

1 Döhner H, et al. Acute myeloid leukemia. N Engl J Med. 2015;373(12):1136-1152.
2 American Cancer Society (2018). Typical Treatment of Most Types of Acute Myeloid Leukemia (Except Acute Promyelocytic M3). https://www.cancer.org/cancer/acute-myeloid-leukemia/treating/typical-treatment-of-aml.html 
3 Yoon J, Byung-Sik C, Hee-Je K, Jung-Ho K et al. Outcomes of elderly de novo acute myeloid leukemia treated by a risk-adapted approach based on age, comorbidity, and performance status. American Journal of Hematology. 2013; 88:1074–1081.

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