0224/2020 - Incorporações de medicamentos para doenças raras no Brasil: é possível acesso integral a estes pacientes? Incorporation of drugs for rare diseases in Brazil: is it possible to have full access to these patients?
Descrever o perfil de solicitações de incorporação de medicamentos para doenças raras (DR) enviadas à CONITECe suas recomendações, comparando critérios usados para incorporação com outras agências de ATS no mundo.Para tanto,foramavaliadas assolicitações submetidas à CONITEC e suas recomendações ao SUS, de julho de 2012a junho de 2019, para tratamento de DR. A seguir, foi feita comparaçãodos critérios utilizados pela CONITEC e por outras agências de ATSpara incorporação destes medicamentos.Houve 60 solicitações de incorporação para 30DR à CONITEC. A maioria das solicitações (66%) foifeitapor indústrias farmacêuticas. Análises de impacto orçamentário foram apresentadas em 85% das solicitações e análises econômicas de tecnologias em saúdeem 68% delas. Trinta e duas (52%)do total de avaliações foram incorporadas no SUS. As justificativas da CONITEC para a não incorporação foram ausência de evidência clínica, tecnologiasnão custo-efetivas e modestos benefícios clínicos que não justificam o preço.Agências de ATS internacionais(UK, FR, CAN, AUS) usam critério diferenciadopara avaliações de DR. Os dados apontam que a maioria dos medicamentos avaliados foi incorporado ao SUS e quea adoção de critério diferenciado para avaliação da incorporação de medicamentos para DR possivelmente trará robustez à tomada de decisão.
Palavras-chave:
Doenças raras, Avaliação da Tecnologia em Saúde, SUS
Abstract:
To describe the solicitationsprofile for incorporation of rare diseases drugs sent to CONITEC and its recommendations, comparing the incorporation criteria used by other HTA agencies worldwide. To this end, solicitations for the treatment of rare diseases submitted to CONITEC07/2012 to 06/2019 and its recommendations to SUS were included in this study. Subsequently, a comparison was made of the criteria used by CONITEC and other HTA agencies to incorporate these drugs. There were 60requests ofdrug incorporation to treat 30 rare disease to CONITEC. Most requests (66%) were made by pharmaceutical companies. Budget impact analyses were presented in 85% of requests and economic analyses in 68% of them. 52% of the solicitations were incorporated into SUS. CONITEC\'s justifications for non-incorporation were the absence of quality clinical evidence, non-cost-effective technologies and modest clinical benefits that do not justify the high prices.International HTA agencies (CAN, UK, FR, AUS) use different criteria for rare diseases evaluations. The data indicate that most of the evaluated drugs were incorporated into SUS and that the adoption of different criteria to assess the incorporation of rare diseases drugs will possibly bring robustness to decision making.
Keywords:
Rare diseases, Health Technology Assessment, Unified Health System, SUS
Incorporation of drugs for rare diseases in Brazil: is it possible to have full access to these patients?
Resumo (abstract):
To describe the solicitationsprofile for incorporation of rare diseases drugs sent to CONITEC and its recommendations, comparing the incorporation criteria used by other HTA agencies worldwide. To this end, solicitations for the treatment of rare diseases submitted to CONITEC07/2012 to 06/2019 and its recommendations to SUS were included in this study. Subsequently, a comparison was made of the criteria used by CONITEC and other HTA agencies to incorporate these drugs. There were 60requests ofdrug incorporation to treat 30 rare disease to CONITEC. Most requests (66%) were made by pharmaceutical companies. Budget impact analyses were presented in 85% of requests and economic analyses in 68% of them. 52% of the solicitations were incorporated into SUS. CONITEC\'s justifications for non-incorporation were the absence of quality clinical evidence, non-cost-effective technologies and modest clinical benefits that do not justify the high prices.International HTA agencies (CAN, UK, FR, AUS) use different criteria for rare diseases evaluations. The data indicate that most of the evaluated drugs were incorporated into SUS and that the adoption of different criteria to assess the incorporation of rare diseases drugs will possibly bring robustness to decision making.
Palavras-chave (keywords):
Rare diseases, Health Technology Assessment, Unified Health System, SUS
Biglia, L.V, Mendes, S. J., Lima, T.M, Aguiar, P.M.. Incorporações de medicamentos para doenças raras no Brasil: é possível acesso integral a estes pacientes?. Cien Saude Colet [periódico na internet] (2020/jul). [Citado em 22/12/2024].
Está disponível em: http://cienciaesaudecoletiva.com.br/artigos/incorporacoes-de-medicamentos-para-doencas-raras-no-brasil-e-possivel-acesso-integral-a-estes-pacientes/17706?id=17706
