0133/2017 - Incorporação de novos medicamentos pela Comissão Nacional de Incorporação de Tecnologias do SUS, 2012 a junho de 2016 Incorporation of new medicines by the National Commission for Incorporation of Technologies, 2012 to June 2016
• Rosângela Caetano - Caetano, Rosângela - Universidade do Estado do Rio de Janeiro, Politicas, Planejamento e Administração em Saúde Rio de Janeiro - <caetano.r@gmail.com> +
A Comissão Nacional de Incorporação de Tecnologias em Saúde (CONITEC), instituída em 2011, assessora o Ministério da Saúde nas decisões relacionadas à incorporação, exclusão ou alteração de novos medicamentos, produtos e procedimentos no Sistema Único de Saúde. O estudo investigou o processo de recomendação pela CONITEC e o perfil das demandas e incorporações de medicamentos, de janeiro/2012 a junho/2016. A fonte de dados baseou-se nos registros disponíveis no site da CONITEC. Demandas foram classificadas pelos tipos de submissão, de tecnologia e demandante. Medicamentos incorporados foram analisados segundo as classificações Anatômico-Terapêutica-Química e Internacional de Doença (CID) da indicação clínica, e presença de registro na Agência Nacional de Vigilância Sanitária. Foram recebidas 485 submissões, 92,2% relativa a pedidos de incorporação e 62,1% para medicamentos, dos quais 93 (30,1%) com recomendação favorável à incorporação. Demandas internas obtiveram maior sucesso que as originadas externamente. Seis medicamentos sem registro foram incorporados. Doenças infecto-parasitárias e osteomusculares foram as principais indicações clínicas. Benefícios clínicos adicionais e o baixo impacto orçamentário foram as principais justificativas de recomendação.
Palavras-chave:
MedicamentosAvaliação de Tecnologias em SaúdeTomada de DecisãoSistema Único de Saúde
Abstract:
The National Commission for incorporation of Health Technologies (CONITEC), established in 2011, advises the Ministry of Health in decisions related to the incorporation, exclusion or change of medicines, products and procedures in the Unified Health System (SUS). The study investigated the decision-making process, profile of demands and incorporation of new medicines in the SUSJanuary/2012 to June/2016, based on data available on the CONITEC website. All submissions were evaluated and characterized by technology and applicant type. The incorporations were analyzed according to the Anatomical-Therapeutic-Chemical classification, International Classification of Disease of the clinical indication and active record in the National Health Surveillance Agency. In the period, 485 submissions were received, 92.2% concerning requests for incorporation and 62.1% for medicines, of which 93 (30.1%) received a favorable recommendation for incorporation. Domestic demands were more successful than externally originated ones. Six unregistered drugs were incorporated. Infectious and parasitic diseases and musculoskeletal diseases constituted the main clinical indications. The recommendation of incorporation occurred mainly based on the additional clinical benefits and low budget impact.
Keywords:
MedicinesHealth Technology AssessmentDecision MakingUnified Health System
Incorporation of new medicines by the National Commission for Incorporation of Technologies, 2012 to June 2016
Resumo (abstract):
The National Commission for incorporation of Health Technologies (CONITEC), established in 2011, advises the Ministry of Health in decisions related to the incorporation, exclusion or change of medicines, products and procedures in the Unified Health System (SUS). The study investigated the decision-making process, profile of demands and incorporation of new medicines in the SUSJanuary/2012 to June/2016, based on data available on the CONITEC website. All submissions were evaluated and characterized by technology and applicant type. The incorporations were analyzed according to the Anatomical-Therapeutic-Chemical classification, International Classification of Disease of the clinical indication and active record in the National Health Surveillance Agency. In the period, 485 submissions were received, 92.2% concerning requests for incorporation and 62.1% for medicines, of which 93 (30.1%) received a favorable recommendation for incorporation. Domestic demands were more successful than externally originated ones. Six unregistered drugs were incorporated. Infectious and parasitic diseases and musculoskeletal diseases constituted the main clinical indications. The recommendation of incorporation occurred mainly based on the additional clinical benefits and low budget impact.
Palavras-chave (keywords):
MedicinesHealth Technology AssessmentDecision MakingUnified Health System
Caetano, Rosângela, Silva, R.M., Pedro, Érica Militão, Oliveira, I.A.G., Biz, Aline Navega, Santana, Pamela. Incorporação de novos medicamentos pela Comissão Nacional de Incorporação de Tecnologias do SUS, 2012 a junho de 2016. Cien Saude Colet [periódico na internet] (2017/mar). [Citado em 22/01/2025].
Está disponível em: http://cienciaesaudecoletiva.com.br/artigos/incorporacao-de-novos-medicamentos-pela-comissao-nacional-de-incorporacao-de-tecnologias-do-sus-2012-a-junho-de-2016/16179?id=16179&id=16179
