Incorporação de novos medicamentos pela Comissão Nacional de Incorporação de Tecnologias do SUS, 2012 a junho de 2016
Incorporação de novos medicamentos pela Comissão Nacional de Incorporação de Tecnologias do SUS, 2012 a junho de 2016
Data
2017
Autores
Caetano, Rosângela
Silva, Rondineli Mendes da
Pedro, Érica Militão
Oliveira, Ione Ayala Gualandi de
Biz, Aline Navega
Santana, Pamela
Journal Title
Journal ISSN
Volume Title
Publisher
Ciência & Saúde Coletiva
Resumo
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 Co-
nitec. Demandas foram classificadas pelos tipos de
submissão, de tecnologia e demandante. Medica-
mentos incorporados foram analisados segundo
as classificações Anatômico-Terapêutica-Química
e Internacional de Doença (CID) da indicação
clínica, e presença de registro na Agência Nacio-
nal de Vigilância Sanitária. Foram recebidas 485
submissões, 92,2% relativas a pedidos de incorpo-
ração e 62,1% para medicamentos, dos quais 93
(30,1%) com recomendação favorável à incorpo-
ração. Demandas internas obtiveram maior suces-
so que as originadas externamente. Seis medica-
mentos sem registro foram incorporados. Doenças
infecto-parasitárias e osteomusculares foram as
principais indicações clínicas. Benefícios clínicos
adicionais e baixo impacto orçamentário foram as
principais justificativas de recomendação.
The National Commission for incorpo- ration of Health Technologies (CONITEC), estab- lished 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 in- vestigated the decision-making process, profile of demands and incorporation of new medicines in the SUS from January/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-Ther- apeutic-Chemical classification, International Classification of Disease of the clinical indication and active record in the National Health Sur- veillance Agency. In the period, 485 submissions were received, 92.2% concerning requests for in- corporation 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 un- registered drugs were incorporated. Infectious and parasitic diseases and musculoskeletal diseases constituted the main clinical indications. The rec- ommendation of incorporation occurred mainly based on the additional clinical benefits and low budget impact.
The National Commission for incorpo- ration of Health Technologies (CONITEC), estab- lished 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 in- vestigated the decision-making process, profile of demands and incorporation of new medicines in the SUS from January/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-Ther- apeutic-Chemical classification, International Classification of Disease of the clinical indication and active record in the National Health Sur- veillance Agency. In the period, 485 submissions were received, 92.2% concerning requests for in- corporation 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 un- registered drugs were incorporated. Infectious and parasitic diseases and musculoskeletal diseases constituted the main clinical indications. The rec- ommendation of incorporation occurred mainly based on the additional clinical benefits and low budget impact.
Description
Palavras-chave
Medicamentos, Avaliação de tecnologias em saúde, Tomada de decisão, Sistema Único de Saúde, Medicines, Health technology assessment, Decision making, Unified Health System
Citação
Caetano R, Silva RMD, Pedro ÉM, Oliveira IAG, Biz AN, Santana P. Incorporation of new medicines by the National Commission for Incorporation of Technologies, 2012 to June 2016. Cien Saude Colet. 2017 Aug;22(8):2513-2525. Portuguese, English. doi: 10.1590/1413-81232017228.02002017.