Caetano Rosângela, Silva Rondineli Mendes da, Pedro Érica Militão, Oliveira Ione Ayala Gualandi de, Biz Aline Navega, Santana Pamela
Instituto de Medicina Social, Universidade do Estado do Rio de Janeiro. R. São Francisco Xavier 524/7º/Blocos D/E, Maracanã. 20550-900 Rio de Janeiro RJ Brasil.
Núcleo de Assistência Farmacêutica, Escola Nacional de Saúde Pública Sérgio Arouca, Fiocruz.
Cien Saude Colet. 2017 Aug;22(8):2513-2525. doi: 10.1590/1413-81232017228.02002017.
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 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-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.
国家卫生技术纳入委员会（CONITEC）成立于2011年，就统一卫生系统（SUS）中药物、产品和程序的纳入、排除或变更相关决策向卫生部提供建议。该研究基于CONITEC网站上的可用数据，调查了2012年1月至2016年6月期间SUS中的决策过程、需求概况以及新药的纳入情况。所有提交材料均按技术和申请人类型进行评估和分类。根据解剖治疗化学分类、临床适应症的国际疾病分类以及国家卫生监督局的活跃记录对纳入情况进行分析。在此期间，共收到485份提交材料，其中92.2%是纳入申请，62.1%是药物申请，其中93份（30.1%）获得了纳入的有利推荐。国内需求比国外需求更成功。六种未注册药物被纳入。传染病和寄生虫病以及肌肉骨骼疾病是主要的临床适应症。纳入建议主要基于额外的临床益处和低预算影响。
