Curado Daniel da Silva Pereira, Silva Everton Nunes da
Universidade de Brasília, Programa de Pós-Graduação em Saúde Coletiva, Brasília, DF, Brazil.
Ministério da Saúde, Secretaria-Executiva da Comissão Nacional de Incorporação de Tecnologias no Sistema Único de Saúde, Brasília, DF, Brazil.
Epidemiol Serv Saude. 2025 Sep 8;34:e20250122. doi: 10.1590/S2237-96222025v34e20250122.en. eCollection 2025.
Systematize the methodological decisions adopted in the budget impact analyses of the recommendation reports of the National Commission for the Incorporation of Technologies into the Unified Health System (Conitec) regarding drugs incorporated into the SUS (Brazilian Unified Health System) in the period from 2012 to 2024.
This is an exploratory, descriptive, retrospective study, based on document analysis of Conitec's technical recommendation reports with decisions on the incorporation of drugs published up to 2024. Information from the Budget Impact Analyses (BIA) was extracted and presented in terms of percentage, median and interquartile range.
291 analyses for the incorporation of drugs were identified. More than half of these were requested by the public sector (65.3%). Chronic non-communicable diseases were most frequent (39.2%), followed by infectious diseases (22.3%) and rare conditions (21.0%). The majority of the drugs included represented new additions (55.3%). The presence of BIA in the analyses was quite gradual, reaching 100% only from 2019 onwards. 64.5% used claims data-based and 84.0% conducted sensitivity analyses in the BIAs analysed. The total median of the incorporation diffusion (market share) ranged from 30.0% (1st year) to 72.0% (5th year). The cost analyses were essentially focused on the acquisition cost of drugs. However, the quantity of pharmaceutical units was not clearly reported in 55.5% of the analyses.
The findings indicate that methodological inconsistencies persist in BIAs, such as the absence of sensitivity analyses and cost analyses limited to the acquisition cost of drugs. Therefore, it is suggested that there may be weaknesses in the estimates of the real budget impacts of technologies on the SUS.
对国家技术纳入统一卫生系统委员会（Conitec）2012年至2024年期间关于纳入巴西统一卫生系统（SUS）的药物的推荐报告预算影响分析中采用的方法学决策进行系统化整理。
这是一项探索性、描述性、回顾性研究，基于对Conitec截至2024年发布的关于药物纳入决策的技术推荐报告的文献分析。从预算影响分析（BIA）中提取信息，并以百分比、中位数和四分位间距呈现。
共识别出291项药物纳入分析。其中超过一半是由公共部门要求的（65.3%）。慢性非传染性疾病最为常见（39.2%），其次是传染病（22.3%）和罕见病（21.0%）。纳入的大多数药物为新增药物（55.3%）。BIA在分析中的出现较为渐进，直到2019年才达到100%。在分析的BIA中，64.5%使用基于索赔数据的方法，84.0%进行了敏感性分析。纳入扩散（市场份额）的总中位数从第1年的30.0%到第5年的72.0%不等。成本分析主要集中在药物的采购成本上。然而，在55.5%的分析中，药品单位数量未明确报告。
研究结果表明，BIA中存在方法学不一致的问题，如缺乏敏感性分析以及成本分析仅限于药物采购成本。因此，建议技术对SUS实际预算影响的估计可能存在弱点。
