Drugs incorporated into the Brazilian Unified Health System: document analysis of methodological decisions in budget impact analyses between 2012 and 2024.

Objective: 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.

Methods: 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.

Results: 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.

Conclusion: 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.