Affordability of new drugs in the Brazilian public health system: a 13-year monitoring analysis of reimbursement decisions based on health technology assessments (2012–2024)

Background In low- and middle-income countries, reimbursement decisions often rely on projected incremental budget impact (IBI) analyses. We assessed whether drug incorporations into the Brazilian public health system (SUS) between 2012 and 2024 were consistent with affordability considerations within the health technology assessment (HTA) framework. Methods A retrospective documentary analysis was conducted using technical recommendation reports issued by the Brazilian National Committee for Health Technology Incorporation (Conitec). The primary variable was the total projected IBI of incorporated drugs. Subgroup analyses were performed by year of incorporation, health condition, and budget impact output. The proportion of total projected IBI relative to the Specialized Component of Pharmaceutical Care (CEAF) budget was assessed. Findings A total of 199 incorporated drugs were analyzed, 64 of which were projected to be cost-saving (Int$ 6·67 billion). These savings exceeded the total positive projected IBI generated by the remaining drugs (Int$ 4·05 billion). When COVID-19 vaccines were excluded, the cumulative projected IBI became positive, totaling Int$ 2·80 billion over the period analyzed, with sensitivity analyses yield estimates ranging from Int$ 2·36 billion to Int$ 2·88 billion. Preventable diseases exhibited the lowest median per capita IBI (Int$ 28; IQR Int$ 15; IQR Int$ 132), and oncological diseases the highest (Int$ 23,550; IQR Int$ 6789; IQR Int$ 57,154). Among drugs reimbursed exclusively by the Ministry of Health, the cumulative projected IBI represented 29% of the CEAF budget in 2024, exceeding 45% from 2019 to 2022. Interpretation The findings suggest that Conitec's decisions were consistent with HTA principles related to affordability. This interpretation is based on the evidence available at the time of the HTA decision rather than on observed real-world data following incorporation into the SUS. Funding None.