Da incorporação ao acesso real: atraso na dispensação e inequidades territoriais de medicamentos incorporados ao SUS (2024–2025)

Abstract

Introduction (with objective): Following a favorable decision from the National Commission for the Incorporation of Technologies (Conitec), the legal deadline for offering the technology is 180 days; however, dispensing depends on coding in SIGTAP, the development of a Clinical Protocol and Therapeutic Guideline (PCDT), agreement in the Tripartite Inter-managerial Commission (CIT), and the organization of the network in the Federative Units (UFs). The Federal Court of Accounts (TCU) identified, in 2026, that 33 of the 110 technologies incorporated between 2021 and 2023 were offered after this deadline. However, evidence on compliance with the deadline and territorial equity in access to more recent incorporations is scarce; therefore, we propose to analyze the time between the publication of the incorporation and the start of dispensing of recently incorporated medications into the SUS (Brazilian Unified Health System), verify the proportion dispensed within the legal deadline of 180 days, and identify inequities among the UFs. Material and Method: This was a descriptive, retrospective study using publicly available secondary data. New medications from the Specialized Component of Pharmaceutical Assistance (CEAF), with a single indication, incorporated by CONITEC between January 2024 and July 2025 (excluding expanded uses), were included. The existence of a code in SIGTAP and dispensing in the SUS Outpatient Information System (SIA/SUS) were verified, with data up to February 2026. The primary outcome was the time, in days, between publication of the incorporation and the first dispensing record, using the legal deadline of 180 days as a parameter (Decree No. 7,646/2011, art. 25). The state of the first record was identified. Descriptive analysis: absolute and relative frequencies; time described by amplitude and maximum value. Results: 36 new incorporations were identified; only 8 (22.2%) had a code in SIGTAP. Of these 8, only 4 (50%) — corresponding to 11.1% of the total — had active dispensing until February 2026. None of the 36 incorporations were dispensed within the legal deadline of 180 days. The longest interval between incorporation and dispensing was 604 days (424 days beyond the deadline) for ravulizumab (paroxysmal nocturnal hemoglobinuria); the shortest, 301 days (121 days beyond the deadline) for hydroxyurea (sickle cell anemia). Tafamidis (transthyretin amyloid cardiomyopathy) had 712 days (532 beyond the deadline) and triple inhaled therapies, 452 days (272 beyond the deadline). The distribution among states was heterogeneous: hydroxyurea started in Bahia and two months later only four states registered active dispensing; tafamidis had a single registration in São Paulo; Inhalable therapies began in Rio Grande do Sul with subsequent concentration in Goiás. Conclusions: None of the analyzed incorporations were made available within the legal timeframe, and most remained without operational coding until February 2026. Significant delays and initial concentration of access in a few states highlight administrative bottlenecks and territorial inequality. The study broadens the TCU's perspective by demonstrating that post-incorporation implementation should be evaluated not only by time but also by federal equity. It is recommended to strengthen monitoring, timely coding, and inter-federative coordination to ensure the effectiveness of decisions and equitable access to technologies in the SUS (Brazilian Unified Health System).