Desalinhamento entre PCDTs e SIGTAP: fragilidades de governança e risco financeiro na execução do CEAF

Abstract

Introduction (with objective): Clinical Protocols and Therapeutic Guidelines (PCDTs) regulate access to medications from the Specialized Component of Pharmaceutical Assistance (CEAF) in the Brazilian Unified Health System (SUS) based on scientific evidence and clinical criteria, including age restrictions. The SUS Procedure, Medication, and OPM Table Management System (SIGTAP) operationalizes the registration and reimbursement of these dispensations. Inconsistencies between the age ranges defined in the PCDTs and registered in SIGTAP constitute a governance problem: dispensing according to clinical criteria may be subsequently questioned in an audit, generating a risk of denial of payment and reduction of reimbursements to the states; conversely, SIGTAP may restrict access authorized by the PCDT. Both scenarios threaten the financial execution of CEAF and the comprehensiveness of care. Identifying and analyzing these inconsistencies can contribute to improving the governance of Pharmaceutical Assistance (AF) in the SUS. Material and Method: This was a cross-sectional, descriptive, and documentary study using descriptive statistics. The unit of analysis was the pharmaceutical specialty, defined as a combination of active ingredient, concentration, and pharmaceutical form. Pharmaceutical specialties recommended in current Clinical Protocols and Therapeutic Guidelines (PCDTs) up to November 2022 with age range restrictions were included. Specialties without an active code in SIGTAP were excluded. The age ranges in the PCDTs were compared with those registered in SIGTAP, with data up to April 2026. Inconsistencies were categorized as: SIGTAP without a minimum age limit when the PCDT restricts it; SIGTAP more restrictive than the PCDT; and ICD-10 incompatibility. Specialties without inconsistencies were classified as convergent. Analysis was performed using absolute and relative frequencies. Results: 280 pharmaceutical specialties with age range restrictions in PCDTs were identified. Of these, 112 (40.0%) were excluded due to the absence of an active code in SIGTAP. Among the 168 analyzable specialties, 82 (48.8%) presented inconsistencies. The main inconsistency occurred in 71 (42.3%), in which SIGTAP displayed a broad range of 0 to 130 years, a system convention for the absence of registered restrictions, without reflecting the minimum age defined in the PCDT, creating a divergence between clinical rule and operational parameter. Conversely, 2 (1.2%) specialties presented a more severe age restriction in SIGTAP than in the PCDT, with potential access blockage: abatacept and mepolizumab, indicated for pediatric use in the PCDTs for juvenile idiopathic arthritis and asthma, respectively, but registered with a minimum age of 18 years in SIGTAP. Additionally, 9 (5.2%) specialties presented ICD-10 incompatibility. Of the 86 convergent specialties, 45 (26.8%) had no age restriction and 41 (24.4%) showed full agreement between PCDTs and SIGTAP. Conclusions: Almost half of the analyzable pharmaceutical specialties showed misalignment between PCDTs and SIGTAP, revealing weak governance between clinical standards and CEAF operational systems. The inconsistencies identified may favor denials in audits, undue restriction of access, and administrative insecurity for state managers. It is recommended to implement a systematic and timely mechanism for synchronized updating of SIGTAP after PCDT revisions, with definition of institutional responsibility and regulatory deadline, as a strategic measure to strengthen the sustainability of CEAF and equity in access to SUS technologies.