ONE NATIONAL PROTOCOL, MANY LOCAL REALITIES: A REAL-WORLD ANALYSIS OF THE ADRENAL INSUFFICIENCY CLINICAL GUIDELINE IN BRAZIL'S UNIFIED HEALTH SYSTEM
Author(s)
Lucas Gabriel Vieira de Oliveira, Graduate1, Pedro Henrique Donizetti Santos, Undergraduate2, Luciana Melo de Moura, Dr2, Francino Machado Azevedo Filho, PhD2.
1Health Technology Assessment Unit of the Brazilian Center for Health Outcomes Research, Brasília, Brazil, 2Health Technology Assessment Unit of the Brazilian Center for Health Outcomes Research, Brasilia, Brazil.
1Health Technology Assessment Unit of the Brazilian Center for Health Outcomes Research, Brasília, Brazil, 2Health Technology Assessment Unit of the Brazilian Center for Health Outcomes Research, Brasilia, Brazil.
OBJECTIVES: To characterize the real-world operation of the adrenal insufficiency clinical protocol (PCDT-IA) in Brazil's Unified Health System (SUS) - utilization, medication adherence, equity, and clinical outcomes -to inform the ongoing protocol update by the National Committee for Health Technology Incorporation (CONITEC).
METHODS: Observational study (descriptive, longitudinal, and ecological) using DATASUS public administrative microdata and CMED/PMVG price lists (2024-2025). We included individuals with a medication authorization (APAC) for fludrocortisone and a primary ICD-10 code of E27.1-E27.4. Adherence was measured by the Proportion of Days Covered (PDC). Demographics, self-reported race/skin color, hospitalizations (SIH-SUS), and deaths (SIM) were analyzed; inter-state variation and racial equity were benchmarked against the 2022 national Census.
RESULTS: In 2024, the PCDT-IA covered 1,345 unique patients (54.7% women; median age 53 years; 68.7% White, 25.8% Mixed-race, 3.7% Black), with 9,414 authorizations and an estimated minimum cost of ~US$0.37 million (R$1.94 million; median US$278/patient [R$1,441]) (converted at US$1 = R$5.18; June 2026). Median PDC was 0.725, and only 42.3% achieved PDC ≥80%. Adherence varied nearly 90-fold across neighboring states (Rio Grande do Sul: 0.9% vs. Paraná: 83% with PDC ≥80%). Black patients were markedly underrepresented (3.7% vs. 10.2% expected; gap ≈87 patients) and, once enrolled, faced higher discontinuation risk (adjusted HR 1.68; 95% CI 1.15-2.45). In-hospital lethality was 4.5% (9/201); of 68 deaths coded to E27.x, ~59 (87%) occurred outside hospital.
CONCLUSIONS: A single national protocol effectively functions as multiple local programs. Suboptimal adherence, racial inequity in access, and substantial out-of-hospital mortality - despite the protocol absorbing only 0.5% of analyzed pharmaceutical spending - signal managerial attention disproportionate to clinical severity. The update should embed equity indicators, minimum operational standards, and active surveillance.
METHODS: Observational study (descriptive, longitudinal, and ecological) using DATASUS public administrative microdata and CMED/PMVG price lists (2024-2025). We included individuals with a medication authorization (APAC) for fludrocortisone and a primary ICD-10 code of E27.1-E27.4. Adherence was measured by the Proportion of Days Covered (PDC). Demographics, self-reported race/skin color, hospitalizations (SIH-SUS), and deaths (SIM) were analyzed; inter-state variation and racial equity were benchmarked against the 2022 national Census.
RESULTS: In 2024, the PCDT-IA covered 1,345 unique patients (54.7% women; median age 53 years; 68.7% White, 25.8% Mixed-race, 3.7% Black), with 9,414 authorizations and an estimated minimum cost of ~US$0.37 million (R$1.94 million; median US$278/patient [R$1,441]) (converted at US$1 = R$5.18; June 2026). Median PDC was 0.725, and only 42.3% achieved PDC ≥80%. Adherence varied nearly 90-fold across neighboring states (Rio Grande do Sul: 0.9% vs. Paraná: 83% with PDC ≥80%). Black patients were markedly underrepresented (3.7% vs. 10.2% expected; gap ≈87 patients) and, once enrolled, faced higher discontinuation risk (adjusted HR 1.68; 95% CI 1.15-2.45). In-hospital lethality was 4.5% (9/201); of 68 deaths coded to E27.x, ~59 (87%) occurred outside hospital.
CONCLUSIONS: A single national protocol effectively functions as multiple local programs. Suboptimal adherence, racial inequity in access, and substantial out-of-hospital mortality - despite the protocol absorbing only 0.5% of analyzed pharmaceutical spending - signal managerial attention disproportionate to clinical severity. The update should embed equity indicators, minimum operational standards, and active surveillance.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
RWD43
Topic
Clinical Outcomes, Health Service Delivery & Process of Care, Real World Data & Information Systems
Topic Subcategory
Distributed Data & Research Networks
Disease
Diabetes/Endocrine/Metabolic Disorders (including obesity)