Abstract
Introduction (with objective): The National List of Essential Medicines (Rename) guides the financing, supply, and rational use of medicines in the Brazilian Unified Health System (SUS). In oncology, the adequacy of this list is strategic to guarantee timely access, implementation of clinical guidelines, and comprehensive care. However, the rapid incorporation of technologies and the therapeutic complexity of cancer can generate a mismatch between official lists, care recommendations, and the needs of the population. Therefore, the oncology component of Rename was analyzed regarding the criteria of essentiality and comprehensiveness of health care, considering international references, national guidelines, and incorporations approved in the SUS. Material and Method: Descriptive documentary study. The list of Pharmaceutical Assistance in Oncology (AF-Onco) in effect on March 10, 2026, was compared to the 24th Model List of Essential Medicines of the World Health Organization (WHO). The medications listed in 29 clinical-assistance guidelines in effect on April 2, 2026, and in 52 reports from the National Commission for the Incorporation of Technologies in the SUS (Conitec) with favorable decisions published between 2012 and March 2026 were also collected. The lists were compared to the AF-Onco/Rename for evaluation of essentiality and comprehensiveness. Medications without current sanitary registration in Brazil were excluded. Results: The AF-Onco contained 56 drugs, of which 13 (23.2%) were not included in the WHO model list. Twenty-one discrepancies were identified between international recommendations and the Rename, mainly concentrated in cytotoxic drugs indicated for leukemias and lymphomas. Among 79 drugs recommended in national guidelines, 24 (30.4%) were not included in the Rename, and only one had a standardized therapeutic alternative. Of the 42 drugs evaluated by Conitec and incorporated or with expanded use in the SUS (Brazilian Unified Health System) since 2012, only 15 (35.7%) were included in AF-Onco, with therapeutic equivalents for two unlisted medications. The observed gaps compromised care pathways for 24 neoplasms, including breast, lung, prostate, ovarian, stomach, liver, kidney, melanoma, central nervous system tumors, and hematological neoplasms. The impact was more significant in advanced, metastatic, or palliative stages, where 17 incorporated medications remained absent from Rename. Conclusions: Rename presents significant inadequacies in meeting therapeutic needs in oncology within the SUS, with misalignment between the national list, international recommendations, current clinical guidelines, and formally approved incorporations. These gaps can hinder the implementation of healthcare policies and compromise the comprehensiveness of oncological care. Periodic and transparent updates to the oncology component of the National List of Essential Medicines (Rename) are recommended, aligned with scientific evidence, regulatory decisions, and the epidemiological needs of the Brazilian population.
