No. 38

Federal Official Gazette

NORMATIVE RESOLUTION ANS No. 652, OF NOVEMBER 24, 2025. Amends Annexes I and II of Normative Resolution (RN) No. 465, of February 24, 2021, which governs the List of Health Procedures and Events (Rol) within Supplementary Health, to incorporate the drug Larotrectinib Sulfate into the procedure ORAL ANTINEOPLASTIC THERAPY FOR THE TREATMENT OF CANCER (WITH UTILIZATION GUIDELINE) for the treatment of pediatric patients with locally advanced or metastatic solid tumors positive for NTRK gene fusion; to incorporate the procedure NTRK – MUTATION TESTING (WITH UTILIZATION GUIDELINE) for the eligibility diagnosis of pediatric patients with an indication for a medication whose package insert requires analysis of the presence of NTRK gene fusion before treatment begins; to incorporate the procedure HISTOPLASMA ANTIGEN DETECTION (URINE); and to amend Utilization Guideline No. 124 regarding the procedure IMMUNOPROPHYLACTIC THERAPY FOR RESPIRATORY SYNCYTIAL VIRUS (RSV) – drug Nirsevimab, in compliance with paragraphs 4 and 10 of Article 10 of Law No. 9,656/1998.

NORMATIVE RESOLUTION ANS No. 651, OF NOVEMBER 24, 2025. Amends Normative Resolution (RN) No. 465, of February 24, 2021, which governs the List of Health Procedures and Events (Rol) within Supplementary Health, to regulate the mandatory coverage of the immunobiological drug Dupilumab, for the complementary treatment of adult patients with severe chronic obstructive pulmonary disease (COPD), in compliance with paragraphs 4, 7 and 8 of Article 10 of Law No. 9,656/1998.