638th Ordinary Meeting of the ANS Board of Directors

Decisions and analysis

1. APPROVAL of the draft minutes of the 7th Extraordinary Meeting of the Board of Directors (DICOL), of May 8, 2026, and of the draft minutes of the 637th Ordinary Meeting of the Board of Directors (DICOL), of May 15, 2026.

Votes: APPROVED

2. DIFIS ITEM REPORT on the release of the Excellence and quarterly IGR Reduction targets for the third evaluation cycle of RN No. 623/2024. Case No. 33910.060457/2025-26.

The Board of Directors (DICOL) took note of the DIFIS report on the Excellence and Complaint Management Index (IGR) Reduction targets for the third evaluation cycle of RN No. 623/2024, concerning health plan operators’ performance in handling beneficiaries’ complaints, which will be released on the afternoon of this Monday.

Votes: APPROVED

3. DIPRO ITEM CONSIDERATION of the proposed Normative Resolution amending RN No. 585/2023 and the proposed Normative Instruction amending IN/ANS No. 28/2022. Product Change System in the Health Plan Registry – RPS/ANS. Case No. 33910.015974/2026-21.

The proposal aims to allow health plan operators to submit requests to change the status and name of their plans through their own electronic system, in place of sending documents to open administrative proceedings; and it provides for the creation of a specific functionality within the existing Hospital Network Change system, by means of a dedicated icon for requesting changes to the commercial name of products, amending Article 17 of IN ANS No. 28/2022. The proposal now goes to the ANS Attorney General’s Office for review, before being examined by the Board of Directors (DICOL) on a conclusive basis.

Votes: CONSIDERED

4. DIFIS ITEM APPROVAL of the proposal to enter into a Technical Cooperation Agreement between ANS and the COURT OF JUSTICE OF THE STATE OF PARÁ – TJ/PA, under the Programa Parceiros da Cidadania. Case No. 33910.003953/2021-59.

Votes: APPROVED

5. EXTRA-AGENDA DIPRO ITEM DECISION on the proposal to update the List of Health Procedures and Events (Rol). Opening of Public Consultation. Consideration of the Preliminary Recommendation Technical Note NTRF regarding UAT No. 202. Case No. 33910.012596/2026-24.

The Board of Directors (DICOL) accepted the DIPRO referral and authorized the opening of a public consultation for a period of 20 days to decide on the expansion of coverage regarding UAT No. 202, which concerns digital mammography, removing the age restriction (40 69 years) and the gender restriction, whenever indicated by the attending physician.

Votes: APPROVED

6. EXTRA-AGENDA DIPRO ITEM DECISION on the proposal to update the List of Health Procedures and Events (Rol). Return of the Public Consultation. Consideration of the Final Recommendation Technical Note NTRF regarding UAT No. 171. Case No. 33910.048937/2025-19.

UAT No. 171 concerns inclisiran, a messenger RNA inhibitor that reduces hepatic synthesis of LDL cholesterol, indicated for adults with established atherosclerotic cardiovascular disease in secondary prevention who do not reach LDL targets despite optimized lipid-lowering treatment with statins at the maximum tolerated dose, with or without ezetimibe. The clinical evidence showed efficacy in reducing LDL with moderate certainty, but the evidence for reducing major adverse cardiovascular events (MACE) was classified as low certainty. The incremental cost-utility ratio (ICUR) calculated was approximately R$ 262 thousand per QALY gained, a level considered excessively high for incorporation into the Rol. The Board of Directors (DICOL) endorsed the DIPRO referral and decided against incorporation.

Votes: NOT INCORPORATED

7. EXTRA-AGENDA DIPRO ITEM DECISION on the proposal to update the List of Health Procedures and Events (Rol). Return of the Public Consultation. Consideration of the Final Recommendation Technical Note NTRF regarding UATs No. 183 and No. 196. Case No. 33910.008417/2026-54.

UAT No. 183 concerns evolocumab, a PCSK9-inhibiting monoclonal antibody for hypercholesterolemia with established atherosclerotic cardiovascular disease in secondary prevention, for the same indication as inclisiran. The studies showed a reduction of approximately 15% in the risk of MACE compared with placebo, with moderate certainty of evidence, but without a statistically significant reduction in overall or cardiovascular mortality. UAT No. 196 concerns the combination of acalabrutinib + venetoclax for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) without 17p deletion or TP53 mutation. The AMPLIFY study showed a 67% reduction in the risk of death and a 35% reduction in the risk of disease progression, with moderate certainty of evidence and a safety profile considered manageable. The Board of Directors (DICOL) endorsed the DIPRO referral and decided against incorporation of both technologies.

Votes: NOT INCORPORATED

8. EXTRA-AGENDA DIPRO ITEM DECISION on health technologies positively recommended by the National Commission for the Incorporation of Technologies into the Unified Health System (CONITEC) for incorporation into the Unified Health System (SUS). Technology for incorporation into the List of Health Procedures and Events (Rol). Case No. 33910.000122/2026-30.

The Board of Directors approved the draft RN updating Annex II of RN No. 465/2021 (DUT), effective as of Jul 1, 2026 (SEI No. 35848803). The incorporation of amniotic membrane transplantation will be postponed until the Ministry of Health publishes the respective PCDTs. In summary:

Votes: DECIDED