Ritmo de Incorporação de Tecnologias em Saúde pela Agência Nacional de Saúde Suplementar 2019 – 2025

Abstract

Introduction (with objective): Introduction: In 2021, the National Supplementary Health Agency (ANS) launched Resolution No. 470/2021, which restructured the procedural process for updating the List of Health Events and Procedures, receiving and analyzing update proposals continuously. With this, the review of the List became semi-annual, instead of biennial. The following year, Resolution No. 555/2022 established the current procedural process for updating the List, with continuous submissions and updates. Objective: This study presents data on the trajectory of incorporation of health technologies, comparing the periods 2019-2020 and 2021-2025 to answer the following question: how have the changes impacted the pace of incorporation of medicines into the ANS List? Material and Method: All eligible Proposals for Updating the List of Procedures (PAR) at the UAT (Technical Analysis Unit) level for the 2019-2020 and 2021-2025 cycles were included. The UATs were selected and classified according to the following criteria: "medications", "incorporated", "year of submission". Then, the number of medications incorporated annually was quantified, counting only the first incorporation of the technology into the ANS List, not including subsequent approvals for new indications. The databases obtained were updated on 02/25/2026. Results: The analyzed UATs (Urban Treatment Agents) are concentrated in two main categories: oral medications for advanced or metastatic tumors (frequently in late or maintenance lines and with a strong presence of populations defined by biomarkers, reflecting the advancement of precision medicine in oncology) and subcutaneous immunobiologics for immune-mediated inflammatory diseases in moderate to severe patients (generally after failure of standard therapies). In the 2019-2020 cycle, 37 new molecular entities were incorporated into the ANS (National Supplementary Health Agency) list. Between 2021 and 2025, this number was 29 molecules, potentially reaching 34 when the 5 first-time approval PARs (Preliminary Approval Requests) still under analysis at the time of analysis are completed. Comparing the two periods, a decrease is observed in both the absolute number of new molecules incorporated and the rate of incorporation: 37 in 2 years (18.5 per year, on average), versus 28 medications in 4 years (7 per year). Regarding the expansion of indications for previously incorporated molecules, a similar pattern was observed: there were 12 expansions in the 2019-2020 cycle (an average of 6 per year), compared to 23 expansions between 2021 and 2024 (an average of 5.8 per year). Thus, the change in the procedural steps for updating the List did not translate into a faster pace of increased access – neither for new molecules nor for new indications of already incorporated therapies. An increase in the number of unfavorable decisions regarding incorporation was also observed between 2022 and 2024, mainly under the argument that the clinical studies supporting the submissions presented a low level of certainty of evidence. It should be noted that the analysis for 2025 does not yet allow for robust conclusions. Conclusions: The evidence suggests that the change in the rules for updating the ANS List did not generate an increase in the number of incorporated medications or accelerate the pace of incorporation. Further study is needed to assess the reasons why the rate of incorporations into supplementary health insurance was reduced during this period.