Abstract
Introduction: The incremental costeffectiveness ratio (ICER) is essential for health technology incorporation decisions. In resourceconstrained settings, the need arose for a benchmark to guide these decisions, leading to the adoption of a costeffectiveness threshold (CET). Proposed in 1976, the CET has become a reference for healthcare decisionmaking in many countries and by the World Health Organization, based on the premise that technologies with an ICER above the threshold are not considered costeffective. In Brazil, the CET was adopted by the National Committee for Health Technology Incorporation into the Brazilian Unified Health System (Conitec) in 2022, with thresholds of BRL 40,000 per qualityadjusted life year (QALY) and BRL 35,000 per lifeyear gained, which may reach BRL 120,000 per QALY in specific cases such as rare diseases. Although this represents progress in economic evaluation within the Brazilian Unified Health System (SUS), its implementation occurs amid budget constraints and inequalities in healthcare access, raising questions about its effectiveness. This study analyzes oncology technology incorporations between 2022 and 2024, focusing on the application of the CET. Objective: To analyze how the CET influenced Conitec's decisions regarding the incorporation of oncology medicines into SUS between 2023 and 2024, identifying patterns and implications for access policy. Methods: A retrospective, exploratory study was conducted based on Conitec recommendation reports for oncology medicines incorporated between January 2023 and December 2024. Data were extracted using a standardized approach, including variables such as technology type, health condition, quality of evidence, type of economic evaluation, ICER, and incremental budget impact (BI). In cases where the ICER exceeded the CET, the full reports were analyzed to identify factors influencing the decision. Results: Between 2022 and 2024, nine oncology technologies were incorporated into SUS, with 77.8% originating from internal demands. Five technologies presented ICERs above the CET, four of which targeted rare cancers. The mean ICER for these technologies was BRL 259,025.02, compared with BRL 51,495.00 for nonrare conditions. Despite exceeding the CET, these technologies were incorporated, suggesting the influence of factors such as disease severity, lack of therapeutic alternatives, and clinically relevant outcomes. Two technologies with the highest ICERs (BRL 565,280.70 and BRL 211,710.00) were supported by low or very lowcertainty evidence. Among the evaluated technologies, the mean budget impact per patient was BRL 43,213.36, ranging from BRL 537.30 to BRL 93,844.37. These findings indicate that the CET has been applied flexibly within a broader decisionmaking process. Conclusions: The CET has been an important, but not absolute, parameter in Conitec's decisionmaking process. The incorporation of technologies with ICERs above the threshold, even when supported by weak evidence, demonstrates that factors such as disease rarity and the absence of therapeutic alternatives carry substantial weight. While this flexibility may be beneficial, it also raises concerns regarding the predictability and equity of the decisionmaking process. Thus, the challenge lies in balancing technical rigor with social sensitivity, ensuring that the CET serves as a guide rather than a barrier in public health decisionmaking.
