A Recent Adoption of Cost-Effectiveness Thresholds in Brazil and Its Repercussions

OBJECTIVES: The National Commission for Health Technology Incorporation (CONITEC), HTA Agency in Brazil, advises the Brazilian Ministry of Health about inclusion or exclusion of health technologies at Unified Health System (SUS). A recently (2022) approved law mandates the adoption of cost-effectiveness thresholds in technical appraisals, aiming to optimize resources and enhance the system efficiency. The adopted thresholds are fixed and linked to the GDP: 120,000 BRL per capita per QALY for rare diseases and 40,000 BRL. This study aims to discuss the impact of the thresholds’ adoption in health technologies incorporation.

METHODS: A survey was conducted on all recommendation reports for rare diseases issued by CONITEC between January 2012 and February 2022. Out of 35 recommendation reports published during this period, those for technology exclusion or expansion of use were excluded, along with reports lacking ICER values per QALY.

RESULTS: The analysis of CONITEC's appraisals for 18 rare disease’s health technologies incorporation found ICERs ranging from 22,468 to 75,938,549 BRL per QALY. With the recently adopted threshold, 90.9% of incorporated technologies would have surpassed it. Also, Brazilian thresholds, when dollarized, seem low compared to other countries. These points raise concerns about the threshold becoming a barrier to population’s access to new health technologies, questioning the threshold's pragmatic function.

CONCLUSIONS: Considering the exposed, adopting an internationally aligned cost-effectiveness threshold, tailored to rare diseases, is paramount. The disparity between the current threshold and historical ICERs, especially for rare diseases, is critical. Rectifying this not only reinforces system cohesion but also mitigates barriers to innovative treatment access.