CONITEC in Action: A Trend Analysis of CONITEC’s Evaluation Outcomes From 2020 to Present Day
Author(s)
Dominika Meszarosova, MSc1, Daniel Bacheschi, B.S.2.
1Precision AQ, London, United Kingdom, 2Precision AQ, New York City, NY, USA.
1Precision AQ, London, United Kingdom, 2Precision AQ, New York City, NY, USA.
OBJECTIVES: Presenting a unique public-private dual marketplace, Brazil’s healthcare landscape is heavily shaped by its public HTA evaluation body (CONITEC). CONITEC directly informs the Ministry of Health’s SUS incorporation decisions for new and existing health technologies. The research presented here aims to provide insights into trends in CONITEC’s incorporation outcomes from 2020 to present day via publicly available decision data.
METHODS: We exported regulatory information on all CONITEC decision outcomes since 2020 from the CONITEC website. Next, we isolated data related to drug submissions and categorized them by therapeutic area. We then analyzed incorporations and denials across each category.
RESULTS: CONITEC has completed 341 assessments since 2020, 85% (289) of which were new health technology evaluations, 6% (20) indication expansions and 9% (32) re-evaluations. In total, 46% (158) of assessments resulted in a positive recommendation and inclusion on the positive reimbursement list (RENAME), while the remaining 54% (183) were not recommended or excluded from RENAME. The number of submissions each year generally increases over time, with an exception in 2023, where a dip in assessment volumes was observed. The largest proportion of new technology evaluations are in oncology (22%), followed by immunology (18%), infectious diseases (14%) and rare genetic diseases (11%), with the remaining disease areas accounting for less than 10% of evaluations. In contrast, the highest approval rates in therapeutic areas with more than five assessments have been observed in endocrinology (85%) and infectious diseases (78%).
CONCLUSIONS: Over the past five years, CONITEC has prepared an increasingly higher number of recommendations for Brazil’s public health system, with a clear alignment to the MoH’s public health initiatives. There exists however, a potential misalignment between trends in pharmaceutical R&D focus and new technology submissions and CONITEC’s final recommendations, with positive review probabilities concentrating around endocrinal and infectious therapeutic areas rather than in oncology and immunology.
METHODS: We exported regulatory information on all CONITEC decision outcomes since 2020 from the CONITEC website. Next, we isolated data related to drug submissions and categorized them by therapeutic area. We then analyzed incorporations and denials across each category.
RESULTS: CONITEC has completed 341 assessments since 2020, 85% (289) of which were new health technology evaluations, 6% (20) indication expansions and 9% (32) re-evaluations. In total, 46% (158) of assessments resulted in a positive recommendation and inclusion on the positive reimbursement list (RENAME), while the remaining 54% (183) were not recommended or excluded from RENAME. The number of submissions each year generally increases over time, with an exception in 2023, where a dip in assessment volumes was observed. The largest proportion of new technology evaluations are in oncology (22%), followed by immunology (18%), infectious diseases (14%) and rare genetic diseases (11%), with the remaining disease areas accounting for less than 10% of evaluations. In contrast, the highest approval rates in therapeutic areas with more than five assessments have been observed in endocrinology (85%) and infectious diseases (78%).
CONCLUSIONS: Over the past five years, CONITEC has prepared an increasingly higher number of recommendations for Brazil’s public health system, with a clear alignment to the MoH’s public health initiatives. There exists however, a potential misalignment between trends in pharmaceutical R&D focus and new technology submissions and CONITEC’s final recommendations, with positive review probabilities concentrating around endocrinal and infectious therapeutic areas rather than in oncology and immunology.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HTA89
Topic
Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas