Abstract
BackgroundThe quality of the evidence used in health technology assessment (HTA) agency reports has been considered essential for decision-making processes and their legitimacy. In Brazil, CONITEC is the agency responsible for defining data mandatory for the submission of proposals for the incorporation of new technologies. The objective of this study was to analyse CONITEC recommendation reports, the type of scientific evidence used in them and their compliance with operational procedures.MethodsThis is a descriptive study based on CONITEC official reports from July 2012 through December 2016. Data were collected with a specific extraction form and analysed using descriptive statistics.ResultsWe evaluated 199 CONITEC recommendation reports. The annual number of reports increased during the study period. The absolute annual number of new technologies incorporated in 2013 (n = 24) was similar to that observed for 2014 (n = 24) and 2015 (n = 22), decreasing in 2016 (n = 13). The type of technology most frequently evaluated was ‘drugs’ (68.3%), followed by ‘procedures’ (20.1%). Overall, 117 (58.8%) reports were internal demands, 75 (37.7%) were external demands and 7 (3.5%) were mixed demands. There were differences between internal and external demands in terms of the evidence used in the reports and the decision regarding the recommendation to incorporate the technologies. Among the internal demands, the recommendation to incorporate the new technology was made for 70.9% of the reports, only 9.6% of which included full HTAs. Among the external demands, the incorporation of the new technology was recommended for 17.3% of the reports, 76.9% of which included full HTAs. Of the 101 reports in which incorporation of the new technology was recommended, 88 (87.1%) did not include a full health economic evaluation and ICER calculation. There are compliance difficulties with the recommendations in the CONITEC internal regulations regarding the type and quality of evidence considered in the analysis of recommendation reports.ConclusionsThe characteristics of the evidence used in recommendation reports and those considered to be mandatory were very different, indicating problems in decision-making processes. There is a need to study, with a broader perspective, the factors that influence the type of evidence used in decision-making processes in order to contribute to the development of better practices and policies.
Highlights
The quality of the evidence used in health technology assessment (HTA) agency reports has been considered essential for decision-making processes and their legitimacy
The CONITEC internal regulations, established through an ordinance enacted in 2012, state that data related to efficacy, effectiveness, accuracy and safety have to be considered in the proposals submitted demanding the incorporation of new technologies, and that scientific data must be obtained by systematic reviews or other means of scientific knowledge synthesis methodologies, and in accordance with national guidelines for health economic evaluations (HEEs) and budget impact analysis [7, 8]
When comparing the incremental cost-effectiveness ratio (ICER) values with the cost-effectiveness threshold (CET) adopted by the Centre for Health Economics, we found that only 3 technologies showed ICERs < R$ 17,106.18 and would be considered cost-effective (Fig. 2)
Summary
The quality of the evidence used in health technology assessment (HTA) agency reports has been considered essential for decision-making processes and their legitimacy. The CONITEC internal regulations, established through an ordinance enacted in 2012, state that data related to efficacy, effectiveness, accuracy and safety have to be considered in the proposals submitted demanding the incorporation of new technologies, and that scientific data must be obtained by systematic reviews or other means of scientific knowledge synthesis methodologies, and in accordance with national guidelines for health economic evaluations (HEEs) and budget impact analysis [7, 8]. With the inclusion of HEEs as part of the evidence to be considered, the CONITEC internal regulations follow the recommendations of most HTA agencies in developed countries, in particular the United Kingdom’s National Institute for Health and Clinical Excellence (NICE) [9]
Sign-in/Register to view highlights & summary 
Published Version (
Free)
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
