OBJECTIVES: To assess CONITEC HTA evaluation methods for the decision-making process in order to identify historical patterns and trends since the agency establishment in 2011.

METHODS: The analysis included in this study rely on CONITEC decision reports publicly available on the agency web site. The assessment of historical decision-making breakdown reports into medicines, devices, procedures, and guidelines reflecting CONITEC's internal definition stated in each report. To refine quantitive evaluations, it was also applied information refinement process, which took into account the number of unique technologies evaluated per report to exclude the effect of multi-product submissions. Information pulled from CONITEC reports was assessed using a four-dimension framework which includes economic, clinical / evidence, dossier submission characteristics, and external factors.

RESULTS: A total of 369 reports were evaluated, being 57% (n=211) from internal MOH submission, 35% (n=129) from manufacturers and the remaining from other external stakeholders or combined submissions. Overall positive decision-making sums up to 57% (n=213) being highly influenced by the entity responsible where internal MOH positive decision rates are 74% (n=157) compared to manufacturers 33% (n=42). Also, other factors have a strong correlation to CONITEC approval decisions such as therapeutic class / disease, availability of treatment, and the degree of competition. Therapeutic areas having high levels of competition such as rheumatoid arthritis and multiple sclerosis have approval rates in a range of 70% while oncology yearly approval rates are lower than 30%.

CONCLUSIONS: CONITEC decision-making process has evolved since the publication of its first report in 2012 as a result of a continuous improvement process. Economic criteria and availability of treatment among those factors a carrying the most influence on decision making, while clinical evidence shows a weak correlation to the decision-making results.