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

METHODS : 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 on each report. For a number quantitative analysis, we also developed a standardization process considering the number o technologies evaluated instead of single reports to exclude the effect of multi product submissions. Information pulled from reports were evaluated 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 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 the decision making while clinical evidence show a weak correlation to the decision making results.