OBJECTIVES: The National System for the Evaluation of Health Technologies (SiNATS), in force since June 2015, reshaped HTA policy in Portugal. Three years after, this research provides a descriptive analysis of the assessments made fully under the new framework.

METHODS: Data was extracted from the assessment reports of the Ministry of Health (INFARMED) up to June 2018. Variables collected: regulatory approval (RA) date, type of procedure (hospital or ambulatory setting), decision outcome, conclusion of therapeutic value (added, equivalence or inferior) and type of economic analysis (cost-effectiveness (CEA), cost-utility (CUA), cost-minimization (CMA) or price comparison). Degree of added therapeutic value was categorised into major, considerable, minor, non-quantifiable or not applicable if otherwise. The RA date consisted of initial marketing authorisation or type II variations for extended indications. When applicable, the latter was retrieved from EMA. Exclusion criteria: generic or biosimilar status and RA date before June 2015.

RESULTS: Forty-nine assessment reports were analysed. Overall, 89.8% (45 out of 49) of the funding decisions were positive. Rejections occurred mostly (80.0%) during the therapeutic assessment, with the hospital setting having a higher rejection rate than the ambulatory: 11.8% versus CONCLUSIONS: Under SiNATS assessment criteria are more explicit. The majority of public funding decisions were positive. Absence of added therapeutic value is conditioning the type of economic analysis performed.