OBJECTIVES: National System for the Evaluation of Health Technologies (SiNATS) came into force in June 2015, however health technology assessment (HTA) was already being systematically performed in Portugal since 2006. The aim of this research was to assess the decision-making efficiency before and after the implementation of SiNATS.

METHODS: Efficiency measures were annual decision-making rate (ADR), probability of public funding and time to decision-making. Data was extracted from the assessment reports by the Ministry of Health (INFARMED) up to June 2018. Variables considered: regulatory approval (RA) date, HTA decision date and outcome, type of assessment (hospital or ambulatory). Date of RA consisted of initial marketing authorisation or type II variations for extended indications. When applicable, the latter was withdrawn from EMA website. Assessment before and after SiNATS was defined using RA cut-off date of June 2015. Logistic regression was used to model the probability of public funding. Time to decision-making since RA was based on Kaplan-Meier estimator. Log-rank test was used to evaluate survival differences between groups. A significance level of 5% was adopted.

RESULTS: Overall, the ADR before SiNATS was 34.2 dropping to 24.5 decisions/year after SiNATS. The probability of a positive public funding decision was 0.82 and 0.90 before and after SiNATS, respectively. The odds of a positive decision was 91% higher after SiNATS (OR 1.91 [95% CI 0.73-5.04]). Time to decision, regardless of the outcome, was significantly different before and after SiNATS (Log-rank p-value < 0.001). Median [95%CI] time to decision-making was significantly lower after SiNATS implementation (1.4 years [1.13-1.67], n=49 decisions) in comparison to the period before SINATS (2.51 years [2.27-2.73], n=330 decisions).

CONCLUSIONS: For assessments made fully under the new framework, SiNATS has substantially reduce the time to decision-making, without impacting the outcome of the decision. There is reason to argue for an incremental gain in decision-making efficiency after SiNATS.