OBJECTIVES

A previous research demonstrated that for assessments made fully under the new framework, the National Heatlh Technology System (SiNATS) had substantially reduced time to decision, without impacting its outcome. The number of assessments almost doubled (from 51 to 101) during the additional year of follow-up.

The aim of this research is to update the decision-making efficiency analysis.

METHODS

Efficiency measures were the probability of public positive decision, recognition of therapeutic or economic value and time to decision since regulatory approval date (RA). Logistic regression and the Kaplan-Meier estimator were used. The log-rank test was used to evaluate differences between subgroups. A significance level of 5% was adopted.

Health Technology Assessments (HTA) reports published by INFARMED up to June 2019 were reviewed. Variables collected: RA date, decision date and outcome, therapeutic or economic value conclusion. Multiple decisions within the same report were considered as individual observations. Exclusion criteria: generic or biosimilar drugs. Data were categorized as before or after SiNATS according to regulatory and funding decision dates.

RESULTS

Compared with the 3-year cut-off, the probability of a positive public funding decision dropped from 0.90 to 0.84 after SiNATS, however still higher than before (0.82). The odds ratio of a positive decision after SiNATS substantially decreased with the updated data: OR=1.18 [95%CI 0.65-2.14] vs OR=1.91 [95%CI 0.73-5.04]. The recognition of therapeutic value was substantially lower after SiNATS, whereas the probability of having economic value demonstrated the opposite trend: OR=0.7 [95% CI 0.37-1.34] and OR=6.86 [95%CI 0.91-51.4], respectively. Time to overall decision is still statistically different before and after SiNATS (p-value < 0.001). Median times were 2.7 and 1.6 years, respectively.

CONCLUSIONS

SiNATS has substantially reduced the time to decision-making, however there is now reason to argue that it might be impairing the decision profile, shifting the bottleneck to the therapeutic assessment.