OBJECTIVES

In force since June 2015, National Health Technology System (SiNATS) has triggered the creation of pharmacotherapeutic assessment guidelines (November 2016), and, in 2018, the review of the economic assessment guidelines, whose conclusion is expected during 2019.

This 4-year landmark analysis provides a deep insight into all assessments and appraisals before the new guidelines’ milestone.

METHODS

All Health Technology Assessments (HTA) reports published by INFARMED up to June 2019 were reviewed. Variables collected: type of health technology, health care setting (hospital or ambulatory), therapeutic value assessment and degree, economic value assessment, type of economic analysis and decision outcome. Assessments of drugs with initial marketing authorisation or variation date after June 2015 were included. Multiple decisions within the same report were considered as individual observations. Exclusion criteria: generic or biosimilar drugs.

RESULTS

The final sample was composed of 101 assessments/appraisals made fully under SiNATS. Only one was related to medical devices. Overall, 84.2% (85 out of 101) of the funding decisions were positive. Negative funding decisions occurred mostly (93.8%) during the therapeutic assessment (15 out of 16). The hospital setting was more frequent (76.2%, 77 out of 101) and presented a higher rejection rate than the ambulatory: 18.2% versus 8.3%, respectively. Added therapeutic value was recognised in 47.5% of the assessments, followed by equivalence (37.6%) and no therapeutic value (14.9%). Degree of added therapeutic value was only explicit in 64.4% of the conclusions, of which non-quantifiable value referred to 37.5%. Cost-minimization or price comparisons represented the majority of the economic analysis (57.1 %), as cost-effectiveness and/or cost-utility analysis accounted for 42.9% of the total. The frequency of the latter increased up to 78.3% within added therapeutic value conclusions.

CONCLUSIONS

Therapeutic assessment is driving the outcome of funding decisions as well as influencing the type of economic analysis.