Element card for assessment element D0005 in HTA Core Model Application for Pharmaceuticals (2.0) application

D. Clinical Effectiveness

Morbidity

How does the technology affect symptoms and findings (severity, frequency) of the target condition?

Core

Describe the efficacy and effectiveness of the technology on relevant disease outcomes and other changes in physical and psychological conditions. Outcomes such as function, quality of life and patient satisfaction are reported in other assessment elements of this domain. Report changes in severity, frequency and recurrence of symptoms and findings, both in absolute terms and relative to the comparator. See also Methodological guideline for REA of pharmaceuticals: Endpoints used for relative effectiveness assessment of pharmaceuticals, clinical endpoints http://www.eunethta.eu/sites/5026.fedimbo.belgium.be/files/Clinical%20endpoints.pdf

Trials, observational studies

,,SPC and EPAR.

Critical
Partial

H0005

E0005