Element card for assessment element D0011 in HTA Core Model Application for Pharmaceuticals (2.0) application

D. Clinical Effectiveness

Function

What is the effect of the technology on patients’ body functions

Core

International classification of function proposes the following categories for body functions: mental, sensory and pain, voice and speech, cardiac, respiratory and immune functions, genitourinary and reproductive functions, movement-related, and skin functions. Report the results 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 and observational studies with functioning as an outcome. The instruments for outcome reporting should be validated

SPC and EPAR..

Critical
Partial

H0005

E0005

F0101

ICF http://apps.who.int/classifications/icfbrowser