Element card for assessment element G0009 in HTA Core Model Application for Pharmaceuticals (2.0) application

A. Health Problem and Current Use of the Technology


G. Organisational aspects


Who decides which people are eligible for the technology and on what basis?


Provide information on who are the key actors in deciding on the use of the technology. Do most important decisions take place on the national level (e.g. population screening) or for example by individual professionals (e.g. surgical method for a specific disease)? How is the decision made; are there some documented criteria?

Information about the possible variations in the decision level and criteria has ethical implications.

This issue is related to the issue of work processes (G0001)

Companion diagnostics (tests or measurements)  assist physicians in making treatment decisions for their patients  by elucidating the efficacy and/or safety of a specific pharmaceutical or class of pharmaceuticals for a targeted patient group or sub-groups. How companion diagnotic should be used to identify eligible patient should be specified and explained.

Criteria must be specified for higher risk groups of patients such as elderly and children.

Literature search, guidelines, documents of hospitals, own study: questionnaires and interviews of different actors of the process (monitoring authorities, hospitals, hospital districts, laboratory).




:B0016,  D0021, F0012, I0012, H0012

Kristensen 2007 {24}