Element card for assessment element D0029 in HTA Core Model Application for Pharmaceuticals (2.0) application

D. Clinical Effectiveness

Benefit-harm balance

What are the overall benefits and harms of the technology in health outcomes?

Core

This question integrates all benefits and harms concerning mortality, morbidity, QoL and further patient relevant outcomes, also considering the amount of false positive and false negative test results. There is no common quantitative summary measure, and even qualitatively a balanced and meaningful presentation is difficult to reach.

The integration of information across domains into the benefit-harm-balance is essential. This issue provides input for ETH (F0010) andECO (E0005) to calculate the incremental effectiveness of the new technology. Information from SAF is needed for this issue: all harms to the patient are listed in outcomes and units which are comparable to the outcomes in EFF domain  representing benefits.

See Template 7 in the  the HTA Core Model for Rapid Relative Effectiveness Assessment of pharmaceuticalshttp://www.eunethta.eu/sites/5026.fedimbo.belgium.be/files/Model%20for%20Rapid%20REA%20of%20pharmaceuticals_final_20130311_reduced.pdf

Trials, observational studies, modelling studies

Critical
Partial

A0007, A0011, C0001, C0003, C0004, C0005, C0006, C0007, C0061,  E0005, F0001, F0011

A0007, A0011, C0001, C0003, C0004, C0005, C0006, C0007, C0061,