How well can the pre-launch study design provide information on the relative effectiveness of a new medicine 

François Mayer

HAS France 

Assessment model of drugs in (HTA) -

study conducted in France

SMR- service medical rendu 

Drug eligibility reimbursement

Added therapeutic benefit 

5 ASMR levels model

major

important 

minor

no improvement 

post launch of observational studies

OS results are considered 

comparable

un-interpretable

not comparable

Reassessment SMR/ASMR

Clinical effectiveness

Safety

Quality of life 

Improvement of is quite rare post launch! 

Many cases when results do not confirm what was observed during RCTs!