How well can the pre-launch study design provide information on the relative effectiveness of a new medicine
Assessment model of drugs in (HTA) -
study conducted in France
SMR- service medical rendu
Drug eligibility reimbursement
Added therapeutic benefit
5 ASMR levels model
post launch of observational studies
OS results are considered
Quality of life
Improvement of is quite rare post launch!
Many cases when results do not confirm what was observed during RCTs!