December 25, 2021

Risk-sharing agreements for drugs (3)

 Characterization of the Pharmaceutical Risk‑Sharing Arrangement Process in Catalonia

Table 1

Uncertainty type, scope, and considered variables for drug assessment

Uncertainty typeUncertainty scopeConsidered variables
ClinicalEfficacy, effectiveness, and safetyTime frame
Clinical trial phase
Patient characteristics
Primary endpoint
Surrogate endpoints
Active comparator
Sensitivity analysis
Statistical analysis
Patient subgroup analyses
Time frames for treatment follow-up
FinancialBI and CEIndication extension and concretion
Treatment regimen
Potentially replaceable treatments
Net financial impact of treatment inclusion/replacement
Potential use extensions
Other modifications in use of resources linked to new treatment
Availability of CE or CU studies

Adapted from []