Characterization of the Pharmaceutical Risk‑Sharing Arrangement Process in Catalonia
Table 1
Uncertainty type, scope, and considered variables for drug assessment
| Uncertainty type | Uncertainty scope | Considered variables |
|---|---|---|
| Clinical | Efficacy, effectiveness, and safety | Time 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 | ||
| Financial | BI and CE | Indication 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 [14]
