Reason for request
Extension of indication
Clinical Benefit
| Substantial |
The actual benefit of ROACTEMRA is substantial in the MA indication.
|
Clinical Added Value
| no clinical added value |
In the absence of direct comparison with other available biological agents in the treatment of polyarticular JIA and given its intravenous administration route requiring hospitalisation and monitoring, the Transparency Committee considers that ROACTEMRA IV infusion does not provide an improvement in actual benefit (level V, non-existent) in the management of this new paediatric indication.
|
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
CgNrU6bau63eDKx9