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.