Reason for request

Extension of indication

High clinical benefit combined with deferoxamine (DESFERAL) in thalassaemia major, when monotherapy with a different iron chelator is ineffective, or when iron overload is life-threatening, and minor clinical added valuecompared to deferoxamine monotherapy.

Insufficient clinical benefit combined with deferasirox (EXJADE) to justify its reimbursement for this same indication.

»  FERRIPROX has been granted marketing authorisation in combination with another iron chelator in the treatment of thalassaemia major, when monotherapy with any iron chelator is ineffective, or when prevention or treatment of life-threatening consequences of iron overload (mainly cardiac overload) justifies rapid or intensive correction.

»  For this indication, the superiority of the FERRIPROX/deferoxamine (FERRIPROX/DESFERAL) combination compared to deferoxamine (DESFERAL) monotherapy has been demonstrated in cardiac iron overload, though not for long-term survival due to a lack of robust data.

»  The clinical benefit of the FERRIPROX/deferasirox (FERRIPROX/EXJADE) combination has not been established, due to insufficient clinical data to document its efficacy and safety and due to the contraindication of EXJADE in combination with other iron chelators.


Clinical Benefit




Clinical Added Value



Therapeutic use


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