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FERINJECT (ferric carboxymaltose) - iron deficiency
Reason for request
Key points
Maintenance of favourable opinion for reimbursement in the treatment of iron deficiency when oral iron preparations are ineffective or cannot be used or there is a clinical need to deliver iron rapidly by the IV route.
Clinical Benefit
| Substantial |
The Committee deems that the new data from the AFFIRM-AHF trial, which assessed FERINJECT 50 mg/ml (ferric carboxymaltose) dispersion for injection/infusion in adult patients with heart failure with a reduction in ventricular ejection fraction and concomitant iron deficiency (defined as ferritin <100 μg/L, or 100–299 μg/L with transferrin saturation <20%, with or without anaemia) hospitalised and stabilised after an episode of cardiac decompensation, are not of a nature to modify its previous conclusions. |
Clinical Added Value
| no clinical added value |
Considering all these elements, the Committee deems that the new data from the AFFIRM-AHF trial, which assessed FERINJECT 50 mg/ml (ferric carboxymaltose) dispersion for injection/infusion in adult patients with heart failure with a reduction in ventricular ejection fraction and concomitant iron deficiency (defined as ferritin <100 μg/L, or 100–299 μg/L with transferrin saturation <20%, with or without anaemia) hospitalised and stabilised after an episode of cardiac decompensation, are not of a nature to modify the its previous conclusions. FERRINJECT continues to provide no clinical added value (CAV V) in the care pathway. |
