FERINJECT (ferric carboxymaltose) - Iron deficiency

The Committee deems that the clinical benefit of FERINJECT 50 mg/ml (ferric carboxymaltose) dispersion for injection/infusion is moderate 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, in patients aged 1 to 13 years.

Considering:

• the results of the randomised, double-blind, phase 3 1VIT17044 study revealing no significant difference compared to oral iron in terms of mean change in Hb levels at D35 compared to baseline (2.22 g/dl versus 1.92 g/dl, p = 0.3108) in children aged 1 to 17 years with iron-
  deficiency anaemia;
• inclusion of a population partially representative of the population targeted by the indication:
  • only 22% of the patients included in the study were aged 1 to 12 years (25% in the ferric carboxymaltose group) and only 20% of the patients were male;
  • the study protocol scheduled the inclusion of patients with iron deficiency with anaemia only, whereas the indication also targets patients with iron deficiency without anaemia;
  • inclusion of patients with a documented history of an episode of inadequate response to all oral iron therapy at least 8 weeks (56 days) prior to randomisation and who responded to oral treatment during the study, raising the hypothesis of poor treatment compliance;
• the absence of specific data in children aged 1 to 13 years with haemodialysis-dependent chronic kidney disease;
• the absence of data in patients in whom there is a clinical need to deliver iron rapidly;
• the lack of long-term efficacy and safety data (follow-up duration of 6 weeks);
• the absence of comparative data versus the other injectable iron products;

the Committee deems that FERINJECT 50 mg/ml (ferric carboxymaltose) dispersion for injection/infusion provides no clinical added value (CAV V) in the current care pathway in patients aged 1 to 13 years, which includes the relevant comparators VENOFER (iron hydroxide-sucrose complex) and other injectable iron sucrose products.