GVS advice on ferrimaltol (Feraccru®) for treating iron deficiency
Zorginstituut Nederland has completed its assessment whether the product ferrimaltol (Feraccru®) is interchangeable with another product that is included in the Medicine Reimbursement System (GVS). Ferrimaltol (Feraccru®) is indicated for treating iron deficiency in adults. The Zorginstituut recommends that ferrimaltol (Feraccru®) should not be included in the GVS.
Registered indication
Feraccru® is available as a capsule containing 30 mg ferric (Fe3+) iron (as ferrimaltol). It is licensed for treating iron deficiency in adults. The marketing authorisation holder is asking for inclusion in List 1B of the GVS for a subpopulation of the licensed indication:
- treatment of adults with mild to moderate iron deficiency anaemia, who have previously failed with oral ferrous (Fe2+) iron preparations because of insufficient efficacy or intolerance.
Assessment
The assessment compared ferrimaltol against intravenously administered iron. Due to the lack of evidence, no conclusions can be drawn about the beneficial and adverse effects of ferrimaltol compared to intravenously administered iron for the subpopulation mentioned above. The Zorginstituut reached a final conclusion that when compared to intravenously administered iron, ferrimaltol does not meet established medical science and medical practice for the mentioned patient group.
Zorginstiuut's advice
The Zorginstituut recommends that ferrimaltol (Feraccru®) should not be included in the Medicine Reimbursement System. The Zorginstituut is of course prepared to reassess the package eligibility of ferrimaltol (Feraccru®) if additional peer-reviewed research data not previously assessed by the Zorginstituut becomes available.