iron isomaltoside 100mg/ml (Monofer)

following a full submission

iron isomaltoside 1000 (Monofer®) is accepted for restricted use within NHS Scotland.

Indication under review: Treatment of iron deficiency anaemia in the following conditions:
• When oral iron preparations are ineffective or cannot be used;
• Where there is a clinical need to deliver iron rapidly.

SMC restriction: use is restricted to administration by high dose infusion within the licensed indication but excluding use in patients receiving haemodialysis. The manufacturer’s economic case did not consider the cost-effectiveness of iv bolus administration or use in haemodialysis patients.

Efficacy data are limited to two small open-label non comparative studies in patients with chronic kidney disease and chronic heart failure.  Haemoglobin levels significantly increased from baseline in one study only.