The Scottish Medicines Consortium (SMC) has accepted iron isomaltoside 1000 (Monofer®) for restricted within NHS Scotland for the reatment 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

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, but haemoglobin levels significantly increased from baseline in one study only.