The National Institute for Health and Clinical Excellence (NICE) has recommended that Roche's MabThera is used by the National Health Service to treat a rare form of vasculitis.

In draft guidance published this morning, the Institute said the drug should be considered as an option for some adults with anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis, a rare autoimmune disorder of which there are around 1,200 new cases in England and Wales every year.

Back in July, the cost watchdog warned that it was minded not to endorse MabThera (rituximab) in this setting, "because of gaps and uncertainties in the evidence submitted by the manufacturer". 

At the time NICE requested further clarification from Roche, including extra data to show the drug's benefits in the longer term and a revised economic model representing the management of severe ANCA-associated vasculitis in the UK, including current comparators and routine clinical practice.

After considering new information submitted, NICE has now concluded that MabThera is indeed a cost-effective use of NHS resources for people with severe ANCA-associated vasculitis who can have cyclophosphamide, but only if further treatment with cyclophosphamide would exceed the maximum cumulative dose, after calculating the cost to be around £12,100 per QALY in this scenario.

However, its independent Appraisal Committee decided that there was insufficient evidence to determine whether the drug is value for money when used in patients unable to receive cyclophosphamide.

According to Roche, the average cost of a course of treatment for condition is £4889.64.