UK’s NICE thumbs up for Roche drug in rare autoimmune disease in draft guidance

In a U-turn on a previous recommendation (The Pharma Letter July 23), the UK’s drugs watchdog, the National Institute for Health and Care Excellence (NICE), this morning (October 3) published draft guidance recommending Swiss drug major Roche’s (ROG: SIX) MabThera (rituximab) as a National Health Service option for treating some adults with the rare autoimmune condition, anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis.

Back in July, the NICE said it was minded not to recommend rituximab, which is also licensed for inducing remission in adults with a type of vasculitis (inflammation of the blood vessels) called anti-neutrophil cytoplasmic antibody [ANCA]-associated vasculitis (severely active granulomatosis with polyangiitis [GPA] and microscopic polyangiitis), in combination with glucocorticoids as an option for this patient group, and asked for further information from the manufacturer for consideration at the next Committee meeting.

Conditions on recommendation