Regulatory Focus™ > News Articles > Roche’s MabThera Wins NICE Recommendation for Autoimmune Condition

Roche’s MabThera Wins NICE Recommendation for Autoimmune Condition

Posted 03 October 2013 | By Louise Zornoza

The UK's cost containment agency, the National Institute for Health and Care Excellence (NICE), has issued draft guidance recommending reimbursement for Roche's MabThera (rituximab) as an option for treating some adults with the rare autoimmune condition, anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis (severely active granulomatosis with polyangiitis [GPA] and microscopic polyangiitis).

MabThera is a genetically engineered chimeric (mouse/human) monoclonal antibody that depletes B cells by targeting cells bearing the CD20 surface marker. The treatment induces remission, maintains remission and treats relapse when necessary. With adequate ongoing care, most people with ANCA-associated vasculitis will have a good quality of life and normal life expectancy.

ANCA-associated vasculitis is an inflammatory autoimmune disease affecting blood vessel walls. It can affect many organs and leads to tissue breakdown and damage. GPA and microscopic polyangiitis are both types of ANCA-associated vasculitis that affect small blood vessels. ANCA-associated vasculitis usually affects the lungs, kidneys, ears, nose or sinuses. Depending on the organs involved it can cause bleeding, rash, or deafness. It is estimated that around 1200 people are diagnosed with ANCA-associated vasculitis each year in England and Wales, and it is most common in those aged between 60 and 70 years.

Final guidance is expected to be published in March 2014.

NICE Draft Guidance on MabThera

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Tags: UK, EU

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