Regulatory Focus™ > News Articles > NICE Not Inclined to Recommend Roche's Rituximab for Treatment of ANCA-Associated Vasculitis

NICE Not Inclined to Recommend Roche's Rituximab for Treatment of ANCA-Associated Vasculitis

Posted 24 July 2013 | By Louise Zornoza

In draft guidance issued on 23 July 2013, the UK's National Institute for Health and Care Excellence (NICE) expressed its inclination not to recommend Roche's MabThera (rituximab) in combination with glucocorticoids for treatment of adults with anti-neutrophil cytoplasmic antibody [ANCA]-associated vasculitis, a severely active inflammation of the blood vessels.

The aim of treatment is initially to induce and maintain remission, and then to treat relapse when necessary.

ANCA-associated vasculitis is an inflammatory autoimmune disease affecting blood vessel walls which can affect many organs and lead to tissue breakdown and damage. The disease usually affects the lungs, kidneys, ears, nose or sinuses, and can cause bleeding, rash, or deafness. Without treatment, it can be fatal. It is estimated that around 1,200 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.

Health Technology Evaluation Centre Director at NICE Professor Carole Longson said: "ANCA-associated vasculitis is a rare but serious autoimmune disease and causes the white blood cells to attack the walls of small vessels in different tissues and organs of the body. Unfortunately, the independent Committee was minded not to recommend rituximab for this condition because of gaps and uncertainties in the evidence submitted by the manufacturer. The next step is for the manufacturer to respond to the Committee's comments and submit further information as requested."

In its draft guidance NICE also requests further information from the manufacturer, including

  • the definition of severe disease and of the subgroup of people for whom avoiding the treatment is desirable
  • additional data to show the long term benefits of rituximab
  • a revised economic analysis of the management of severe ANCA-associated vasculitis in the UK,  including current comparators and routine clinical practice, in view of the independent committee's conclusion that an accurate cost-effectiveness estimate for rituximab was not provided.

NICE Draft Guidance on MabThera

Read all Breaking News from RegLink

Tags: UK, EU

Regulatory Focus newsletters

All the biggest regulatory news and happenings.