NICE has today (23 July) published draft guidance on rituximab (MabThera, Roche Products). Rituximab is licensed for inducing remission in adults with a type of vasculitis (inflammation of the blood vessels) called anti-neutrophil cytoplasmic antibody [ANCA]-associated vasculitis [i] (severely active granulomatosis with polyangiitis [GPA] and microscopic polyangiitis). NICE is minded not to recommend rituximab in combination with glucocorticoids [ii] as an option for this patient group, and asks for further information from the manufacturer for consideration at the next Committee meeting.
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.
The aim of treatment is initially to induce remission, then to maintain remission and treat relapse when necessary. With adequate ongoing care, most people with ANCA-associated vasculitis will have a good quality of life and normal life expectancy. Without treatment, it can be fatal.
Professor Carole Longson, Health Technology Evaluation Centre Director at NICE 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."
NICE requests further clarification from the manufacturer, which should include the following:
- The definition of severe disease and of the subgroup of people, for whom avoiding the treatment cyclophosphamide, is desirable.
- Further data to show benefits of rituximab in the longer term.
- A revised economic model which represents the management of severe ANCA-associated vasculitis in the UK, including current comparators and routine clinical practice.
The independent Committee concluded that none of the incremental cost-effectiveness ratios (ICERs) presented by the manufacturer and the Evidence Review Group (ERG)iii provided an accurate cost-effectiveness estimate for rituximab for treating ANCA-associated vasculitis, and that it needed additional analyses to inform its decision-making.