NICE U-turn on MabThera
pharmafile | October 3, 2013 | News story | Sales and Marketing | MabThera, NHS, NICE, Roche
NICE is thinking about recommending Roche’s MabThera for a rare autoimmune condition – a move which represents a partial victory for the manufacturer.
The second piece of draft guidance on this sees the UK health watchdog suggesting that Mabthera (rituximab) should be an option on the NHS for treating adults with anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis.
An umbrella term for several related conditions, including microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA), it affects blood vessel walls, often damaging the lungs, kidneys, ears, nose or sinuses, and can be fatal if not treated: around 1,200 people are diagnosed in England and Wales each year.
NICE wants the drug to induce and maintain remission and to treat any relapse because most people, with appropriate care, will have a good quality of life and normal life expectancy.
This is a complete U-turn from NICE’s first draft document in June, when it expressed doubts about “gaps and uncertainties in the evidence submitted by the manufacturer”.
In particular it said that none of Roche’s incremental cost effectiveness ratios (ICERs) stacked up for the drug in this patient group, and that it wanted a revised economic model which represents the management of the condition in the UK, including current comparators and routine clinical practice.
NICE also wanted more data demonstrating the benefits of MabThera in the longer term.
Not only does Roche appear to have changed NICE’s mind, it seems to have done so without offering to drop the price of the drug: no patient access scheme has been offered.
Roche estimates the average cost of a course of treatment is £4,889.
“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,” explained Professor Carole Longson, Health Technology Evaluation Centre director at NICE.
The watchdog has recommended MabThera in combination with glucocorticoids (a type of steroid hormone) as an option for this patient group, if further treatment with the alkylating agent cyclophosphamide would exceed the maximum cumulative cyclophosphamide dose (which could in turn lead to infertility).
Final guidance is expected to be published next March.
Adam Hill
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