NICE ‘no’ for MabThera
pharmafile | July 23, 2013 | News story | Sales and Marketing | MabThera, NHS, NICE, Roche
Roche has been dealt a blow by NICE, with the health watchdog deciding that MabThera should not be used on the NHS to treat a type of vasculitis – a rare but serious autoimmune disease.
MabThera (rituximab) is authorised to treat adults with anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis – severely active granulomatosis with polyangiitis (GPA) and microscopic polyangiitis – but NICE has declined to recommend it in combination with glucocorticoids, a type of steroid hormone.
GPA and microscopic polyangiitis affect small blood vessels – usually the lungs, kidneys, ears, nose or sinuses – and can cause bleeding, rash, or deafness, with around 1,200 people diagnosed in England and Wales each year. It can be fatal if not treated.
A consultation on the decision is open until 12 August, with a NICE appraisal committee meeting on 28 August – at which NICE will look at further information which it expects Roche to provide.
Final guidance is not expected until November, but this draft decision puts pressure on Roche: NICE decisions have been overturned when a manufacturer offers – or improves on – a patient access scheme, for example.
In a statement, NICE outlined a lengthy ‘to do’ list for Roche after warning of “gaps and uncertainties in the evidence submitted by the manufacturer”.
Cost is certainly set to be an issue, with the committee which looked at MabThera concluding that none of the manufacturer’s incremental cost effectiveness ratios (ICERs) stacked up for the drug in this patient group, which means Roche will have to provide more analyses.
Specifically, NICE wants: “A revised economic model which represents the management of severe ANCA-associated vasculitis in the UK, including current comparators and routine clinical practice.”
The watchdog also needs to know what the definition of ‘severe disease’ is in this instance, and which subgroup of patients Roche thinks should be avoiding cyclophosphamide treatment.
More data demonstrating the benefits of MabThera in the longer term is also required.
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.
“The next step is for the manufacturer to respond to the Committee’s comments and submit further information as requested,” explained Professor Carole Longson, Health Technology Evaluation Centre director at NICE.
Adam Hill
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