NICE rejects Xolair for children
pharmafile | June 3, 2010 | News story | Sales and Marketing | NICE, Xolair, asthma
The drug was first approved in Europe in November 2005 for patients aged 12 or older, and gained NICE approval in these patients two years later.
But NICE has concluded that the drug, which is injected every two to four weeks, provides little extra benefit over existing drugs for severe persistent allergic asthma in children aged 6-11 years.
Asthma affects approximately 1.1 million children in the UK. Of the 80,000 hospital admissions for asthma in the UK every year, 41% are for children under 14 years, according to Novartis. Xolair is the only licensed medicine shown to stabilise severe allergic asthma in a significant proportion of patients.
Sir Andrew Dillon, NICE’s chief executive said: “The Independent Appraisal Committee considered all the evidence on omalizumab’s clinical effectiveness. Clinical trials demonstrated no proven reduction in hospitalisation rates, accident and emergency visits, symptom-free days and nights, clinically significant severe exacerbations or health related quality of life. An effect was only proven for a reduction in the rate of clinically significant exacerbations for children who had had three or more exacerbations per year.“
The Committee also concluded that, considering the very limited benefits omalizumab offers in this age group, the price the NHS is being asked to pay for omalizumab is too high.
Dr Tim Cave, medical director, Novartis said: “We are disappointed by NICE’s initial decision, and concerned that the small number of young children with severe asthma in whom omalizumab would be used will be denied access to this drug. If the initial decision stands, doctors will not be able to give children a treatment which could alleviate their asthma symptoms.”
NICE’s decision stands in contrast to the ruling by the Scottish Medicines Consortium (SMC). It accepted the use of Xolair for children in Scotland aged 6-11 years with severe, persistent allergic asthma who are prescribed chronic systemic steroids.
NICE has invited Novartis and other consultees/commentators in the appraisal process, including patient/carer groups, to comment on the ACD by 5pm on 22 June. NICE is expected to publish its final guidance to the NHS in October.
Xolair (omalizumab) works by blocking the antibody immunoglobulin E (IgE), which is responsible for triggering chemical reactions that can lead to asthma attacks and symptoms, and is administered via injection every two to four weeks.
Brett Wells
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