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NICE consults on preliminary recommendation not to recommend omalizumab for children under 12

Omalizumab (Xolair, Novartis Pharmaceuticals UK) provides little additional benefit over existing drugs for the treatment of severe persistent allergic asthma in most children aged 6-11 years, according to the National Institute for Health and Care Excellence (NICE). Its high cost also means that for the limited benefit it provides, omalizumab does not present value for money for the NHS. NICE is therefore unable to recommend omalizumab as a treatment option for this age group in draft guidance published today (1 June 2010.)

In line with the technology appraisals process this draft guidance has now been issued for consultation: NICE has not yet published final guidance to the NHS. Final guidance is expected in October 2010.

Although asthma is a common condition, affecting approximately 1.1 million children in the UK, only a very small proportion would be eligible to try omalizumab. For these children, around 300 in the UK, their asthma is not adequately controlled despite best available therapy which recommends a stepwise approach.[1]

Sir Andrew Dillon, NICE 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.”

[1] Control is maintained by stepping up treatment (up to step 5) as necessary and stepping down when symptoms are well controlled.

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This page was last updated: 07 June 2010

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Copyright 2014 National Institute for Health and Care Excellence. All rights reserved.