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Pioneering Asthma Drug For Children Turned Down By NICE

Wednesday, 27 October 2010

The National Institute for Health and Clinical Excellence (NICE) has turned down a new treatment for children with severe asthma under 12 years of age.
Background: NICE Press release
Omalizumab (Xolair, Novartis Pharmaceuticals UK) is not recommended as a treatment for severely asthmatic children under the age of 12, according to new guidance published today (27 October). The National Institute for Health and Clinical Excellence (NICE) looked at whether use of the drug would be an appropriate use of NHS resources for children aged between six and eleven years old with severe persistent allergic asthma. Although omalizumab is recommended in specific circumstances for people aged 12 and over with this type of asthma, the evidence for this younger age group showed the drug offered limited benefits compared with currently available treatments, meaning the extra cost of the drug does not represent good value for money for the NHS.
However, the guidance does state that children currently receiving omalizumab should be able to continue with the treatment until it is considered appropriate to stop.
Sir Andrew Dillon, NICE Chief Executive, said: "The evidence reviewed by our independent advisory committee showed little benefit for young children between six and eleven years old. Omalizumab does not reduce hospitalisation rates, A&E visits, unscheduled doctor visits or total emergency visits. The only demonstrable benefit was in reducing the rate of clinically significant exacerbations for children who had had three or more exacerbations per year. With such little extra benefit for these young patients, NICE is unable to recommend diverting NHS resources to such a high cost treatment.
"We understand that this may be a disappointing decision, especially as NICE does recommend omalizumab for some people aged twelve and over. The Appraisal Committee who developed the guidance on behalf of NICE recognised that it would be preferable to have a single piece of guidance covering recommendations for all age groups. In light of this, NICE does intend to review its guidance on omalizumab for both age groups at the earliest opportunity."
During the development of this guidance, NICE received one appeal from the Royal College of Paediatrics and Child Health but the points raised did not fall within the grounds for appeal and therefore the appeal did not proceed. The guidance published today now constitutes final guidance to the NHS. For more information, please visit www.nice.org.uk
Asthma UK comment:
Neil Churchill, Chief Executive at Asthma UK, said: 'We are extremely disappointed that NICE has decided not to recommend Xolair for children under the age of 12. This action will deny children across England with the most severe, allergic asthma, a pioneering treatment that many doctors tell us they want to prescribe and that could free these children from endless trips to hospital and huge amounts of time off school. It is good news however, that the guidance indicates that those children who have already trialled Xolair and had their lives transformed, should not have their treatment withdrawn by their PCTs. We are also urging PCTs to consider exceptional funding for the very small number of children who would derive significant benefit from Xolair.'
Pioneering Asthma Drug For Children Turned Down By NICE