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NICE rejects omalizumab use in children

NICE has rejected the use of omalizumab for the treatment of severe persistent allergic asthma in children aged 6 to 11 years

In its final appraisal determination, the National Institute for Health and Clinical Excellence (NICE) has rejected the use of omalizumab (Novartis' Xolair) for the treatment of severe persistent allergic asthma in children aged 6 to 11 years.

Value for money was a key driver of NICE's decision as well as the clinical effectiveness of the drug. According to NICE, omalizumab as an add-on to standard care has not been shown to statistically significantly affect key effectiveness indicators such as hospitalisation rates, accident and emergency visits, unscheduled doctor visits or total emergency visits, symptom-free days and nights or health-related quality of life. Although for some of these outcomes there was a trend towards a beneficial effect of omalizumab.

Following the issue of provision guidance from NICE regarding the use of omakizumab in children, the drug's manufacturer, Novartis, stated in a letter: "Novartis is very disappointed that the preliminary guidance from NICE does not recommend the use of omalizumab in children aged 6 to 11 years. We are concerned that, should NICE's preliminary recommendation become final guidance, children with the most severe allergic asthma will not be able to access treatment with omalizumab until they reach the age of 12 years and meet the eligibility criteria of NICE Technology Appraisal (TA) 133."

Omalizumab was granted a marketing authorisation as an adjunct therapy for improving control of asthma in adults and adolescents (12 years and older) with severe persistent allergic asthma. In July 2009, the marketing authorisation was extended to include children aged 6 to 11 years who had severe persistent allergic asthma, a positive skin test or invitro reactivity to a perennial aeroallergen, frequent daytime symptoms or night-time awakenings, and multiple documented severe exacerbations of asthma despite daily high-dose inhaled corticosteroids plus a long-acting inhaled beta-2 agonist.

The marketing authorisation stated that treatment with omalizumab "should only be considered for patients with convincing IgE (immunoglobulin E) mediated asthma". It also recommends that at 16 weeks after the start of therapy, doctors should assess patients for the effectiveness of treatment before administering further injections, and that the decision to continue omalizumab should be based on whether a marked improvement in overall asthma control is seen.

12th August 2010

From: Healthcare

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