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Asthma drug for under 12s not recommended for NHS use

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 Care 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[1].

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

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Notes to Editors

About the guidance

  • The guidance is available to view at: http://guidance.nice.org.uk/TA201 (from Wednesday 27 October)
  • Although asthma is a common condition, affecting around 1.1 million children in the UK[2], the manufacturer of omalizumab estimates that there would be just 307 children in the UK who would be eligible for omalizumab. For these children, their asthma is not adequately controlled despitebest available therapy which recommends a stepwise approach[3].
  • Omalizumab is a recombinant humanised anti-immunoglobulin E (anti-IgE) antibody, which is administered by injection every two or four weeks by a healthcare provider.
  • The cost of omalizumab ranges from approximately £1,665 per patient per year (excluding VAT) for a 75 mg dose administered every four weeks to approximately £26,640 per patient per year (excluding VAT) for a 600 mg dose (the maximum recommended dose) administered every two weeks. The marketing authorisation specifies weight-based dosing, which may change over time as children are expected to grow and gain weight between six and eleven years of age and costs may vary in different settings because of negotiated discounts.
  • Where omalizumab is used for patients who had three or more clinically significant exacerbations, the Committee considered that the incremental cost effectiveness ratio (ICER) for this treatment would be £82,600 per quality adjusted life year (QALY) gained.

About NICE

1. The National Institute for Health and Care Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health

2. NICE produces guidance in three areas of health:

  • public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
  • health technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHS
  • clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.

3. NICE produces standards for patient care:

  • quality standards - these reflect the very best in high quality patient care, to help healthcare practitioners and commissioners of care deliver excellent services
  • Quality and Outcomes Framework - NICE develops the clinical and health improvement indicators in the QOF, the Department of Health scheme which rewards GPs for how well they care for patients

4. NICE provides advice and support on putting NICE guidance and standards into practice through its implementation programme, and it collates and accredits high quality health guidance, research and information to help health professionals deliver the best patient care through NHS Evidence.

[1] This decision should be made jointly by the clinician and the child and/or the child's parents or carers.

[2] Asthma UK, 2010

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

This page was last updated: 26 October 2010

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

Accessibility | Cymraeg | Freedom of information | Vision Impaired | Contact Us | Glossary | Data protection | Copyright | Disclaimer | Terms and conditions

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