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In its latest draft guidance, the National Institute for Health and Clinical Excellence (NICE) remains unable to recommend omalizumab (Xolair, Novartis Pharmaceuticals UK) for the treatment of severe persistent allergic asthma in children aged 6-11 years.

This decision was reached after evidence highlighted little extra benefit compared with existing treatments, for children in this age group, meaning the extra cost does not represent value for money for the Health Service. Children currently receiving omalizumab should have the opportunity to continue treatment until it is considered appropriate to stop.1

The draft guidance is now with consultees who have the opportunity to appeal against it. NICE has not yet issued final guidance to the NHS. Final guidance is expected in September 2010.

Dr Gillian Leng, NICE Deputy Chief Executive, said: “The Independent Appraisal Committee considered all the evidence on omalizumab’s clinical effectiveness in children aged 6-11. This evidence demonstrates no proven reduction in hospitalisation rates, accident and emergency visits, unscheduled doctor visits or total emergency visits for children in this age group treated with omalizumab. The Committee found that omalizumab is only useful in reducing the rate of clinically significant exacerbations for children who had had three or more exacerbations per year.

“We are unable to recommend that NHS funds be diverted to a treatment with such high costs which only provides very limited benefits for patients.”

“The Committee did consider comments received during consultation that not recommending omalizumab in this age group is unfair because NICE recommends it under specific circumstances for children aged 12 years and above. However, our recommendation is not based on the age of patients, but rather on the fact that the evidence implies the use of omalizumab is not cost-effective in this younger age group.

“Nevertheless, the Committee recognizes it would be preferable to develop a single piece of guidance covering recommendations for all age groups, and recommends a review of the recommendations for all age groups together at the earliest opportunity.”

For more information call the NICE press office on 0845 003 7782 or 07775 583 813.

Notes to Editors

About the guidance

1. The final appraisal determination (FAD) is available from Thursday 12 August 2010.

2. 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.2

3. Omalizumab was considered as a treatment option to improve asthma control in children aged 6-11 with severe persistent allergic asthma.

4. Omalizumab is a recombinant humanised anti-immunoglobulin E (anti-IgE) antibody. Omalizumab is administered by injection every two or four weeks by a healthcare provider.

5. According to the manufacturer’s estimates the cost of omalizumab is £256.15 for a 150-mg vial excluding VAT. The marketing authorisation specifies weight-based dosing, which may change over time as children are expected to grow and gain weight between 6-11 years of age.

6. Where omalizumab is used for patients who had three or more clinically significant exacerbations, the Committee considered that the treatment would cost £82,600 per quality adjusted life year (QALY) gained.

7. Asthma is characterised by symptoms such as dyspnoea, chest tightness, wheezing, sputum production and cough associated with variable airflow obstruction and airway hyperresponsiveness. Asthma attacks vary in frequency and severity. Some people who have asthma are symptom-free most of the time, with only occasional episodes of shortness of breath. Other people cough and wheeze frequently and may have severe attacks after viral infections, exercise or exposure to irritants, including cigarette smoke. Asthma can have an allergic component resulting in over-production of human immunoglobulin E (IgE) in response to environmental allergens e.g. pollen or house dust mite. IgE binds to cell membrane receptors resulting in the release of inflammatory mediators.

8. Clinically significant exacerbations are defined as a worsening of asthma symptoms which require doubling of the baseline dose of inhaled corticosteroid and/or treatment with rescue systemic (oral or intravenous) corticosteroids for at least 3 days.

9. Clinically significant severe exacerbations are defined as exacerbations that require treatment with systemic corticosteroids and where the child had a peak expiratory flow rate or forced expiratory volume at 1 second (FEV1) of less than 60% of their personal best.

About NICE

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

11. 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 and procedures within the NHS
• clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.

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

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