It is looking unlikely that Novartis’ Xolair will be endorsed by the National Institute for Health and Clinical Excellence as a treatment for six-11 year olds with severe allergic asthma on the National Health Service.

The European Commission approved Xolair (omalizumab) as add-on therapy for severe persistent allergic asthma in children aged six to 11 years in August last year, based in part on a study which showed that the drug reduced asthma attacks by 34% after 24 weeks of treatment and provided an overall reduction of 50% at one year in patients aged six to 11 years.

But according to an appraisal consultation document published by the cost watchdog this morning, its Independent Appraisal Committee believes Xolair provides “little additional benefit” over existing drugs currently used to treat the condition in this age group.

And crucially, Xolair’s high cost also means that, for the limited benefit it provides, it does not present value for money for the NHS, NICE said, explaining its preliminary recommendation to reject the drug for this patient group.

While noting that Xolair was indeed shown to reduce the rate of clinically significant exacerbations for children who had three of more than three a year, clinical trials have failed to demonstrate a “proven reduction in hospitalisation rates, accident and emergency visits, symptom-free days and nights, clinically significant severe exacerbations or health related quality of life,” argued NICE chief executive Andrew Dillon.

Xolair costs £256.15 for a 150-mg vial (excluding VAT), but the Committee has ruled that, given the drug’s limited benefits, the price is simply too high for the NHS, despite the fact that only around 300 children with asthma in the UK would be eligible for treatment anyway.

Novartis disappointed
"We are disappointed by NICE’s initial decision and concerned that the small number of young children with severe asthma in whom omalizumab would be used will be denied access to this drug," said Tim Cave, Medical Director, Novartis UK, and added that if decision stands, "doctors will not be able to give children a treatment which could alleviate their asthma symptoms".

In 2007, the cost regulator backed the use of the Xolair for patients aged over 12, provided that they have had either two or more severe exacerbations requiring hospital admission within the previous year, or three or more within the previous year, at least one of which required admission to hospital, and a further two which required special treatment/monitoring in an A&E unit.

NICE’s recommendations for the drug in patients aged six-11 years are now open for consultation, and final guidance is expected in October.