Ban on asthma drug 'nonsensical'

The National Institute for Health and Clinical Excellence (Nice) has refused Xolair

(omalizumab) for use on the NHS, saying its high cost does not justify its "little extra benefit compared with existing treatments".

The medicine, which could be used for up to 300 children in Britain, is injected into the skin to control severe allergic asthma which has not responded to conventional treatments.

It is already approved for adults and children over the age of 12 but Nice yesterday rejected it for youngsters aged six to 11 in draft guidance, which is subject to appeal.

The charity Asthma UK condemned the decision, saying children on the drug in UK trials "have experienced massive improvements to their quality of life". Xolair costs 256.15 plus VAT per vial.

Chief medical adviser to Asthma UK Dr Mike Thomas said: "Hundreds of children across England with the most severe, allergic asthma will now be denied a pioneering treatment that could free them from crippling daily asthma symptoms, endless trips to hospital and huge amounts of time off school."

The drug has been approved for young children in Scotland, although that is now likely to be reviewed in light of Nice's decision.

"For parents of children with severe asthma aged six to 11 who have already trialled Xolair and had their lives transformed, this news will come as a massive blow," said Dr Thomas.

"It's vital that these children do not have the treatment withdrawn by primary care trusts as a result of the Nice decision, as this would be completely unjust.

"We will continue to fight for Xolair to be made available to people of all ages with severe asthma throughout the UK."

Professor of Paediatrics at Imperial College London John O Warner said Nice had based its decision on a study submitted by the manufacturer, Novartis, which had a too-small sample.

"The study did show that there were equal improvements in asthma quality of life in these patients as has been seen in all the adult studies," he said.

"What was not demonstrated was any significant difference in hospital admissions or severe exacerbations.

"This is directly as a consequence of the study not being adequately powered to show this.

"Given that the asthma quality of life improvements were equal to those in adults and the demonstration of highly beneficial and clinically meaningful improvements in children with severe asthma aged 6 to 11, it is a great tragedy that Nice have failed to approve Xolair.

"It is nonsensical that Xolair will be available to children aged 6 to 11 in Scotland but not in England. It is also nonsensical that it can be administered on the NHS to a child of 12 but not to one of 11."

Nice deputy chief executive Dr Gillian Leng said it had considered all the research.

He said: "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."

She said the recommendation was not based on the age of patients, but rather on the fact the drug had not been shown to be cost-effective for those under 12.

About 1.1 million children in Britain suffer from asthma, a condition which affects the airways which become inflamed and swollen, leaving patients struggling to breathe.

While everyday conditions such as the weather, or pollution, can make the condition worse, a severe attack can also be caused by allergens such dust-mites, pet fur, or pollen, and can be fatal.