NICE has been accused of being “nonsensical” for denying young children with severe asthma access to a drug.
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NICE 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 the UK, 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approved for adults and children over the age of 12, but NICE today rejected it for youngsters aged six to 11 in draft guidance, which is subject to appeal.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”.
John O Warner, professor of Paediatrics at Imperial College London, said NICE based its decision on a study submitted by the manufacturer, Novartis, which had too-small a 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.
Dr Gillian Leng, NICE deputy chief executive, said it considered all the research.
“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.”