NICE has failed to recommend Xolair (omalizumab) for the treatment of severe persistent allergic asthma in adults and children in draft guidance after reviewing new evidence.
The guidance reviewed two separate appraisals in 2007 – one which recommended Xolair for adults and one which did not for use in children.
Sir Andrew Dillon, Chief Executive of NICE, said that new data showed that the treatment is “not as clinically or cost-effective as was first thought.”
Xolair has a UK marketing authorisation as an add-on therapy to standard care to improve control of asthma in adults and youngsters aged 6 and above with severe persistent allergic asthma.
However, after new evidence was made available, particularly on mortality data, NICE’s independent Appraisal Committee decided that the draft guidance should not recommend the treatment for either children or adults.
In addition, the Committee also took into account changes to the dosing schedule and the effect this would have on the cost effectiveness of the treatment. This, when combined with uncertainties over the new clinical data, did not support a positive recommendation.
The Committee did recognise that Xolair was an effective therapy for asthma sufferers but said evidence submitted as part of the appraisal included people whose condition was less severe than those currently being treated in the UK.
“The Committee is aware that severe, persistent allergic asthma can have a detrimental effect on a person’s life and that omalizumab is an effective therapy for children, adolescents and adults with severe persistent allergic asthma,” said Sir Andrew Dillon.
“Unfortunately, the Committee was unable to continue to recommend omalizumab for use in the NHS.”
Patients currently taking Xolair should be able to continue treatment until their clinician considers it appropriate to stop.
Final guidance is now expected in April 2013.