Cost regulators for the National Health Service in England have asked for more information on the use of Novartis’ asthma blockbuster Xolair (omalizumab) for the treatment of hives, to determine whether or not it will endorse funding for the drug in this setting.

The National Institute for Health and Care Excellence said its Appraisal Committee is seeking clarification on a number of points to ensure an informed decision on cost-effectiveness can be made.

Xolair, a monoclonal antibody targeting Immunoglobulin E, was cleared in Europe earlier this year to treat chronic spontaneous urticaria (CSU) - characterised by a debilitating form of chronic itch, hives and deep swelling in the tissue of the skin - making it the only approved therapy for the up to 50% of patients who do not respond to antihistamines. 

The green light was based on data from three Phase III studies involving nearly 1,000 patients, which showed that Xolair improved quality of life and was significant super to placebo at reducing the symptoms of CSU, even completely clearing symptoms in many cases.

Novartis has until December 9 to submit any extra information to NICE.