November 19, 2014
By Riley McDermid, BioSpace.com Breaking News Editor
British health regulators have asked Novartis for more information on its blockbuster asthma drug Xolair (omalizumab) for the treatment of hives, as questions about the cost effectiveness of the drug continue to surface.
Cost regulators for the National Health Service said its Appraisal Committee wants clarification on multiple, unspecified points in order to see if the drug is affordable enough for U.K. taxpayers. Novartis has until Dec. 9 to provide NICE authorities with the information they have requested.
“This is why we have requested more details and analysis from the manufacturer,” said Carole Longson, director of NICE‘s health technology evaluation center, in a statement. “We want to ensure that we have as much information as possible to make an informed recommendation.”
This isn’t the first time Novartis has tangled with NICE over the drug. In, 2012, the agency said it planned to rescind an early 2007 recommendation that approved Xolair as an add-on treatment for severe asthma caused by allergies. Novartis then argued successfully for reinstatement, but only after offering the drug at a discount overseen by U.K. regulators. NICE will likely seek a similar discounted program for Xolair’s usage in the treatment of hives.
The monoclonal antibody targeting Immunoglobulin E was approved by European regulators in March to treat chronic spontaneous urticaria (CSU), which causes chronic itching, raised red welts (hives) and swelling. Xolair had shown in three Phase III studies involving almost 1,000 patients that it was more effective than a placebo at soothing CSU, good news for the 50 percent of patients who do not respond to antihistamines.
Novartis did not issue a statement on the NICE request as of press time Wednesday.
