|Courtesy of Genentech/Novartis|
The U.K.'s cost-effectiveness gatekeepers have flip-flopped on Novartis' ($NVS) Xolair before, withdrawing support for the drug in 2012 before expanding its approval for asthma the following year. Now, the National Institute for Health and Care Excellence (NICE) is asking the drugmaker to pony up more data on Xolair as a treatment for chronic hives in kids.
The agency decided "there were still questions to be answered" about the drug's cost-effectiveness after an independent appraisal committee weighed in on the drug. NICE is looking for more details and analysis, Health Technology Evaluation Centre Director Carole Longson said.
Novartis, which co-developed Xolair with Roche's ($RHHBY) Genentech unit, has until Dec. 9 to turn in the new data.
Xolair snagged approval earlier this year in Europe and the U.S. to treat chronic hives. In the U.K., a 24-week course of the drug for hives adds up to more than £3,000, Pharmafile notes.
Winning the U.K. cost watchdog's stamp of approval is critical for Novartis as it eyes a lucrative dermatology market and bigger sales for Xolair. The drug brought in $613 million last year in outside-the-U.S. sales for asthma, and an expanded indication for hives could add about $500 million to Novartis' stockpile. David Epstein, who heads up Novartis Pharmaceuticals, told analysts at a healthcare conference in March that dermatology represents a $2 billion to $3 billion opportunity for Novartis, according to PMLive.
Meanwhile, Novartis is facing some regulatory pushback for Xolair as an asthma treatment. The FDA in September slapped the drug with product label warnings about cardiovascular risks. That decision was based on data from a 5-year study comparing Xolair with placebo, which showed that the drug may increase the risk of clots, hearts attacks, mini-strokes and chest pain. But due to study weaknesses the FDA could not quantify the risks, the agency said at the time of its decision.
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