National Institute for Clinical Excellence (NICE) U-Turn on Novartis AG's Xolair for Asthma

The National Institute for Health and Clinical Excellence (NICE) has backed down on draft guidance to withdraw its recommendation for Novartis' Xolair in the treatment of asthma. The cost-effectiveness body for England and Wales said in November 2012 that, in the light of new evidence following changes to the drug's dosing schedule, it was no longer able to recommend Xolair (omalizumab) for severe persistent allergic asthma in adults – overturning its initial recommendation in 2007. However, Novartis has now offered Xolair at a discount through a patient access scheme, convincing NICE to release final draft guidance upholding the 2007 recommendation. In a boon for Novartis, the latest recommendation also covers adolescents and children aged six years and over with severe, persistent allergic asthma, opening up a new market for the drug in England and Wales. Both recommendations cover Xolair's use as an add-on therapy for people whose asthma remains poorly controlled despite receiving optimised standard therapy, such as high-dose inhaled corticosteroids. Professor Carole Longson, Health Technology Evaluation Centre director at NICE, explained the “significant effect” asthma can have on an individual.

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