NICE gives go ahead for Xolair to treat potentially disabling skin condition

The medicines cost watchdog the National Institute of Health and Care Excellence (NICE) has recommended Swiss pharma giant Novartis’ (NOVN:VX) Xolair (omalizumab) as an option for add-on therapy for treating severe chronic spontaneous urticaria (CSU) for adults and young people (aged 12 and above) across England who have not responded to treatment with H1-antihistamines and leukotriene receptor antagonists (LTRAs).

Already approved by the European Commission, omalizumab is the first and only add-on therapy to H1-antihistamines for patients who do not respond to other treatments and is the first new type of medicine licensed for the treatment of CSU since the 1950s. The committee that developed NICE’s recommendation commented that the speed at which omalizumab works, and its comparative safety profile, means it can be considered ‘innovative’ in the treatment of this condition. Subject to appeal, clinicians and patients will have access to omalizumab by the summer.

Sinisa Savic, Consultant Immunologist at St James's University Hospital, Leeds, comments: "CSU can be an unpleasant condition which can have a huge impact on patients' physical and psychological wellbeing. For some of my patients CSU has had a devastating effect on their lives. For many years treatment options for patients with the severe form of CSU have been quite limited and there has been a real medical need for an effective, licensed medicine to be available to patients and clinicians. The positive final appraisal determination issued today by NICE is a very welcome and important step forward for health care professionals and people living with CSU."

International experts agree that effective treatment for CSU should ultimately result in patients being symptom-free, which is not possible in up to 50% of cases with the only other licensed therapy, H1-antihistamines, given at licensed doses.