Over the next couple of months patients suffering from chronic hives across England and Wales should be offered routine access to Novartis’ Xolair on the National Health Service.

The National Institute for Health and Care Excellence has now published final guidance endorsing the drug’s use as a possible treatment for people aged 12 years and over with severe chronic spontaneous urticaria (CSU), but only if antihistamines or leukotriene receptor antagonists have failed to work.

Also, the Institute has stipulated that therapy with Xolair (omalizumab) should be stopped at the fourth dose if the condition has not responded, and at the end of the sixth dose if it has, only to be restarted if the hives come back.

Xolair, a monoclonal antibody targeting Immunoglobulin E, won European approval last year to treat CSU - a debilitating form of chronic itch, hives and deep swelling in the tissue of the skin - thereby offering the only approved therapy for 50% of patients failing to respond to antihistamines. 

Value for money

A 24-week course of treatment costs £3,073 (excluding VAT), but the drug is available through a confidential patient access scheme to boost its value for money, which is also a condition of NICE’s endorsement.

The Institute’s Expert Review Committee concluded that the incremental cost effectiveness ratio for treating only chronic forms would likely be lower than the Novartis’ own estimate of £26,000 per QALY gained, “because a more realistic utility value for severe disease would likely decrease the ICER”. 

Also, the benefit of avoiding immunosuppressant side effects - which can last a lifetime - was not accounted for in the company’s analyses which could decrease the figure even further, it said.