Regulatory Focus™ > News Articles > NICE Gives Novartis’ Asthma Drug Thumbs Up After Price Lowered

NICE Gives Novartis’ Asthma Drug Thumbs Up After Price Lowered

Posted 25 April 2013 | By Louise Zornoza

The UK's cost containment agency, the National Institute for Health and Care Excellence (NICE), has given its approval in final guidance for the reimbursement of Novartis' Xolair (omalizumab) for the treatment of severe asthma.

The recommendation reverses the earlier reimbursement denial made in November 2012 that cited the drug's lack of cost effectiveness, which led Novartis to lower the price of the drug.

Professor Carole Longson, Health Technology Evaluation Centre Director at NICE said: "NICE is pleased to recommend omalizumab, with the agreed patient access scheme submitted by the manufacturer, as an effective add-on therapy for adults, adolescents and children with severe, persistent allergic asthma, which can have a significant effect on a person's life."

British charity Asthma UK has described omalizumab (Xolair) as the only treatment that works for some people with severe asthma and that its benefits can be life changing.

Xolair's precise indication is for the treatment of severe, persistent confirmed allergic immunoglobulin E (IgE)-mediated asthma in people aged 6 years and older as an add-on to optimised standard therapy for those people who need continuous or frequent treatment with oral corticosteroids (defined as 4 or more courses in the previous year). 

There are currently more than 5.2 million people in the UK being treated for asthma; about 1.1 million of whom are children. In its development of the appraisal, NICE heard from clinical specialists and patient experts that, in current UK clinical practice, the population for which omalizumab would be considered smaller than that covered by the marketing authorization.


Read all Breaking News from RegLink

NICE: Asthma (severe, persistent, patients aged 6+, adults) - omalizumab (rev TA133, TA201) (TA278)

Tags: UK

Regulatory Focus newsletters

All the biggest regulatory news and happenings.