Regulatory Focus™ > News Articles > In Reversal, NICE Gives Thumbs-up to Novartis Asthma Treatment

In Reversal, NICE Gives Thumbs-up to Novartis Asthma Treatment

Posted 07 March 2013 | By Louise Zornoza

The UK's National Institute for Health and Clinical Excellence (NICE) today published final draft guidance recommending omalizumab (Xolair, Novartis Pharmaceuticals UK) as an option for treating severe, persistent allergic asthma in adults, adolescents and children, reversing a decision it made in November 2012.

The reversal comes as a result of additional analyses and a move by Novartis to offer a so-called patient access scheme to discount Xolair's list price.

NICE is recommending omalizumab as an option for treating severe, persistent confirmed allergic IgE-mediated asthma in people aged six years and older as an add-on to optimized standard therapy for those people who need continuous or frequent treatment with oral corticosteroids (defined as four or more courses in the previous year), subject to the drug being available with the agreed patient access scheme. Omalizumab works by blocking immunoglobulin E (IgE) antibodies from attaching to allergens, a process that eventually leads to an allergic reaction.

Omalizumab is approved in the UK as an add-on therapy to standard care to improve control of asthma in adults and adolescents (12 years and over) and children aged 6 to 11 years with severe persistent allergic asthma. It is currently only offered to those whose asthma remains poorly controlled despite receiving optimized standard therapy. Standard therapies for asthma include high-dose inhaled corticosteroid, long-acting beta-2 agonists and, where appropriate, oral corticosteroids.

NICE Health Technology Evaluation Centre Director Prof. Carole Longson commented that "NICE is aware that severe, persistent allergic asthma can have a significant effect on a person's life.

"We are therefore pleased to now be able to recommend omalizumab as an effective therapy for adults, adolescents and children with this condition in final draft guidance, with the discount agreed in the patient access scheme submitted by the manufacturer," Longson added.

NICE said its final decision had not yet been issued in guidance to the NHS and noted that it could still change in the event of an appeal. It said final guidance is expected to be published in April 2013.

Tags: UK

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