NICE is recommending Novartis’ asthma drug Xolair as a cost effective treatment for young children and adults with a severe form of the condition in England.

Novartis’ Xolair (omalizumab) is now recommended as an option for treating severe, persistent confirmed allergic immunoglobulin E (IgE)-mediated asthma in people aged six years and older.

It is to be used as an add-on to optimised standard therapy for those people who need continuous or frequent treatment with oral corticosteroids (defined as four or more courses in the previous year).

NICE had been minded not to recommend the drug in December last year as it did not believe it was a cost effective treatment – however, a last minute patient access scheme from Novartis, which cuts the price of the drug, has swayed the Institute.

This new guidance also removes the requirement of the 2007 NICE guidance for patients aged 12 years and older that all patients should be hospitalised for asthma before being eligible for treatment, meaning more patients should be able to have access to the treatment at an earlier stage.

Novartis points to one study suggesting that one year of treatment with its drug has been shown to reduce inpatient hospital admissions by 61%, and accident and emergency visits by 70 per cent.

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.”

The cost of the treatment ranges from £1,665 per patient per year for a 75mg dose administered every month, to £26,640 per patient per year for the maximum 600mg dose given every fortnight. These costs will be lower owing to the PAS, but by just how much lower is uncertain as the discount remains ‘confidential in confidence’.

Dr Robert Niven, senior lecturer in respiratory medicine, University Hospital of South Manchester NHS Foundation Trust, said on behalf of Novartis: “The final guidance is excellent news for patients with severe asthma. For the first time, children aged 6-11 years with severe persistent allergic asthma will be able to access an innovative and effective treatment on the NHS.

“In addition, adult patients aged 12 and over can be reassured that the beneficial treatment they are currently receiving will continue to be funded by the NHS.”

Dr Niven added: “Many people with uncontrolled severe asthma live in fear that their next asthma attack could be fatal. Today’s final guidance, means that treatment may be available that can significantly improve their quality of life and help reduce patient exposure to the well documented issues associated with long-term use of corticosteroids.”

Asthma in the UK

There are currently more than 5.2 million people in the UK being treated for asthma, with about 1.1 million of these being children. According to Asthma UK, the NHS spends around £1 billion per year treating people with asthma, with around 80% of this is spent on managing those with the most severe asthma symptoms

In its development of the appraisal, the Committee heard from clinical specialists and patient experts that, in current UK clinical practice, the population for which the drug would be considered was in fact smaller than that covered by the marketing authorisation.

One clinical specialist noted that the number of people currently being offered Xolair in his practice accounts for around 1 in 200 people.