The National Institute for Health and Clinical Excellence has backed the use of inhaled corticosteroids for asthma in children under 12 and Xolair for severe persistent allergic asthma in adolescents and adults.

NICE has now published final guidance recommending Novartis’ Xolair (omalizumab) for treating patients aged over 12 with severe persistent forms of the condition on the National Health Service, provided that they have had either two or more severe exacerbations requiring hospital admission within the previous year, or three or more within the previous year, at least one of which required admission to hospital, and a further two which required special treatment/monitoring in an A&E unit.

Furthermore, it insists that therapy is initiated and monitored by a doctor experienced in allergy/respiratory care in a specialist centre, and patient should be taken off the if they don’t respond within 16 weeks.

Xolair has been available in the UK since 2005 and, according to Novartis, is the first drug to demonstrate its ability to stabilise severe allergic asthma in a “significant portion of patients” by going straight to the root of the problem. A humanised monoclonal antibody, the drug block’s the body’s reaction to inhaled particles – such as pollen and house-dust mite droppings - that trigger the symptoms of the condition, thereby helping to reduce the risk of sever exacerbations and the need for emergency treatment and improve the quality of life, the group said.

“Severe persistent asthma greatly restricts the quality of life of the individual and can result in limited physical activity, continuous daytime symptoms and frequent symptoms at night. The approval of omalizumab improves the options available to the minority of people with asthma who are classified as having this more severe form,” commented Gillian Leng, NICE’s executive lead for the guideline and deputy chief executive.

A spokesman for Novartis told PharmaTimes UK News that treatment with the drug costs £8,400 per patient per year.

The drug was assessed under NICE’s rapid single technology appraisal fast-track programme, which takes around six months to complete compared to some 12-14 months for the standard Multiple Technology Appraisal.

Option for children endorsed
Meanwhile, the Institute also published final guidance backing the use of inhaled corticosteroids in children under the age of 12 who have asthma.

The advice is that, in children where this therapy is considered appropriate, the least costly product suitable for each patient should be used. Furthermore, whether a combination inhaler or two separate devices is most appropriate should also be assessed on an individual basis, taking into consideration therapeutic need and the likelihood of treatment adherence, it said.

According to NICE, there are around 5.2 million people with asthma in the UK, of which nearly 1 million are children, making it the most common chronic disease in this age group.

“Asthma can prevent children from doing every day activities such as playing at school, riding a bike, and even participating in organised sports. Other effects can include school absence and night disturbances. The committee has concluded that inhaled corticosteroids are both a good use of NHS resources and an effective way of controlling the symptoms of asthma and preventing severe asthma attacks,” Leng explained.