Xolair Endorsement Retracted by NICE

The National Institute for Health and Clinical Excellence (NICE) have released draft guidance withdrawing their recommendation of Novartis’ Xolair for severe persistent allergic asthma.

In 2007, NICE circulated guidelines supporting the use of Xolair (omalizumab) on the National Health Service (NHS) for adults whose asthma is poorly controlled.  Then in 2011 they reject the treatment’s use in children aged six to eleven years.

However, a review of the recommendations, in which new evidence, in particular new mortality data, was taken into account, has prompted the Institute to reject the medication’s use in both children and adults, as it is not as clinically and cost-effective as previously thought.

Alterations to the dosing schedule and the associated effect on Xolair’s cost effectiveness were also taken into account, and this, along with doubts surrounding the evidence and analysis presented, “did not support a positive recommendation for omalizumab,” the cost watchdog noted.

The medication costs roughly £8,000 per patient per year.  Around 2,000 people are believed to be taking omalizumab, while an additional 2,000 could benefit from the drug.

Unsurprisingly, the verdict was criticised by Novartis, which commented that the change comes despite the availability of “additional data demonstrating sustained, real-life benefits in severe persistent allergic asthma patients.”

Novartis also argues that one year of therapy with Xolair “has been shown to reduce hospital admissions by 61% and overnight hospital stays by 70%”, as well as induce significant improvements in patients’ quality of life in the ‘real world’.”

“NICE’s proposed retraction of its existing guidance is concerning for people with severe persistent allergic asthma,” noted Rob Niven, Senior Lecturer in Respiratory Medicine, University Hospital of South Manchester NHS Foundation Trust.

“These people have severe symptoms of asthma with increased rates of mortality, live in fear of life-threatening attacks and endure frequent hospitalisations, leading to a negative impact on their day-to-day quality of life and a heavy burden on NHS,” he added.

The only alternative medication for severe asthma is oral corticosteroid therapy.  While this can be effective, it can also cause long-term side effects including weight gain, hypertension, osteoporosis and depression.


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