The National Institute for Health and Clinical Excellence has published draft guidance revoking its endorsement of Novartis' Xolair for the treatment of severe persistent allergic asthma.

In 2007, the Institute published guidelines supporting the use of Xolair (omalizumab) on the National Health Service for adults whose asthma is poorly controlled, and in 2011 went on to reject its use in children aged six-11 years.

But a review of these guidelines, in which new evidence, particularly new mortality data, was considered, has prompted NICE to turn down the drug's use in both children and adults, because it is not as clinically and cost-effective as previously thought.

Changes to the dosing schedule and the related impact on Xolair's cost effectiveness were also taken into account, and this, coupled with uncertainties in the evidence and analysis presented, "did not support a positive recommendation for omalizumab", the cost watchdog said.

Unsurprisingly, the decision was slammed by Novartis, which said it comes despite the availability of "additional data demonstrating sustained, real-life benefits in severe persistent allergic asthma patients".

It 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," commented 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 said.

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

Javlor ousted

Meanwhile, in final draft guidance NICE has rejected Pierre-Fabre's Javlor (vinflunine) for the treatment of advanced or metastatic transitional cell carcinoma of the urothelial tract which has spread despite prior treatment with platinum-containing chemotherapy.

"The manufacturer has been unable to provide the Appraisal Committee with conclusive evidence on how effective vinflunine is, particularly the extent to which it can prolong survival compared with best supportive care,” said Andrew Dillon, the Institute's chief executive.