NICE to withdraw recommendation of Novartis’ asthma drug

Hannah Blake

pharmaphorum

Britain’s National Institute for Health and Clinical Excellence (NICE) has decided to withdraw its recommendation for asthma drug, Xolair, citing that a review of up-to-date clinical trial data showed it is no longer thought to be good value for money.

Xolair (omalizumab) was approved by NICE in 2007 for treatment of severe persistent allergic asthma in adults and children over the age of 12. However, the clinical trials data submitted as evidence included people whose asthma was less severe than those currently being treated with Xolair in the UK. Therefore, NICE concluded that the analyses presented may not be applicable to the current population of patients with severe asthma for whom Xolair is used in clinical practice.

"The Committee is aware that severe, persistent allergic asthma can have a detrimental effect on a person's life and that omalizumab is an effective therapy for children, adolescents and adults with severe persistent allergic asthma. But new evidence that has become available since our original appraisal of omalizumab in 2007 indicates that it is not as clinically or cost-effective as was first thought. The Committee explored ways to identify a subgroup of people for whom omalizumab might provide a cost effective treatment, including using favourable assumptions in the modelling. In addition, the Committee recognised that there could be additional health-related benefits for patients and carers as a result of using omalizumab. However, there was no quantifiable data relating to these benefits. Unfortunately, the Committee was unable to continue to recommend omalizumab for use in the NHS.”

Sir Andrew Dillon, Chief Executive of NICE.

This recommendation for the NHS to stop funding Xolair in the UK and Wales is still in review stage and NICE has said it is now up to Novartis and other interested parties to respond to its concerns. Final guidance is expected to be published by NICE in April 2013.

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