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NICE to reverse approval for Novartis' asthma drug Xolair

Draft guidance doesn't recommend omalizumab for severe asthma

National Institute for Health and Clinical Excellence (NICE) 

NICE is set to rescind its backing for Novartis' Xolair after issuing new draft guidance that does not recommend the drug's use to treat the most severe form of asthma.

The UK cost-effectiveness body previously approved the drug in 2007 as a treatment for severe persistent allergic asthma in adults and subsequently did not recommend it to treat the same condition in children.

Reviewing this earlier guidance in the light of new evidence, and particularly new mortality data, NICE's new draft guidance does not recommend Xolair for either adults or children.

NICE's appraisal committee noted changes to the drug's dosing schedule had impacted its cost effectiveness and said this, in combination with “uncertainties in the evidence and analysis presented”, did not support a positive recommendation.

Sir Andrew Dillon, chief executive of NICE, said: “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."

He said the appraisal committee had tried to identify a subgroup of patients for whom Xolair might be cost effective treatment and recognised 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. The next step is for the manufacturer and other consultees to respond to the committee's concerns.”

Novartis said it remains confident that Xolair is a cost-effective option for the treatment of severe persistent allergic asthma.

“While today's announcement recognises that omalizumab is an effective treatment for severe persistent allergic asthma, the draft guidance concludes that it is not a cost-effective use of NHS resources. This is despite new efficacy data becoming available and the NICE appraisal committee highlighting that 'omalizumab is an innovative treatment and a step-change',” the company said in a statement.

It added: “Novartis will continue to engage constructively with NICE and other stakeholders to better understand this draft decision and ensure that all patients who could benefit from omalizumab can continue to access this important asthma treatment.”

Final guidance is expected to be finalised and published in April 2013.

9th November 2012

From: Sales, Healthcare

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