Novartis must provide more information on its injectable medicine Xolair if it wants to be available for routine use on the NHS in England to treat hives.
The National Institute for Heath and Care Excellence (NICE) issued draft guidance today that does not recommend the use of the Xolair (omalizumab) to treat chronic hives – a raised, itchy rash that appears on the skin – as questions remain about the cost-effectiveness of the drug.
“This is why we have requested more details and analysis from the manufacturer,” said Prof Carole Longson, director of NICE’s health technology evaluation centre. “We want to ensure that we have as much information as possible to make an informed recommendation.”
Xolair, which was approved in Europe in March this year to treat chronic hives, has had a mixed history with NICE.
The monoclonal antibody is also approved in Europe as an add-on treatment to improve the control of severe persistent asthma caused by an allergy and was recommended in 2007 by NICE to treat adults with this condition.
However, in 2012 NICE said it planned to rescind this recommendation as new evidence that had subsequently been published meant the drug was not a cost-effective option in allergic asthma.
Novartis argued its case and managed to get NICE to uphold its original recommendation, although only after offering the drug at a discount through a patient access scheme.
NICE then published further guidance in 2013 that recommended Xolair as an option for treating severe allergic asthma in adults, adolescents and children, bringing together previous recommendations across different age groups, again with a patient access scheme.
A similar access scheme is an option for Novartis if it wants to pursue a NICE recommendation for Xolair as a treatment for chronic hives if the agency is unsatisfied with the company’s answers to its questions.
In any case Novartis has until Monday December 9 to submit any extra information to NICE to support the use of Xolair in this indication before final guidance is published.