(Reuters) - Novartis's multiple sclerosis pill Gilenya, one of its biggest new drug hopes, has been rejected by healthcare cost-effectiveness watchdog NICE, which judges it not worth using on the state health service.
The National Institute for Health and Clinical Excellence (NICE) said on Friday there were uncertainties over Gilenya's clinical effectiveness and, based on the available evidence, prescribing it would not be a cost-effective use of resources.
Gilenya, which was licensed in Europe in March, represents a significant change in multiple sclerosis (MS) treatment, since existing drugs such as beta interferons and Elan and Biogen Idec's Tysabri must be injected.
Although it was cleared by regulators for people with highly active relapsing-remitting disease, NICE said it was not clear if the drug, which is known generically as fingolimod, was any better than existing treatments.
NICE said Novartis should have submitted comparisons with both beta interferons and Tysabri, rather than just against placebo.
"Unfortunately, our independent committee wasn't given sufficient evidence to show that fingolimod could reduce relapses considerably better than the other treatments currently being used," said Carole Longson, director of NICE's health technology evaluation centre.
Friday, August 05, 2011
NICE says No to Novartis MS pill | Reuters
via uk.reuters.com
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