Novartis's multiple sclerosis pill Gilenya, one of its biggest new drug hopes, has been rejected by Britain's healthcare cost-effectiveness watchdog, which judges it not worth using on the state health service.
The National Institute for Health and Clinical Excellence (Nice) said today 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.
The draft guidance from the agency is now open for comment until August 26th.
Despite the rebuff, Novartis said it believed Gilenya was "a highly efficacious and cost-effective treatment", adding it was committed to engaging with Nice to make sure patients got access to the medicine within Britain's National Health Service.
The MS Trust charity said it was disappointed by the NICE verdict, which would deny up to 5,500 people with MS a valuable extra treatment option that might delay severe disability.
Gilenya's convenient dosing and encouraging results in clinical trials are widely expected to make it a popular alternative to current injections. The average forecast from analysts suggests global sales will reach $2.2 billion a year by 2015, according to Thomson Reuters Pharma.
The drug does not come cheap. The annual cost of Gilenya in Britain is around £19,000 per person a year, according to Nice, which is around a third less than the price in the United States.
MS treatment has been a controversial area for Nice over the years.
While the organisation has recommended Tysabri for rapidly evolving severe relapsing-remitting MS, it caused a furore back in 2002 by rejecting the older beta interferon therapies. That rejection eventually led to a special access deal for beta interferons, negotiated between manufacturers and the Department of Health, which allows them to be offered on the state health service under certain conditions.
Gilenya is the first MS pill of its kind, but other competitors in development include teriflunomide from Sanofi and BG-12 from Biogen, as well as laquinimod from Teva Pharmaceutical Industries, which produced disappointing clinical trial results earlier this week.
Reuters
