UK's NICE turns down Novartis MS drug Gilenya in draft guidance

In provisional draft guidance published last Friday, UK drugs watchdog the National Institute for Health and Clinical Excellence (NICE) said it does not recommend that Swiss drug major Novartis’ (NOVN: VX) Gilenya (fingolimod), licensed to treat people who have a particular type of multiple sclerosis, should be prescribed on the National Health Service. This is because there are uncertainties over its clinical effectiveness and, based on the available evidence, it would not be a cost effective use of NHS resources, the NICE stated.

While clinical trials have shown that Gilenya can reduce the number of relapses in some people who have highly active relapsing-remitting multiple sclerosis (RRMS), it is unclear how much the drug may help the specific groups of people for whom it is licensed, ie, adults with RRMS who experience at least one relapse in a year despite being treated with beta interferons, and adults with rapidly evolving severe RRMS who experience two or more disabling relapses regardless of their treatment. The evidence submitted by Novartis mainly looked at a subgroup of the former, the agency said.

As well as this, the NICE's independent committee of experts could not determine how much fingolimod reduces the rate of relapses compared with some of the treatments already available. This is because Novartis only submitted evidence which compared fingolimod with a placebo, and fingolimod with a specific type of a beta interferon (beta interferon 1a, Biogen Idec’s Avonex) that is not believed to be widely prescribed in the NHS.