Regulatory Focus™ > News Articles > UK: First Oral Therapy for MS Gets NICE Approval

UK: First Oral Therapy for MS Gets NICE Approval

Posted 25 April 2012 | By Louise Zornoza

In final guidance released 24 April, the UK's National Institute for Clinical Exellence (NICE) recommends that the National Health Service provide Novartis' fingolimod (Gilenya) as long as it gets a special NHS discount from the manufacturer. 

Fingolimod is the first pill-based medicine to help reduce the number of relapses for some adults who have highly active relapsing-remitting multiple sclerosis (RRMS) - only if Novartis provides the drug at a confidential discounted price.

"We are pleased to recommend fingolimod as a treatment option for the specific patient population for whom it has been demonstrated to be cost effective, providing Novartis applies its proposed discount," said Professor Carole Longson, NICE's Director of the Health Technology Evaluation Centre in a statement. "Multiple sclerosis can be a disabling condition and so we hope that this novel treatment will help to reduce relapses for these people."

NICE says the drug can be used for adults with RRMS who have an unchanged or increased relapse rate, or ongoing severe relapses in comparison with the previous year, despite taking beta interferons. 

NICE also says that people with RRMS who currently receive fingolimod, but whose disease does not meet these criteria, should be able to continue receiving the drug until they and their doctors decide it is appropriate to stop.

Multiple sclerosis is a condition where white blood cells attack the coating of nerve cells which help messages from the brain travel to the rest of the body.

The most common form of this condition is relapsing-remitting multiple sclerosis (RRMS), where symptoms come and go, and periods of good health are followed by a sudden onset of symptoms.

Around 27,500 people in England and Wales are thought to have RRMS, which is normally treated through injection.

Read more:

NICE - Gilenya Decision

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