Fingolimod, the first ever MS (multiple sclerosis) pill, will soon be recommended by the UK’s National Institute for Clinical Excellence (NICE). NICE is a UK government body which decides which therapies should be covered by the National Health Service, the country’s universal health care system. Fingolimod, brand name Gilenya, is made and marketed by Swiss pharmaceutical giant, Novartis.

In its final appraisal determination (final draft guidance), issued on 16th March, 2012, NICE lays out its plans to recommend the usage of Gilenya pills for the treatment of highly active RRMS (relapsing-remitting multiple sclerosis). This reverses a previous recommendation in December 2011, after Novartis provided extra clinical data. Since December NICE also carried out a public consultation.

In a communiqué, NICE wrote:

“(NICE) recommends fingolimod (Gilenya) as a treatment option for some adults who have highly active relapsing-remitting multiple sclerosis (RRMS); this is a type of the condition characterised by periods when symptoms worsen and then improve”

The provisional recommendation is for treating adults with unchanged or increased relapse rates, as well as those with ongoing severe relapses, compared to symptoms during the previous year (even if they took other medications, including beta interferons).

Professor Carole Longson, Director of the Health Technology Evaluation Centre at NICE wrote:

“The latest draft guidance from our committee recommends the NHS-use of fingolimod for a specific group of adults who have highly active relapsing-remitting multiple sclerosis. Following new information provided during the consultation, the analyses show that for these people, treatment with fingolimod will be a cost effective option for the NHS in this group of people with multiple sclerosis, if Novartis provides the drug at a discounted price, as proposed in its patient access scheme.

We have published the latest version of our draft guidance on our website so that interested parties can highlight any factual errors or appeal against our final draft recommendations.”

NICE announced that those who wish to appeal to its final appraisal determination (registered stakeholders) may do so up to Friday, 20th March, at 5pm. If there are no appeals, the final guidance for the NHS will be published in April 2012.

Gilenya (Fingolimod) is an oral medication for highly active RRMS. In MS, lymphocytes (white blood cells) attack and destroy nerve coating cells, resulting in symptoms of tingling, numbness, mobility and balance problems, and some problems with vision.

Fingolimod stops the lymphocytes from attacking nerve cells in the spinal cord and brain – it is a disease modifying drug.

Written by Christian Nordqvist