pharmiweb.com today archive

In its final draft guidance, NICE, the healthcare guidance body outlines its plans to recommend fingolimod, the first pill-based medicine to help reduce the number of relapses for some adults who have a particular type of multiple sclerosis. This positive recommendation is a change from NICE's previous draft guidance from December and follows a public consultation during which the manufacturer (Novartis) and clinicians provided additional information and analyses.

The draft document (called a final appraisal determination) 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.

Specifically, NICE provisionally recommends the treatment for adults who have an unchanged or increased relapse rate or ongoing severe relapses compared to the previous year, despite them taking other drugs such as beta interferons. The provisional recommendation relates to a subgroup of the population for which fingolimod is licensed.

Professor Carole Longson, Director of the Health Technology Evaluation Centre at NICE said: "The latest draft guidance from our committee recommends the NHS-use of fingolimod for a specific group of adults who have highly active relapsing-remitting multiple sclerosis.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"We have published the latest version of our draft guidance on our website so that interested parties can highlight any factual errors or appeal against our final draft recommendations."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 Press Release