Gilenya - pill for relapsing-remitting multiple sclerosis recommended by NICE

By Dr. Ananya Mandal, MDMar 19 2012

In a new development at least 3,000 people in the UK with multiple sclerosis (MS) could benefit from the world's first pill for the condition.

The National Institute for Health and Clinical Excellence (Nice) issued new draft guidance recommending fingolimod (brand name Gilenya) on the NHS for some patients with a form of MS. The new drug can help reduce the number of relapses in adults with highly active relapsing-remitting multiple sclerosis (RRMS), which is characterized by periods when symptoms worsen and then improve.

The guidance, which is in its final draft form but has not yet been issued to the NHS, relates to people who have experienced an unchanged or increased relapse rate, or ongoing severe relapses, compared to the previous year. This is despite them taking other drugs such as beta interferons.

Nice's new guidance reverses a previous version issued in December and follows extra information provided by doctors and the drug manufacturer, Novartis, agreeing to a discount scheme. Professor Carole Longson, director of the health technology evaluation centre at Nice, said, “The latest draft guidance from our committee recommends the NHS use of fingolimod for a specific group of adults who have highly active relapsing-remitting multiple sclerosis.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.”

The MS Society estimates around 3,000 patients in the UK could benefit, although it says the figure could be higher. Multiple sclerosis, or MS, affects about a 100,000 people in the UK but until now, patients have had to be treated with injections.

In MS, white blood cells attack the coating of the nerve cells which help messages from the brain travel to the rest of the body. As these cells are damaged, people experience symptoms such as numbness and tingling, blurred vision, mobility and balance problems, and muscle weakness and tightness. Fingolimod works by preventing the white blood cells from attacking nerve cells in the brain and spinal cord. The drug costs almost £20,000 per patient per year but is expected to be lower under the discount scheme.

Nick Rijke, director of policy and research at the MS Society, said, “We are delighted; this decision signifies a major step forward in the treatment of this devastating condition. Gilenya has been found to be highly effective in trials and taking a daily tablet will come as welcome relief from frequent, often unpleasant, injections. Making this new treatment available will increase patient choice for thousands of people with MS across England and Wales, but we're deeply disappointed by the Scottish Medicines Consortium's decision in Scotland - and urge them to reconsider.”

Consultant neurologist Dr Eli Silber and MS patient Elizabeth Kinder say the pill brings several benefits.