Health news

MS charity 'disappointed' at drug rejection

5^th August 2011 - A new drug for relapsing remitting multiple sclerosis, fingolimod (Gilenya), should not get be prescribed on the NHS according to the National Institute for Health and Clinical Excellence (NICE).

One MS charity has said it is disappointed by the draft decision and is concerned about poor access to treatments experienced by people with MS.

Fingolimod

Fingolimod is a disease modifying oral medicine designed preventing the lymphocytes from attacking nerve cells in the brain and spinal cord.

Taking a daily tablet would cost the NHS around £19,196 per person.

MS is the most common neurological condition in young adults, with around 100,000 people in the UK having some form of the condition, according to the MS Society.

Uncertainties over effectiveness

NICE says clinical trials have shown that fingolimod can reduce the number of relapses in some people who have highly active relapsing-remitting multiple sclerosis (RRMS). However, it says it is not clear how much it helps the specific groups of people it is licensed for, and would not be a cost effective use of NHS resources.

Fingolimod is licensed to treat:

• Adults with RRMS who have at least one relapse a year, even though they are being treated with beta interferons.
• Adults with rapidly evolving severe RRMS who experience two or more disabling relapses regardless of their treatment.

NICE says it could not determine how much fingolimod reduces the rate of relapses compared with some of the treatments already available.

It was given evidence from the manufacturer mainly looked at a subgroup of the first group of patients. This covered fingolimod compared with a dummy treatment (placebo), and fingolimod compared with a type of a beta interferon called Avonex. NICE says Avonex is not widely used by the NHS.

NICE says fingolimod needs to be compared with other beta interferons as well as natalizumab (Tysabri).

In a statement, Professor Carole Longson, Director of the Health Technology Evaluation Centre at NICE says: "While it’s important that people with multiple sclerosis have treatment options, NICE has to ensure that the NHS provides treatments that bring benefits that are value for money. This is so that everyone who uses the NHS can receive the best care possible.

"Unfortunately our independent committee wasn’t given sufficient evidence to show that fingolimod could reduce relapses considerably better than the other treatments currently being used. Based on the available clinical evidence and economic analysis, our independent committee concluded that fingolimod would not be effective good use of NHS resources."

Reaction

Reacting to the NICE draft guidance in an emailed statement, Simon Gillespie, chief executive of the MS Society, says: "This is disappointing news for people with MS and it will leave some people with no effective treatment option.

"Access to MS treatments in the UK is very poor - in fact people with MS would be better off living almost anywhere else in Europe, and this decision will only deepen that inequality."

He wants more work to be done to provide better evidence for fingolimod: "We’re concerned at how this decision has been reached and now strongly encourage NICE and Novartis [the makers of Gilenya] to work together to look at how the treatment can be better re-considered and evaluated."

The NHS can ignore NICE guidelines. In 2002, it rejected beta interferons or glatiramer acetate for relapsing remitting MS, however the Department of Health agreed a patient access scheme with the drug manufacturers to allow NHS patients to be treated under certain conditions.  

NICE wants to hear from healthcare professionals and people who have MS to comment on the draft guidelines before it issues a final decision. Until then, local NHS organisations will have to make their own decisions about funding fingolimod.