NICE says initial 'no' to MS drug
19th February 2014 – A multiple sclerosis (MS) charity says it is disappointed that the NHS spending watchdog does not intend to recommend that dimethyl fumarate be made available on the NHS in England and Wales.
Draft guidance from the National Institute for Health and Care Excellence (NICE) is calling on the manufacturer to provide detailed evidence that the medication is cost-effective compared with other comparable treatments.
Dimethyl fumarate – also known as BG-12, or by its brand name Tecfidera – is a tablet developed for treating relapsing remitting MS. It is manufactured by US biotechnology firm Biogen Idec.
Positive trial results
It is not known exactly how BG-12 works but studies have demonstrated that it has an anti-inflammatory effect. This may be helpful in preventing the inflammation that causes damage in the brain and spinal cord of people with MS.
Clinical trials demonstrated that BG-12 reduced the number of relapses among patients during the course of a year by up to 53% compared with those taking a placebo. This compares with beta interferons and glatiramer acetate which reduce the number of relapses by about one third compared to placebo.
The medication was granted a licence by the European Medicines Agency earlier this month.
Value for money
In a statement, Sir Andrew Dillon, chief executive of NICE, says: "When reviewing the evidence for dimethyl fumarate, the Appraisal Committee concluded that there were still questions to be answered about the clinical and cost effectiveness of the drug for adults with relapsing-remitting multiple sclerosis. This is why we have requested more details from the manufacturer; we want to ensure that we have as much information as possible to make an informed final recommendation."
Reacting to the decision in a statement, Amy Bowen, director of service development at the MS Trust, says: "The MS Trust is very disappointed that dimethyl fumarate has not been approved as a treatment for the NHS in England and Wales.
"People with relapsing remitting multiple sclerosis currently have limited treatment options. The committee heard from both clinical and patient experts about the importance of access to a range of medicines, particularly for those who are unable to tolerate current treatments.
"We remain hopeful that NICE will reconsider its draft guidance, but it is very frustrating that, yet again, access to an effective new treatment for people with relapsing remitting MS remains uncertain."
Comments on the draft recommendation can be made up until 12th March 2014.