News
Open Door - November 2011 page 3
NICE guidance on fingolimod
In August, NICE (National Institute for Health and Clinical Excellence) issued draft guidance to not recommend fingolimod (Gilenya).
Fingolimod is an oral drug licensed for people who continue to have relapses despite treatment with one of the current disease modifying drugs or who have rapidly evolving severe relapsing remitting MS - two or more relapses a year.
The second NICE appraisal committee met in October to consider responses to the draft recommendation, including those from the MS Trust.
The MS Trust stressed the need to understand the impact of relapses, highlighted that best supportive care (management not using drugs) is not comparable to disease modification with drug therapy, and the importance of providing additional treatment options, particularly to those who are unable to tolerate current treatments.
The committee were sensitive to the impact and challenges of living with MS and took the unusual step of asking clinical experts to attend for a second time to discuss further the issues around living with MS. The committee noted the views of the many clinical experts and discussed the personal evidence submitted by people with MS.
The final decision from NICE is expected at the start of 2012.
NICE Guideline review
NICE has set the timetable and started recruiting members of its guideline development group who will start reviewing the MS clinical guideline next year. Originally issued in 2003, the guideline sets the benchmark for best practice in delivery of MS services in England and Wales. The new review, which is expected to take several years, will take account of changes in diagnosis and treatment.
NICE consultation on CCSVI
Following a review of the evidence, NICE has issued draft recommendations on the use of percutaneous venoplasty for CCSVI (chronic cerebro-spinal venous insufficiency). The recommendation is that treatment should only be offered as part of structured clinical trials, ideally using 'sham venoplasty' as the comparator.
The MS Trust responded to the consultation making a number of points. We agree that current evidence is weak and further research is required but we do not believe 'sham venoplasty' is a valid control. The duration of follow up needs to be sufficient to demonstrate the efficacy of treatment and measures of efficacy need to be relevant to people with MS. The research needs to be undertaken in an appropriate group of people with MS.
Final guidance is expected before the end of the year.
Tysabri blood test
A new test has been launched that allows people on Tysabri to make informed choices about their treatment.
Treatment with Tysabri has been associated with PML, a rare but serious brain infection caused by a mutation of the JC virus. The JC virus is a common virus that usually causes no symptoms but can be very serious in people whose immune system has been suppressed through medication or illness.
The new test, called Stratify JCV, shows if someone has been exposed to the JC virus. It can not identify who will get PML, but it can suggest the relative level of risk.
People on Tysabri or considering treatment, should talk to their neurologist.
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