News - May 2012
Open Door - May 2012 page 3
- Fingolimod - yes in England and Wales, no in Scotland
- Fingolimod safety review
- NICE review MS guideline
- Information needs research
Fingolimod - yes in England and Wales, no in Scotland
NICE (National Institute of Health and Clinical Excellence) has approved the prescribing of fingolimod (Gilenya) on the NHS in England and Wales.
Fingolimod is a disease modifying drug that is taken by mouth as a capsule and is approved for people with highly active relapsing remitting MS who continue to have relapses despite treatment with one of the beta interferon drugs (Avonex, Betaferon, Extavia or Rebif).
The MS Trust has been an active contributor to the review process and welcomes this decision by NICE. Fingolimod is an important addition to the range of disease modifying therapies for relapsing remitting MS. It is crucial now that neurologists are able to prescribe fingolimod without local restriction or rationing.
The approval by NICE in March came days after the SMC (Scottish Medicines Consortium), which serves a similar function to NICE, announced that they do not recommend the drug for use within Scotland, stating that there was insufficient evidence of cost effectiveness. The manufacturer (Novartis) plans to submit further evidence.
Fingolimod safety review
In January, the EMA (European Medicines Agency) began a review of fingolimod following the death of someone within 24 hours of receiving their first dose of the drug. The review is also considering ten other cases of people who have died whilst taking fingolimod. Although fingolimod is known to cause temporary changes in heart rate and blood pressure in some people, it is not yet clear if any of these deaths are associated with the drug. In the interim, new guidance has been issued on monitoring people during the first dose of fingolimod. The EMA review was expected to be finalised by April 2012.
NICE review MS guideline
In April, the MS Trust was present at a meeting to decide on the scope of the revised NICE clinical guideline Management of multiple sclerosis in primary and secondary care. The guideline reviews published evidence to describe a reasonable level of care that people with MS across England should expect. Since the guideline was originally issued in 2003, there have been a number of developments, including revised criteria for diagnosing MS, fatigue management and cognitive training programmes and functional electrical stimulation. The guideline does not cover disease modifying drugs but new treatments for symptoms, such as spasticity, memory and walking, may be considered. The revised guideline is expected to be published in 2014.
Information needs research
The research project on the information needs and preferences of people newly diagnosed with MS, mentioned in the previous issue of Open Door, has got off to a great start. 190 people volunteered to give their views and the researchers are talking to people with all types of MS as well as some family members.
It is clear that people who are newly diagnosed have very diverse information needs. Some want to know as much as possible, while others are more cautious about what they might learn while they are still coming to terms with their diagnosis. Most people want both medical information and information to help them live their lives as fully as possible. The tone is important too, and several people have told us they don't only want to hear doom and gloom and they really value information on what they can do to help themselves.
When the research is complete, there will be more news in Open Door and the report will be widely available.
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