The MS Trust is very disappointed that Nice is unable to recommend siponimod (Mayzent) as an NHS treatment for active secondary progressive MS.
However, Nice has concluded that they are unable to recommend siponimod as a cost-effective treatment for the NHS for England and Wales without more detailed evidence and analysis of the data.
We are hugely disappointed by this initial decision. Time and time again, we hear from people with secondary progressive MS struggling at home, feeling like they have been forgotten. Just earlier this month, a new report has highlighted the significant gaps in support and services for people with SPMS. Not everybody will be eligible for siponimod, but we hope that the availability of a new treatment will lead to a renewed focus on the needs of all people with SPMS.
- David Martin, Chief Executive, MS Trust
The MS Trust is reviewing Nice’s decision and we will continue to make the strongest possible case for NHS approval.
We encourage people to add their own comments on this initial decision; you can do so via the Nice website by 5pm on Thursday 23 July 2020.
Nice will meet again to review this decision in the light of comments received and further evidence from the manufacturer; the date for this meeting has not been confirmed.
The Scottish Medicines Consortium has also scheduled an appraisal of siponimod but this is currently on hold. In Northern Ireland, the Department of Health reviews Nice guidance.
Siponimod is taken as a tablet, once a day.
In clinical trials for secondary progressive MS, siponimod reduced the risk of disability getting worse by 26% compared to placebo. Further analysis indicated a 37% reduction in the risk of worsening disability for those with active SPMS, defined as those who had relapsed in the two years prior to starting the trial or showed MRI evidence of MS activity.
In clinical trials, low white blood cell count, increased liver enzyme levels, slower heart rate when starting treatment, macular oedema (swelling in the back of the eye affecting vision), high blood pressure, shingles, and convulsions occurred more frequently with siponimod than with placebo.
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The MS Trust is delighted that ofatumumab (Kesimpta) has been approved by NICE for people with active relapsing remitting multiple sclerosis.
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Ofatumumab (Kesimpta) gets UK licence for relapsing remitting MS
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The MHRA has granted marketing authorisation for ofatumumab (Kesimpta) for active relapsing remitting MS.