NHS England has agreed that Mayzent (siponimod) can be prescribed for people with active secondary progressive multiple sclerosis (MS) whose MS has progressed despite taking a disease modifying drug (DMD).
This is in addition to the existing eligibility criteria which allow you to be prescribed Mayzent if you have secondary progressive MS but you are still experiencing relapses, or if your MRI scan shows signs of new or growing areas of damage (lesions). This is described as active secondary progressive MS.
Many people initially diagnosed with relapsing remitting MS notice that, over time, they have fewer relapses and increasing disability, such as walking difficulties, poor balance and coordination, bladder and bowel problems. This is called secondary progressive MS (SPMS).
The change from relapsing remitting to secondary progressive MS is gradual so people often continue taking the DMD they were prescribed for relapsing remitting MS. The DMD masks signs of active SPMS because it prevents relapses and reduces the number of lesions on MRI scans. So, in order to meet the previous criteria, you would have to stop taking your DMD and wait to have a relapse or an MRI scan with signs of new MS activity before you could start Mayzent.
The expanded criteria means that you may now also be eligible for Mayzent if you have secondary progressive MS and you have had progression (increased disability) for at least 6 months, unrelated to relapses, and while taking a disease modifying drug. Progression is defined as 1 point increase in EDSS if your score was initially less than 6 or a 0.5 point increase if your EDSS was initially 6. An EDSS of 6 indicates that you need to use a walking stick to walk about 100 metres.
Eligibility criteria are unchanged in Scotland, Wales and Northern Ireland. For more information, contact your local MS team.
Mayzent is the brand name for siponimod. It is taken as a tablet, once a day.
In clinical trials for secondary progressive MS, Mayzent delayed disability progression by 26% compared to placebo. Further analysis focussed on people who had relapsed in the two years before starting the trial or showed MS activity on MRI scans. For this active SPMS subgroup, Mayzent delayed disability progression by 37% compared to placebo. This slowing down of progression has the potential to delay the need for a wheelchair by 4.3 years.
In addition to its effect on disability progression, Mayzent can improve aspects of memory and thinking (cognition) through an improvement in the speed at which the brain processes information.
Common side effects include: headache, high blood pressure, and increased levels of liver enzymes which can be a sign of damage to the liver. Cases of basal cell carcinoma, a slow-growing skin cancer, and macular oedema (swelling in the back of the eye affecting vision) have been reported in people taking Mayzent.
See our webpage for more information about Mayzent.
We've reported on Mayzent (siponimod) as it passed through clinical trials and the licencing process. Here are the major milestones on the journey so far.
October 2020
Siponimod approved by NICE (National Institute for Health and Care Excellence) for use in England and Wales, and by the Scottish Medicines Consortium (SMC) for use in Scotland.
June 2020
NICE rejects siponimod for active SPMS. The MS Trust challenges this recommendation, making the case for treatment options in SPMS.
January 2020
European Commission grants marketing licence for siponimod for active SPMS.
November 2019
The European Medicines Advisory (EMA) recommends a licence be granted for siponimod. The MS Trust collects the views of people with MS to create a considered response to the NICE appraisal.
August 2019
MS Trust invites people living with MS to comment on their experiences of SPMS, current NHS care and thoughts on siponimod.
