Siponimod (Mayzent) approved for active secondary progressive MS in England and Wales

14 October 2020

The MS Trust is delighted that siponimod (Mayzent) has been approved by NICE for people with secondary progressive MS who continue having relapses or show signs of MS activity on MRI scans.

Siponimod is the first oral treatment for active secondary progressive MS.

What is 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 and people may continue having relapses or show signs of new and active lesions on MRI scans while at the same time their disability increases. This is described as active secondary progressive MS.

About siponimod

Siponimod is taken as a tablet, once a day.

In clinical trials for secondary progressive MS, siponimod delayed disability progression by 26% compared to placebo. Further analysis focussed on a subset with active SPMS – people who had relapsed in the two years before starting the trial or showed MS activity on MRI scans. For the active SPMS subgroup, siponimod delayed disability progression by 37% compared to placebo.

In addition to its effect on disability progression, siponimod can improve aspects of memory and thinking (cognition) through an improvement in the speed at which the brain processes information.

Side effects which have occurred more frequently in people taking siponimod include: 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.

What does this mean for people with MS?

The approval of siponimod (Mayzent) marks a significant advance in the treatment of progressive MS.

But we know this is just the start. More treatments for progressive MS are still desperately needed, and the MS Trust will continue to fight to ensure everyone with MS can access the treatments they need.

At the moment there are few options for someone whose MS is changing from relapsing remitting to secondary progressive, so this approval is very welcome and a big step forward. By slowing down disability progression and improving cognition, siponimod has the potential to allow people to carry on working, remain independent and stay connected with family and friends. More broadly, we hope that the availability of this new treatment will lead to a greater focus on services for progressive MS which would benefit a much wider group of people.

- David Martin, Chief Executive Officer, MS Trust

This is fabulous news. While many of us won't meet the criteria, it is a game-changer for some and hopefully signals the start of more treatments for all with SPMS.

- Caroline, person with SPMS

The MS Trust played an integral part in the NICE appraisal. Before preparing our submission, we conducted a survey to gather the views of those affected by SPMS. Nearly 400 people shared their experiences and views, allowing us to give a compelling account of the challenges of living with secondary progressive MS and make a strong case for this new treatment. Thank you to everybody who shared their experiences.

Following an approval from NICE, the NHS will have two months in Wales and three months in England to prepare for prescribing the drug. After that it is expected that the NHS will fund the treatment if a doctor feels it is appropriate.

This announcement reverses NICE’s decision earlier this year to reject siponimod. NICE requested more detailed evidence and analysis of the data and is now satisfied that siponimod is cost-effective and can be prescribed by the NHS in England and Wales.

Earlier this week, the Scottish Medicines Consortium also approved siponimod for active SPMS.

In Northern Ireland, NICE guidance is generally accepted once it has been checked by the Department of Health for any policy and financial consequences.