Cladribine access expanded for people with active relapsing MS

The National Institute for Health and Care Excellence (NICE) has expanded access to Mavenclad (cladribine) for England and Wales.

From today, Mavenclad (cladribine) can be prescribed to adults with active relapsing remitting MS, if they would otherwise be offered highly effective disease modifying drugs (DMDs). If a person is not being offered highly effective DMDs because they plan a pregnancy, then they can also be offered cladribine.

This means that Mavenclad can be offered to people with MS as an alternative to Ocrevus (ocrelizimab) or Kesimpta (ofatumumab) in England and Wales. Cladribine is taken as two short courses of tablets, lasting for just one week each year. Many people taking cladribine do not need any further DMDs for four years. 

If your MS is not actively relapsing then you won't be affected by this news. If you are already taking Mavenclad for highly active RRMS or rapidly evolving severe MS, your prescription will not be affected. 

There is an active clinical trial on cladribine for people with progressive and advanced MS in the UK. Results from the ChariotMS trial are expected by the end of 2027. You can read more about this and other clinical trials on our MS research webpages.

A decision for Northern Ireland usually follows NICE announcements in due course. The Scottish Medicines Consortium (SMC) decide drug licencing for Scotland and have an appraisal underway. The MS Trust will be contributing to the appraisal process.

As different disease modifying drugs (DMDs) have been developed for MS over recent years, they have been licenced with different eligibility criteria. This left loopholes that made it hard for neurologists to prescribe treatments for some people with MS within NHS guidelines. Today's announcement means that some people with active relapsing MS will now have more options to choose from. For people who are unable to take some DMDs, or have side effects or breakthrough activity while taking them, this could mean that they still have a highly effective treatment option available.

MS Trust CEO, Lucy Taylor said:

Having more treatment options which work around individual lifestyles is vital to living well with MS. This is a positive step in making MS care more reactive to the individual needs of people living with the disease.

The MS Trust contributed to the NICE appraisal process, nominating clinical and patient experts and representing the views and needs of people with MS in our submission. We also attended the committee hearings so as to be able to speak up on behalf of people who might benefit from the expanded access.

Our nominated patient expert, Carla, spoke from her personal experience and brought the issues to life for the NICE committee. Here is how she prepared for the role and what it involved:

"I was very honoured to participate as the Patient Expert in the NICE committee meeting looking at expanding the criteria for Mavenclad, an MS treatment I took almost two years ago. I was equally grateful to be there alongside the MS Trust, Professor Ruth Dobson and Dr. Wallace Brownlee, and it was genuinely moving to see everyone fight so hard to demonstrate its effectiveness and potential to help thousands more if the criteria were expanded.

As a Patient Expert, I had to prepare a 'statement' which is a series of questions NICE ask, as part of the pack we all received a few weeks before the meeting. I spent a long time over this. I felt the weight of the expert role and I wanted to do it justice. After all, there aren't many opportunities to make impacts of this kind. This was made a little more worthwhile when the NICE liaison told me mine was the one of the most thorough they had seen!

Participating as the Patient Expert as a panel member was eye-opening, if exhausting, but the outcome was far better than I could have hoped. Expanded criteria will mean potentially thousands of people will have a wider choice of treatment options and potentially better health outcomes. 

MS doesn't give you much of a choice. It's an unwanted tenant and one that has outstayed its welcome. So, when there is an opportunity to raise your voice and make it count, you surely grab it! Despite the panel meeting lasting an unusual four hours, I desperately held on, and I am so glad I did as it felt empowering having the final word at the meeting. Hearing the positive outcome recently has made it all worthwhile. 

I don't know what my future following Mavenclad will hold, but it feels good to be heard as someone with lived experience."

If you'd like to read more about the drug development and licencing process:

Drug development process: Explains how new medications are developed and evaluated for safe use.

Drug approval process: How NICE and SMC determine whether new treatments are cost-effective for the NHS.

Drugs in development: Lists the pipeline of new MS drugs coming through clinical trials at the moment.

If you'd like to read more about Mavenclad (cladribine):

Mavenclad (cladribine) : comprehensive information about this medication, including side effects.

Jenna's treatment story: Mavenclad: Personal experience of choosing and taking cladribine.

If you would like to explore the range of DMDs available in MS:

MS Decisions: Our online tool that helps you compare disease modifying drugs for relapsing MS.

What are disease modifying drugs?: A podcast on DMDs featuring consultant neurologist Kate Petheram

Disease modifying drugs: Ask the expert: An interview with a health professional about DMDs.