Thousands of NHS patients in England with multiple sclerosis (MS) are set to benefit from a life-changing ‘take at home’ tablet, as the NHS becomes the first healthcare system in Europe to roll it out widely to patients with active disease.
The tablet, cladribine, requires just 20 days of treatment spread over four years, providing a convenient alternative to existing therapies that involve regular hospital infusions, frequent self-injections, and extensive monitoring.
Patients planning a pregnancy can also safely conceive in years three and four of their treatment cycle because cladribine is administered in short courses over two years.
Approved today by the National Institute for Health and Care Excellence (NICE) for patients with active relapsing-remitting MS, cladribine offers comparable clinical benefits to current treatments while significantly reducing hospital visits and clinical monitoring time.
Previously approved only for patients with more severe, highly active MS, today’s NICE decision means cladribine is now available to a much wider group of patients.
The rollout is expected to save thousands of clinical hours each year, freeing up capacity within the NHS by reducing the need for hospital appointments.
Nearly eight in ten patients taking cladribine experienced no relapses, and MRI scans showed they developed 7.5 times fewer new brain lesions compared to patients given a placebo, in clinical trials lasting almost two years.
MS is a debilitating neurological condition affecting the brain and spinal cord, causing severe pain, fatigue, cognitive issues, and vision problems. More than 150,000 people in the UK currently live with the condition.
Professor James Palmer, NHS Medical Director for Specialised Commissioning, said: “The NHS is proud to be the first healthcare system in Europe to roll out this innovative ‘take at home’ tablet widely for patients with active multiple sclerosis.
“Broadening access to cladribine means thousands more patients will benefit from managing their treatment at home rather than regularly attending hospital appointments – as well giving women with MS who want to get pregnant more flexibility to do so around their treatment.
“This decision will also significantly free up clinical time, helping clinicians see more patients and boosting NHS productivity. It’s another clear example of the NHS’s commitment to improving patient care through innovation.”
Minister for Public Health, Ashley Dalton, said: “We know that patients with neurological conditions such as multiple sclerosis face immense challenges, so I am delighted that this decision means more patients will get access to a treatment that will greatly improve their quality of life.
“By expanding access to medicines that can be taken at home, we can shift care out of hospitals and into the community, giving patients more freedom and saving the NHS money.
“This government is committed to backing researchers and our life sciences sector to develop innovative therapies, so that NHS patients are among the first to benefit from cutting-edge healthcare.”
Laura Thomas, Head of Policy at the MS Society, said: “It’s great news that NICE have recommended the disease modifying treatment (DMT) cladribine (Mavenclad) as an option for those with active relapsing remitting MS. Over 150,000 people live with MS in the UK, and many of them rely on DMTs like cladribine to help reduce MS relapses, so expanding patient choice is vital.
“Cladribine is self-administered, so this decision could particularly benefit people who’d struggle to go into hospital regularly, like younger working-age adults. It will also benefit patients considering starting a family, as it’s safe to get pregnant six months after the final course of treatment – which is less restrictive than many other DMT options. We’re so glad that more people with MS will now be able to choose an effective treatment which suits their lifestyle.”
Cladribine tablets, developed by pharmaceutical company Merck, join other NHS-adopted time-saving innovations such as injectable atezolizumab and injectable Phesgo, two cancer medicines that have reduced clinical workloads, improved patient experience, and boosted NHS productivity.
It is estimated about 2,000 patients could be offered the treatment over the first three years.
This rollout builds on recent NHS successes, including delivering an extra 2.2 million planned appointments between July and November 2024 — achieving the government’s productivity ambition seven months ahead of schedule.
Clare Elgar, 37, from Southampton was diagnosed with relapsing MS in January 2021 after experiencing loss of function in her right arm and numbness across her face. Her MS causes a range of symptoms including tingling and heavy legs. She took a course of cladribine for her highly active MS.
Clare says: “I truly believe that cladribine has been the key to my MS stabilising, and since starting the treatment in 2021, I’ve experienced no relapses. Being able to take the treatment at home meant I could maintain my day-to-day routine and not have to travel to hospital. I’m thrilled that the new criteria will now give others like me the opportunity to benefit from this life-changing medication. I’m beyond excited to know that more people will have the chance to share in this success and lead a much better life with MS.”
Dr Stuart Hill, Medical Director at Merck UK & Ireland, said “We are pleased that NICE has recognised the benefit of cladribine and that more people living with the impact of RRMS are able to access this first-line treatment. We look forward to the final NICE guidance and remain committed to supporting people living with MS to live fuller, more independent lives.”
