NICE recommends new treatment option for highly active multiple sclerosis

Thousands of people living with a form of multiple sclerosis (MS) will benefit from greater treatment choice, following new guidance from NICE. 

NICE has today (Friday, 2 January) recommended the drug, natalizumab, as an option for adults with relapsing-remitting MS (RRMS) that remains highly active after a full course of at least one disease-modifying therapy, and for whom another treatment called cladribine is not suitable. 

Two versions of natalizumab are being recommended: Tysabri (the originator, made by Biogen) which can be given as an injection, and Tyruko (made by Sandoz) given as an infusion. Tyruko is a biosimilar – a newer version of the drug that works in the same way as the original. Biosimilars are medicines developed to be equivalent to existing biological treatments, offering the same clinical outcomes. 

This recommendation means that people with highly active relapsing-remitting MS now have access to an additional treatment option allowing them and their clinicians to choose the treatment that is most suitable for their individual circumstances.  

MS is a lifelong condition affecting around 123,000 people and is around three times more common in women than men. An estimated 43,000 people have RRMS at any one time and thousands of these people will have highly active RRMS. 

In MS, immune system cells called T and B cells – which normally fight viruses and bacteria – mistakenly attack myelin, the protective covering around nerves in the brain and spinal cord. This leads to damage (lesions) in the body, progressive disability and symptoms including pain, fatigue, mobility problems and cognitive impairment. 

Natalizumab works by binding to these immune cells and keeping them in the bloodstream, preventing them from entering the brain and spinal cord where they would otherwise damage nerves. It is given every four weeks as an infusion in hospital, or as an injection under the skin. 

Natalizumab offers particular benefits for people who are at high risk of further relapses, such as in people with a large lesion load or enhancing lesions on imaging.  

This recommendation reflects NICE's continued work to support the adoption of biosimilar medicines in the NHS. Biosimilars offer the same clinical outcomes as original treatments, often at lower cost, which can mean they can be recommended as cost effective for expanded patient populations while also helping the NHS spend smarter on medicines. 

Helen Knight, director of medicines evaluation, said: 

"This recommendation means people living with highly active relapsing-remitting MS now have a meaningful additional treatment option. Having choice matters enormously to people managing a lifelong condition — it allows individuals and their clinicians to select the treatment that best fits their personal circumstances. 

"Our 'whole lifecycle' approach means that when more affordable versions of treatments become available, we can look again at medicines and widen access. It's an example of smarter spending in action — better outcomes for patients and better value for the NHS.” 

Ceri Smith, Head of Policy at the MS Society, said:  

"Natalizumab is a highly effective treatment, and we're really pleased that people with highly active relapsing MS who haven't responded to previous DMT(s) will now have the option to take it. NICE's decision will particularly benefit people who want to start a family as natalizumab can be taken during pregnancy, unlike other highly effective DMTs." 

Professor Ruth Dobson, Centre Lead for the Centre of Preventive Neurology at the Wolfson Institute of Population Health, QMUL said: 

“This is welcome news for the thousands of people who have breakthrough MS activity on treatment. They now have access to a wider range of treatments without needing to wait, meaning that they and their clinicians can choose the treatment that is most suitable for them.” 

Highly active relapsing-remitting MS describes disease that continues to cause relapses or show signs of activity despite a full course of treatment that delays, slows or reverses the progression of the disease by targeting its underlying cause. 

For this appraisal, the committee evaluated natalizumab originator and biosimilar only for people with highly active RRMS. This is because NICE's appraisal for the treatment of adults with highly active relapsing–remitting multiple sclerosis already recommends natalizumab originator for people with rapidly evolving severe RRMS but not for people with highly active RRMS. 

This is the second biosimilar treatment recommendation made by NICE in the past two weeks. On 24 December NICE published final draft guidance recommending bevacizumab with chemotherapy for people with metastatic bowel cancer benefitting up to 7,000 people. In addition, in November NICE recommended abiraterone and its generic variants as an option for adults with newly diagnosed high-risk hormone‑sensitive metastatic prostate cancer, with as many as 4,000 people now able to benefit from the additional treatment option.   

Read the full final draft guidance for natalizumab (originator and biosimilar) for treating highly active relapsing–remitting multiple sclerosis after disease-modifying therapy. 

ENDS 

Notes to editors 

The natalizumab biosimilar is, by extension, recommended for the treatment of adults with rapidly evolving severe RRMS under TA127 through the NICE position statement on biosimilar technologies.