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The National Institute for Health and Care Excellence (NICE) has recommended a new treatment option for adults with highly active relapsing-remitting multiple sclerosis (RRMS) for use on the NHS in England.
In final guidance, published on 2 January 2025, NICE approved natalizumab, a monoclonal antibody that can be given by injection or infusion, for adults with RRMS who have not responded to a “full and adequate course” of at least one disease-modifying therapy and for whom an alternative NICE-recommended drug, cladribine (Mavenclad; Merck), is not suitable.
The drug is recommended in the originator form (Tysabri; Biogen) as an injection and in the biosimilar form (Tyruko; Sandoz) as an infusion, meaning that they must be funded in England within 90 days of the guidance’s publication.
However, NICE has not recommended Tysrabi as an infusion, as it says this formulation does not represent value for money.
NICE had previously not recommended the drug in any form for highly-active RRMS.
In draft guidance, published in March 2025, NICE said that while natalizumab was already recommended for rapidly evolving, severe RRMS, the evidence at the time did not suggest it was value for money for the highly active version of the disease.
In its final guidance, NICE said: “The committee concluded that there were uncertainties in the cost-effectiveness evidence.
“But, when also considering uncaptured benefits, natalizumab (subcutaneous originator and intravenous biosimilar) were cost-effective treatments when the characteristics of the person and the activity of their MS mean that cladribine is not suitable. But natalizumab (intravenous originator) was not.”
Uncaptured benefits include that natalizumab is safe to use during pregnancy, whereas all other treatments for highly active RRMS come with pregnancy safety warnings, NICE added.
Helen Knight, director of medicines evaluation at NICE, commented: “This recommendation means people living with highly active RRMS now have a meaningful additional treatment option.
“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.”
Commenting on the NICE decision, Ceri Smith, MS Society head of policy, 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 [disease-modifying therapies] 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 [disease-modifying therapies].”
