The UK health watchdog National Institute for Health and Care Excellence (NICE) last week recommended natalizumab as a new treatment option for adults with relapsing remitting multiple sclerosis (RRMS) whose disease remains highly active despite at least one prior disease-modifying therapy and who are not suitable candidates for cladribine.
The decision expands treatment choice for a subset of MS patients who have limited options despite prior therapy, and it marks another step in NICE’s broader effort to use biosimilars to widen access while managing NHS drug spending.
Under the guidance, NICE has endorsed two versions of natalizumab: Tysabri, the originator product marketed by Biogen, and Tyruko, a biosimilar developed by Sandoz. Tysabri can be administered either as a subcutaneous injection or an infusion, while Tyruko is given as an intravenous infusion every four weeks.
NICE said the recommendation gives clinicians and patients greater flexibility to tailor treatment based on individual clinical needs, lifestyle considerations, and risk profiles, an important factor in a lifelong neurological disease with highly variable progression.
Multiple sclerosis affects around 123,000 people in the UK, with relapsing-remitting disease accounting for roughly 43,000 patients at any given time. Thousands of those patients are estimated to have highly active disease, defined by ongoing relapses or radiological activity despite standard disease-modifying therapies.
In MS, immune T and B cells mistakenly attack myelin, the protective sheath surrounding nerve fibers in the brain and spinal cord. This leads to inflammatory lesions, progressive neurological damage, and symptoms that can include fatigue, pain, mobility impairment, and cognitive decline. Natalizumab works by blocking immune cells from crossing the blood–brain barrier, preventing them from entering the central nervous system where they would otherwise cause damage.
NICE highlighted that natalizumab can offer particular benefit for patients at high risk of further relapses, such as those with a heavy lesion burden or active inflammatory lesions on MRI imaging. Importantly, the drug can be used during pregnancy, a factor that differentiates it from some other highly effective MS therapies and may influence treatment choice for people planning to start a family.
The recommendation also reflects NICE’s “whole lifecycle” approach to medicines evaluation. As biosimilar versions of established biologics enter the market at lower cost, NICE has increasingly revisited prior decisions to reassess whether access can be broadened without compromising value for money.
“This is an example of smarter spending in action,” said Helen Knight, NICE’s director of medicines evaluation, noting that biosimilars can deliver the same clinical outcomes as originator drugs while enabling the NHS to treat more patients within existing budgets.
Patient advocacy groups welcomed the decision. The MS Society said the guidance would benefit people with breakthrough disease activity who previously faced limited options or delays in accessing alternative therapies. Clinicians also emphasized that earlier access to highly effective treatment can reduce long-term disability and improve quality of life.
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The decision reinforces the growing role of biosimilars in neurology, an area historically dominated by high-cost biologics. By recommending both the originator and biosimilar natalizumab products, NICE avoids forcing a single option while still encouraging price competition, an approach that could influence future appraisals in MS and other chronic immune-mediated diseases.
The guidance follows a string of recent NICE decisions expanding access to biosimilar and generic medicines across oncology and urology, underscoring a policy shift toward maximizing patient reach as more affordable alternatives emerge.
