NICE recommends natalizumab, including a lower-cost biosimilar, as a new MS treatment for adults with highly active relapsing-remitting multiple sclerosis, expanding options for thousands of patients
The National Institute for Health and Care Excellence (NICE) has recommended a new treatment option for adults with highly active relapsing‑remitting multiple sclerosis (MS), potentially benefiting thousands of people across the UK. The guidance includes natalizumab, available as both the original drug Tysabri and a lower‑cost biosimilar, Tyruko, giving clinicians and patients greater choice when standard therapies are no longer effective. This move marks a significant expansion in MS care, especially for those with persistent disease activity despite prior treatment.
What do these new MS treatment options really mean for patients?
Tysabri, developed by Biogen, is administered by injection, and Tyruko, made by Sandoz, is 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 Tyruko is a biosimilar, a newer version of the drug that works in the same way as the original.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.
This new recommendation means that people with highly active relapsing-remitting MS can access an additional treatment option, allowing patients and clinicians to choose the most suitable drug.
MS affects 123,000 people and is around three times more common in women than men. In MS, immune system cells called T and B cells, which typically fight viruses and bacteria, instead attack myelin. This leads to pain, mobility problems, and cognitive impairment. Highly active relapsing-remitting MS is a disease that continues to cause relapses or show signs of activity despite a full course of treatment that delays, slows, or reverses disease progression by targeting its underlying cause.
How natalizumab works and what experts are saying
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. Additionally, it offers various benefits for people at risk of further relapses, such as in people with a large lesion load or enhancing lesions on imaging.
“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,” commented Helen Knight, director of medicines evaluation.
Helen continues, “Our ‘whole lifecycle’ approach means that when more affordable versions of treatments become available, we can revisit medicines and widen access. It’s an example of smarter spending in action — better outcomes for patients and better value for the NHS.”
“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. Our decision will particularly benefit people who want to start a family as natalizumab can be taken during pregnancy, unlike other highly effective DMTs,” added Ceri Smith, Head of Policy at the MS Society.
“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 delay, meaning that they and their clinicians can choose the most suitable option for them,” said Professor Ruth Dobson, Centre Lead for the Centre of Preventive Neurology at the Wolfson Institute of Population Health, QMUL.
