The National Institute for Health and Care Excellence (NICE) has announced that Biogen’s drug, Tysabri, is now approved for broader use within the National Health Service (NHS) in England and Wales. This recommendation includes both the original Tysabri brand of natalizumab and a lower-cost biosimilar version, Tyruko, produced by Sandoz and Polpharma Biologics, which received approval in 2023.
The new draft guidance specifies that either version of natalizumab is suitable for patients diagnosed with highly active relapsing-remitting multiple sclerosis (MS) who have not responded adequately to at least one full course of another disease-modifying therapy. This is particularly relevant for patients who cannot receive Merck KGaA’s oral therapy, Mavenclad (cladribine), due to its contraindications, such as during pregnancy. The introduction of natalizumab provides new options for women with MS who are considering starting a family.
Previously, NICE had limited the use of Tysabri to patients with rapidly evolving severe MS, a more severe form of the disease. The extension of this recommendation to include those with highly active relapsing-remitting MS represents a significant shift in treatment accessibility.
Emily, a patient expert who participated in the NICE appraisal process, shared her experience, stating, “As a young woman whose MS was highly active, I was faced with the potential choice of a more effective treatment or having a baby. It made a huge difference talking to my MS team, who told me that I didn’t have to choose one or the other with natalizumab.”
Broader Treatment Options for MS Patients
Tysabri is administered as an intravenous infusion, while Tyruko can also be delivered via subcutaneous injection. The intravenous formulation of Biogen’s drug is not included in the guidance due to cost-effectiveness considerations. MS, a debilitating neurological condition, affects approximately 123,000 individuals in the UK, with around 43,000 living with the relapsing-remitting form, and thousands classified as having highly active disease.
In a statement, NICE emphasized that the new guidance aligns with its ongoing efforts to promote the adoption of biosimilar medicines within the NHS. This move brings England and Wales closer to Scotland, which has provided restricted NHS access to natalizumab for patients with highly active MS since 2007. Northern Ireland is also expected to adopt NICE’s recommendation.
The MS Society expressed its support for the expanded access to natalizumab, noting the importance of providing more treatment options for patients. “In March 2025, NICE decided not to recommend natalizumab for anyone with highly active relapsing-remitting MS. We told them why giving more people another option would make a difference. We’re pleased they reversed the decision based on all the evidence,” the organization stated.
The approval of Tysabri and its biosimilar version marks a significant advancement in the treatment landscape for MS, providing hope and enhanced options for patients grappling with this challenging condition.
