NICE recommends wider use of Biogen MS drug via NHS

NICE has said Biogen's Tysabri can now be used by the NHS in England and Wales to treat highly active relapsing-remitting multiple sclerosis (MS), along with a lower-cost biosimilar version of the drug.

The new draft guidance (PDF) covers the use of Biogen's original Tysabri brand of natalizumab and Sandoz and Polpharma Biologics' biosimilar equivalent Tyruko, which was approved in 2023.

The document notes that either version of natalizumab can be used in patients with highly active relapsing-remitting MS who have not responded to a full and adequate course of at least one other disease-modifying therapy and are unsuitable for treatment with Merck KGaA's oral therapy Mavenclad (cladribine), which was recommended for wider NHS use in this form of MS last year.

Cladribine cannot be used during pregnancy, for example, and natalizumab will particularly benefit patients with this form of MS who want to start a family. Previously, the reimbursement authority only recommended it for people with more severe relapsing remitting MS, known as rapidly evolving severe MS.

"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," said Emily, who was diagnosed with relapsing remitting MS in 2015 and took part in the NICE appraisal process as a patient expert.

"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."

Also formulated as an intravenous infusion, Tysabri can be used in a subcutaneous injection for highly active relapsing-remitting MS, with Tyruko as an IV alternative. The IV formulation of Biogen's drug is not covered by the guidance on cost-effectiveness grounds.

MS is a debilitating neurological condition affecting the brain and spinal cord, causing severe pain, fatigue, cognitive issues, and vision problems. Around 123,000 people in the UK currently live with the condition, with 43,000 of them having the relapsing-remitting form and those with highly active disease numbering in the thousands.

NICE said in a statement that the new guidance "reflects our continued work to support the adoption of biosimilar medicines in the NHS."

The guidance brings England and Wales closer into line with Scotland, which has supported restricted NHS use of natalizumab for patients with highly active disease since 2007. Northern Ireland, meanwhile, is expected to follow the NICE recommendation.

"We're glad to see NICE widen the access to natalizumab," said the MS Society. "In March 2025, NICE decided not to recommend natalizumab for anyone with highly active relapsing remitting MS," it added. "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."

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