The National Institute for Health and Care Excellence has issued new final draft guidance recommending natalizumab as a treatment option for certain people in England with hard-to-control relapsing-remitting multiple sclerosis. The decision determines which medicines are funded by the NHS in England and often influences access across the UK.
Under the new guidance, natalizumab is recommended for adults with relapsing-remitting MS whose disease remains highly active despite completing a full course of at least one disease-modifying therapy, and for whom cladribine is not suitable. Relapsing-remitting MS is characterised by episodes of new or worsening neurological symptoms followed by periods of partial or complete recovery.
NICE has specified that the recommendation applies to the subcutaneous formulation of natalizumab marketed as Tysabri, the name-brand medication marketed by Biogen, but not to the intravenous formulation of the branded drug. The guidance also includes Tyruko, a biosimilar version of natalizumab administered by intravenous infusion sold by Sandoz. Biosimilars are designed to be clinically equivalent to existing biologic medicines and are typically offered at a lower cost, supporting wider NHS access.
According to NICE, the updated recommendation reflects its aim to increase patient choice while ensuring value for money for the health service. The availability of more affordable treatment options has enabled a reassessment of natalizumab’s role in the management of highly active disease.
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Natalizumab is a disease-modifying therapy that works by preventing inflammatory immune cells from crossing into the brain and spinal cord, thereby reducing inflammation and slowing disease progression. NICE already recommends natalizumab for people with rapidly evolving severe relapsing-remitting MS, defined by frequent relapses and MRI evidence of active disease.
Patient organisations and clinical experts have welcomed the decision, highlighting that it expands treatment options for people who continue to experience disease activity despite existing therapies. The guidance may be particularly relevant for individuals planning a family, as natalizumab can be used during pregnancy in some circumstances.
Because natalizumab is associated with an increased risk of progressive multifocal leukoencephalopathy, NICE advises testing for the causative virus before starting treatment and during ongoing therapy.
This news item has been summarised using AI and checked by humans before publication.
Sources
National Institute for Health and Care Excellence
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