NICE has recommended natalizumab, sold as Tysabri and Tyruko, as an option for certain people with hard-to-control multiple sclerosis.
The decision by the National Institute for Health and Care Excellence will allow NHS coverage of the drug in England, with decisions also influencing NHS coverage in other parts of the UK.
The guidance specifically recommends natalizumab as an option for people with relapsing-remitting MS (RRMS), a form of the condition characterised by flare-ups and periods of remission, whose disease remains highly active after a full course of at least one disease-modifying therapy, and for whom the oral MS therapy Mavenclad is not suitable.
Helen Knight, director of medicines evaluation at NICE, said: “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.”
“Our ‘whole lifecycle’ approach means that when more affordable versions of treatments become available, we can look again at medicines and widen access. It’s an example of smarter spending in action, better outcomes for patients and better value for the NHS.”
In MS, immune cells enter the brain and cause inflammation that damages healthy brain cells. Natalizumab is a disease-modifying therapy designed to slow MS progression by stopping inflammatory immune cells from getting into the brain.
The decision specifically applies to a subcutaneous, or under-the-skin, formulation of Tysabri, the name-brand medication marketed by Biogen. It does not cover the intravenous formulation of Tysabri.
The recommendation also covers Tyruko, a biosimilar of Tysabri that is given by infusion into the bloodstream and is sold by Sandoz. Biosimilars are medicines that work in the same way as branded biologics and are usually cheaper.
NICE had already recommended Tysabri for rapidly evolving severe RRMS, referring to patients who have had two or more relapses in the previous year and who have MRI evidence of overt disease activity.
Ceri Smith, head of policy at the MS Society UK, said: “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.”
Smith said the recommendation “will particularly benefit people who want to start a family as natalizumab can be taken during pregnancy, unlike other highly effective DMTs.”
Ruth Dobson, centre lead for the Center of Preventive Neurology at the Wolfson Institute of Population Health, said the recommendation “is welcome news for the thousands of people who have breakthrough MS activity on treatment.”
She added that these individuals “now have access to a wider range of treatments without needing to wait, meaning that they and their clinicians can choose the treatment that is most suitable for them.”
Because natalizumab increases the risk of progressive multifocal leukoencephalopathy, a rare and potentially life-threatening brain infection, the NICE guidance suggests that patients should be tested for the virus that causes the condition before and during treatment.
