Natalizumab now recommended in England to treat hard-to-control MS
NICE decision will allow NHS coverage of Tysabri, Tyruko for relapsing-remitting MS
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- The National Institute for Health and Care Excellence in England has recommended natalizumab, sold as Tysabri and Tyruko, to treat hard-to-control MS.
- The approved medication is indicated for people with highly active relapsing-remitting MS that's unresponsive to other therapies.
- The NICE recommendation will allow NHS coverage of the medication in England.
The National Institute for Health and Care Excellence (NICE) in England is recommending natalizumab — sold as Tysabri and Tyruko — as an option for certain people with hard-to-control multiple sclerosis (MS).
NICE is responsible for deciding which medicines will be covered by the National Health Service (NHS) in England, with decisions also influencing NHS coverage in other parts of the U.K.
The new final draft guidance specifically recommends natalizumab as an option for people with relapsing-remitting MS (RRMS) — characterized by periods of new or worsening symptoms interspersed with periods of remission —whose disease remains highly active after a full course of at least one disease-modifying therapy, and for whom the short-course oral MS therapy Mavenclad (cladribine) is not suitable.
“This recommendation means people living with highly active relapsing-remitting MS now have a meaningful additional treatment option,” Helen Knight, director of medicines evaluation at NICE, said in a press release from the agency announcing the decision.
“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,” Knight added.
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, or into-the-vein, formulation of Tysabri, which is the only version of the medication approved in the U.S.
The recommendation also covers Tyruko (natalizumab-sztn), a biosimilar of Tysabri that’s given by infusion into the bloodstream and is sold by Sandoz.
Biosimilars are medications that are functionally identical to name-brand biologic medicines. Much like generic therapies for traditional medicines, biosimliars are usually cheaper than their name-brand counterparts. Tyruko is currently approved as an alternative to intravenous Tysabri in Europe and the U.S.
Recommendation gives more treatment options to people with RRMS
According to Knight, NICE is aiming to give patients more treatment options.
“Our ‘whole lifecycle’ approach means that when more affordable versions of treatments become available, we can look again at medicines and widen access,” Knight said. “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. RRMS, the most common form of the disease, is marked by relapses or flares where symptoms suddenly worsen, followed by periods of remission where symptoms ease. Natalizumab is a disease-modifying therapy (DMT) designed to slow MS disease progression by stopping inflammatory immune cells from getting into the brain.
The new recommendation for people with highly active RRMS specifically refers to individuals who continue to experience relapses or show other signs of disease activity despite a full course of at least one other treatment designed to target the underlying cause of MS.
NICE already recommended Tysabri for rapidly evolving severe RRMS — referring to RRMS patients who have experienced two or more relapses in the previous year and who have MRI evidence of overt disease activity.
Advocates call natalizumab ‘a highly effective treatment’ for MS
The decision is good news for patients, advocates say.
“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,” said Ceri Smith, head of policy at the MS Society UK.
[The NICE recommendation] 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 needing to wait, meaning that they and their clinicians can choose the treatment that is most suitable for them.
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, PhD, center lead for the Center of Preventive Neurology at the Wolfson Institute of Population Health, added that the NICE recommendation “is welcome news for the thousands of people who have breakthrough MS activity on treatment.”
According to Dobson, 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 (PML), a rare and potentially life-threatening brain infection, the NICE guidance suggests that patients should be tested for the virus that causes PML before and during treatment.
