Updated NICE guidance for natalizumab

More people with relapsing remitting MS can now be prescribed the natalizumab drugs Tysabri and Tyruko.  This follows updated guidance from NICE (National Institute for Health and Care Excellence) about the use of natalizumab in MS. 

NICE recommend that natalizumab can be used as an option to treat highly active relapsing remitting MS in adults, so long as that person has tried a full course of at least one other disease modifying drug, and that cladribine (Mavenclad) is not suitable for them. 

Neurologists can now prescribe subcutaneous Tysabri or infused Tyruko for people with highly active MS but not infused Tysabri. Tysabri infusion remains a recommended option for people with rapidly evolving severe MS.

• Highly active RRMS means that MS is causing relapses and MRI activity despite the person taking a full course of effective treatment. This is known as breakthrough activity.
• Rapidly evolving severe RRMS means having two or more disabling relapses in the past year and evidence of increasing lesions in two consecutive MRI scans. 

The new guidance also recommends that people taking natalizumab should have regular JC virus antibody tests using the test specific to the brand of natalizumab being used.

Up to now, people with rapidly evolving severe MS could be prescribed natalizumab, but not people with highly active MS. People with highly active MS could not be prescribed natalizumab without stopping treatment and waiting for two relapses to occur within a year. 

People with MS and their neurologists can now decide to switch directly to natalizumab if required. 

This is particularly important for women with MS who are planning pregnancy, as natalizumab can be prescribed during pregnancy when some other highly effective disease modifying drugs cannot. This means women can protect themselves from MS relapse and be confident that the treatment is not harmful to their babies.

Natalizumab is a highly effective disease modifying drug, marketed under the brand names Tysabri and Tyruko. Tysabri is available as an infusion and as a subcutaneous (under the skin) injection. Tyruko is currently available as an infusion only.

Tyruko is known as a biosimilar medication and costs the NHS less to prescribe than Tysabri, although trials indicate that it is no different in its effectiveness and safety. NICE take cost-effectiveness into account when deciding what the NHS should prescribe for free. 

MS Trust contributed to the NICE appraisal process, providing views and evidence on behalf of people with MS. We are delighted to see the guidance change, so that people having breakthrough MS activity can have access to the treatments that are most suitable for them without having to wait.

NICE recommends new treatment option for highly active multiple sclerosis | NICE: News article from the National Institute for Health and Care Excellence

Overview | Natalizumab (originator and biosimilar) for treating highly active relapsing–remitting multiple sclerosis after disease-modifying therapy | Guidance | NICE: The full guidance document