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Natalizumab (originator and biosimilar) for treating highly active relapsing–remitting multiple sclerosis after disease-modifying therapy

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ID6369, natalizumab and biosimilar, DG_final for PM web version [noCON].docx

Recommendations

1.1

Natalizumab (originator and biosimilar) should not be used to treat relapsing–remitting multiple sclerosis (MS) that is highly active despite a full and adequate course of at least 1 disease-modifying therapy in adults.

1.2

This recommendation is not intended to affect treatment with natalizumab (originator or biosimilar) that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS healthcare professional consider it appropriate to stop.

NICE has recommended natalizumab (originator or biosimilar) for rapidly evolving severe relapsing–remitting MS in NICE's technology appraisal guidance on natalizumab for the treatment of adults with highly active relapsing–remitting MS.

What this means in practice

Natalizumab is not required to be funded in the NHS in England to treat highly active relapsing–remitting MS after at least 1 disease-modifying therapy in adults. It should not be used routinely in the NHS in England.

This is because the available evidence does not suggest that natalizumab is value for money.

Why the committee made these recommendations

Usual treatment for highly active relapsing–remitting MS after at least 1 disease-modifying therapy includes ocrelizumab, ofatumumab, ublituximab or cladribine.

Clinical trial evidence shows that natalizumab originator reduces the rate of relapse compared with placebo. Natalizumab biosimilar is expected to be highly similar and clinically equivalent to natalizumab originator.

Natalizumab (originator or biosimilar) has not been directly compared in a clinical trial with ocrelizumab, ofatumumab, ublituximab or cladribine. The results of an indirect comparison are uncertain but suggest that natalizumab is likely to have a similar efficacy to these treatments.

There are uncertainties in the economic model, including:

  • the source of the data informing progression of MS and risk of death

  • how often people have natalizumab.

Because of the uncertainties in the economic model, it is not possible to determine the most likely cost-effectiveness estimates for natalizumab. So, natalizumab should not be used.

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