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

  • Technology appraisal guidance
  • TA1126
  • Published: 
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1 Recommendations

Natalizumab (subcutaneous originator and intravenous biosimilar)

1.1

Natalizumab (subcutaneous originator or intravenous biosimilar) can be used as an option to treat highly active relapsing–remitting multiple sclerosis (RRMS) in adults, only if:

  • it has not responded to a full and adequate course of at least 1 disease-modifying therapy

  • the characteristics of the person and the activity of their MS mean that cladribine is not suitable.

    Natalizumab (subcutaneous originator or intravenous biosimilar) can only be used if the companies have an agreed price within the Medicines Procurement and Supply Chain.

1.2

Offer people having natalizumab regular anti‑John Cunningham human polyomavirus (JCV) antibody level tests before and during treatment. Use the test specific to the brand being used when starting, or switching to, natalizumab (originator or biosimilar).

Natalizumab (intravenous originator)

1.3

Natalizumab (intravenous originator) should not be used to treat highly active RRMS that has not responded to a full and adequate course of at least 1 disease-modifying therapy in adults.

About these recommendations

1.4

These recommendations are not intended to affect treatment with natalizumab that was started in the NHS before this guidance was published. People having treatment outside these recommendations 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 RRMS in NICE's technology appraisal guidance on natalizumab for the treatment of adults with highly active RRMS (TA127).

What this means in practice

Natalizumab (subcutaneous originator or intravenous biosimilar)

Natalizumab (subcutaneous originator and intravenous biosimilar) must be funded in the NHS in England for the condition and population in the recommendations, if it is considered the most suitable treatment option.

Natalizumab (subcutaneous originator and intravenous biosimilar) must be funded in England within 90 days of final publication of this guidance.

There is enough evidence to show that natalizumab (subcutaneous originator and intravenous biosimilar) provides benefits and value for money, so it can be used routinely across the NHS in this population.

NICE has produced tools and resources to support the implementation of this guidance.

Natalizumab (intravenous originator)

Natalizumab (intravenous originator) is not required to be funded and should not be used routinely in the NHS in England for the condition and population in the recommendations.

This is because the available evidence does not suggest that natalizumab (intravenous originator) is value for money in this population.

Why the committee made these recommendations

Usual treatment for highly active RRMS 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 work as well as, and be as safe as, natalizumab (originator). Natalizumab (either 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 work as well as these treatments.

The most likely cost-effectiveness estimates for natalizumab (subcutaneous originator and intravenous biosimilar) when the characteristics of the person and the activity of their MS mean that cladribine is not suitable are within the range that NICE considers an acceptable use of NHS resources. So, natalizumab (subcutaneous originator and intravenous biosimilar) can be used.

The most likely cost-effectiveness estimates for natalizumab (intravenous originator) when the characteristics of the person and the activity of their MS mean that cladribine is not suitable are higher than the range that NICE considers an acceptable use of NHS resources. So, natalizumab (intravenous originator) should not be used.