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1 Recommendations

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1 Recommendations

1.1

Rozanolixizumab is not recommended, within its marketing authorisation, as an add-on to standard treatment for generalised myasthenia gravis in adults who test positive for:

  • anti-acetylcholine receptor antibodies or

  • anti-muscle-specific tyrosine kinase antibodies.

1.2

This recommendation is not intended to affect treatment with rozanolixizumab 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.

Why the committee made these recommendations

Standard treatment for generalised myasthenia gravis in adults who test positive for anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase antibodies includes surgery, acetylcholinesterase inhibitors, corticosteroids and immunosuppressants. For people whose condition does not improve with standard treatment, intravenous immunoglobulin or plasma exchange may be added. Rozanolixizumab would be used as an add-on to standard treatment.

Clinical trial evidence suggests that rozanolixizumab plus standard treatment improves symptoms and people's ability to carry out their normal activities compared with standard treatment alone. But its treatment effect in the longer term is uncertain. Rozanolixizumab has not been compared with plasma exchange, and the results of an indirect comparison of rozanolixizumab with intravenous immunoglobulin are uncertain. So, it is unclear how well it works compared with these treatments.

There are also uncertainties in the economic model and the cost-effectiveness estimates for rozanolixizumab. The most likely estimates are substantially above what NICE considers an acceptable use of NHS resources. So, rozanolixizumab is not recommended.