1 Recommendations

1.1

Rozanolixizumab, as an add-on to standard treatment, can be used as an option to treat generalised myasthenia gravis in adults who test positive for anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibodies. It can only be used if:

the condition is classified as Myasthenia Gravis Foundation of America (MGFA) class 2 to 4a
the condition is uncontrolled after 2 or more treatments, excluding acetylcholinesterase inhibitors, and
intravenous immunoglobulin (IVIg) or plasma exchange (PLEX) would otherwise be offered, or has been tried and stopped because of side effects or because it did not work well enough.

Rozanolixizumab can only be used if the company provides it according to the commercial arrangement (see section 2).

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.

What this means in practice

Rozanolixizumab 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. Early funding for rozanolixizumab is available through the Innovative Medicines Fund from 29 April 2026 until 90 days after final publication of this guidance. After that, rozanolixizumab must be funded through routine commissioning in England.

There is enough evidence to show that rozanolixizumab 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.

Why the committee made these recommendations

Standard treatment for generalised myasthenia gravis in adults who test positive for anti‑AChR or anti‑MuSK antibodies includes:

surgery
acetylcholinesterase inhibitors
corticosteroids
non-steroidal immunosuppressants.

For some people whose condition does not improve with standard treatment, IVIg or PLEX may be added. But access to IVIg and PLEX varies, and they are not suitable for everyone. So, people who cannot have them continue to try standard treatments. Rozanolixizumab would be used as an add-on to corticosteroids or non-steroidal immunosuppressants.

For this evaluation, the company asked for rozanolixizumab to be considered for generalised myasthenia gravis if:

it is classified as MGFA class 2 to 4a
it is uncontrolled after 2 or more treatments, excluding acetylcholinesterase inhibitors, and
IVIg or PLEX is being administered or considered (IVIg or PLEX would otherwise be offered).

This does not include everyone who rozanolixizumab is licensed for. Some people with generalised myasthenia gravis have IVIg or PLEX, or both, and have to stop treatment because of side effects or because it did not work well enough. This group of people is included in the recommendation.

Clinical trial evidence suggests that rozanolixizumab plus standard treatment reduces symptoms and improves people's ability to carry out their normal activities compared with standard treatment alone. But it is uncertain if this improvement lasts in the longer term. Indirect comparisons suggest that rozanolixizumab works better than IVIg or PLEX, but the extent of the benefit is uncertain.

There are uncertainties in the economic model and in the cost-effectiveness estimates for rozanolixizumab. But the most likely estimates are within the range that NICE considers an acceptable use of NHS resources. So, rozanolixizumab can be used.