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Draft guidance consultation

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1 Recommendations

1.1 Ravulizumab 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.

1.2 This recommendation is not intended to affect treatment with ravulizumab 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 clinician 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 antibodies includes surgery, acetylcholinesterase inhibitors or immunosuppressants. Ravulizumab would be used as an add-on to standard treatment.

Clinical trial evidence suggests that ravulizumab plus standard treatment improves symptoms and people's ability to do their normal activities compared with standard treatment alone. But it is uncertain if the people in the trial reflect the people who would have ravulizumab in the NHS.

There are also uncertainties in the economic model that make the cost-effectiveness estimates for ravulizumab uncertain. These estimates are above what NICE considers an acceptable use of NHS resources. So, ravulizumab is not recommended.