The Scottish Medicines Consortium (SMC) has completed its assessment of efgartigimod alfa (Vyvgart®) as an add-on to standard therapy for the treatment of adults with generalised Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive. The assessment has found that the treatment should not be used in Scotland. The SMC advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on the use of treatments in NHS Scotland.
The SMC advice acknowledges that in a phase III study, efgartigimod significantly improved Myasthenia Gravis Activities of Daily Living (MG-ADL) responder rate compared with placebo in patients with gMG who were AChR antibody positive; but found that argenx, the company that produce the treatment, did not present sufficiently robust clinical and economic analysis to gain acceptance by SMC.
A number of patients in Scotland have already begun treatment with efgartigimod through argenx’s free-of-charge (FOC) scheme. The company has confirmed that all patients who have received the treatment will continue to do so for as long as they need it. However, no new patients will be able to enrol on this scheme.
argenx has also confirmed that it is continuing to explore options to make efgartigimod available to patients in Scotland and that it has plans to resubmit to the SMC in the near future. Under SMC processes, companies may request a meeting if their treatment has not been recommended. The aim of the meeting is to help the company understand why their medicine has not been accepted and determine the nature and focus of any resubmission or independent review panel (IRP).
In England, the second NICE (The National Institute for Health and Care Excellence) Appraisal Committee Meeting for efgartigimod is taking place on Thursday 16 November 2023.
If you have any questions or would like more information about our work on access to treatments, email campaigns@musculardystrophyuk.org. Our helpline is available Monday-Thursday 10am-2pm on 0800 652 6352.
If you are a patient in Scotland already receiving efgartigimod and have any questions about the FOC scheme, speak to your treating physician who will use the appropriate channels to discuss this with argenx.