following a full submission assessed the under orphan medicine process:
efgartigimod alfa (Vyvgart®) is not recommended for use within NHSScotland.
Indication under review: as an add-on to standard therapy for the treatment of adult patients with generalised Myasthenia Gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.
In a phase III study, efgartigimod alfa significantly improved Myasthenia Gravis Activities of Daily Living (MG-ADL) responder rate compared with placebo in patients with gMG who were AChR antibody positive.
The submitting company did not present sufficiently robust clinical and economic analysis to gain acceptance by SMC.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.
Download detailed advice1019KB (PDF)
Medicine details
- Medicine name:
- efgartigimod alfa (Vyvgart)
- SMC ID:
- SMC2561
- Indication:
As an add on to standard therapy for the treatment of adult patients with generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor antibody positive (AChR-Ab+).
- Pharmaceutical company
- argenx
- BNF chapter
- Central nervous system
- Submission type
- Full
- Status
- Not recommended
- Date advice published
- 13 November 2023