PBAC's latest decision on Efgartigimod alfa: Recommended with restriction (2025). Considered for Add-on to standard therapy for the treatment of adult patients with generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
2
first 2025
Submissions
2
2025 → 2025
Eligible population
Adult patients with generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.
Therapy area
Neurology
Line of therapy
Not applicable
Evidence base
RCT
Primary endpoint
Surrogate
Pivotal trial size
110 patients
Key trials
ADAPT-SC
Comparator
efgartigimod alfa intravenous (EFG IV) 400 mg/20 mL
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis performed; no ICER calculated as this was a cost comparison submission.
Risk sharing
Risk-sharing arrangement in place — EFG SC should be included in the same risk sharing arrangement (RSA) as advised in March 2025 for EFG IV and other new gMG therapies, to mitigate risk of use outside the intended restriction.
Submission history
Mar 2025: Recommended with restriction · Authority Required
Nov 2025: Recommended with restriction · Authority Required