PBAC's latest decision on Rozanolixizumab: Recommended with restriction (2025). Considered for Treatment of adult patients with generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive, as an alternative bridging therapy to intravenous immunoglobulin (IVIg) and plasma exchange (PLEX) while remission induction occurs with non-steroidal immunosuppressants.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2025
Submissions
1
2025 → 2025
Eligible population
Adult patients with generalised myasthenia gravis (MGFA Disease Class II to IVa) who are AChR antibody positive, with a Myasthenia Gravis Composite (MGC) score of at least 4 points, receiving concomitant treatment with at least one non-steroidal immunosuppressant (azathioprine, methotrexate, cyclophosphamide, ciclosporin, or mycophenolate), and not receiving concurrent IVIg or plasma exchange.
Therapy area
Neurology
Line of therapy
Not applicable
Evidence base
RCT
Primary endpoint
Surrogate
Key trials
MycarinG, MG0007
Comparator
intravenous immunoglobulin (IVIg)
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated as the submission was based on equi-effective dosing with IVIg.