PBAC's latest decision on Ocrelizumab: Recommended with restriction (2025). Considered for Treatment of adult patients with relapsing-remitting multiple sclerosis (RRMS). Ocrelizumab SC provides an alternative subcutaneous administration route to the currently listed intravenous formulation.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
4
first 2017
PBS spend
$225M
13,721 scripts · 2024
Eligible population
Adults with clinically definite relapsing-remitting multiple sclerosis (diagnosed by MRI of brain and/or spinal cord), who have experienced at least 2 documented attacks of neurological dysfunction in the preceding 2 years, are ambulatory without assistance, and for whom ocrelizumab would be the sole PBS-subsidised disease-modifying therapy.
Therapy area
Neurology
Line of therapy
Any
Evidence base
RCT
Primary endpoint
Surrogate
Key trials
OCARINA II (CN42097), OCARINA I (CN41144)
Comparator
ocrelizumab IV (intravenous infusion 300 mg in 10 mL, 600 mg total dose)
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated. Submission presented cost-minimisation approach comparing ocrelizumab SC with ocrelizumab IV.
PBS expenditure
The Australian government paid $225M in PBS benefits for Ocrelizumab in 2024 across 13,721 scripts, at $16,417 per script.
Submission history
Jul 2017: Recommended with restriction · Authority Required
Nov 2017: Not recommended · Restricted
Jul 2020: Recommended with restriction · Restricted
Jul 2025: Recommended with restriction · Authority Required