PBAC's latest decision on Ublituximab: Recommended with restriction (2025). Considered for Treatment of adult patients with relapsing-remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features.
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 relapsing-remitting multiple sclerosis (RRMS) diagnosed as clinically definite by MRI of brain and/or spinal cord, who have experienced at least 2 documented attacks of neurological dysfunction in the preceding 2 years, and are ambulatory without assistance or support.
Therapy area
Neurology
Line of therapy
First-line
Evidence base
Meta-analysis
Primary endpoint
ARR
Pivotal trial size
1,089 patients
Key trials
ULTIMATE I, ULTIMATE II, ASCLEPIOS I, ASCLEPIOS II, OPERA I, OPERA II, FREEDOMS I, FREEDOMS II, TEMSO, TOWER, TENERE
Comparator
ocrelizumab, ofatumumab, fingolimod
Economic model
Cost-minimisation
ICER note
Cost-minimisation approach; no ICER calculated as submission was based on cost comparison analysis versus comparators rather than cost-utility analysis.