PBAC's latest decision on Ofatumumab: Noted (2024). Considered for Treatment of relapsing remitting multiple sclerosis (RRMS) in adult patients with relapsing forms of multiple sclerosis to delay progression of physical disability and reduce frequency of relapse.
PBAC outcome
Noted
Restricted
ICER (AUD/QALY)
Not modelled
no economic evaluation
Submissions
3
first 2014
Submissions
3
2014 → 2024
Eligible population
Adult patients with relapsing remitting multiple sclerosis (RRMS), including those with relapsing forms of MS who experience exacerbations followed by remission of symptoms.
Therapy area
Neurology
Line of therapy
Any
Evidence base
Meta-analysis
Primary endpoint
ARR
Pivotal trial size
927 patients
Key trials
ASCLEPIOS I, ASCLEPIOS II, FREEDOMS I, FREEDOMS II, TRANSFORMS, TEMSO, TOWER
Comparator
fingolimod
Economic model
Cost-minimisation
ICER note
This was a cost-minimisation submission in March 2021; the March 2024 submission is a Category 2 request for tier restructuring with no new economic evaluation presented. No ICER is stated or calculated in this PSD.
Submission history
Nov 2014: Not recommended · Authority Required
Mar 2021: Recommended with restriction · Authority Required