UblituximabBRIUMVI
Treatment of adult patients with relapsing-remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features.
Decision on record
- Meeting May 2025 Recommended Relapsing-remitting multiple sclerosis
Access path
- TGA registered · BRIUMVI
TGA label narrower than the PBS population
- May 2025Recommended · restricted
vs ocrelizumab, ofatumumab, fingolimod
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended the Section 100 (Highly Specialised Drugs Program – Public and Private Hospitals), Authority Required (Streamlined) listing of ublituximab for the treatment of relapsing-remitting multiple sclerosis (RRMS).PSD · May 2025
7.2 In making this recommendation, the PBAC noted the submission made a claim of superior comparative effectiveness over fingolimod, however considered the clinical evidence presented was not sufficiently reliable for the purposes of establishing superiority over fingolimod (or any of the other comparators). The PBAC’s view of the presented evidence and clinical claims are discussed further below.PSD · May 2025
6.71 The submission presented a cost analysis to construct a proposed price for ublituximab and proposed that the price should be a weighted average of the three comparators, ocrelizumab, ofatumumab and fingolimod, with weights determined by current relative PBS prescribing. The submission proposed a % price premium over the current fingolimod price as part of the calculations, on the grounds of claimed superiority of ublituximab over fingolimod.PSD · May 2025
6.72 The submission noted that both ocrelizumab and ofatumumab have Special Pricing arrangements and used the published prices in the analysis, acknowledging that these would need to be recalculated.PSD · May 2025
6.66 The submission described ublituximab as superior to fingolimod in terms of effectiveness. This evaluation considered this claim was not adequately supported.PSD · May 2025
The key issue was, as PBAC has previously advised (in its consideration of ofatumumab in March 2024), the weaknesses of the trials making up the multi-step indirect treatment comparison likely means the available evidence is not sufficiently reliable for the purposes of establishing superiority. However, the evaluation considered the available evidence does not suggest ublituximab is likely to be less effective than fingolimod.PSD · May 2025
6.2 The PBAC noted and welcomed the input from an individual (1), and a consumer organisation (1) via the Consumer Comments facility on the PBS website. The comments described disease burden, including the inability to return to work and the challenges of continuing disability impacting daily life.PSD · May 2025
6.3 The PBAC welcomed the input from MS Australia supporting the listing of ublituximab, and noted the input stressed the importance of having more treatment options available for patients as due to the varied nature of the disease, no one treatment suited all.PSD · May 2025
Cost-effectiveness
Cost-minimisation approach; no ICER calculated as submission was based on cost comparison analysis versus comparators rather than cost-utility analysis.
In the context of the cost-minimisation approach taken by the submission, a further consideration for PBAC is that, under Section 101(3B) of the National Health Act 1953, when the proposed medicine is substantially more costly than an alternative therapy, the committee cannot make a positive recommendation unless it is satisfied that, for some patients, the proposed medicine provides a significant improvement in efficacy and/or reduction of toxicity over the alternative therapy. PBAC · 2025
Decision context
PopulationAdult 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.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| May 2025 | Recommended · restricted | ocrelizumab, ofatumumab, fingolimod | — | Meta-analysis · ARR |
Consumer voice
An individual and MS Australia consumer organisation provided input describing disease burden including inability to work and disability challenges. MS Australia emphasized the need for multiple treatment options given the varied nature of the disease and highlighted ublituximab's comparable efficacy to other high-efficacy monoclonal antibody therapies.
The comments described disease burden, including the inability to return to work and the challenges of continuing disability impacting daily life. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to RRMS only, requires ≥2 attacks in 2 years, MRI confirmation, and ambulatory status; TGA includes all RMS forms.