- The Pharmaceutical Benefits Advisory Committee (PBAC) will meet in May to discuss new treatments to include on the PBS, including ublituximab (Briumvi®) for adults with relapsing remitting MS.
- Inclusion on the PBS would make ublituximab affordable and give people with MS more choices in their treatment.
- The PBAC is calling for public submissions in support of this application.
What will the Pharmaceutical Benefits Advisory Committee (PBAC) be doing?
In May 2025, the Pharmaceutical Benefits Advisory Committee (PBAC) will meet to consider a proposal to recommend adding ublituximab (Briumvi®) to the Pharmaceutical Benefits Scheme (PBS) for adults with relapsing remitting MS. When it is included on the PBS, the cost of the medication is subsidised by the government, making it more affordable for people.
The PBAC considers clinical trial data, submissions from the community, as well as pricing data. Then it provides recommendations to the government on whether they think a medication should be included on the PBS. It is then up to the Federal Government to give the final approval.
What is ublituximab?
Ublituximab is a monoclonal antibody treatment that targets a protein called CD20 on B cells, a type of immune cell. B cells have an important role in driving the autoimmune attack on the brain and spinal cord in MS as they produce molecules that promote inflammation. Ublituximab reduces the number of B cells that express CD20 and thus reduces the number of relapses, progression of disability and new magnetic resonance imaging (MRI) lesions.
Recent phase 3 clinical trials (ULTIMATE I and ULTIMATE II) showed people with MS who received ublituximab had significantly fewer relapses and fewer new MRI lesions compared to people taking oral teriflunomide (a medication that blocks white blood cells from multiplying) combined with an intravenous placebo (mock treatment). There were no differences between the two treatments for brain volume or progression of disability.
While most of the ublituximab group experienced some side effects, most were manageable. Nearly half had reactions related to the infusion. The next-most common side effects were headaches (34.3%), sore throat (18.3%), fever (13.9%) and nausea (10.6%).
Most of the participants in the teriflunomide group also experienced some side effects, with the most common being headache (26.6%), sore throat (17.9%), hair loss (15.3%), infusion-related reactions (12.2%) and diarrhoea (10.6%).
In the ublituximab group, there were three deaths due to infections. While these infections occurred during the treatment, it’s important to remember that such serious adverse events can happen in clinical trials, particularly in people with weakened immune systems. However, these events are closely monitored, and safety measures are in place to protect participants as much as possible.
How does ublituximab compare to current MS treatments?
There are other monoclonal antibody treatments available on the PBS:
- Ofatumumab (Kesimpta®) and ocrelizumab (Ocrevus®), which also target CD20.
- Alemtuzumab (Lemtrada®), which targets C52 on various immune cells.
- Natalizumab (Tysabri®), which targets T cells, a type of immune cell.
Ublituximab targets a different part of CD20 that ofatumumab and ocrelizumab do. A systematic review and network meta-analysis showed ublituximab has similar effects on relapse rate and disability progression to ocrelizumab, ofatumumab, natalizumab and alemtuzumab.
Like other MS treatments targeting CD20, ublituximab is administered intravenously. However, it is the first to be given twice a year after the initial dose and with an infusion time of just one hour. This dosing schedule is less frequent than that of ofatumumab and natalizumab and the infusion time is shorter compared to ocrelizumab and alemtuzumab.
How does the PBAC decide what will be included on the PBS?
The PBAC considers several factors when making recommendations, including the effectiveness and cost of a treatment relative to the other available medicines. The decision of the PBAC is the first step in a process where final approval is given by the Federal Government.
What can we and the MS community do to support the inclusion of this MS treatment on the PBS?
MS Australia supports affordable access to all proven treatment options allowing people of all ages with MS and their doctors to find effective therapies suited to their individual needs. No two people with MS are the same and having a range of treatments for MS on the PBS means people with MS have a greater choice and ability to find a treatment that suits them.
MS Australia will be making a submission to support the inclusion of ublituximab on the PBS, as we welcome affordable access to all treatment options that have been shown in clinical trials to provide safe and effective treatment for MS.
The MS community are also invited to provide comments in support of these applications. Consumer comments to the PBAC are due 26 March 2025 and can be submitted here.
More information about PBAC consumer comments is available here and here. For helpful tips for submitting consumer comments to the PBAC, please see here.
