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Ofatumumab (Kesimpta) recommended for PBS subsidy

autopen injector image
23 April 2021
  • Today, the Pharmaceutical Benefits Advisory Committee(PBAC) has announced their recommendation that ofatumumab be subsidised under the Pharmaceutical Benefit Scheme (PBS).
  • In March 2021 the Therapeutic Good Administration (TGA) approved this medication for the treatment of relapsing forms of MS.
  • The positive recommendation for PBS subsidy of ofatumumab will now go before the Federal Government for final approval.

The Pharmaceutical Benefits Advisory Committee (PBAC) has announced on Friday it will recommend that ofatumumab (Kesimpta) be subsidised for people with relapsing forms of MS.

Ofatumumab was approved by the Therapeutic Goods Administration (TGA) in March 2021 for the treatment of adults with relapsing forms of multiple sclerosis. While the TGA approves the use of medication in Australia, it is up to the PBAC to recommend whether it should be listed on the PBS, meaning it will be made affordable to all Australians. Once a medication receives a positive recommendation from the PBAC, it is then submitted to the Federal Government for final approval. You can track the progress of approvals for medications in Australia at the PBS Medicine Status web page here.

Ofatumumab is an antibody against a protein called CD20 found on the surface of B cells. B cells are immune cells involved in the damage to the brain and spinal cord in MS, and ofatumumab targets these B cells for destruction. Ofatumumab is similar to another MS medication ocrelizumab (Ocrevus), which also targets B cells bearing the CD20 protein. You can read more about ofatumumab here.

One novel feature of ofatumumab is that this treatment is given once per month, via injection using a special injector known as a Sensoready Pen (a patient-friendly autoinjector pen). In comparison, Ocrevus is a 6-monthly infusion. For more information about treatment with ofatumumab including the benefits in MS, details of injecting and potential side effects, please click here.

Clinical trials of ofatumumab showed that it was able to reduce the number of B cells in the body and decrease the number of new MS lesions in the brain. There were two randomized, double-blind Phase 3 studies that compared the efficacy and safety of ofatumumab against aubagio (teriflunomide), an oral MS treatment. The trials enrolled 1,881 people with either RRMS or active SPMS were. You can read more about the clinical trial results here.

The PBAC is required to consider a number of factors when making recommendations, including the effectiveness and cost of a treatment relative to other available medicines and the cost to the government of a new listing. This decision is the first step in a process which will now see the recommendation go before the Federal Government for final approval. If approved, it will then allow people with MS across Australia affordable access to this new treatment option.

MS Australia provided a written submission to the PBAC in support of subsidising ofatumumab in Australia. MS Australia and its research arm, MS Research Australia, support and actively advocate for affordable access to all proven treatment options to increase the opportunity for people with MS and their doctors to find effective therapies suited to their individual circumstances and welcomes the addition of ofatumumab as an affordable treatment option for people with relapsing remitting MS.

MS affects everyone differently and not everyone with MS responds to medications in the same way. It is important to discuss all medication options with your medical team to determine which medication is suited to your personal circumstances.