In March 2021, the Pharmaceutical Benefits Advisory Committee (PBAC) will be meeting to consider a proposal to recommend adding ofatumumab (Kesimpta) to the Pharmaceutical Benefits Scheme (PBS) for people with relapsing MS. The PBAC considers clinical trial data, submissions from the community as well as pricing data and then 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. Being included on the PBS means that the cost of these medications can be subsidised by the Government, making the medication affordable for everyone.
Ofatumumab is a repurposed cancer treatment that targets specific immune cells for destruction. The medication targets a protein, CD20, found on the surface of B cells. B cells have an important role in driving the autoimmune attack on the brain and spinal cord in MS. CD20 is also the target of other MS medications such as rituximab (Rituxan) and ocrelizumab (Ocrevus).
Clinical trials of ofatumumab showed that it reduced the number of relapses compared to another MS drug, Aubagio. Ofatumumab-treated patients also experienced less worsening of disability, as well as dramatically lower numbers of lesions on MRI. While there were no significant effects on brain volume, people treated with ofatumumab exhibited lower levels of a marker of neurodegeneration in the blood called serum neurofilament light. Side effects of the drug included injection reactions and infections, with 2.5% of ofatumumab-treated patients experiencing serious infections compared to 1.8% in the teriflunomide-treated patients.
Importantly, ofatumumab can be self-administered by monthly injection at home, which may assist people for whom hospital infusions are difficult, such as those living in remote areas. You can read more about ofatumumab here.
The PBAC considers a number of factors when making recommendations, including the effectiveness and cost of a treatment relative to other available medicines. The decision of the PBAC is the first step in a process where final approval is given by the Federal Government.
MS Research 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 circumstances. MS Research Australia will be making a submission to support the inclusion of ofatumumab 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 too. Consumer comments to the PBAC are due 10th Feb 2021, and can be submitted here.
For helpful tips for submitting consumer comments to the PBAC, please see here.