What will the Pharmaceuticals Benefits Advisory Committee (PBAC) be doing?
In July, the Pharmaceutical Benefits Advisory Committee (PBAC) will be meeting to consider proposals to recommend adding siponimod (Mayzent) and ocrelizumab (Ocrevus) onto the Pharmaceutical Benefits Scheme (PBS) for people with a history of relapsing forms of MS and people with primary progressive MS (PPMS), respectively. The PBAC provides recommendations to the government of what they think 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 them affordable for everyone.
Siponimod will be considered by the PBAC for the treatment of people with a history of relapsing forms of MS. Siponimod was considered for PBS inclusion at the November 2019 PBAC meeting for the treatment of secondary progressive MS (SPMS) but was unfortunately knocked back (see here). It is an oral treatment in the same class as fingolimod (Gilenya), a medication approved in Australia for the treatment of relapsing remitting MS (RRMS). It acts by targeting immune cells and preventing them from moving into the areas of inflammation in MS (the brain and spinal cord). Clinical trials have shown that in addition to reducing disability progression, siponimod also reduced brain tissue loss (atrophy) and reduced the number of new or active lesions. You can view the trial results in more detail here.
Ocrelizumab will be considered by the PBAC for the treatment of PPMS. Back in 2017, ocrelizumab was approved by the TGA for the treatment of both RRMS and PPMS. That same year, the PBAC recommended ocrelizumab for inclusion on the PBS for people with RRMS, and the Federal Government listed it on the PBS in early 2018 (see here). Unfortunately, later attempts to get it included on the PBS for PPMS were knocked back.
Administered as an intravenous infusion, ocrelizumab targets immune cells called B cells that are thought to contribute to the continued progression of disability experienced by people with PPMS. It is important to note ocrelizumab may not benefit all people with PPMS and is unlikely to completely halt progression. However, in clinical trials, people with PPMS taking ocrelizumab had a slower rate of disability progression compared to people on the placebo. More details about the trial results can be found here.
How does the PBAC decide what will be included on the PBS?
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.
What can we and the MS community do to support the inclusion of these MS treatments on the PBS?
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 siponimod and ocrelizumab 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 June 2020, and can be submitted here.
For helpful tips for submitting consumer comments to the PBAC, please see here.