Siponimod under consideration for treatment of secondary progressive MS

  • Secondary progressive MS, a form of MS that can follow on from relapsing remitting MS, currently has no approved treatment options available in Australia.
  • A large clinical trial in people with secondary progressive MS showed that siponimod can reduce the risk of disability progression in those with secondary progressive MS.
  • The Pharmaceutical Benefits Advisory Committee (PBAC) will be meeting in November to assess the use of siponimod, brand name Mayzent, in people with secondary progressive MS and submissions in support of these applications are invited from the MS community.

Secondary progressive MS is a type of MS that can follow on from the most common form of MS, relapsing remitting MS. Rather than experiencing symptoms that come and go, secondary progressive MS involves the slow accumulation of disability over time. Currently, there are no approved treatments available for secondary progressive MS in Australia.

In November, the Pharmaceutical Benefits Advisory Committee will be meeting to consider a proposal to add Siponimod, brand name Mayzent, onto the Pharmaceutical Benefits Scheme for people with secondary progressive MS. This means that the cost of the medication can be subsidised by the Government. Earlier this year, the US Food and Drug Administration (FDA) approved the use of siponimod in people with relapsing remitting MS and active secondary progressive MS in the United States. Active secondary progressive MS is when the disease enters a phase of gradual disability progression but there is still active inflammation, marked by relapses or active lesions on a (magnetic resonance imaging) MRI scan.

Siponimod is an oral treatment from the same class as fingolimod (Gilenya), a medication already approved in Australia for the treatment of relapsing remitting MS. 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 promising results with siponimod. Taking place in 31 countries, the trial compared people with secondary progressive MS who were given a placebo (mock tablets) with those that were given siponimod. People were treated for up to three years and disability progression was tracked every three months to check if siponimod was working. The results have shown that siponimod reduced disability progression, slowed brain tissue loss (atrophy), and reduced the number of new lesions. There were some side effects of the treatment, including reduced white blood count as well as cardiac and liver abnormalities, which were consistent with other MS treatments in this class. More details of the study can be found in our article 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, and they invite submissions in support of these applications from the MS community. The decision of the PBAC is the first step in a process where final approval is given by the Federal Government. If approved, it will then allow people with SPMS across Australia to access this new treatment option under the PBS.

MS Research Australia will be making a submission advocating for this treatment to be listed 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.


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Siponimod under consideration for treatment of secondary progressive MS