Siponimod not recommended for PBS listing

In what comes as an extremely frustrating and disappointing blow for people with secondary progressive MS (SPMS) and their families, the new MS medication, siponimod (Mayzent), has not been recommended for reimbursement on the Pharmaceutical Benefits Scheme (PBS).

In November, siponimod was approved by the Therapeutic Goods Administration (TGA) for use by people with SPMS, making it the first medication available in Australia for people with SPMS (see article here). The TGA grants approval for new medications after assessing the clinical evidence for their safety and efficacy. However, it is the Pharmaceutical Benefits Advisory Committee (PBAC) that advises the Federal Government on which medications should be listed for reimbursement on the PBS.

Siponimod was considered at the November meeting of the PBAC. The outcome was published on their website on 20th December. The PBAC is required to consider a number of factors when making recommendations, including the clinical efficacy and cost-effectiveness of a treatment, relative to other medicines, and the cost to the government of a new listing.

The PBAC summary for siponimod states, “The PBAC did not recommend the listing of siponimod for the treatment of SPMS. The PBAC acknowledged the high clinical need for effective treatments in this therapeutic area. The evidence presented supported the clinical claim that siponimod is superior compared with placebo with regards to confirmed disability progression and annualised relapse rate for patients with SPMS. However, the PBAC considered that the appropriate place of siponimod in the treatment algorithm for multiple sclerosis was uncertain, and the submission did not provide a reliable basis to assess the cost-effectiveness of siponimod. The PBAC also considered the financial estimates to be uncertain”.

Essentially, the summary indicates that while the clinical benefits of siponimod for people with SPMS are clear, the PBAC is uncertain about the appropriate place for it in the treatment plan for people with MS and its cost-effectiveness.

MS Research Australia is incredibly disappointed with this outcome, however, this is certainly not the end. We will continue to strongly advocate for affordable access to treatment options that have been shown in clinical trials to provide a clinical benefit. In particular, for people with secondary progressive MS, there is a very great and urgent need for any proven medication that can safely slow down the progression of the disease.

Given that MS is a highly variable disease and that the responses to treatments varies between people, affordable access to a range of treatment options is crucial. Every person with MS and their healthcare team needs to be able to find the most appropriate and effective treatment option for them.


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Siponimod not recommended for PBS listing