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PBS listing for Siponimod (brand name Mayzent®) for SPMS not recommended by PBAC

pills
20 December 2019

The Pharmaceutical Benefits Advisory Committee (PBAC) announced today (20/12/19), that they have not recommended the listing of siponimod (Mayzent®) for secondary progressive MS (SPMS) on the Pharmaceutical Benefits Scheme (PBS), stating as follows:

“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 PBAC considered 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.”

Source: http://www.pbs.gov.au/info/industry/listing/elements/pbac-meetings/pbac-outcomes

On 1 November 2019, siponimod (Mayzent®) was registered for use in Australia by the Therapeutic Goods Administration (TGA), for the treatment of patients with SPMS, to reduce the immune attack on nerve cells in the brain and spinal cord caused by MS. It is taken as a film-coated tablet, once daily.

Siponimod (Mayzent®) is the only TGA-registered oral treatment for SPMS in Australia.  SPMS is a form of MS that can follow on from relapsing remitting MS and involves the slow accumulation of disability over time.

Siponimod is not currently marketed in Australia.

As the national advocacy organisation for people living with MS, MS Australia continues to work with our partner organisations to ensure the MS community and their healthcare teams have access to the broadest range of affordable treatments as possible.  We will continue to work with Novartis, the PBAC and the Australian Government to progress a listing for this treatment in the future.

We will keep you posted on any developments.

Always speak to your neurologist about what treatment best suits your individual circumstances.