Cropped shot of a young one child family on a beach with the father giving his daughter a piggyback

Gilenya approved for children with MS and more treatments under consideration

02 May, 2019
  • Based on new evidence in young people, Gilenya (fingolimod) has been approved for use in younger people with MS.
  • At the July meeting of the Pharmaceutical Benefits Advisory Committee (PBAC), two medications, Gilenya and Tysabri (natalizumab) will be assessed for use in children with MS and submissions in support of these applications are invited from the MS community.

The Therapeutic Goods Administration (TGA) has approved the use of Gilenya (fingolimod) in children with MS, providing a much needed treatment option for this group. This approval was based on recent evidence of good outcomes of this treatment in younger patients.

MS most commonly strikes during young adulthood, but up to 5% of diagnoses occur in children, including some as young as two years of age. Since clinical trials in children can be challenging, there is a lack of information about the safety and side effects of MS medications in children. However, in practice, children with MS are often treated “off-label” with adult MS medications, so approvals for medications specifically for children are welcome.

Gilenya, which was approved for adults in 2011, is an oral medication that acts on the immune system and dampens down the MS attack by immune cells on the brain and spinal cord. In July the Pharmaceutical Benefits Advisory Committee (PBAC) will consider a proposal to add a new lower dose of Gilenya onto the Pharmaceutical Benefits Scheme (PBS); this is specifically for people with MS who weigh 40kg or less including children. At the same PBAC meeting the committee will be also considering whether Tysabri (natalizumab) should be subsidised for people of all ages; this could lead to Tysabri being added to the PBS for all ages including children and young adults.

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.

Their decision is the first step in a process where final approval is given by the federal Government. If approved, it will then allow children with MS across Australia access to this new treatment option under the PBS.

MS Research Australia supports affordable access to all proven treatment options to increase the opportunity for people with MS and their doctors to find effective therapies suited to their individual circumstances, and welcomes the addition of these treatments as options for children with MS.

MS affects everyone differently and not everyone with MS responds to medications in the same way. It is important to discuss all medication options with your medical team to determine which medication is suited to your personal circumstances.

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