Younger people to have affordable access to Gilenya and Tysabri

29 October, 2019
  • The Federal Government has expanded the PBS listing of fingolimod (Gilenya) and natalizumab (Tysabri) to include younger people.
  • From 1st November 2019, the age restriction for Tysabri will be removed and a lower strength of Gilenya to treat people who are less than 40kg will be added to the PBS.
  • This will enable younger people with MS affordable access to more treatment options.

Following the positive recommendation by the Pharmaceutical Benefits Advisory Committee (PBAC) back in August, the Government has announced the extended listing of fingolimod (Gilenya) and natalizumab (Tysabri) on the Pharmaceutical Benefits Scheme (PBS) for children with relapsing remitting MS or to those people with relapsing remitting MS who are under 40kg, respectively. These modifications will officially take effect from 1st November 2019.

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.  Up until now, children with MS are often treated “off-label” with adult MS medications, so approval and support for affordable medications that can be applied to children is most welcome.

Gilenya is an oral medication that selectively targets immune cells and redirects them away from the brain and spinal cord, and is normally taken daily at a dose of 0.5mg. Clinical trials of Gilenya involving children aged 10 to 17 years at a dose of 0.5mg or 0.25mg a day for people weighing less than 40kg, found  Gilenya resulted in fewer relapses and reduced accumulation of lesions over a two-year period compared to interferon beta-1a. From 1st November 2019, a lower strength of Gilenya at 0.25mg will be listed on the PBS, which can be used to treat people who are less than 40kg, including children.

Tysabri is provided as a monthly infusion and acts by binding to immune cells to prevent them from moving into the brain and spinal cord where they cause inflammation. There have been a number of observational studies that have shown that treatment with Tysabri is safe, well-tolerated and highly effective in children. From 1st November 2019, the PBS listing of Tysabri will be amended to remove the age restriction.

Having written submissions to the PBAC in support of the amendment for Gilenya and Tysabri, MS Research Australia is very pleased with this outcome and looks forward to the extended listings on the PBS, which will allow younger people affordable access to more treatment options. In turn, this will enable their doctors to find effective therapies suited to their individual circumstances.

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