PBAC Recommends Skyclarys for Listing on PBS

Today the Pharmaceutical Benefits Advisory Committee (PBAC) announced that they have recommended that Friedreich Ataxia treatment Omaveloxolone (Skyclarys) be placed on the Pharmaceutical Benefits Scheme (PBS).

This followed their November 2025 meeting.

The news is truly brilliant for our community and the most significant step forward in our long history.

We are particularly thrilled for every FA patient including those who participated for years in Omaveloxolone trials both here in Australia and around the world.

It comes after years of tireless work by the many who have given their time, raised funds and advocated in anticipation of helping to discover and bring to Australia the first FA treatment.

It is also pleasing to note that the PBAC acknowledged the engagement from our community in Public Submissions.

At this time, we also acknowledge our outstanding clinical and research communities for their skill, dedication and professionalism. And of course, we thank the Biogen Australia team and their international colleagues for their work to bring Skyclarys to our country.

We are indebted to you all!

What This Means

The PBAC decision means that Skyclarys has been recommended to the Federal Government for PBS funding.

Read their published statement here under November 2025 – PBAC Outcomes

This follows the Therapeutic Goods Administration July listing of Skyclarys on the Australian Register of Therapeutic Goods (ARTG). The ARTG is the public database of therapeutic goods that can be legally supplied in Australia. (Please note that Skyclarys remains approved only for those 16 years old and over.)

What Happens Now

This is a highly important step but not the end of the process. From here Skyclarys moves to a ‘listing phase’ which includes detailed discussions and negotiation between the Department of Health and Biogen on:

• Eligibility criteria: i.e. PBS restrictions on who can be prescribed and what the ‘rules’ are around its use.

• Price & total cost to the federal government

• Supply contracts.

Once all of this is agreed between the company and the Department of Health, the following occurs:

·      Government consideration: The recommendation moves to the government for final consideration and approval to list the treatment.

• Listing on the PBS:  The treatment is listed on the PBS schedule, allowing it to be prescribed and dispensed at the subsidised price. 

We will continue to keep you informed of any updates as they become public.

Once again our thanks and gratitude to everyone who has helped make this possible!