SKYCLARYS Returns for PBAC Evaluation
The Pharmaceutical Benefits Advisory Committee has today published the Agenda for their November 2025 meeting. FA Treatment Skyclarys is listed on that Agenda.
What Does This Mean?
The Pharmaceutical Benefits Scheme (PBS) ensures that all Australian residents have access to necessary and lifesaving medicines at an affordable price.
The Pharmaceutical Benefits Advisory Committee (PBAC) assesses applications for listing of medicines on the PBS.
The meeting is scheduled to be held on 5th - 7th November 2025.
What Has Happened So Far?
On Friday 27th June the Therapeutic Goods Administration listed SKYCLARYS on the Australian Register of Therapeutic Goods (ARTG); this is the public database of therapeutic goods that can be legally supplied in Australia.
This followed news in May that the PBAC had rejected the first submission for the treatment to be listed on the Pharmaceutical Benefits Scheme for reimbursement. Whilst this was disappointing, Biogen Australia have resubmitted Skyclarys to the PBAC for consideration.
What You Can Do?
This is an exciting phase in the multi-stage Australian Regulatory & Reimbursement process as it is now that individuals and organisations can submit Consumer Comments to the PBAC.
Consumer Comments opened today and will close on Wednesday 24th September 2025.
Whilst the PBAC considers robust facts on what the new medicine is, which patient population it is for and what the evidence is for its clinical and cost-effectiveness, patients’ and caregivers’ lived experiences, preferences and needs can be invaluable when making sense of this evidence.
If you made a public comment previously, you will need to do so again for this round.
Preparing For & Making Your Comments
The Consumer Comment process is one many individuals and organisations have undertaken before us for other treatments.
A summary of the process and how to prepare for your comments based on this collective experience can be found on the Patient Voice Initiative Website.
It is an excellent guide covering how the PBAC works and how to ensure your input can have the greatest impact. It includes clear “Do’s” and “Don’ts” to help you i.e. Don’t explain the condition, explain the reality of living with the condition.
We strongly urge you to read and understand this material before making your Comments.
When you believe you are ready, Consumer Comments to the PBAC can be lodged on this Link. Please note you will need to search for Omaveloxolone.
A simple Tip Sheet for submitting Consumer Comment to the PBAC can also be downloaded here.
Timeline
Summarised below are some key dates for the November 2025 PBAC Meeting:
· Publication of main Agenda Wednesday 30th July 2025
· Consumer Comments open Wednesday 30th July 2025
· Publication of updated Agenda Friday 5th September 2025
· Consumer Comments close Wednesday 24th September 2025
· PBAC Meeting Wed 5th – Friday 7th November 2025
· Posting of Outcomes Friday 19th December 2025
As more information becomes available, we will continue to share it with our community.
If you require further support making your Consumer Comments, please contact us on info@fara.org.au