PBAC Release Outcomes on omav Reimbursement
The Pharmaceutical Benefits Advisory Committee has today published the Minutes of their March 2025 meeting.
At this meeting the PBAC decided not to recommend reimbursement of omaveloxolone through the Pharmaceutical Benefits Scheme.
The PBAC March Meeting Minutes can be found here.
What we can do now
At fara we are deeply disappointed by this news but as always, we look forward.
We will continue to work with government & industry to achieve the best possible outcome for Australians living with FA
We urge you to recontact your Member of Parliament following the federal election to discuss the importance of omav to you
And we would remind those that are eligible of the omav Early Compassionate Access Program that commenced in February. Click here for details.
What happens next
In response to the announcement, Biogen have reaffirmed that they stand behind the clinical data demonstrating the safety and efficacy of omaveloxolone and note that the medicine is registered for the treatment of FA in people aged 16 years and older in the UK, Europe, Canada, Brazil, and the USA.
Further they have committed to continue engaging with the PBAC and the Department of Health and Aged Care to find a way forward.
Please note that omav / Skyclarys is still under review for registration by the Therapeutic Goods Administration who are considering the quality, safety and efficacy of the treatment.
As always, we will continue to keep our community updated with developments as they occur.