Recently fara Australia requested a comment from Biogen ANZ on the recent decision in Ireland to reimburse SKYCLARYS™. Their response is reproduced below.
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Biogen ANZ welcomes the recent agreement in Ireland to provide reimbursed access to SKYCLARYS™ (omaveloxolone) for people living with Friedreich ataxia (FA). The decision means that people in Ireland will have access to the first and only approved treatment for this progressive rare neurological condition.
Ireland joins a growing number of countries that have established public reimbursement pathways for omaveloxolone. Like Australia, Ireland uses a rigorous health technology assessment process that considers clinical benefit, cost-effectiveness and budget impact when making reimbursement decisions. This outcome reflects a recognition of the significant unmet need faced by people living with FA.
In addition to Ireland, a growing number of countries provide access to omaveloxolone through national reimbursement, including Germany, Slovenia, Luxembourg, Austria, Switzerland, Poland, Italy, Spain, Slovakia, Portugal and Croatia. These join a further 21 countries in which people have access to omaveloxolone though a variety of other publicly-funded access mechanisms.
These developments demonstrate that different health systems are finding ways to evaluate and provide access to innovative therapies for rare diseases. As experience with omaveloxolone continues to grow internationally, each new reimbursement agreement contributes valuable insights into how health systems can support people living with FA while maintaining sustainable access frameworks.
Biogen remains committed to supporting the FA community in Australia. Since 2025, eligible Australians have been able to access omaveloxolone through a company-sponsored Early Access Program, which is no longer enrolling new participants. However, a sustainable reimbursement pathway remains the most equitable way to ensure appropriate and predictable access for people living with FA who may benefit from treatment.
Biogen is committed to working constructively with the Pharmaceutical Benefits Advisory Committee and the Department of Health, Disability and Ageing to seek mutually agreeable outcomes that support reimbursed access to omaveloxolone for people living with FA who could benefit from treatment.