Migalastat (Galafold, Amicus Therapeutics) is now available through the Pharmaceutical Benefits Scheme (PBS) under the General Schedule, rather than the Life Saving Drugs Program (LSDP).
Effective 1 September 2024, migalastat is available as a first line therapy for amenable patients aged ‘12 years or older’.
There is no change to arrangements for enzyme replacement therapies (ERT) for Fabry disease (agalsidase alfa (Replagal) and agalsidase beta (Fabrazyme)). These medicines will continue to be accessed through the LSDP.
Migalastat (Galafold) is now available through the Pharmaceutical Benefits Scheme (PBS) under the General Schedule
Importantly migalastat (Galafold) can only be prescribed by a physician with expertise in the management of Fabry disease, and completed authority application form for Fabry disease will be required to transition patients to the PBS.