Fabry disease (FD) Program in Pharmaceutical Benefits Scheme (PBS) 012-24080524

FD restriction and item codes

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PBS FD restriction and item codes

PBS Complex Drugs Programs

PBS schedule for Fabry disease

Table 1: see Table 2 in Processing Complex Authority Required Listings for FAQs about all Complex programs.

Item	Description
1	Is there an age restriction for patients applying for PBS-subsidised treatment of Fabry disease (FD)? Yes. Patients must be at least 12 years of age.
2	Are patients currently receiving Enzyme Replacement Therapy (ERT) funded under the Australian Government’s Life Saving Drugs Program (LSDP) for FD eligible to transition to PBS-subsidised migalastat under the grandfather restriction? Yes, patients currently on LSDP-funded ERT are allowed to transition to PBS-subsidised migalastat, providing that they meet the grandfathering restriction criteria for FD. The same applies to patients currently on LSDP-funded migalastat transitioning to PBS supply.
3	Will the grandfather restriction of FD expire after 12 months of listing? No. The grandfather restriction will stay in place for longer than the standard 12-month timeframe, depending on the transition of other treatments for FD (i.e. ERT) to the PBS.
4	Can increased quantity and/or repeats be authorised for migalastat? No increase (NO INC) in the PBS-listed quantity of 14 and repeats of 5 are allowed for this item which is dosed at 1 capsule every second day.