FD restriction and item codes
Do not share these attachments externally. See Freedom of Information - Information Publication Scheme.
PBS FD restriction and item codes
Contact details
PBS Complex Drugs Programs
Forms
Fabry disease - migalastat - initial authority application (PB373)
Fabry disease - migalastat - initial grandfather authority application (PB374)
Services Australia website
Fabry disease
External website
PBS schedule for Fabry disease
FAQs from Service Officers
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. |
Expand all