FD restriction and item codes
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PBS FD restriction and item codes
Contact details
PBS Complex Drugs Programs
Forms
Fabry disease - migalastat or pegunigalsidase alfa - initial authority application (PB373)
Fabry disease - migalastat or pegunigalsidase alfa - initial grandfather authority application (PB374)
Services Australia website
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 migalastat for treatment of FD? Yes. Patients must be at least 12 years. |
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 or pegunigalsidase alfa under the grandfather restriction? Yes, patients currently on LSDP-funded ERT are allowed to transition to PBS-subsidised migalastat or pegunigalsidase alfa, providing 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 (that is - ERT) to the PBS. |
4 | Can increased quantity and/or repeats be authorised for migalastat? No. The PBS listing for migalastat does not allow for the increase (NO INC) to the quantity of 14 capsules and 6 repeats. This is based on the required dosing schedule of one capsule every second day. |
5 | Can increased quantity and/or repeats be authorised for pegunigalsidase alfa? Yes and it is dosed at 1 mg/kg of body weight administered once every two weeks. Prescribers must request the appropriate number of vials, based on the weight of the patient, to provide sufficient drug for 4 weeks of treatment. The maximum number of repeats is 5. |
6 | Is there an age restriction for patients applying for PBS-subsidised pegunigalsidase alfa for treatment of FD? No. There is no age restriction for this drug. |
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