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Patient eligibility
The Pharmaceutical Benefits Scheme (PBS) subsidises treatment with migalastat under the National Health Act 1953, section 85 for patients at least 12 years of age with Fabry disease.
The PBS subsidises treatment with pegunigalsidase alfa under the National Health Act 1953, section 100 for patients with Fabry disease.
Patients must be eligible for the PBS and meet the relevant restriction criteria.
The Schedule of Pharmaceutical Benefits on the PBS website outlines the restrictions for prescribing migalastat and pegunigalsidase alfa.
Section 100 arrangements
Pegunigalsidase alfa
This item is only PBS-subsidised for non-admitted patients, day admitted patients, or patients on discharge who are attending either:
- an approved private hospital
- a public hospital.
This item isn’t PBS-subsidised for public hospital in-patients. You must include the hospital name and provider number on the authority application form.
Treatment specifics
To be eligible for PBS-subsidised treatment with migalastat or pegunigalsidase alfa, patients must be treated by a physician with expertise in the management of Fabry disease.
Authority applications
Applying for initial treatment
Please note: You don’t need to complete this application in writing when you request PBS authority online.
Applications for initial authority approval to prescribe PBS-subsidised migalastat or pegunigalsidase alfa to treat Fabry disease can be made:
- using the Online PBS Authorities system
- in writing and using HPOS Form upload
- in writing and mailed to PBS Complex Drugs Programs.
All written applications must include:
- details of the proposed prescription or prescriptions
- the completed Fabry disease - migalastat or pegunigalsidase alfa - initial authority application form.
Applying for initial grandfather treatment
Please note: You don’t need to complete this application in writing when you request PBS authority online.
Applications for initial grandfather authority approval to prescribe PBS-subsidised migalastat or pegunigalsidase alfa to treat Fabry disease can be made:
- using the Online PBS Authorities system
- in writing and using HPOS Form upload
- in writing and mailed to PBS Complex Drugs Programs.
All written applications must include:
- details of the proposed prescription or prescriptions
- the completed Fabry disease - migalastat or pegunigalsidase alfa - initial authority application form.
Applying for continuing treatment
Applications for continuing authority approval to prescribe PBS-subsided migalastat or pegunigalsidase alfa to treat Fabry disease can be made either:
- in real time using the Online PBS Authorities system
- by calling the PBS Complex Drugs Programs enquiry line.
More information
Call the PBS Complex Drugs Programs enquiry line for more information.