Fabry disease

The PBS subsidises migalastat for patients with Fabry disease.

Patient eligibility

The Pharmaceutical Benefits Scheme (PBS) subsidises treatment with migalastat under the National Health Act 1953, section 85 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.

Treatment specifics

To be eligible for PBS-subsidised treatment with migalastat, patients must be treated by a physician with expertise in the management of Fabry disease.

Authority applications

Applying for initial treatment

Apply for initial authority approval to prescribe PBS-subsidised migalastat to treat Fabry disease in writing and either:

All written applications must include:

Applying for initial grandfather treatment

For patients who received migalastat treatment or Enzyme Replacement Therapy under the Life Saving Drugs Program before 1 September 2024 for Fabry disease, apply for initial grandfather authority approval in writing and either:

All written applications must include:

Applying for continuing treatment

Applications for continuing authority approval to prescribe PBS-subsided migalastat to treat Fabry disease can be made either:

More information

Call the PBS Complex Drugs Programs enquiry line for more information.

Page last updated: 1 September 2024.
QC 74495