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Patient eligibility
The Pharmaceutical Benefits Scheme (PBS) subsidises treatment with eculizumab, pegcetacoplan and ravulizumab under the National Health Act 1953, section 100 for patients with PNH.
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 eculizumab, pegcetacoplan and ravulizumab.
Section 100 arrangements
eculizumab, pegcetacoplan and ravulizumab
These items are only PBS-subsidised for non-admitted patients, day admitted patients, or patients on discharge who are attending:
- an approved private hospital
- a public hospital.
These items aren’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 these medicines, patients must be treated by either a:
- haematologist
- non-specialist medical practitioner in consultation with a haematologist.
Complement 5 (C5) inhibitors are defined as eculizumab or ravulizumab
Patients switching from a C5 inhibitor to pegcetacoplan are required to take pegcetacoplan in addition to their current dose of C5 inhibitor for the first 4 weeks of treatment. This minimises the risk of haemolysis occurring when treatment stops abruptly. After 4 weeks, the patient should discontinue treatment with the C5 inhibitor before continuing on monotherapy with pegcetacoplan.
Authority applications
C5 inhibitors - eculizumab and ravulizumab
Applying for initial, switching, returning or balance of supply treatment
Please note: You don’t need to complete this application in writing when you request PBS authority online.
Applications for initial, switching, returning or balance of supply authority approval to prescribe PBS-subsidised eculizumab or ravulizumab to treat PNH can be made:
- using the Online PBS Authorities system
- in writing and use HPOS Form upload
- in writing and mail to PBS Complex Drugs Programs.
All written applications must include:
- details of the proposed prescription or prescriptions
- the completed paroxysmal nocturnal haemoglobinuria - eculizumab or ravulizumab - initial, switching, returning or balance of supply authority application form
- relevant attachments.
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 eculizumab or ravulizumab to treat PNH can be made:
- using the Online PBS Authorities system
- in writing and use HPOS Form upload
- in writing and mail to PBS Complex Drugs Programs.
All written applications must include:
- details of the proposed prescription or prescriptions
- the completed paroxysmal nocturnal haemoglobinuria - eculizumab or ravulizumab - initial grandfather authority application form
- relevant attachments.
Applying for continuing treatment
Please note: You don’t need to complete this application in writing when you request PBS authority online.
Applications for continuing authority approval to prescribe PBS-subsidised eculizumab or ravulizumab to treat PNH can be made:
- using the Online PBS Authorities system
- in writing and use HPOS Form upload
- in writing and mail to PBS Complex Drugs Programs.
All written applications must include:
- details of the proposed prescription or prescriptions
- the completed paroxysmal nocturnal haemoglobinuria - eculizumab or ravulizumab - continuing authority application form
- relevant attachments.
Pegcetacoplan
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 pegcetacoplan to treat PNH can be made:
- using the Online PBS Authorities system
- in writing and use HPOS Form upload
- in writing and mail to PBS Complex Drugs Programs.
All written applications must include:
- details of the proposed prescription or prescriptions
- the completed paroxysmal nocturnal haemoglobinuria - pegcetacoplan - initial authority application form
- relevant attachments.
Applying for continuing or returning treatment
Please note: You don’t need to complete this application in writing when you request PBS authority online.
Applications for continuing or returning authority approval to prescribe PBS-subsidised pegcetacoplan to treat PNH can be made:
- using the Online PBS Authorities system
- in writing and use HPOS Form upload
- in writing and mail to PBS Complex Drugs Programs.
All written applications must include:
- details of the proposed prescription or prescriptions
- the completed paroxysmal nocturnal haemoglobinuria - pegcetacoplan - continuing or returning authority application form
- relevant attachments.
More information
Call the PBS Complex Drugs Programs enquiry line for more information.