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Patient eligibility
The Pharmaceutical Benefits Scheme (PBS) subsidises treatment with eculizumab and ravulizumab under the National Health Act 1953 section 100 for patients with atypical haemolytic uraemic syndrome (aHUS).
Patients must be eligible for the PBS and meet the relevant restriction criteria.
You need to provide serial haematological results every 3 months while the patient is receiving treatment with each subsequent application for treatment.
The Schedule of Pharmaceutical Benefits on the PBS website outlines the restrictions for prescribing eculizumab and ravulizumab.
Section 100 arrangements
Eculizumab and ravulizumab
These items are PBS-subsidised for non-admitted patients, day admitted patients or patients on discharge who are attending either:
- an approved private hospital
- a public hospital.
Eculizumab is also PBS-subsidised for public hospital in-patients but ravulizumab is not. You must include the hospital name and provider number on the authority application form.
Treatment specifics
To be eligible for PBS-subsidised treatment with eculizumab or ravulizumab, patients must be treated by either:
- a haematologist or a nephrologist
- a medical practitioner in consultation with a haematologist or a nephrologist.
There must be agreement to use this pharmaceutical benefit before the patient starts treatment.
Authority applications
Please note: You don’t need to complete applications in writing when you request PBS authorities online.
Applying for initial or switching treatment
Applications for initial or switching authority approval to prescribe PBS-subsidised eculizumab or ravulizumab to treat aHUS can be made:
- using the Online PBS Authorities system
- in writing and using HPOS Form upload
- in writing and faxed to 1800 785 672
- in writing and mailed to PBS Complex Drugs Programs.
All written applications must include:
- details of the proposed prescription or prescriptions
- detailed cover letter from the prescriber (initial treatment only)
- the completed atypical haemolytic uraemic syndrome (aHUS) - eculizumab or ravulizumab - initial or switching authority application form
- relevant attachments.
Applying for initial grandfather treatment
Applications for initial grandfather authority approval to prescribe PBS-subsidised ravulizumab to treat aHUS can be made:
- using the Online PBS Authorities system
- in writing and using HPOS Form upload
- in writing and faxed to 1800 785 672
- in writing and mailed to PBS Complex Drugs Programs.
All written applications must include:
- details of the proposed prescription or prescriptions
- detailed cover letter from the prescriber
- the completed atypical haemolytic uraemic syndrome (aHUS) - ravulizumab - initial grandfather authority application form
- relevant attachments.
Applying for recommencement of treatment
Applications to recommence authority approval to prescribe PBS-subsidised eculizumab or ravulizumab to treat aHUS can be made:
- using the Online PBS Authorities system
- in writing and using HPOS Form upload
- in writing and faxed to 1800 785 672
- in writing and mailed to PBS Complex Drugs Programs.
All written applications must include:
- details of the proposed prescription or prescriptions
- the completed atypical haemolytic uraemic syndrome (aHUS) - eculizumab or ravulizumab - recommencement authority application form
- relevant attachments.
Patients who show an adequate response before a break in treatment can restart if they have a disease flare.
Applying for continuing treatment
Applications for continuing authority approval to prescribe PBS-subsidised eculizumab or ravulizumab to treat aHUS can be made :
- using the Online PBS Authorities system
- in writing and using HPOS Form upload
- in writing and faxed to 1800 785 672
- in writing and mailed to PBS Complex Drugs Programs.
All written applications must include:
- details of the proposed prescription or prescriptions
- the completed atypical haemolytic uraemic syndrome (aHUS) - eculizumab or ravulizumab - continuing authority application form
- relevant attachments.
More information
Call the PBS Complex Drugs Programs enquiry line for more information.