Atypical haemolytic uraemic syndrome

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 only PBS-subsidised for non-admitted patients, day admitted patients, or patients on discharge who are attending:

• an approved private hospital
• a public participating hospital (eculizumab only)
• a public hospital.

Ravulizumab isn’t PBS-subsidised for public hospital in-patients but eculizumab is. 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

Applying for initial or switching treatment

Apply for initial or switching authority approval to prescribe PBS-subsidised eculizumab or ravulizumab to treat aHUS in writing and either:

• use HPOS Form upload
• fax to 1800 785 672
• mail to PBS Complex Drugs Programs.

All written applications must include the completed:

• authority prescription form or forms
• detailed cover letter from the prescriber (initial treatment only)
• Atypical haemolytic uraemic syndrome (aHUS) - eculizumab or ravulizumab - initial or switching authority application form
• relevant attachments.

Applying for initial grandfather treatment

For patients who received non-PBS-subsidised ravulizumab treatment before 1 January 2024 for aHUS, apply for initial grandfather authority approval in writing and either:

• use HPOS Form upload
• fax to 1800 785 672
• mail to PBS Complex Drugs Programs.

All written applications must include the completed:

• authority prescription form or forms
• detailed cover letter from the prescriber
• Atypical haemolytic uraemic syndrome (aHUS) - ravulizumab - initial grandfather authority application form
• relevant attachments.

Applying for recommencement of treatment

Apply to recommence authority approval to prescribe PBS-subsidised eculizumab or ravulizumab to treat aHUS in writing and either:

• use HPOS Form upload
• fax to 1800 785 672
• mail to PBS Complex Drugs Programs.

All written applications must include the completed:

• authority prescription form or forms
• 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

Apply for continuing authority approval to prescribe PBS-subsidised eculizumab or ravulizumab to treat aHUS in writing and either:

• use HPOS Form upload
• fax to 1800 785 672
• mail to PBS Complex Drugs Programs.

All written applications must include the completed:

• authority prescription form or forms
• 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.