Paroxysmal nocturnal haemoglobinuria

Patient eligibility

The Pharmaceutical Benefits Scheme (PBS) subsidises treatment with eculizumab or ravulizumab under the National Health Act 1953, section 100 for patients with paroxysmal nocturnal haemoglobinuria (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 or ravulizumab.

Section 100 arrangements

eculizumab or ravulizumab

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

an approved private hospital
a public participating hospital
a public hospital.

These items aren’t PBS subsidised for 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 eculizumab or ravulizumab, patients must be treated by a haematologist or by a non-specialist medical practitioner in consultation with a haematologist.

Authority applications

Applying for initial treatment, switching due to pregnancy or balance of supply

Apply for initial, switching due to pregnancy or balance of supply authority approval to prescribe PBS subsidised eculizumab or ravulizumab to treat paroxysmal nocturnal haemoglobinuria in writing and either:

upload through Health Professional Online Services (HPOS)
post to PBS Complex Drugs Programs.

All written applications must include the completed:

authority prescription form or forms
paroxysmal nocturnal haemoglobinuria - eculizumab or ravulizumab - initial, switching due to pregnancy or balance of supply authority application form
relevant attachments.

Applying for initial grandfather treatment

Patients who received non-PBS subsidised eculizumab or ravulizumab treatment before 1 March 2022 for paroxysmal nocturnal haemoglobinuria can apply for initial grandfather authority approval in writing and either:

upload through HPOS
post to PBS Complex Drugs Programs.

All written applications must include the completed:

authority prescription form or forms
paroxysmal nocturnal haemoglobinuria - eculizumab or ravulizumab - initial grandfather authority application form
relevant attachments.

Applying for continuing treatment

Apply for continuing authority approval to prescribe PBS subsidised eculizumab or ravulizumab to treat paroxysmal nocturnal haemoglobinuria in writing and either: