Severe asthma

Patient eligibility

The Pharmaceutical Benefits Scheme (PBS) subsidises treatment with biological medicines under the National Health Act 1953, section 100 for patients with severe asthma.

Where the term biological medicine appears, it refers to benralizumab, dupilumab, mepolizumab and omalizumab.

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 biological medicines.

Section 100 arrangements

benralizumab, dupilumab, mepolizumab and omalizumab

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

• 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 biological medicines, patients aged 12 years or older must be treated by one of the following:

• a respiratory physician
• a clinical immunologist
• an allergist
• a general physician with expertise in managing asthma.

Patients aged 6 to less than 12 years old must be treated by one of the following:

• a paediatric respiratory physician
• a clinical immunologist
• an allergist.

They can also be treated by either of the following in consultation with a respiratory physician:

• a paediatrician experienced in the management of patients with severe asthma
• a general physician experienced in the management of patients with severe asthma.

Authority applications

Adolescent and adult patients (12 years or older)

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 biological medicines to treat uncontrolled severe asthma 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 severe asthma - adolescent and adult - initial or recommencement after 12 months break authority application form
• relevant attachments.

You can also use this authority application form to recommence treatment in a new treatment cycle. The new cycle must follow a mandatory 12-month break where there was no response after 4 biological treatments.

Applying for change of treatment

Please note: You don’t need to complete this application in writing when you request PBS authority online.

Applications to change authority approval to prescribe PBS-subsidised biological medicines to treat uncontrolled severe asthma 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 severe asthma - adolescent and adult - change authority application form
• relevant attachments.

Applying for recommencement of treatment

Please note: You don’t need to complete this application in writing when you request PBS authority online.

Applications to recommence authority approval to prescribe PBS-subsidised biological medicines to treat uncontrolled severe asthma 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.

For patients recommencing treatment after a voluntary break in treatment where a demonstration of response was recorded prior to commencing the treatment break, apply under either:

• the continuing treatment restriction where the patient is recommencing treatment with the same biological medicine approved for the most recent PBS-subsidised treatment
• the initial 2 (change) treatment restriction where the patient is recommencing with a biological medicine other than the one approved for the most recent PBS-subsidised treatment.

For patients recommencing treatment after a mandatory 12-month treatment break after failing to demonstrate a response, apply under the initial treatment restriction.

All written applications must include:

• details of the proposed prescription or prescriptions
• the completed authority application form according to the relevant treatment restriction
• relevant attachments.

Applying for continuing treatment excluding omalizumab

Please note: You’ll get an immediate assessment when you request PBS authorities online.

Applications for continuing authority approval to prescribe PBS-subsidised biological medicines to treat uncontrolled severe asthma can be made in:

• real time using the Online PBS Authorities system
• writing and use HPOS Form upload
• writing and mail to PBS Complex Drugs Programs.

All written applications must include:

• details of the proposed prescription or prescriptions
• the completed severe asthma - adolescent and adult - continuing authority application form
• relevant attachments.

Applying for continuing treatment with omalizumab

Applications for continuing authority approval to prescribe PBS-subsidised omalizumab to treat uncontrolled severe asthma can be made:

• in real time using the Online PBS Authorities system
• by calling the PBS Complex Drugs Programs enquiry line.

Application for continuing PBS-subsidised treatment with biosimilar brand of omalizumab is Authority Required (Streamlined). You don’t need authority approval from us for the listed quantities and repeats.

Paediatric patients (aged 6 to less than 12 years)

Applying for initial treatment or recommencement of treatment after a break of at least 12 months

Please note: You don’t need to complete this application in writing when you request PBS authority online.

Applications for initial or recommencement authority approval to prescribe PBS-subsidised dupilumab or omalizumab to treat uncontrolled severe asthma or severe allergic asthma 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 severe asthma paediatric - dupilumab or omalizumab - initial or recommencement 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 dupilumab to treat uncontrolled severe asthma 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 severe asthma paediatric - dupilumab - initial grandfather authority application form
• relevant attachments.

Applying for change of treatment

Please note: You don’t need to complete this application in writing when you request PBS authority online.

Applications to change authority approval to prescribe PBS-subsidised dupilumab or omalizumab to treat uncontrolled severe asthma or severe allergic asthma 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 severe asthma paediatric - change or continuing authority application form
• relevant attachments.

Applying for continuing treatment with dupilumab

Please note: You’ll get an immediate assessment when you request PBS authorities online.

Applications for continuing authority approval to prescribe PBS-subsidised dupilumab to treat uncontrolled severe asthma can be made in:

• real time using the Online PBS Authorities system
• writing and use HPOS form upload
• writing and mail to PBS Complex Drugs Programs.

All written applications must include:

• details of the proposed prescription or prescriptions
• the completed severe asthma paediatric - change or continuing authority application form
• relevant attachments.

Applying for continuing treatment with omalizumab

Applications for continuing authority approval to prescribe PBS-subsidised omalizumab to treat uncontrolled severe allergic asthma can be made either:

• in real time using the Online PBS Authorities system
• by calling the PBS Complex Drugs Programs enquiry line.

Application for continuing PBS-subsidised treatment with biosimilar brand of omalizumab is Authority Required (Streamlined). You don’t need authority approval from us for the listed quantities and repeats.

More information

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