Severe asthma

The PBS subsidises biological medicines for patients with 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:

  • 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.

Toxicity and severity descriptors

When demonstrating a patient’s intolerance to prior treatment, use the asthma toxicity and severity descriptors with the authority application.

Treatment specifics

To be eligible for PBS-subsidised treatment with biological medicines, patients aged 12 years or older must be treated by either:

  • 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:

  • 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

Apply for initial authority approval to prescribe PBS-subsidised biological medicines to treat uncontrolled severe asthma in writing and either:

All written applications must include:

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

Apply to change authority approval to prescribe PBS-subsidised biological medicines to treat uncontrolled severe asthma in writing and either:

All written applications must include:

Applying for continuing treatment excluding omalizumab

Apply for continuing authority approval to prescribe PBS-subsidised biological medicines to treat uncontrolled severe asthma in writing and either:

All written applications must include:

Applying for continuing treatment with omalizumab

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

Applying for recommencement of treatment

Apply to recommence authority approval to prescribe PBS-subsidised biological medicines to treat uncontrolled severe asthma in writing and either:

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

Paediatric patients (aged 6 to less than 12 years)

Applying for initial treatment

Apply for initial authority approval to prescribe PBS-subsidised omalizumab to treat uncontrolled severe allergic asthma in writing and either:

All written applications must include:

Applying for continuing treatment

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

More information

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

Page last updated: 1 July 2024.
QC 32021