Severe asthma

The PBS subsidises biological agents for patients with severe asthma.

Patient eligibility

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

Where the term biological agent 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 agents.

Section 100 arrangements

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.

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 agents, adult patients must be treated by either:

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

Paediatric patients 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

Adult and adolescent patients

Applying for initial treatment

Apply for initial authority approval to prescribe PBS subsidised biological agents to treat patients aged 12 years and older with severe asthma in writing and either:

All written applications must include the completed:

Applying for initial grandfather treatment

For patients aged 12 years and older who received non-PBS subsidised dupilumab treatment before 1 April 2021 for severe asthma, apply for initial grandfather authority approval in writing and either:

All written applications must include the completed:

Applying for change of treatment

Apply for authority approval to change PBS subsidised biological agents to treat patients aged 12 years and older with severe asthma in writing and either:

All written applications must include the completed:

Applying for continuing treatment

Apply for continuing authority approval to prescribe PBS subsidised biological agents to treat patients aged 12 years and older with severe asthma in writing and either:

All written applications must include the completed:

Applying for recommencement of treatment

Apply for authority approval to recommence PBS subsidised biological agents to treat 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:

  • the continuing treatment restriction where the patient is recommencing treatment with the same biological agent approved for the most recent PBS subsidised treatment
  • the initial 2 (change) treatment restriction where the patient is recommencing with a biological agent 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 the completed:

  • authority prescription form or forms
  • authority application form according to the relevant treatment restriction
  • relevant attachments.

Paediatric patients (under the age of 12 years)

Applying for initial treatment

Apply for initial authority approval to prescribe PBS subsidised omalizumab to treat paediatric patients with severe allergic asthma in writing and either:

All written applications must include the completed:

Applying for continuing treatment

Apply for continuing authority approval to prescribe PBS subsidised omalizumab to treat paediatric patients with severe allergic asthma in writing and either:

All written applications must include the completed:

Further information

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

Page last updated: 1 July 2021