Cystic fibrosis

The PBS subsidises ivacaftor and lumacaftor+ivacaftor for patients with cystic fibrosis.

Patient eligibility

The Pharmaceutical Benefits Scheme (PBS) subsidises treatment with ivacaftor and lumacaftor+ivacaftor under the National Health Act 1953, section 100 for a patient with cystic fibrosis.

Patients must be eligible for the PBS and meet the relevant restrictions criteria.

The Schedule of Pharmaceutical Benefits on the PBS website outlines the restrictions for prescribing ivacaftor and lumacaftor+ivacaftor.

Section 100 arrangements

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

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

You must include the hospital name and provider number on the authority application form. These items aren't PBS subsidised for hospital in-patients. 

Treatment specifics

To be eligible for PBS subsidised treatment with ivacaftor and lumacaftor+ivacaftor, the patient must be treated by a specialist respiratory physician with expertise in cystic fibrosis, or in consultation with a specialist respiratory physician with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.

Treatment must also be at a clinic or centre with expertise in cystic fibrosis, or in consultation with a clinic or centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation.

The patient must be registered in the Australian Cystic Fibrosis Database Registry.

Applications

Initial treatment

Ivacaftor

Apply for initial authority approval to prescribe PBS subsidised ivacaftor to treat cystic fibrosis in writing and either:

All applications must include the completed:

Lumacaftor+ivacaftor

Apply for initial authority approval to prescribe PBS subsidised lumacaftor+ivacaftor to treat cystic fibrosis in writing and either:

All applications must include the completed:

Continuing treatment

Ivacaftor

Apply for authority approval to continue PBS subsidised ivacaftor to treat cystic fibrosis in writing and either:

All applications must include the completed:

Lumacaftor+ivacaftor

Apply for authority approval to continue PBS subsidised lumacaftor+ivacaftor to treat cystic fibrosis in writing and either:

All applications must include a completed:

More information

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

Page last updated: 26 July 2019