Cystic fibrosis

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

Patient eligibility

Treatment with ivacaftor and lumacaftor+ivacaftor can be subsidised through the Pharmaceutical Benefits Scheme (PBS) 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 outlines restrictions for prescribing ivacaftor and lumacaftor+ivacaftor.

Section 100 arrangements

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

  • an approved private hospital
  • a public participating hospital, or
  • a public hospital

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

Treatment specifics

Treatment must be prescribed:

  • 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

Ivacaftor

Initial treatment

Make all initial applications for authority approval to prescribe PBS subsidised ivacaftor for the treatment of cystic fibrosis in writing and:

All applications must include the completed:

Continuing treatment

Make all applications for continuing authority approval to prescribe PBS subsidised ivacaftor for the treatment of cystic fibrosis in writing and:

All applications must include the completed:

Lumacaftor+ivacaftor

Initial treatment

Make all initial applications for authority approval to prescribe PBS subsidised lumacaftor+ivacaftor for the treatment of cystic fibrosis in writing and:

All applications must include the completed:

Continuing treatment

Make all applications for continuing authority approval to prescribe PBS subsidised lumacaftor+ivacaftor for the treatment of cystic fibrosis in writing and:

All applications must include a completed:

Further information

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

Page last updated: 1 October 2018