Cystic fibrosis

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

Patient eligibility

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

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 ivacaftor, lumacaftor+ivacaftor, tezacaftor+ivacaftor and elexacaftor+tezacaftor+ivacaftor.

Section 100 arrangements

ivacaftor, lumacaftor+ivacaftor, tezacaftor+ivacaftor and elexacaftor+tezacaftor+ivacaftor

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.

Treatment specifics

To be eligible for PBS-subsidised treatment with these medications, patients must be treated by a specialist respiratory physician with expertise in cystic fibrosis. Consultation with a specialist respiratory physician with expertise in cystic fibrosis is required if the patient isn’t able to attend due to geographic isolation.

Treatment must take place in a clinic or centre with expertise in cystic fibrosis, or in consultation with such a clinic or centre.

Authority applications

ivacaftor

Applying for initial treatment

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

All written applications must include:

Applying for continuing treatment

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

All written applications must include:

lumacaftor+ivacaftor or tezacaftor+ivacaftor

Applying for initial treatment

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

All written applications must include:

Applying for continuing treatment

Apply for continuing authority approval to prescribe PBS-subsidised lumacaftor+ivacaftor or tezacaftor+ivacaftor to treat cystic fibrosis in writing and either:

All written applications must include:

elexacaftor+tezacaftor+ivacaftor

Applying for initial treatment

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

All written applications must include:

Applying for continuing treatment

Apply for continuing authority approval to prescribe PBS-subsidised elexacaftor+tezacaftor+ivacaftor to treat cystic fibrosis in writing and either:

All written applications must include:

More information

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

Page last updated: 17 June 2024.
QC 31871