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

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.

Treatment specifics

To be eligible for PBS-subsidised treatment with ivacaftor, lumacaftor+ivacaftor, tezacaftor+ivacaftor or elexacaftor+tezacaftor+ivacaftor, 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

Applying for initial treatment

Ivacaftor

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

upload through Health Professional Online Services (HPOS)
post to the PBS Complex Drugs Programs.

All written applications must include the completed:

authority prescription form or forms
cystic fibrosis - ivacaftor - initial authority application
relevant attachments.

Lumacaftor+ivacaftor or tezacaftor+ivacaftor

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

upload through HPOS
post to the PBS Complex Drugs Programs.

All written applications must include the completed:

authority prescription form or forms
cystic fibrosis - lumacaftor+ivacaftor or tezacaftor+ivacaftor - initial authority application
relevant attachments.

Elexacaftor+tezacaftor+ivacaftor

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

upload through HPOS
post to the PBS Complex Drugs Programs.

All written applications must include the completed:

authority prescription form or forms
cystic fibrosis - elexacaftor+tezacaftor+ivacaftor - initial PBS authority application
relevant attachments.

Applying for continuing treatment

Ivacaftor

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

upload through HPOS
post to the PBS Complex Drugs Programs.

All written applications must include the completed:

authority prescription form or forms
cystic fibrosis - ivacaftor continuing authority application
relevant attachments.

Lumacaftor+ivacaftor or tezacaftor+ivacaftor

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