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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
Please note: You don’t need to complete this application in writing when you request PBS authority online.
Applications for initial authority approval to prescribe PBS-subsidised ivacaftor to treat cystic fibrosis can be made:
- using the Online PBS Authorities system
- in writing and use HPOS Form upload
- in writing and mail to PBS Complex Drugs Programs.
All written applications must include:
- details of the proposed prescription or prescriptions
- the completed cystic fibrosis - ivacaftor - initial authority application
- relevant attachments.
Applying for continuing treatment
Please note: You don’t need to complete this application in writing when you request PBS authority online.
Applications for continuing authority approval to prescribe PBS-subsidised ivacaftor to treat cystic fibrosis can be made:
- using the Online PBS Authorities system
- in writing and use HPOS Form upload
- in writing and mail to PBS Complex Drugs Programs.
All written applications must include:
- details of the proposed prescription or prescriptions
- the completed cystic fibrosis - ivacaftor - continuing authority application
- relevant attachments.
Lumacaftor+ivacaftor or tezacaftor+ivacaftor
Applying for initial treatment
Please note: You don’t need to complete this application in writing when you request PBS authority online.
Applications for initial authority approval to prescribe PBS-subsidised lumacaftor+ivacaftor or tezacaftor+ivacaftor to treat cystic fibrosis can be made:
- using the Online PBS Authorities system
- in writing and use HPOS Form upload
- in writing and mail to PBS Complex Drugs Programs.
All written applications must include:
- details of the proposed prescription or prescriptions
- the completed cystic fibrosis - lumacaftor+ivacaftor or tezacaftor+ivacaftor - initial authority application
- relevant attachments.
Applying for continuing treatment
Please note: You don’t need to complete this application in writing when you request PBS authority online.
Applications for continuing authority approval to prescribe PBS-subsidised lumacaftor+ivacaftor or tezacaftor+ivacaftor to treat cystic fibrosis can be made:
- using the Online PBS Authorities system
- in writing and use HPOS Form upload
- in writing and mail to PBS Complex Drugs Programs.
All written applications must include:
- details of the proposed prescription or prescriptions
- the completed cystic fibrosis - lumacaftor+ivacaftor or tezacaftor+ivacaftor - continuing authority application
- relevant attachments.
Elexacaftor+tezacaftor+ivacaftor
Applying for initial treatment
Please note: You don’t need to complete this application in writing when you request PBS authority online.
Applications for initial authority approval to prescribe PBS-subsidised elexacaftor+tezacaftor+ivacaftor to treat cystic fibrosis can be made:
- using the Online PBS Authorities system
- in writing and use HPOS Form upload
- in writing and mail to PBS Complex Drugs Programs.
All written applications must include:
- details of the proposed prescription or prescriptions
- the completed cystic fibrosis - elexacaftor+tezacaftor+ivacaftor - initial authority application
- relevant attachments.
Applying for continuing treatment
Please note: You don’t need to complete this application in writing when you request PBS authority online.
Applications for continuing authority approval to prescribe PBS-subsidised elexacaftor+tezacaftor+ivacaftor to treat cystic fibrosis can be made:
- using the Online PBS Authorities system
- in writing and use HPOS Form upload
- in writing and mail to PBS Complex Drugs Programs.
All written applications must include:
- details of the proposed prescription or prescriptions
- the completed cystic fibrosis - elexacaftor+tezacaftor+ivacaftor - continuing authority application
- relevant attachments.
More information
Call the PBS Complex Drugs Programs enquiry line for more information.