The Pharmaceutical Benefits Scheme (PBS) subsidises ivacaftor for patients with cystic fibrosis.
Authority to provide ivacaftor for the treatment of cystic fibrosis is available under Section 100 of the National Health Act 1953.
Patients must be assessed through a cystic fibrosis clinic or centre which is under the control of specialist respiratory physicians with experience and expertise in the management of cystic fibrosis. If attendance at the unit is not possible because of geographical isolation, management, including prescribing may be in consultation with such a unit. The patients must be registered with the Australian Cystic Fibrosis Database Registry.
Section 100 arrangements
This item is only available to a patient who is attending either:
- an approved private hospital
- a participating public hospital or
- a public hospital
the patient must be either a
- day admitted patient
- non-admitted patient or
- patient on discharge
This item is not available as a PBS benefit for in-patients of the hospital. The hospital provider number must be included on the application form.
The Schedule of Pharmaceutical Benefits on the PBS website outlines restrictions for prescribing ivacaftor to patients.
Initial and continuing treatment
All patients starting treatment with ivacaftor must meet all aspects of the restriction. Evidence must be provided of a G551D mutation in the cystic fibrosis transmembrane conductase regulator (CFTR) gene on at least 1 allele or other gating (class III) mutation in the CFTR gene on at least 1 allele.
For all applications submit:
- the result of a FEV1 measurement performed in an accredited pulmonary function laboratory
- a copy of a sweat chloride test
- a copy of current medication history, including any CYP3A4 inhibitors and CYP3A4 inducers
Schedule item details
Dose - Ivacaftor is available as a 150mg tablet, in a pack size of 56 tablets.
A maximum of 5 repeats will be authorised. Dosage is dependent on whether the patient is taking strong, moderate, or no CYP3A4 inhibitors. Patients taking CYP3A4 inducers are not eligible for PBS subsidised ivacaftor.
Patients must meet the relevant criteria as indicated in the restrictions and be eligible for the Pharmaceutical Benefits Scheme.
Lodging an application
- lodge Cystic Fibrosis - Ivacaftor Initial PBS Authority Application Supporting Application (PB120) for a patient starting initial treatment for cystic fibrosis. The patient and prescriber acknowledgements must be completed
- lodge Cystic Fibrosis - Ivacaftor - Continuing PBS Authority Application Supporting Information (PB126) for a patient continuing treatment for cystic fibrosis
For more information contact us on the Complex Drugs enquiry line.