Orkambi (Lumacaftor + ivacaftor)
lumacaftor 100 mg + ivacaftor 125 mg tablet, 112 · ORAL · PBS code 11464J
AUTHORITY_REQUIREDWhat it costs
AU$16921.88 PBS-determined price per 112 units
Most patients pay only the standard PBS co-payment, not the full price above — up to AU$25.00 per script (general) or AU$7.70 (concession/Safety Net) in 2026. The figure above is what the PBS pays the pharmacy; the Australian Government subsidises the rest. Always confirm the current amount with your pharmacist.
- • First listed on the PBS: 2018-10-01.
- • Repeats: 5.
- • PBS program: HS.
Eligibility criteria for subsidised access
The following is the government's own wording from the PBS Schedule, shown unchanged.
Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1
Cystic fibrosis
Initial treatment
Must be treated 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; AND
Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND
Patient must be homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene; AND
The treatment must be given concomitantly with standard therapy for this condition; AND
Patient must have either chronic sinopulmonary disease or gastrointestinal and nutritional abnormalities; AND
The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND
Patient must be aged between 6 and 11 years inclusive.
This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.
The authority application must be in writing and must include:
(1) details of the proposed prescription; and
(2) a completed Cystic Fibrosis Authority Application Supporting Information Form; and
(3) details of the pathology report substantiating the patient being homozygous for the F508del mutation on the CFTR gene - quote each of the: (i) name of the pathology report provider, (ii) date of pathology report, (iii) unique identifying number/code that links the pathology result to the individual patient; and
(4) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.
Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1
Cystic fibrosis
Continuing treatment
Must be treated 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; AND
Must be treated in a centre with expertise in cystic fibrosis or in consultation with a centre with expertise in cystic fibrosis if attendance is not possible due to geographic isolation; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
The treatment must be the sole PBS-subsidised cystic fibrosis transmembrane conductance regulator (CFTR) modulator therapy for this condition; AND
The treatment must be given concomitantly with standard therapy for this condition; AND
Patient must be aged between 6 and 11 years inclusive.
This pharmaceutical benefit is not PBS-subsidised for this condition in a patient who is currently receiving one of the strong CYP3A4 inducers outlined in the Product Information.
The authority application must be in writing and must include:
(1) details of the proposed prescription; and
(2) a completed Cystic Fibrosis Continuing Authority Application Supporting Information Form; and
(3) current CYP3A4 inhibitors, CYP3A4 inducers and IV antibiotics.
Sponsor: Vertex Pharmaceuticals (Australia) Pty. Ltd. ABN 34 160 157 157
Not medical advice. Voxsanity republishes public PBS data in plain English. PBS listing status and criteria can change; always confirm current subsidised availability with your doctor or pharmacist.
Source: Pharmaceutical Benefits Scheme (PBS), © Commonwealth of Australia. Data used and redistributed under permission; not modified from its original wording where displayed verbatim.