Rozlytrek (Entrectinib)
entrectinib 200 mg capsule, 90 · ORAL · PBS code 12092K
AUTHORITY_REQUIREDWhat it costs
AU$6771.89 PBS-determined price per 90 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: 2020-08-01.
- • Repeats: 3.
- • PBS program: GE.
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
Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Initial treatment
The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND
The condition must be non-squamous type non-small cell lung cancer (NSCLC) or not otherwise specified type NSCLC; AND
Patient must have a WHO performance status of 2 or less; AND
Patient must have evidence of c-ROS proto-oncogene 1 (ROS1) gene rearrangement in tumour material, defined as either: (i) 15% (or greater) positive cells by fluorescence in situ hybridisation (FISH) testing, (ii) positive next generation sequencing (NGS) testing; AND
Patient must not have received prior treatment with a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor for this condition; or
Patient must have developed intolerance to a c-ROS proto-oncogene 1 (ROS1) receptor tyrosine kinase inhibitor necessitating permanent treatment withdrawal.
Applications for authorisation of initial treatment must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail.
If the application is submitted through HPOS form upload or mail, it must include:
(a) details of the proposed prescription; and
(b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
The following must be documented in the patient's medical records:
(a) evidence of c-ROS proto-oncogene 1 (ROS1) gene rearrangement in tumour material.
Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1
Stage IIIB (locally advanced) or Stage IV (metastatic) non-small cell lung cancer (NSCLC)
Continuing treatment
The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition; AND
Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition.
Sponsor: Roche Products Pty Ltd ABN 70 000 132 865
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.