Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p80
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 80/162)
Character Range: 15088629–15096384

P14323         CN14323          Azacitidine                                          Acute Myeloid Leukaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures
                                                                                                         Dose escalation therapy - Continuing treatment
                                                                                                         Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                         Patient must have, in order to extend the dose schedule as per the TGA-approved Product Information, between 5% to 15% blasts in either the:
                                                                                                          (i) bone marrow, (ii) peripheral blood, in conjunction with clinical assessment; AND
                                                                                                         Patient must not be receiving concomitant PBS-subsidised treatment with midostaurin.
                                                                                                         Authority applications 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) a completed authority prescription form; 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)
                                                                                                         (c) details (date, unique identifying number/code or provider number) of the pathology report from an Approved Pathology Authority demonstrating the blast percentage.
                                                                                                         All reports must be documented in the patient's medical records.
C14324              P14324         CN14324          Pembrolizumab                                        Recurrent, unresectable or metastatic triple negative breast cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 14324
                                                                                                         The condition must have been (up until this drug therapy) untreated in the unresectable/metastatic disease stage; AND
                                                                                                         The condition must have been (up until this drug therapy) untreated with programmed cell death-1/ligand 1 (PD-1/PD-L1) inhibitor therapy in breast cancer; AND
                                                                                                         Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 1 prior to treatment initiation; AND
                                                                                                         The treatment must be in combination with chemotherapy; AND
                                                                                                         The condition must have both:
                                                                                                          (i) programmed cell death ligand 1 (PD-L1) expression confirmed by a validated test, (ii) a Combined Positive Score (CPS) of at least 10 at treatment initiation; AND
                                                                                                         Patient must be undergoing initial treatment with this drug - this is the first prescription for this drug; or
                                                                                                         Patient must be undergoing continuing treatment with this drug - both the following are true:
                                                                                                          (i) the condition has not progressed on active treatment with this drug, (ii) this prescription does not extend PBS subsidy beyond 24 cumulative months from the first administered dose; AND
                                                                                                         Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions.  or
                                                                                                         Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.
C14326              P14326         CN14326          Obinutuzumab                                         Chronic lymphocytic leukaemia (CLL)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 14326
                                                                                                         Combination use with chlorambucil only
                                                                                                         The condition must be CD20 positive; AND
                                                                                                         The condition must be previously untreated; AND
                                                                                                         The