Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p28
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 28/69)
Character Range: 385237–392525

development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
                                                                                                                Oligo‑secretory and non‑secretory patients are defined as having active disease with less than 10 g per L serum M protein.
C13018              P13018         Pertuzumab                                                                   Metastatic (Stage IV) HER2 positive breast cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures
                                                                                                                Initial treatment
                                                                                                                Patient must have evidence of human epidermal growth factor receptor 2 (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) either in the primary tumour or a metastatic lesion, confirmed through a pathology report from an Approved Pathology Authority; AND
                                                                                                                Patient must have a WHO performance status of 0 or 1; AND
                                                                                                                Patient must not have received prior anti‑HER2 therapy for this condition; AND
                                                                                                                Patient must not have received prior chemotherapy for this condition; AND
                                                                                                                The treatment must be in combination with trastuzumab and a taxane; AND
                                                                                                                The treatment must not be in combination with nab‑paclitaxel; AND
                                                                                                                The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.
                                                                                                                Details (date, unique identifying number/code, or provider number) of the pathology report from an Approved Pathology Authority confirming evidence of HER2 gene amplification in the primary tumour or a metastatic lesion by in situ hybridisation (ISH) must be provided at the time of application.
                                                                                                                The pathology report must be documented in the patient's medical records.
                                                                                                                Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to seeking the initial authority approval.
C13134              P13134         Brentuximab vedotin                                                          CD30 positive peripheral T‑cell lymphoma, non‑cutaneous type                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Written Authority Required procedures
                                                                                                                Initial treatment
                                                                                                                Patient must have histological confirmation of CD30 expression in at least 3% of malignant cells; AND
                                                                                                                The treatment must be for first line therapy for this condition; AND
                                                                                                                The treatment must be for curative intent; AND
                                                                                                                The treatment must be in combination with cyclophosphamide, doxorubicin and prednisone; AND
                                                                                                                The treatment must not be more than 6 treatment cycles under this restriction in a lifetime.
                                                                                                                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 and must include:
                                                                                                                (a) details (date, unique identifying number/code or provider number) of a histology report on the tumour sample from an Approved Pathology Authority showing CD30 positivity of at least 3% malignant cells; and
                                                                                                                (b) The date of initial diagnosis of Peripheral T‑cell lymphoma.
                                                                                                                All reports must be documented in the patient's medical records.
                                                                                                                If the application is submitted through HPOS form upload or mail, it must include:
                                                                                                                (i) A completed authority prescription form; and
                                                                                                                (ii) A completed authority application form relevant to the indication and treatment