Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p3
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 3/161)
Character Range: 13840079–13846927

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.
C13022              P13022         CN13022          Ponatinib                      Chronic Myeloid Leukaemia (CML)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Written Authority Required procedures
                                                                                   First continuing treatment
                                                                                   Patient must have received initial PBS-subsidised treatment with this drug for this condition; AND
                                                                                   The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                   Patient must have demonstrated a major cytogenic response of less than 35% Philadelphia positive bone marrow cells in the preceding 18 months and thereafter at 12 monthly intervals.  or
                                                                                   Patient must demonstrated a peripheral blood level of BCR-ABL of less than 1% on the international scale in the preceding 18 months and thereafter at 12 monthly intervals.
                                                                                   The first continuing application for authorisation must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail and must include
                                                                                   (i) details (date, unique identifying number/code or provider number) of the pathology report from an Approved Pathology Authority demonstrating a major cytogenetic response [see Note explaining definitions of response]; or
                                                                                   (ii) details (date, unique identifying number/code or provider number) of the pathology report from an Approved Pathology Authority demonstrating a peripheral blood level of BCR-ABL of less than 1% on the international scale [see Note explaining definitions of response].
                                                                                   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 phase (the latest version is located on the website specified in the Administrative Advice).
C13025              P13025         CN13025          Ponatinib                      Chronic Myeloid Leukaemia (CML)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Written Authority Required procedures
                                                                                   Initial treatment
                                                                                   The treatment must