Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p2
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 2/161)
Character Range: 13833632–13840486

ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.
                                                                                   Authority applications for 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
                                                                                   (i) 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); and
                                                                                   (ii) date of last treatment with a taxane and total number of cycles; or
                                                                                   (iii) dates of treatment with trastuzumab and pertuzumab; or
                                                                                   (iv) date of demonstration of progression during or within 6 months of completing treatment with trastuzumab and pertuzumab; or
                                                                                   (v) date of demonstration of progression during or within 6 months of completing treatment with trastuzumab
                                                                                   If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, please provide details of the degree of this toxicity at the time of application.
                                                                                   All reports 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.
                                                                                   If the application is submitted through HPOS upload or mail, it must include
                                                                                   (a) a completed authority prescription form; and
                                                                                   (b) a completed authority form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
C13008              P13008         CN13008          Zanubrutinib                   Waldenstrom macroglobulinaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures
                                                                                   Initial treatment
                                                                                   The condition must have relapsed or be refractory to at least one prior chemo-immunotherapy; or
                                                                                   Patient must be unsuitable for treatment with chemo-immunotherapy, defined by a Cumulative Illness Rating Scale of 6 or greater, if untreated (i.e. treatment-naive) for this condition; AND
                                                                                   The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                   Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND
                                                                                   Patient must be untreated with a Bruton's tyrosine kinase inhibitor for this condition.  or
                                                                                   Patient must have developed intolerance to another Bruton's tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal, when treated for this condition.
C13018              P13018         CN13018          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