Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p221
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 221/312)
Character Range: 16874604–16882389

a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.
                                                                                                                           The following information must be provided by the prescriber at the time of application:
                                                                                                                           (a) 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).
                                                                                                                           (b) dates of treatment with trastuzumab and pertuzumab;
                                                                                                                           (c) date of demonstration of progression following treatment with trastuzumab and pertuzumab; or
                                                                                                                           (d) date of demonstration of progression and date of completion of adjuvant trastuzumab treatment.
                                                                                                                           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.
C15831              P15831         CN15831          Trastuzumab                                                            Early HER2 positive breast cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures - Streamlined Authority Code 15831
                                                                                                                           Initial treatment (weekly regimen)
                                                                                                                           Patient must have undergone surgery (adjuvant) or be preparing for surgery (neoadjuvant); 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; AND
                                                                                                                           Patient must not receive more than 52 weeks of combined PBS-subsidised and non-PBS-subsidised therapy; OR
                                                                                                                           Patient must not receive more than 52 weeks of combined trastuzumab and trastuzumab emtansine therapy if adjuvant trastuzumab emtansine therapy has been discontinued due to intolerance.
                                                                                                                           HER2 positivity must be demonstrated by in situ hybridisation (ISH).
                                                                                                                           Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to initiating treatment with this drug for this condition.
C15832              P15832         CN15832          Trastuzumab deruxtecan                                                 Unresectable and/or metastatic HER2-low breast cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures
                                                                                                                           Patient must have evidence of human epidermal growth factor receptor 2 (HER2)-low disease; AND
                                                                                                                           Patient must have received prior chemotherapy in the metastatic setting; OR
                                                                                                                           Patient must have developed disease recurrence during or within 6 months of completing adjuvant chemotherapy; AND
                                                                                                                           Patient must have received or be ineligible for endocrine therapy in the metastatic setting, if hormone receptor positive; AND
                                                                                                                           Patient must have, at the time of initiating treatment with this drug, a WHO performance status no higher than 1; AND
                                                                                                                           The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND
                                                                                                                           The treatment must not be prescribed where any of the following is present: (i) left ventricular ejection fraction of less than 50%, (ii) symptomatic heart failure; confirm cardiac function testing for the first PBS prescription only.
                                                                                                                           Patient must be