Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p65
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 65/69)
Character Range: 639172–646269

(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.
                                                                                                                Increased maximum amounts may only be authorised where a patient's weight is greater than 125 kg.
C15832                             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 undergoing initial treatment with this drug - the following are true: (i) this is the first prescription for this drug, (ii) this prescription seeks no more than 3 repeat prescriptions; OR
                                                                                                                Patient must be undergoing continuing treatment with drug - the following are true: (i) there has been an absence of further disease progression whilst on active treatment with this drug, (ii) this prescription does not seek to re-treat after disease progression, (iii) this prescription seeks no more than 8 repeat prescriptions.
                                                                                                                HER2-low is defined as an immunohistochemical (IHC) score of 1+ or an IHC score of 2+ and a negative result on in situ hybridization (ISH).
                                                                                                                Confirm that the following information is documented/retained in the patient's medical records once only with the first PBS prescription:
                                                                                                                1) Evidence of HER2-low status
                                                                                                                2) Details of prior drug regimens prescribed for the patient
                                                                                                                3) Cardiac function test results
                                                                                                                Increased maximum amounts may only be authorised where a patient's weight is greater than 125 kg.
C16053              P16053         Avelumab                                                                     Stage IV (metastatic) Merkel Cell Carcinoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures - Streamlined Authority Code 16053

                                                                                                                Initial treatment

                                                                                                                The treatment must be the sole PBS-subsidised therapy for this condition; AND

                                                                                                                The treatment must not exceed a