Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p62
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 62/69)
Character Range: 619606–627324

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:
                                                                                                                (a) details (date, unique identifying number/code or provider number) of the pathology report from an Approved Pathology Authority demonstrating evidence of residual invasive carcinoma in the breast and/or axillary lymph nodes following completion of surgery.
                                                                                                                The pathology report must be documented in the patient's medical records.
                                                                                                                If the application is submitted through HPOS form upload or mail, it must include:
                                                                                                                (i) details of the proposed prescription; 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).
                                                                                                                Increased maximum amounts may only be authorised where a patient's weight is greater than 125 kg.
C15819              P15819         Trastuzumab emtansine                                                        Early HER2 positive breast cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures
                                                                                                                Continuing adjuvant treatment
                                                                                                                Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                Patient must not have developed disease progression while being treated with this drug for this condition; 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
                                                                                                                The treatment must not extend beyond 42 weeks (14 cycles) duration under the initial and the continuing treatment restrictions combined.
                                                                                                                Increased maximum amounts may only be authorised where a patient's weight is greater than 125 kg.
C15820              P15820         Trastuzumab                                                                  Early HER2 positive breast cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 15820
                                                                                                                Initial treatment (3 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.
                                                                                                                Increased maximum amounts may only be authorised where a patient's weight is greater than 125 kg.
C15826                             Trastuzumab deruxtecan                                                       Metastatic (Stage IV) HER2 positive breast cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures
                                                                                                                Patient must have evidence of human epidermal growth factor (HER2) gene amplification as demonstrated by in situ hybridisation (ISH) in either the primary tumour/a metastatic lesion - establish this finding once only with the first PBS prescription; AND