Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p64
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 64/69)
Character Range: 632414–639662

symptomatic heart failure.
                                                                                                                A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.
                                                                                                                The treatment must not exceed a lifetime total of one continuous course for this PBS indication.
                                                                                                                Increased maximum amounts may only be authorised where a patient's weight is greater than 125 kg.
C15828              P15828         Trastuzumab emtansine                                                        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
                                                                                                                The condition must have progressed following treatment with pertuzumab and trastuzumab in combination; OR
                                                                                                                The condition must have progressed during or within 6 months of completing adjuvant therapy with trastuzumab; AND
                                                                                                                Patient must have a WHO performance status of 0 or 1; AND
                                                                                                                The treatment must be the sole PBS-subsidised therapy 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.
                                                                                                                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.
                                                                                                                Increased maximum amounts may only be authorised where a patient's weight is greater than 125 kg.
C15831              P15831         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