Document ID: chunk:federal_register_of_legislation:F2024L01524:schedule:1:p18
Version: federal_register_of_legislation:F2024L01524
Segment Type: schedule
Provision Reference: sch 1 (pt 18/38)
Character Range: 52749–57281

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.

[128] Schedule 4, Part 1, entry for Circumstances Code "C15831"
omit entry for Circumstances Code "C15831" and substitute:
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.

[129] Schedule 4, Part 1, entry for Circumstances Code "C15832"
omit entry for Circumstances Code "C15832" and substitute:
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