Document ID: chunk:federal_register_of_legislation:F2024L01524:schedule:1:p16
Version: federal_register_of_legislation:F2024L01524
Segment Type: schedule
Provision Reference: sch 1 (pt 16/38)
Character Range: 44739–49193

4, Part 1, entry for Circumstances Code "C15819"
omit entry for Circumstances Code "C15819" and substitute:
C15819  P15819  CN15819  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.

[124] Schedule 4, Part 1, entry for Circumstances Code "C15820"
omit entry for Circumstances Code "C15820" and substitute:
C15820  P15820  CN15820  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.

[125] Schedule 4, Part 1, entry for Circumstances Code "C15826"
omit entry for Circumstances Code "C15826" and substitute:
C15826  P15826  CN15826  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
                                                 The condition must have progressed following treatment with at least one prior HER2 directed regimen for metastatic breast cancer; OR
                                                 The condition must have, at the time of treatment initiation with this drug, progressed during/within 6 months following adjuvant treatment with a HER2 directed therapy; 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