Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p220
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 220/312)
Character Range: 16867585–16875115

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.
                                                                                                                           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 gene amplification (evidence obtained in relation to past PBS treatment is acceptable).
                                                                                                                           2) Details of prior HER2 directed drug regimens prescribed for the patient.
                                                                                                                           3) Cardiac function test results (evidence obtained in relation to past PBS treatment is acceptable).
C15827              P15827         CN15827          Trastuzumab emtansine                                                  Metastatic (Stage IV) HER2 positive breast cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures
                                                                                                                           Continuing treatment
                                                                                                                           Patient must have previously received PBS-subsidised treatment with this drug for metastatic (Stage IV) HER2 positive breast cancer; AND
                                                                                                                           Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; 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.
                                                                                                                           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.
C15828              P15828         CN15828          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