Document ID: chunk:federal_register_of_legislation:F2024L01524:schedule:1:p19
Version: federal_register_of_legislation:F2024L01524
Segment Type: schedule
Provision Reference: sch 1 (pt 19/38)
Character Range: 56594–61257

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
                                                 Patient must have developed disease recurrence during or within 6 months of completing adjuvant chemotherapy; AND
                                                 Patient must have received or be ineligible for endocrine therapy in the metastatic setting, if hormone receptor positive; 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 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.
                                                 HER2-low is defined as an immunohistochemical (IHC) score of 1+ or an IHC score of 2+ and a negative result on in situ hybridization (ISH).
                                                 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-low status
                                                 2) Details of prior drug regimens prescribed for the patient
                                                 3) Cardiac function test results

[130] Schedule 4, Part 1, omit entry for Circumstances Code "C16067"
[131] Schedule 4, Part 1, after entry for Circumstances Code "C16148"
insert:
C16151  P16151  CN16151  Nivolumab with relatlimab     Unresectable Stage III or Stage IV malignant melanoma                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures - Streamlined Authority Code 16151
                                                       Continuing treatment
                                                       Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                       The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                       Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition.
                                                       Patients must only receive a maximum of 480 mg nivolumab and 160 mg relatlimab every four weeks under a flat dosing regimen.
                                                       The prescribed dose must be according to the Therapeutic Goods Administration (TGA) Product Information.
                                                       The prescription must include the amount of nivolumab with relatlimab (Opdualag) that is appropriate to be prescribed for the patient. For the purposes of PBS subsidy,