Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p110
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 110/312)
Character Range: 16155452–16162288

methylprednisolone or equivalent) is an acceptable reason.
                                                                                                                           The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
                                                                                                                           The stated maximum quantity of 5 with zero repeats is intended for a patient undergoing the loading dose regimen of 150 mg administered at weeks 0, 1, 2, 3, and 4 (a total of 5 doses) followed by monthly administration thereafter.
                                                                                                                           State in the application whether a loading dose regimen is intended or not.
                                                                                                                           Where a loading dose regimen is intended, request a maximum quantity of 5 and zero repeats to cover doses at weeks 0, 1, 2, 3 and 4. Doses at week 8, 12, and 16 can be sought under the relevant 'Balance of supply' listing.
                                                                                                                           Where no loading dose regimen is intended, request a maximum quantity of 1 and seek an increase in the number of repeats from zero to 4 repeats to cover dosing at weeks 4, 8, 12 and 16. Where increased repeats are sought, the maximum quantity sought must not be greater than 1.
C15163              P15163         CN15163          Dostarlimab                                                            Advanced, metastatic or recurrent endometrial carcinoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures - Streamlined Authority Code 15163
                                                                                                                           Initial treatment covering the first 6 treatment cycles
                                                                                                                           Patient must have deficient mismatch repair (dMMR) endometrial cancer, as determined by immunohistochemistry test; AND
                                                                                                                           The condition must be unsuitable for at least one of the following: (i) curative surgical resection, (ii) curative radiotherapy; AND
                                                                                                                           The treatment must be initiated in combination with platinum-containing chemotherapy; AND
                                                                                                                           The condition must be, at treatment initiation with this drug, either: (i) untreated with systemic therapy, (ii) treated with neoadjuvant/adjuvant systemic therapy, but the cancer has recurred or progressed after more than 6 months from the last dose of systemic therapy; AND
                                                                                                                           Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for this condition; AND
                                                                                                                           Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 1 prior to treatment initiation.
C15164              P15164         CN15164          Ribociclib                                                             Locally advanced or metastatic breast cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures
                                                                                                                           Continuing 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 be in combination with one of: (i) non-steroidal aromatase inhibitor, (ii) fulvestrant; AND
                                                                                                                           The