Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p118
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 118/312)
Character Range: 16207995–16214678

a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
                                                                                                                           An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
                                                                                                                           Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
                                                                                                                           If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.
                                                                                                                           If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.
C15196              P15196         CN15196          Dostarlimab                                                            Advanced, metastatic or recurrent endometrial carcinoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures - Streamlined Authority Code 15196
                                                                                                                           Transitioning from non-PBS to PBS-subsidised treatment - Grandfather treatment
                                                                                                                           Patient must have deficient mismatch repair (dMMR) endometrial cancer, as determined by immunohistochemistry test; AND
                                                                                                                           Patient must have received non-PBS-subsidised treatment with this drug for this condition prior to 1 May 2024; AND
                                                                                                                           The condition must be, prior to initiation of non-PBS-subsidised treatment with this drug, unsuitable for at least one of the following: (i) curative surgical resection, (ii) curative radiotherapy; AND
                                                                                                                           The condition must be, prior to initiation of non-PBS-subsidised treatment 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 have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 1 prior to treatment initiation; AND
                                                                                                                           The treatment must be, at initiation of non-PBS-subsidised treatment with this drug, used in combination with platinum-containing chemotherapy; AND
                                                                                                                           Patient must not have developed disease progression while receiving non-PBS-subsidised treatment with this drug for this condition.
                                                                                                                           Patient must not be undergoing continuing PBS-subsidised treatment where this benefit is extending treatment beyond 36 cumulative months from the first administered dose, once in a lifetime.
C15199              P15199         CN15199          Risankizumab                                                           Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures
                                                                                                                           Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or