Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p103
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 103/162)
Character Range: 15203442–15210575

for permanent withdrawal of treatment.
                                                                                                         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 within this treatment cycle.
C14403              P14403         CN14403          Pembrolizumab                                        Advanced carcinoma of the cervix                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures - Streamlined Authority Code 14403
                                                                                                         Initial treatment
                                                                                                         The condition must be at least one of (i) persistent carcinoma, (ii) recurrent carcinoma, (iii) metastatic carcinoma of the cervix; AND
                                                                                                         The condition must be unsuitable for curative treatment with either of (i) surgical resection, (ii) radiation; AND
                                                                                                         Patient must have WHO performance status no higher than 1; AND
                                                                                                         Patient must not have received prior treatment for this PBS indication; AND
                                                                                                         Patient must be undergoing concomitant treatment with chemotherapy, containing a minimum of:
                                                                                                          (i) a platinum-based chemotherapy agent, plus (ii) paclitaxel; AND
                                                                                                         Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions.  or
                                                                                                         Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.
C14404              P14404         CN14404          Pembrolizumab                                        Advanced carcinoma of the cervix                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures - Streamlined Authority Code 14404
                                                                                                         Continuing treatment
                                                                                                         Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                         The condition must not have progressed while receiving PBS-subsidised treatment with this drug for this condition; AND
                                                                                                         The treatment must not exceed a total of (i) 24 months, (ii) 35 doses (based on a 3-weekly dose regimen), (iii) 17 doses (based on a 6-weekly dose regimen) whichever comes first from the first dose of this drug regardless if it was PBS/non-PBS subsidised; AND
                                                                                                         Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions.  or
                                                                                                         Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.
C14415              P14415         CN14415          Ustekinumab                                          Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Written Authority Required procedures
                                                                                                         Initial treatment - Initial 1, Face, hand, foot (new patient)
                                                                                                         Patient must have severe chronic plaque psoriasis of the face, or palm of a hand or sole of a foot where the plaque or plaques have been present for at least 6 months from the time of initial diagnosis; AND
                                                                                                         Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
                                                                                                         Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 treatments:
                                                                                                          (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at