Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p35
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 35/162)
Character Range: 14844130–14852144

must have indicated they are ready to cease smoking; AND
                                                                                                         Patient must not receive more than 2 x 12-week PBS-subsidised treatment courses per 12 month period; AND
                                                                                                         Patient must be undergoing concurrent counselling for smoking cessation through a comprehensive support and counselling program or is about to enter such a program at the time PBS-subsidised treatment is initiated.
                                                                                                         Details of the support and counselling program must be documented in the patient's medical records at the time treatment is initiated.
C14041              P14041         CN14041          Lenvatinib                                           Advanced, metastatic or recurrent endometrial carcinoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures - Streamlined Authority Code 14041
                                                                                                         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 receiving PBS-subsidised treatment with this drug for this condition; AND
                                                                                                         Patient must be undergoing combination therapy consisting of:
                                                                                                          (i) pembrolizumab, (ii) lenvatinib.  or
                                                                                                         Patient must be undergoing monotherapy with this drug due to a contraindication/intolerance to the other drug in the combination mentioned above, requiring temporary/permanent discontinuation; document the details in the patient's medical records.  or
                                                                                                         Patient must be undergoing monotherapy with this drug after completing an equivalent of 24 cumulative months of pembrolizumab treatment, measured from the first administered dose.
C14042              P14042         CN14042          Lenvatinib                                           Advanced, metastatic or recurrent endometrial carcinoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures - Streamlined Authority Code 14042
                                                                                                         Initial treatment
                                                                                                         Patient must have received prior treatment with platinum-based chemotherapy; AND
                                                                                                         The condition must be untreated with each of:
                                                                                                          (i) programmed cell death-1/ligand-1 (PD-1/PDL-1) inhibitor therapy, (ii) tyrosine kinase inhibitor 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
                                                                                                         Patient must be undergoing combination therapy consisting of:
                                                                                                          (i) pembrolizumab, (ii) lenvatinib.  or
                                                                                                         Patient must be undergoing monotherapy with this drug due to a contraindication/intolerance to the other drug in the combination mentioned above, requiring temporary/permanent discontinuation; document the details in the patient's medical records.
C14044              P14044         CN14044          Pembrolizumab                                        Advanced, metastatic or recurrent endometrial carcinoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures - Streamlined Authority Code 14044
                                                                                                         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 receiving PBS-subsidised treatment with this drug for this condition; AND
                                                                                                         Patient must be undergoing combination therapy consisting of:
                                                                                                          (i) pembrolizumab, (ii) lenvatinib; or
                                                                                                         Patient must be undergoing monotherapy with this drug due to a contraindication/intolerance to the other drug in the combination mentioned above, requiring temporary/permanent discontinuation; document the details in the patient's medical records; AND
                                                                                                         Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions; or
                                                                                                         Patient must