Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p45
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 45/69)
Character Range: 502429–509621

multidisciplinary team, but the PBS authority application must be sought by the treating haematologist); AND
                                                                                                                Patient must be undergoing concomitant treatment limited to each of: (i) bortezomib, (ii) cyclophosphamide, (iii) dexamethasone, at certain weeks of treatment as outlined in the drug's approved Product Information.
                                                                                                                The authority application must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail, and must include:
                                                                                                                Details of the histological evidence supporting the diagnosis of systemic light chain amyloidosis, limited to: (i) the name of pathologist/pathology provider, (ii) the site of biopsy
                                                                                                                If the application is submitted through HPOS form upload or mail, it must include:
                                                                                                                (i) A completed authority prescription form; and
                                                                                                                (ii) 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).
C14027              P14027         Pembrolizumab                                                                Advanced, metastatic or recurrent endometrial carcinoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures ‑ Streamlined Authority Code 14027
                                                                                                                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.
                                                                                                                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 be undergoing treatment with this drug administered once every 6 weeks ‑ prescribe up to 3 repeat prescriptions.
C14044              P14044         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.
                                                                                                                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 be undergoing treatment with this drug administered once every 6 weeks ‑ prescribe up to 3 repeat prescriptions; AND
                                                                                                                Patient must not