Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p30
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 30/161)
Character Range: 14016973–14024204

or
                                                                                   (iii) Limitations due to cumulative prior radiotherapy dose; or
                                                                                   (iv) Progressive disease despite prior irradiation of locally advanced BCC.
                                                                                   For patients with locally advanced BCC, written confirmation from a surgically qualified clinician demonstrating inappropriateness for surgery or written confirmation from a radiation oncologist demonstrating inappropriateness for curative radiotherapy should be kept in the patient's medical records.
C13261              P13261         CN13261          Brentuximab vedotin            CD30 positive systemic anaplastic large cell lymphoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures
                                                                                   Continuing treatment
                                                                                   Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition; AND
                                                                                   Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                   The treatment must not exceed 12 cycles under this restriction in a lifetime.
C13267              P13267         CN13267          Decitabine with cedazuridine   Myelodysplastic syndrome                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures
                                                                                   Initial treatment
                                                                                   The condition must be myelodysplastic syndrome confirmed through a bone marrow biopsy report and full blood examination; AND
                                                                                   The condition must be classified as Intermediate-2 according to the International Prognostic Scoring System (IPSS); or
                                                                                   The condition must be classified as high risk according to the International Prognostic Scoring System (IPSS); AND
                                                                                   The condition must have up to 20% marrow blasts according to World Health Organisation (WHO) Classification.
                                                                                   Classification of the condition as Intermediate-2 requires a score of 1.5 to 2.0 on the IPSS, achieved with the possible combinations
                                                                                   (a) 11% to 20% marrow blasts with intermediate karyotypic status (other abnormalities), and 0 to 1 cytopenias; OR
                                                                                   (b) 11% to 20% marrow blasts with good karyotypic status (normal, -Y alone, del(5q) alone, del(20q) alone), and 2 to 3 cytopenias; OR
                                                                                   (c) 5% to 10% marrow blasts with poor karyotypic status (3 or more abnormalities or chromosome 7 anomalies), regardless of cytopenias; OR
                                                                                   (d) 5% to 10% marrow blasts with intermediate karyotypic status (other abnormalities), and 2 to 3 cytopenias; OR
                                                                                   (e) Less than 5% marrow blasts with poor karyotypic status (3 or more abnormalities or chromosome 7 anomalies), and 2 to 3 cytopenias.
                                                                                   Classification of the condition as high risk requires a score of 2.5 or more on the IPSS, achieved with the possible combinations
                                                                                   (a) 11% to 20% marrow blasts with poor karyotypic status (3 or more abnormalities or chromosome 7 anomalies), regardless of cytopenias; OR
                                                                                   (b) 11% to 20% marrow blasts with intermediate karyotypic status (other abnormalities), and 2 to 3 cytopenias.
                                                                                   The following information must be provided by the prescriber at the time of application
                                                                                   (a) The patient's International Prognostic Scoring System (IPSS) score.
                                                                                   The following reports must be documented in the patient's medical records
                                                                                   (a) bone marrow biopsy report demonstrating that the patient has myelodysplastic syndrome; and
                                                                                   (b) full blood examination report; and
                                                                                   (c) pathology report detailing the cytogenetics demonstrating intermediate-2