Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p33
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 33/476)
Character Range: 904310–913060

Prognostic Scoring System (IPSS).
                                                                                                                                            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 30% marrow blasts with good karyotypic status (normal, ‑Y alone, del(5q) alone, del(20q) alone), and 0 to 1 cytopenias; OR
                                                                                                                                            b. 11% to 20% marrow blasts with intermediate karyotypic status (other abnormalities), and 0 to 1 cytopenias; OR
                                                                                                                                            c. 11% to 20% marrow blasts with good karyotypic status (normal, ‑Y alone, del(5q) alone, del(20q) alone), and 2 to 3 cytopenias; OR
                                                                                                                                            d. 5% to 10% marrow blasts with poor karyotypic status (3 or more abnormalities or chromosome 7 anomalies), regardless of cytopenias; OR
                                                                                                                                            e. 5% to 10% marrow blasts with intermediate karyotypic status (other abnormalities), and 2 to 3 cytopenias; OR
                                                                                                                                            f. 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. 21% to 30% marrow blasts with good karyotypic status (normal, ‑Y alone, del(5q) alone, del(20q) alone), and 2 to 3 cytopenias; OR
                                                                                                                                            b. 21% to 30% marrow blasts with intermediate (other abnormalities) or poor karyotypic status (3 or more abnormalities or chromosome 7 anomalies), regardless of cytopenias; OR
                                                                                                                                            c. 11% to 20% marrow blasts with poor karyotypic status (3 or more abnormalities or chromosome 7 anomalies), regardless of cytopenias; OR
                                                                                                                                            d. 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 or high‑risk disease according to the International Prognostic Scoring System (IPSS).
                                                                                                                                            No more than 3 cycles will be authorised under this restriction in a patient's lifetime.
                                                                       C12986                                                               Acute Myeloid Leukaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures ‑ Streamlined Authority Code 12986
                                                                                                                                            Continuing treatment
                                                                                                                                            Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                                            Patient must not have progressive disease.
                                                                       C13010                                                               Acute Myeloid Leukaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures
                                                                                                                                            Initial treatment
                                                                                                                                            The condition must be acute myeloid leukaemia confirmed through a bone marrow biopsy report and full blood examination; AND
                                                                                                                                            The condition must have 20% to 30% marrow blasts and multi‑lineage dysplasia, according to World Health Organisation (WHO) Classification.
                                                                                                                                            The following reports must be documented in the patient's medical records:
                                                                                                                                            (a) bone marrow biopsy report