Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p34
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 34/476)
Character Range: 912365–926109

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 demonstrating that the patient has acute myeloid leukaemia; and
                                                                                                                                            (b) full blood examination report.
                                                                       C13011                                                               Myelodysplastic syndrome                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures
                                                                                                                                            Continuing treatment
                                                                                                                                            Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                                            Patient must not have progressive disease.
                                                                                                                                            Up to 6 cycles will be authorised.
                                                                       C13012                                                               Acute Myeloid Leukaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures ‑ Streamlined Authority Code 13012
                                                                                                                                            Continuing treatment
                                                                                                                                            Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                                            Patient must not have progressive disease.
                                                                       C13015                                                               Chronic Myelomonocytic Leukaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Authority Required procedures
                                                                                                                                            Continuing treatment
                                                                                                                                            Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                                            Patient must not have progressive disease.
                                                                                                                                            Up to 6 cycles will be authorised.
                                                                       C13029                                                               Chronic Myelomonocytic Leukaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Written Authority Required procedures
                                                                                                                                            Initial treatment
                                                                                                                                            The condition must be chronic myelomonocytic leukaemia confirmed through a bone marrow biopsy report and full blood examination report; AND
                                                                                                                                            The condition must have 10% to 29% marrow blasts without Myeloproliferative Disorder.
                                                                                                                                            The first 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:
                                                                                                                                            (a) details (date, unique identifying number/code or provider number) of the bone marrow biopsy report from an Approved Pathology Authority demonstrating that the patient has chronic myelomonocytic leukaemia; and
                                                                                                                                            (b) details (date, unique identifying number/code or provider number) of the full blood examination report from an Approved Pathology Authority
                                                                                                                                            All reports must be documented in the patient's medical records.
                                                                                                                                            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).
                                                                                                                                            The following reports must be documented in the patient's medical records:
                                                                                                                                            (a) bone marrow biopsy report demonstrating that the patient has chronic myelomonocytic leukaemia; and
                                                                                                                                            (b) full blood examination report
                                                                                                                                            No more than 3 cycles will be authorised under this restriction in a patient's lifetime.
Azithromycin                                                           C6356                                                                Mycobacterium avium complex infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures ‑ Streamlined Authority Code 6356
                                                                                                                                            The treatment must be for prophylaxis; AND
                                                                                                                                            Patient must be human immunodeficiency virus (HIV) positive; AND
                                                                                                                                            Patient must have CD4 cell counts of less than 75 per cubic millimetre.
                                                                       C9604                                                                Mycobacterium avium complex infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures ‑ Streamlined Authority Code 9604
                                                                                                                                            The treatment