Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p32
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 32/476)
Character Range: 895902–904848

received insufficient therapy with this drug for this condition under the Initial treatment restriction; OR
                                                                                                                                            Patient must have received insufficient therapy with this drug for this condition under the First Continuing treatment or Re-initiation of interrupted continuing treatment restriction; OR
                                                                                                                                            Patient must have received insufficient therapy with this drug for this condition under the Second or Subsequent Continuing treatment restriction; OR
                                                                                                                                            Patient must be changing therapy from romiplostim or eltrombopag to this drug for this condition; AND
                                                                                                                                            The treatment must provide no more than the balance of up to 24 weeks treatment under this restriction.
                                                                                                                                            Patients receiving treatment with romiplostim or eltrombopag may change to avatrombopag under this restriction.
                                                                       C15375                                                               Severe thrombocytopenia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures
                                                                                                                                            First Continuing treatment or Re-initiation of interrupted continuing treatment
                                                                                                                                            The condition must be severe chronic immune (idiopathic) thrombocytopenic purpura (ITP); AND
                                                                                                                                            Patient must have demonstrated a sustained platelet response to PBS-subsidised treatment with this drug for this condition under the Initial treatment restriction if the patient has not had a treatment break, confirmed through a pathology report from an Approved Pathology Authority; OR
                                                                                                                                            Patient must have changed treatment from either romiplostim or eltrombopag to this drug under the Balance of Supply/Change of Therapy restriction and demonstrated a sustained response; OR
                                                                                                                                            Patient must have demonstrated a sustained platelet response to the most recent PBS-subsidised treatment with this drug for this condition prior to interrupted treatment, confirmed through a pathology report from an Approved Pathology Authority; AND
                                                                                                                                            The treatment must be the sole PBS-subsidised thrombopoietin receptor agonist (TRA) for this condition.
                                                                                                                                            For the purposes of this restriction, a sustained response is defined as the patient having the ability to maintain a platelet count sufficient to prevent clinically significant bleeding based on clinical assessment.
                                                                                                                                            The platelet count must be conducted no later than 4 weeks from the date of completion of the most recent PBS-subsidised course of treatment with this drug and must be documented in the patient's medical records.
Azacitidine                                                            C12439                                                               Acute Myeloid Leukaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures
                                                                                                                                            The treatment must be used in combination with venetoclax (refer to Product Information for timing of azacitidine and venetoclax doses).
                                                                       C12983                                                               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).
                                                                                                                                            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,