Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p81
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 81/162)
Character Range: 15094994–15103414

repeat prescriptions.
C14326              P14326         CN14326          Obinutuzumab                                         Chronic lymphocytic leukaemia (CLL)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 14326
                                                                                                         Combination use with chlorambucil only
                                                                                                         The condition must be CD20 positive; AND
                                                                                                         The condition must be previously untreated; AND
                                                                                                         The treatment must be in combination with chlorambucil; AND
                                                                                                         The treatment must only be prescribed for a patient with active disease in accordance with the International Workshop on CLL (iwCLL) guidance (latest version) in relation to when to prescribe drug treatment for this condition.
                                                                                                         Treatment must be discontinued in patients who experience disease progression whilst on this treatment.
C14327              P14327         CN14327          Patiromer                                            Chronic hyperkalaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures - Streamlined Authority Code 14327
                                                                                                         Continuing treatment
                                                                                                         Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                         The treatment must not be in place of emergency treatment of hyperkalaemia; AND
                                                                                                         Patient must be undergoing treatment with a renin angiotensin aldosterone system inhibitor; AND
                                                                                                         Patient must not be undergoing dialysis.
C14332              P14332         CN14332          Azacitidine                                          Acute Myeloid Leukaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures
                                                                                                         Treatment following intensive induction chemotherapy - Initial treatment
                                                                                                         Patient must have demonstrated either:
                                                                                                          (i) first complete remission, (ii) complete remission with incomplete blood count recovery following intensive induction chemotherapy; AND
                                                                                                         Patient must not be a candidate for, including those who choose not to proceed to, haematopoietic stem cell transplantation; AND
                                                                                                         Patient must have, at the time of induction therapy, a cytogenetic risk classified as either:
                                                                                                          (i) intermediate-risk, (ii) poor-risk; AND
                                                                                                         Patient must not have undergone a stem cell transplant; AND
                                                                                                         Patient must not be receiving concomitant PBS-subsidised treatment with midostaurin.
                                                                                                         A complete remission is defined as bone marrow blasts of less than 5%, absence of blasts with Auer rods, absence of extramedullary disease, independent of blood transfusions and a recovery of peripheral blood counts with peripheral neutrophil count greater than 1.0 x 109/L and platelet count greater than or equal to 100 x 109/L.
                                                                                                         A complete remission with incomplete blood count recovery is defined as bone marrow blasts of less than 5%, absence of blasts with Auer rods, absence of extramedullary disease, independent of blood transfusions and a recovery of peripheral blood counts with peripheral neutrophil count less than 1.0 x 109/L or platelet count less than 100 x 109/L.
C14337              P14337         CN14337          Zanubrutinib                                         Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures
                                                                                                         First line drug treatment of this indication
                                                                                                         The condition must be untreated with drug treatment at the time of the first dose of this drug; or
                                                                                                         Patient must have developed an intolerance of a severity necessitating permanent treatment withdrawal following use of another drug PBS indicated as first-line drug treatment of CLL/SLL; AND
                                                                                                         The treatment must only be prescribed