Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p82
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 82/162)
Character Range: 15102944–15110284

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 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; AND
                                                                                                         The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND
                                                                                                         Patient must be undergoing initial treatment with this drug - this is the first prescription for this drug.  or
                                                                                                         Patient must be undergoing continuing treatment with this drug - the condition has not progressed whilst the patient has actively been on this drug.
C14338              P14338         CN14338          Azacitidine                                          Acute Myeloid Leukaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures
                                                                                                         Treatment following intensive induction chemotherapy - Continuing treatment
                                                                                                         Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                         Patient must have, for reasons not attributable to any cause other than AML, no more than 15% blasts in either the:
                                                                                                          (i) bone marrow, (ii) peripheral blood; AND
                                                                                                         Patient must not be receiving concomitant PBS-subsidised treatment with midostaurin.
C14340              P14340         CN14340          Venetoclax                                           Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures
                                                                                                         Initial treatment in first-line therapy - Dose titration (weeks 1 to 4 of a 5-week ramp-up schedule)
                                                                                                         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 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; AND
                                                                                                         The treatment must be in combination with obinutuzumab (refer to Product Information for timing of obinutuzumab and venetoclax doses).
C14342              P14342         CN14342          Patiromer                                            Chronic hyperkalaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures
                                                                                                         Initial PBS-subsidised treatment (including grandfathered patients)
                                                                                                         Patient must have stage 3 to stage 4 chronic kidney disease;
                                                                                                         The condition must be inadequately controlled by a low potassium diet.; AND
                                                                                                         Patient must have experienced at least 2 episodes of hyperkalaemia (defined as serum potassium levels of at least 6.0 mmol/L) within the 12 months prior to commencing this drug; 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; or
                                                                                                         Patient must be indicated for treatment with a renin angiotensin aldosterone system inhibitor, but unable to tolerate this