Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p230
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 230/312)
Character Range: 16926294–16933136

more than 4 weeks old at the time of initial application.
                                                                                                                           If the requirement to demonstrate an elevated CRP level could not be met, the reason must be stated in the application. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.
                                                                                                                           The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
                                                                                                                           The authority application must be made in writing and must include:
                                                                                                                           (a) details of the proposed prescription(s); and
                                                                                                                           (b) 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 baseline BASDAI score and CRP level must also be documented in the patient's medical records.
C15861              P15861         CN15861          Ibrutinib                                                              Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures
                                                                                                                           First continuing treatment (treatment cycles 4 to 9 inclusive) of first-line therapy
                                                                                                                           Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                           The treatment must be in combination with venetoclax (refer to Product Information for timing of ibrutinib and venetoclax doses); AND
                                                                                                                           The treatment must cease upon disease progression.
                                                                                                                           There are more ibrutinib capsules (or tablets) in a pack than is required for the completion of a treatment cycle. The patient must not discard any remaining capsules (or tablets) after the completion of any treatment cycle as these capsules (or tablets) will be required for the doses in the final treatment cycle (i.e. treatment cycle 15).
C15863              P15863         CN15863          Ibrutinib                                                              Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures
                                                                                                                           Second and final continuing treatment (treatment cycles 10 to 15 inclusive) of first-line therapy
                                                                                                                           Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                           The treatment must be in combination with venetoclax (refer to Product Information for timing of ibrutinib and venetoclax doses); AND
                                                                                                                           The treatment must cease upon disease progression; OR
                                                                                                                           The treatment must cease upon completion of 15 cycles of treatment with this drug for this condition, whichever comes first.
                                                                                                                           There are more ibrutinib capsules (or tablets) in a pack than is required for the completion of a treatment cycle. The patient must not discard any remaining capsules (or tablets) after the completion of any treatment cycle as these capsules (or tablets) will be