Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p231
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 231/312)
Character Range: 16932899–16939187

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).
C15864              P15864         CN15864          Ibrutinib                                                              Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures
                                                                                                                           Initial treatment in first-line therapy (treatment cycles 1 to 3 inclusive)
                                                                                                                           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 venetoclax (refer to Product Information for timing of ibrutinib and venetoclax doses).
                                                                                                                           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).
C15874              P15874         CN15874          Bimekizumab                                                            Ankylosing spondylitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Written Authority Required procedures
                                                                                                                           Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
                                                                                                                           Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition; AND
                                                                                                                           Patient must have a break in treatment of at least 5 years from the most recently approved PBS-subsidised biological medicine for this condition; AND
                                                                                                                           The condition must be either radiologically (plain X-ray) confirmed: (i) Grade II bilateral sacroiliitis; (ii) Grade III unilateral sacroiliitis; AND
                                                                                                                           Patient must have at least 2 of the following: (i) low back pain and stiffness for 3 or more months that is relieved by exercise but not by rest; (ii) limitation of motion of the lumbar spine in the sagittal and the frontal planes as determined by a score of at least 1 on each of the lumbar flexion and lumbar side flexion measurements of the Bath Ankylosing Spondylitis Metrology Index (BASMI); (iii) limitation of chest expansion relative to normal values for age and gender; AND
                                                                                                                           Patient must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) of at least 4 on a 0-10 scale that is no more than 4 weeks old at the time of application; AND
                                                                                                                           Patient must have an