Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p99
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 99/312)
Character Range: 16090367–16097352

asthma while receiving treatment with oral corticosteroids or optimal doses of inhaled corticosteroids.
C15124              P15124         CN15124          Acalabrutinib                                                          Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures
                                                                                                                           First line drug treatment of this indication - in combination with obinutuzumab
                                                                                                                           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 initiated as a monotherapy for 1 Cycle with treatment in combination with obinutuzumab from Cycle 2 to 7 (refer to Product Information for timing of obinutuzumab and acalabrutinib doses) after which treatment must be monotherapy; 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.
C15125              P15125         CN15125          Golimumab                                                              Non-radiographic axial spondyloarthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures
                                                                                                                           Continuing treatment
                                                                                                                           Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND
                                                                                                                           Patient must have demonstrated an adequate response to treatment with this drug for this condition; AND
                                                                                                                           The treatment must not exceed a maximum of 24 weeks with this drug per authorised course under this restriction; AND
                                                                                                                           Must be treated by a rheumatologist.  or
                                                                                                                           Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.
                                                                                                                           An adequate response to therapy with this biological medicine is defined as a reduction from baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score by 2 or more units (on a scale of 0-10) and 1 of the following
                                                                                                                           (a) a CRP measurement no greater than 10 mg per L; or
                                                                                                                           (b) a CRP measurement reduced by at least 20% from baseline.
                                                                                                                           If the requirement to demonstrate an elevated CRP level could not be met under an initial treatment restriction, a reduction in the BASDAI score from baseline will suffice for the purposes of administering this continuing treatment restriction.
                                                                                                                           The patient remains eligible to receive continuing treatment with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment.
C15126