Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p103
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 103/312)
Character Range: 16113968–16120369

First line drug treatment of this indication - as monotherapy
                                                                                                                           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 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.
C15135              P15135         CN15135          Golimumab                                                              Non-radiographic axial spondyloarthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures
                                                                                                                           Initial treatment - Initial 2 (Change or re-commencement of treatment after a break of less than 5 years)
                                                                                                                           Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
                                                                                                                           The condition must not have responded inadequately to biological medicine on 4 occasions within the same treatment cycle; AND
                                                                                                                           The treatment must not exceed a maximum of 16 weeks with this drug 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; AND
                                                                                                                           Patient must not have failed PBS-subsidised therapy with this biological medicine for this PBS indication more than once in the current treatment cycle.
                                                                                                                           An application for Initial 2 treatment must indicate whether the patient has demonstrated an adequate response (an absence of treatment failure), failed or experienced an intolerance to the most recent supply of biological medicine treatment.
                                                                                                                           A new baseline Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and C-reactive protein (CRP) level may be provided at the time of this application.
                                                                                                                           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.
                                                                                                                           The assessment of the patient's response to the most recent supply of biological medicine must be conducted following a minimum of 12 weeks of treatment.
                                                                                                                           BASDAI scores and CRP levels must be documented in the patient's medical records.
                                                                                                                           The assessment of the patient's response