Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p106
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 106/312)
Character Range: 16132152–16139127

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.
C15141              P15141         CN15141          Olaparib                                                               High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures
                                                                                                                           Initial first-line maintenance therapy (genomic instability without BRCA1/2 gene mutation)
                                                                                                                           The condition must be associated with homologous recombination deficiency (HRD) positive status defined by genomic instability, which has been confirmed by a validated test; AND
                                                                                                                           The condition must not be associated with pathogenic variants (germline mutation class 4/class 5; somatic mutation classification tier I/tier II) of the BRCA1/2 genes - this has been confirmed by a validated test; AND
                                                                                                                           Patient must be in partial or complete response to the immediately preceding platinum-based chemotherapy regimen prior to commencing treatment with this drug for this condition; or
                                                                                                                           The condition must have both:
                                                                                                                            (i) been in a partial/complete response to the immediately preceding platinum-based chemotherapy regimen prior to having commenced non-PBS-subsidised treatment with this drug for this condition, (ii) not progressed since the commencement of non-PBS-subsidised supply of this drug; AND
                                                                                                                           Patient must not have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                           Patient must be undergoing treatment with this drug class for the first time.  or
                                                                                                                           Patient must be undergoing treatment with this drug class on a subsequent occasion, but only because there was an intolerance/contraindication to another drug in the same class that required permanent treatment withdrawal.
                                                                                                                           A response (complete or partial) to the platinum-based chemotherapy regimen is to be assessed using either Gynaecologic Cancer InterGroup (GCIG) or Response Evaluation Criteria in Solid Tumours (RECIST) guidelines.
                                                                                                                           Evidence of homologous recombination deficiency (genomic instability) must be derived through a test that has been validated against the Myriad MyChoice HRD assay, which uses a score of 42 or greater as the threshold for HRD (genomic instability) positivity.
                                                                                                                           Evidence that BRCA1/2 gene mutations are absent must also be derived through a validated test as described above.
C15149              P15149         CN15149          Bimekizumab                                                            Non-radiographic axial spondyloarthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures
                                                                                                                           Initial treatment - Initial 2 (Change or recommencement of treatment after a break