Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p68
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 68/312)
Character Range: 15853835–15862244

of age.
                                                                                                                           The authority application must be made in writing and must include
                                                                                                                           (1) a completed authority prescription form; and
                                                                                                                           (2) 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).
                                                                                                                           In relation to the biological medicine prescribed immediately before this one, provide at least one of the following which is not more than 4 weeks from the last administered dose
                                                                                                                           (i) the Crohn Disease Activity Index (CDAI) score, including the date the score was calculated on; or
                                                                                                                           (ii) the unique serial/identifying number and date(s) of pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; or
                                                                                                                           (iii) confirmation that a severe intolerance occurred that resulted in the cessation of treatment.
C14735              P14735         CN14735          Zoledronic acid                                                        Adjuvant management of breast cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures - Streamlined Authority Code 14735
                                                                                                                           Patient must be post-menopausal;
                                                                                                                           Patient must not be undergoing PBS-subsidised treatment with this drug for this indication for more than 36 months.
C14741              P14741         CN14741          Olaparib                                                               High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures
                                                                                                                           Initial first-line maintenance therapy (BRCA1/2 gene mutation)
                                                                                                                           The condition must be associated with a pathogenic variant (germline mutation class 4/class 5; somatic mutation classification tier I/tier II) of the BRCA1/2 gene(s) - 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; 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 a BRCA1 or BRCA2 gene mutation must be derived through germline or somatic mutation testing.
C14742              P14742         CN14742          Olaparib                                                               High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures
                                                                                                                           Continuation of first-line maintenance therapy (genomic instability without BRCA1/2 gene mutation)
                                                                                                                           Patient must have received previous PBS-subsidised treatment with this drug as first line maintenance therapy for this condition; AND
                                                                                                                           Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND
                                                                                                                           The treatment must