Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p70
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 70/312)
Character Range: 15867362–15874702

weight-based loading dose, containing a quantity of up to 4 vials of 130 mg and no repeats. The second prescription should be written under S85 (General) for 1 vial or pre-filled syringe of 90 mg and no repeats.
                                                                                                                           The most recent fistula assessment must be no more than 4 weeks old at the time of application.
                                                                                                                           A maximum quantity of a weight-based loading dose is up to 4 vials with no repeats and the subsequent first dose of 90 mg with no repeats provide for an initial 16-week course of this drug will be authorised
                                                                                                                           Where fewer than 6 vials in total are requested at the time of the application, authority approvals for a sufficient number of vials based on the patient's weight to complete dosing at weeks 0 and 8 may be requested by telephone through the balance of supply restriction.
                                                                                                                           Under no circumstances will telephone approvals be granted for initial authority applications, or for treatment that would otherwise extend the initial treatment period.
C14760              P14760         CN14760          Olaparib                                                               High grade epithelial ovarian, fallopian tube or primary peritoneal cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 14760
                                                                                                                           Continuation of subsequent-line maintenance therapy (BRCA1/2 gene mutation)
                                                                                                                           The treatment must be continuing existing PBS-subsidised treatment with this drug initiated through the Treatment Phase:
                                                                                                                            Initial subsequent-line maintenance therapy (BRCA1/2 gene mutation); AND
                                                                                                                           The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                                                           Patient must not have developed disease progression while receiving treatment with this drug for this condition.
                                                                                                                           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.
C14761              P14761         CN14761          Olaparib                                                               High grade epithelial ovarian, fallopian tube or primary peritoneal cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures
                                                                                                                           Initial subsequent-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
                                                                                                                           The condition must be platinum sensitive; AND
                                                                                                                           Patient must have received at least two previous platinum-containing regimens; AND
                                                                                                                           Patient must have relapsed following a previous platinum-containing regimen; AND
                                                                                                                           Patient must be in partial or complete response to the immediately preceding platinum-based chemotherapy regimen; AND
                                                                                                                           The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                                                           Patient must not have previously received PBS-subsidised treatment with this drug for this condition.
                                                                                                                           Platinum sensitivity is defined as disease progression greater than 6 months after completion of the penultimate platinum regimen.
                                                                                                                           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