Document ID: chunk:federal_register_of_legislation:F2023L01747:schedule:1:p22
Version: federal_register_of_legislation:F2023L01747
Segment Type: schedule
Provision Reference: sch 1 (pt 22/31)
Character Range: 72547–76931

for patients who are in complete response.
   C14743  P14743     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.
                      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.
   C14760  P14760     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     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;