Document ID: chunk:federal_register_of_legislation:F2023L01747:schedule:1:p20
Version: federal_register_of_legislation:F2023L01747
Segment Type: schedule
Provision Reference: sch 1 (pt 20/31)
Character Range: 64943–69131

maintenance therapy for this condition; 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; AND
                      The treatment must not exceed a total of 24 months of combined non-PBS-subsidised and PBS-subsidised treatment for patients who are in complete response.
   C10937  P10937     High grade epithelial ovarian, fallopian tube or primary peritoneal cancer                                                                                                                                              Compliance with Authority Required procedures - Streamlined Authority Code 10937
                      Continuing treatment - second line treatment
                      Patient must have previously received PBS-subsidised treatment with this drug as a second line therapy for this condition; AND
                      The treatment must be the sole PBS-subsidised therapy for this condition; AND
                      The treatment must be maintenance therapy; 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.
   C10958  P10958     High grade epithelial ovarian, fallopian tube or primary peritoneal cancer                                                                                                                                              Compliance with Authority Required procedures
                      Initial treatment - second line treatment
                      The condition must be associated with a class 4 or 5 BRCA1 or BRCA2 gene mutation; 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
                      The treatment must be maintenance therapy; 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 in Solid Tumours (RECIST) guidelines.
                      Evidence of a BRCA1 or BRCA2 gene mutation must be derived through germline or somatic mutation testing.

         (b)           omit:
   C13226  P13226     High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer                                                                                                                                         Compliance with Authority Required procedures
                      Initial treatment - first line treatment
                      The condition must be associated with a class 4 or 5 BRCA1 or BRCA2 gene mutation; 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
                      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.
                      Patient must be undergoing