Document ID: chunk:federal_register_of_legislation:F2023L01747:schedule:1:p23
Version: federal_register_of_legislation:F2023L01747
Segment Type: schedule
Provision Reference: sch 1 (pt 23/31)
Character Range: 76624–80745

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 in Solid Tumours (RECIST) guidelines.
                      Evidence of a BRCA1 or BRCA2 gene mutation must be derived through germline or somatic mutation testing.
   C14778  P14778     High grade stage III/IV epithelial ovarian, fallopian tube or primary peritoneal cancer                                                                                                                                                                                                                                     Compliance with Authority Required procedures
                      Continuation of first-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 first-line maintenance therapy (BRCA1/2 gene mutation); 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.

     [110]           Schedule 4, Part 1, entry for Pembrolizumab
         (a)           omit:
   C10687        Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma                                                  Compliance with Authority Required procedures
                 Initial treatment - 3 weekly treatment regimen
                 The treatment must be adjuvant to complete surgical resection; AND
                 Patient must have a WHO performance status of 1 or less; AND
                 The treatment must be the sole PBS-subsidised therapy for this condition; AND
                 Patient must not have received prior PBS-subsidised treatment for this condition; AND
                 The treatment must commence within 12 weeks of complete resection; AND
                 Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.

         (b)           omit:
   C10695        Resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma                                                                                         Compliance with Authority Required procedures
                 Continuing treatment - 3 weekly treatment regimen
                 Patient must have previously been issued with an authority prescription for this drug for adjuvant treatment following complete surgical resection; AND
                 Patient must not have experienced disease recurrence; AND
                 The treatment must be the sole PBS-subsidised therapy for this condition; AND
                 Patient must not receive more than 12 months of combined PBS-subsidised and non-PBS-subsidised adjuvant therapy.

         (c)           insert in numerical order after existing text:
   C14770        Stage IIIB, Stage IIIC or Stage IIID