Document ID: chunk:federal_register_of_legislation:F2024L01730:schedule:1:p24
Version: federal_register_of_legislation:F2024L01730
Segment Type: schedule
Provision Reference: sch 1 (pt 24/30)
Character Range: 73277–78081

AND
                                       Patient must not have received PBS-subsidised treatment with this drug in any earlier line of treatment for breast cancer; AND
                                       The condition must be triple negative breast cancer; or
                                       The condition must be hormone-receptor positive breast cancer and the patient has either: (i) progressive disease after receiving endocrine therapy, (ii) been considered inappropriate for endocrine therapy; AND
                                       The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication.
                                       Retain all pathology imaging and investigative test results in the patient's medical records. Do not submit copies of these as part of the authority application.
                                       Treatment with this drug for this condition is restricted to one line of therapy at any disease staging for breast cancer (i.e. if therapy has been prescribed for early disease, subsidy under metastatic disease is no longer available).
C16238  P16238  CN16238  Imatinib      Acute lymphoblastic leukaemia                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures
                                       Induction and Consolidation therapy
                                       Patient must be newly diagnosed; AND
                                       The condition must be expressing the Philadelphia chromosome; or
                                       The condition must have the transcript BCR-ABL; AND
                                       The treatment must be in combination with chemotherapy or corticosteroids; AND
                                       Patient must not have previously experienced a failure to respond to PBS-subsidised first-line treatment with this drug for this condition. or
                                       Patient must have experienced intolerance, not a failure to respond, to initial PBS-subsidised treatment with dasatinib as a first-line therapy for this condition.
                                       A pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of acute lymphoblastic leukaemia with either cytogenetic evidence of the Philadelphia chromosome, or a qualitative PCR report documenting the presence of the BCR-ABL transcript in either peripheral blood or bone marrow must be documented in the patient's medical records.
C16240  P16240  CN16240  Olaparib      Early breast cancer                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures
                                       Initial treatment
                                       The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND
                                       Patient must have received neoadjuvant or adjuvant chemotherapy; AND
                                       The treatment must be adjuvant to surgical resection; AND
                                       The condition must be associated with a class 4 or 5 BRCA1 or BRCA2 gene variant; AND
                                       Patient must have received neoadjuvant chemotherapy, and residual invasive cancer is confirmed in the breast and/or resected lymph nodes (pathological complete response was not achieved); or
                                       Patient must have received adjuvant chemotherapy for triple negative breast cancer, and has either: (a) node positive disease is present, (b) a primary tumour greater than 20 mm; or
                                       Patient must have received adjuvant chemotherapy for hormone receptor positive breast cancer, and has at least 4 positive lymph nodes; AND
                                       The treatment must not be a PBS-subsidised benefit beyond the following, whichever comes first: (i) a total of 52 weeks of treatment (including any non-PBS-subsidised supply), (ii) disease recurrence. Mark