Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p306
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 306/312)
Character Range: 17424992–17433406

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 any remaining repeat prescriptions with the word 'cancelled' where (i)/ (ii) has occurred; AND
                                                                                                                           The treatment must be commenced within 12 weeks of completing other therapy noting that other therapy can be any of the following therapy: (i) surgery, (ii) radiotherapy, (iii) chemotherapy; AND
                                                                                                                           The treatment must not be in combination with any of the following: (i) abemaciclib, (ii) pembrolizumab.
                                                                                                                           Retain all pathology imaging and investigative test results in the patient's medical records.
                                                                                                                           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).
C16241              P16241         CN16241          Olaparib                                                               Metastatic breast cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures
                                                                                                                           Continuing treatment
                                                                                                                           Patient must have received previous PBS-subsidised treatment with this drug in the metastatic setting; AND
                                                                                                                           The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND
                                                                                                                           Patient must not have developed disease progression while receiving treatment with this drug for this condition.
C16242              P16242         CN16242          Somatropin                                                             Severe growth hormone deficiency                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance