Document ID: chunk:federal_register_of_legislation:F2024L01730:schedule:1:p23
Version: federal_register_of_legislation:F2024L01730
Segment Type: schedule
Provision Reference: sch 1 (pt 23/30)
Character Range: 68572–73650

to the 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 imatinib as a first-line therapy for this condition.
                                       The authority application must be made in writing and must include
                                       (a) details of the proposed prescription; and
                                       (b) a completed Acute Lymphoblastic Leukaemia Dasatinib PBS Authority Application - Supporting Information Form; and
                                       (c) a pathology cytogenetic report conducted on peripheral blood or bone marrow supporting the diagnosis of acute lymphoblastic leukaemia to confirm eligibility for treatment, 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. (The date of the relevant pathology report needs to be provided).
C16231  P16231  CN16231  Risperidone   Schizophrenia                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures - Streamlined Authority Code 16231
                                       For a patient switching from oral risperidone, the prescriber must determine the patient dosage of this drug based on the current dose of oral risperidone according to the dose transition table in the Therapeutic Goods Administration (TGA) approved Product Information.
C16233  P16233  CN16233  Enzalutamide  Castration resistant metastatic carcinoma of the prostate                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures
                                       The treatment must not be used in combination with chemotherapy; AND
                                       Patient must have a WHO performance status of 2 or less; AND
                                       Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug; AND
                                       Patient must only receive subsidy for one novel hormonal drug per lifetime for prostate cancer (regardless of whether a drug was subsidised under a metastatic/non-metastatic indication). or
                                       Patient must only receive subsidy for a subsequent novel hormonal drug where there has been a severe intolerance to another novel hormonal drug leading to permanent treatment cessation. or
                                       Patient must have been receiving PBS-subsidised treatment with abiraterone or abiraterone plus methylprednisolone for castration resistant metastatic prostate cancer prior to being associated with a class 4 or 5 BRCA1 or BRCA2 gene mutation.
C16234  P16234  CN16234  Olaparib      Metastatic breast cancer                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Authority Required procedures
                                       Initial treatment
                                       The condition must be human epidermal growth factor receptor 2 (HER2) negative; AND
                                       The condition must be associated with a class 4 or 5 BRCA1 or BRCA2 gene variant; AND
                                       Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score of 2 or less; AND
                                       Patient must have received chemotherapy in the neoadjuvant, adjuvant or metastatic setting; 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