Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p305
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 305/312)
Character Range: 17416652–17425527

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 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