Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p304
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 304/312)
Character Range: 17409387–17418121

beyond the first 24 months from the first administered dose - the patient meets the conditions as outlined below.
                                                                                                                           Conditions for PBS-subsidy beyond 24 months of treatment
                                                                                                                           On the first occasion an authority application extends PBS-subsidy beyond 24 months, confirm that
                                                                                                                           1) The condition is expressing the Philadelphia chromosome,
                                                                                                                           2) Measurable residual disease (MRD) is present,
                                                                                                                           3) MRD has been confirmed in at least one of (i) marrow, (ii) peripheral blood,
                                                                                                                           4) MRD has been confirmed within the preceding 6 months of this authority application,
                                                                                                                           5) MRD has been ascertained by at least one of (i) a molecular method, (ii) flow cytometry,
                                                                                                                           6) Allogenic stem cell transplantation is considered by the prescriber to be unsuitable for the patient.
                                                                                                                           For any subsequent authority application beyond the 24 month time mark, confirm that MRD has been detected within the preceding 12 months of this subsequent authority application. Where MRD has since become undetectable, confirm that PBS-subsidy has not exceeded a further 12 months duration from the date that MRD became undetectable.
C16229              P16229         CN16229          Dasatinib                                                              Acute lymphoblastic leukaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Written 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 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