Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p308
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 308/312)
Character Range: 17440662–17448023

of first complete remission
                                                                                                                           Patient must have previously received PBS-subsidised treatment with this drug for this condition; or
                                                                                                                           Patient must have experienced intolerance, not a failure to respond, to continuing PBS-subsidised treatment with dasatinib as a first-line therapy for this condition; AND
                                                                                                                           The condition must be expressing the Philadelphia chromosome; or
                                                                                                                           The condition must have the transcript BCR-ABL; AND
                                                                                                                           Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND
                                                                                                                           Patient must be undergoing treatment with this drug that is occurring within the first 24 months from the first administered dose. or
                                                                                                                           Patient must be undergoing treatment with this drug that is occurring 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, by annotating the prescription with the Streamlined Authority Required code, the prescriber is declaring 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 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.
C16252              P16252         CN16252          Dasatinib                                                              Acute lymphoblastic leukaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Written Authority Required procedures
                                                                                                                           Initial treatment
                                                                                                                           The condition must be expressing the Philadelphia chromosome; or
                                                                                                                           The condition must have the transcript BCR-ABL; AND
                                                                                                                           Patient must have failed treatment with chemotherapy; AND
                                                                                                                           Patient must have failed treatment with imatinib; AND
                                                                                                                           Patient must have failed an allogeneic haemopoeitic stem cell transplantation if applicable.
                                                                                                                           Failure of treatment is defined as either:
                                                                                                                           (i) Failure to achieve a complete morphological and cytogenetic remission after a minimum of 2 months treatment with intensive chemotherapy and imatinib;
                                                                                                                           (ii) Morphological or cytogenetic relapse of leukaemia after achieving a complete remission induced by chemotherapy and imatinib;
                                                                                                                           (iii) Morphological or cytogenetic relapse or persistence of leukaemia after allogeneic haemopoietic stem cell transplantation.
                                                                                                                           Patients must have active leukaemia, as defined by presence on current pathology assessments of either morphological infiltration of the bone marrow (greater than 5% lymphoblasts) or cerebrospinal fluid or other sites; OR the presence of cells expressing the Philadelphia