Document ID: chunk:federal_register_of_legislation:F2024L01730:schedule:1:p27
Version: federal_register_of_legislation:F2024L01730
Segment Type: schedule
Provision Reference: sch 1 (pt 27/30)
Character Range: 86821–91013

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 chromosome on cytogenetic or FISH analysis in the bone marrow of patients in morphological remission.
                                       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 report demonstrating that the patient has active acute lymphoblastic leukaemia, either manifest as cytogenetic evidence of the Philadelphia chromosome, or morphological evidence of acute lymphoblastic leukaemia plus qualitative RT-PCR evidence of BCR-ABL transcript. The date of the relevant pathology report(s) need(s) to be provided.

[147] Schedule 4, Part 2, second entry for Variation Code "V15457"
omit from the column headed "Variation Code": V15457 substitute: V15527
[148] Schedule 5, entry for Abacavir with lamivudine
omit from the column headed "Brand": Abacavir/Lamivudine Mylan
[149] Schedule 5, omit entries for Acalabrutinib
[150] Schedule 5, entry for Adalimumab in the form Injection 40 mg in 0.4 mL pre-filled pen
insert in the column headed "Brand" after entry for the Brand "Humira": Hyrimoz
[151] Schedule 5, entries for Atorvastatin
omit from the column headed "Brand" (all instances): NOUMED ATORVASTATIN
[152] Schedule 5, entries for Bisoprolol
omit from the column headed "Brand" (all instances): Cipla Bisoprolol
[153] Schedule 5, entries for Celecoxib
omit from the column headed "Brand" (all instances): NOUMED CELECOXIB
[154] Schedule 5, entries for Dimethyl fumarate
omit from the column headed "Brand" (all instances): Dimethyl