Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p309
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 309/312)
Character Range: 17447612–17455016

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.
C16261              P16261         CN16261          Enoxaparin                                                             For prescribing by certain health practitioners
                                                    Labetalol                                                              Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner, (iii) an endorsed midwife who is each of: (a) sharing patient care with a medical practitioner for the current pregnancy episode, (b) continuing existing treatment with this drug that was initiated by a medical practitioner.
                                                    Levothyroxine
                                                    Metformin

C16264              P16264         CN16264          Pembrolizumab                                                          Stage IV (metastatic) non-small cell lung cancer (NSCLC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures - Streamlined Authority Code 16264
                                                                                                                           Initial treatment - 6 weekly treatment regimen
                                                                                                                           Patient must not have previously been treated for this condition in the metastatic setting; or
                                                                                                                           The condition must have progressed after treatment with only one of (i) tepotinib, (ii) selpercatinib; AND
                                                                                                                           Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer; AND
                                                                                                                           Patient must have a WHO performance status of 0 or 1; AND
                                                                                                                           The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c-ROS proto-oncogene 1 (ROS1) gene arrangement in tumour material; AND
                                                                                                                           The treatment must not exceed a total of 4 doses under this restriction.
C16269              P16269         CN16269          Hydroxocobalamin                                                       Anaemias associated with vitamin B12 deficiency
                                                                                                                           Patient must have had a gastrectomy; AND
                                                                                                                           The treatment must be for prophylaxis;
                                                                                                                           Patient must identify as Aboriginal or Torres Strait Islander;
                                                                                                                           Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner, (iii) an endorsed midwife where patient care is being shared with a medical practitioner.
C16270              P16270         CN16270          Selpercatinib                                                          Locally advanced or metastatic non-small cell lung cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures - Streamlined Authority Code 16270
                                                                                                                           The condition must have evidence of rearranged during transfection (RET) gene fusion in