Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p174
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 174/312)
Character Range: 16541616–16550220

convulsive status epilepticus                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures
                                                                                                                           Initial treatment
                                                                                                                           Patient must have been assessed to be at significant risk of status epilepticus; AND
                                                                                                                           Patient must have experienced at least one prolonged seizure (greater than 5 minutes duration) requiring emergency medical attention within the previous 5 years.
                                                                                                                           Patient must be at least one year of age.
                                                                                                                           The treatment must initiated by a specialist physician experienced in the treatment of epilepsy.
C15466              P15466         CN15466          Gilteritinib                                                           Relapsed or refractory Acute Myeloid Leukaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures
                                                                                                                           Continuing treatment
                                                                                                                           Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                           The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                                                           Patient must not have developed disease progression while being treated with this drug for this condition; AND
                                                                                                                           The treatment must not be for maintenance therapy post-transplant.
                                                                                                                           Progressive disease monitoring via a complete blood count must be taken at the end of each cycle.
                                                                                                                           If abnormal blood counts suggest the potential for relapsed AML, following a response to gilteritinib, a bone marrow biopsy must be performed to confirm the absence of progressive disease for the patient to be eligible for further cycles.
                                                                                                                           Progressive disease is defined as the presence of any of the following:
                                                                                                                           (a) Leukaemic cells in the CSF; or
                                                                                                                           (b) Re-appearance of circulating blast cells in the peripheral blood, not attributable to overshoot following recovery from myeloablative therapy; or
                                                                                                                           (c) Greater than 5 % blasts in the marrow not attributable to bone marrow regeneration or another cause; or
                                                                                                                           (d) Extramedullary leukaemia.
C15467              P15467         CN15467          Larotrectinib                                                          Solid tumours (of certain specified types) with confirmed neurotrophic tropomyosin receptor kinase (NTRK) gene fusion                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Written Authority Required procedures
                                                                                                                           Initial treatment
                                                                                                                           The condition must be confirmed to be positive for a neurotrophic tropomyosin receptor kinase (NTRK) gene fusion prior to treatment initiation with this drug through a pathology report from an Approved Pathology Authority - provide the following evidence: (i) the date of the pathology report substantiating the positive NTRK gene fusion, (ii) the name of the pathology service provider, (iii) the unique identifying number/code linking the pathology test result to the patient; the recency of the pathology report may be of any date; AND
                                                                                                                           The condition must be non-small cell lung cancer confirmed through a pathology report from an Approved Pathology Authority (of any date); OR
                                                                                                                           The condition must be soft tissue sarcoma confirmed through a pathology report from an Approved Pathology Authority (of any date); OR
                                                                                                                           The condition must be confirmed through a pathology report from an Approved Pathology Authority (of any date) as either: (i) glioma, (ii) glioneuronal tumour, (iii) glioblastoma; AND
                                                                                                                           The condition must be metastatic disease; OR
                                                                                                                           The condition must be both: (i) locally