Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p172
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 172/381)
Character Range: 12638382–12649625

tumour                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Authority Required procedures
                                                                                                                                                                    Continuing treatment
                                                                                                                                                                    The condition must not be resectable; AND
                                                                                                                                                                    Patient must have received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                    The treatment must be as monotherapy; AND
                                                                                                                                                                    Patient must not have developed disease progression while receiving treatment with this drug for this condition.
C12459              P12459         CN12459          High fat formula with vitamins, minerals and trace elements and low in protein and carbohydrate                 Ketogenic diet                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures
                                                                                                                                                                    Patient must have intractable seizures requiring treatment with a ketogenic diet; or
                                                                                                                                                                    Patient must have a glucose transport protein defect; or
                                                                                                                                                                    Patient must have pyruvate dehydrogenase deficiency; AND
                                                                                                                                                                    Patient must have severe intestinal malabsorption of whole protein ketogenic diet formula; AND
                                                                                                                                                                    Patient must have unsuccessfully trialled at least one of the PBS-listed products with the indication of:
                                                                                                                                                                     'Ketogenic diet'.
                                                                                                                                                                    This product must only be used under strict supervision of a dietitian, together with a metabolic physician and/or neurologist.
C12462              P12462         CN12462          Venetoclax                                                                                                      Acute Myeloid Leukaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures
                                                                                                                                                                    The condition must be previously untreated at the time of initiation with this drug (except for essential treatment with hydroxyurea or leukapheresis); AND
                                                                                                                                                                    Patient must not be considered eligible for standard intensive remission induction chemotherapy at the time of initiation with this drug; AND
                                                                                                                                                                    The treatment must be used in combination with azacitidine (refer to Product Information for timing of azacitidine and venetoclax doses); AND
                                                                                                                                                                    Patient must not have progressive disease while receiving PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                    The condition must not be acute promyelocytic leukaemia.
                                                                                                                                                                    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, a bone marrow biopsy must be performed to confirm the absence of progressive disease for the patient to be eligible for further cycles.
C12464              P12464         CN12464          Lanadelumab                                                                                                     Chronic treatment of hereditary angioedema Types 1 or 2                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures
                                                                                                                                                                    Initial 1: New patient (commencing with no previous treatment with C1-INH for routine prophylaxis)
                                                                                                                                                                    Patient must have experienced at least 12 treated acute attacks of hereditary angioedema within the 6 month period prior to commencing treatment with this drug; AND
                                                                                                                                                                    Patient must not have been receiving a C1-esterase inhibitor through the National Blood Authority as routine prophylaxis for hereditary angioedema at the time of application; AND
                                                                                                                                                                    The treatment must not be used in combination with a C1-esterase inhibitor concentrate; AND
                                                                                                                                                                    Must be treated by a clinical immunologist or a specialist allergist;
                                                                                                                                                                    Patient must be aged 12 years or older.
                                                                                                                                                                    For the purposes of administering this restriction, acute attacks of hereditary angioedema are those of a severity necessitating immediate medical intervention with either (i) icatibant, or (ii)