Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p139
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 139/191)
Character Range: 10938521–10949504

intractable symptoms; AND
                                                                                                                                                                                                                               Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents; AND
                                                                                                                                                                                                                               Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; AND
                                                                                                                                                                                                                               The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 2 months' therapy.
                                                                                                                                                                                                                               Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.
C9233               P9233          CN9233           Octreotide                                                                                                                                                                 Acromegaly                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures - Streamlined Authority Code 9233
                                                                                                                                                                                                                               The condition must be active; AND
                                                                                                                                                                                                                               Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND
                                                                                                                                                                                                                               The treatment must be after failure of other therapy including dopamine agonists; or
                                                                                                                                                                                                                               The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine agonists has failed; or
                                                                                                                                                                                                                               The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND
                                                                                                                                                                                                                               The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks; AND
                                                                                                                                                                                                                               The treatment must cease if IGF1 is not lower after 3 months of treatment at a dose of 100 micrograms 3 time daily; AND
                                                                                                                                                                                                                               The treatment must not be given concomitantly with PBS-subsidised lanreotide or pegvisomant for this condition.
                                                                                                                                                                                                                               In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission
C9234               P9234          CN9234           Pamidronic acid                                                                                                                                                            Hypercalcaemia of malignancy                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures - Streamlined Authority Code 9234
                                                                                                                                                                                                                               Patient must have a malignancy refractory to anti-neoplastic therapy.
C9235               P9235          CN9235           Pegfilgrastim                                                                                                                                                              Chemotherapy-induced neutropenia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures - Streamlined Authority Code 9235
                                                                                                                                                                                                                               Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND
                                                                                                                                                                                                                               Patient must be at greater than 20% risk of developing febrile neutropenia.  or
                                                                                                                                                                                                                               Patient must be at substantial risk (greater than 20%) of prolonged severe neutropenia for more than or equal to seven days.
C9238               P9238          CN9238           Imatinib                                                                                                                                                                   Gastrointestinal stromal tumour                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures
                                                                                                                                                                                                                               Initial treatment
                                                                                                                                                                                                                               The treatment must be adjuvant to complete surgical resection of primary gastrointestinal stromal tumour (GIST); AND
                                                                                                                                                                                                                               Patient must be at high risk of recurrence following complete surgical resection of primary GIST; AND
                                                                                                                                                                                                                               The condition must be histologically confirmed by the detection of CD117 on immunohistochemical staining; AND
                                                                                                                                                                                                                               The treatment must not exceed a dose