Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p285
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 285/476)
Character Range: 2643691–2653605

effective dose.
                                                                       C6390                                                                Functional carcinoid tumour                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures ‑ Streamlined Authority Code 6390
                                                                                                                                            The condition must be causing 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.
                                                                       C8161                                                                Acromegaly                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures ‑ Streamlined Authority Code 8161
                                                                                                                                            The condition must be controlled with octreotide immediate release injections; 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 (8 weeks after the last dose); AND
                                                                                                                                            The treatment must cease if IGF1 is not lower after 3 months of treatment; 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
                                                                       C8165                                                                Acromegaly                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures ‑ Streamlined Authority Code 8165
                                                                                                                                            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
                                                                       C8197                                                                Acromegaly                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures ‑ Streamlined Authority Code 8197
                                                                                                                                            Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                                            The condition must be controlled with