Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p287
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 287/476)
Character Range: 2660994–2669686

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                                                                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 times 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
                                                                       C9262                                                                Acromegaly                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures ‑ Streamlined Authority Code 9262
                                                                                                                                            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
                                                                       C9288                                                                Vasoactive intestinal peptide secreting tumour (VIPoma)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures ‑ Streamlined Authority Code 9288
                                                                                                                                            Patient must have achieved symptom control on octreotide immediate release injections; AND
                                                                                                                                            The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.
                                                                                                                                            Dosage and tolerance to the drug should be assessed regularly and the