Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p286
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 286/476)
Character Range: 2652024–2661522

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 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patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND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
                                                                       C8198                                                                Vasoactive intestinal peptide secreting tumour (VIPoma)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures ‑ Streamlined Authority Code 8198
                                                                                                                                            Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                                            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 dosage should be titrated slowly downwards to determine the minimum effective dose.
                                                                       C8208                                                                Functional carcinoid tumour                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures ‑ Streamlined Authority Code 8208
                                                                                                                                            Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                                            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 dosage should be titrated slowly downwards to determine the minimum effective dose.
                                                                       C9232                                                                Vasoactive intestinal peptide secreting tumour (VIPoma)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures ‑ Streamlined Authority Code 9232
                                                                                                                                            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