Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p288
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 288/476)
Character Range: 2669307–2679083

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.
                                                                       C9289                                                                Functional carcinoid tumour                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures ‑ Streamlined Authority Code 9289
                                                                                                                                            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.
                                                                       C9313                                                                Functional carcinoid tumour                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures ‑ Streamlined Authority Code 9313
                                                                                                                                            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.
                                                                       C10061                                                               Non‑functional gastroenteropancreatic neuroendocrine tumour (GEP‑NET)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures ‑ Streamlined Authority Code 10061
                                                                                                                                            The condition must be unresectable locally advanced disease or metastatic disease; AND
                                                                                                                                            The condition must be World Health Organisation (WHO) grade 1 or 2; AND
                                                                                                                                            The treatment must be the sole PBS‑subsidised therapy for this condition.
                                                                                                                                            Patient must be aged 18 years or older.
                                                                                                                                            WHO grade 1 of GEP‑NET is defined as a mitotic count (10HPF) of less than 2 and Ki‑67 index (%) of less than or equal to 2.
                                                                                                                                            WHO grade 2 of GEP‑NET is defined as a mitotic count (10HPF) of 2‑20 and Ki‑67 index (%) of 3‑20.
                                                                       C10075                                                               Non‑functional gastroenteropancreatic neuroendocrine tumour (GEP‑NET)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures ‑ Streamlined Authority Code 10075
                                                                                                                                            Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                                            The condition must be unresectable locally advanced disease or metastatic disease; AND
                                                                                                                                            The condition must be World Health Organisation (WHO) grade 1 or 2; AND
                                                                                                                                            The treatment must be the sole PBS‑subsidised therapy for this condition.
                                                                                                                                            Patient must be aged 18 years or older.
                                                                                                                                            WHO grade 1