Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p231
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 231/476)
Character Range: 2241374–2251818

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.
                                                                       C16057                                                               Functional carcinoid tumour                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures - Streamlined Authority Code 16057
                                                                                                                                            Initial treatment
                                                                                                                                            Must be treated by a specialist practicing in a hospital who is either: (i) an endocrinologist, (ii) an oncologist; OR
                                                                                                                                            Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types within a hospital setting.
                                                                                                                                            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 3 months' therapy at a dose of 120 mg every 28 days.
                                                                                                                                            Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.
                                                                       C16133                                                               Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures - Streamlined Authority Code 16133
                                                                                                                                            Continuing treatment
                                                                                                                                            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 at least 18 years of age.
                                                                                                                                            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.
Lanthanum                                                              C5530                                                                Hyperphosphataemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures ‑ Streamlined Authority Code 5530
                                                                                                                                            Initiation and stabilisation
                                                                                                                                            The condition must not be adequately controlled by calcium; AND
                                                                                                                                            Patient must have a serum phosphate of greater than 1.6 mmol per L at the commencement of therapy; OR
                                                                                                                                            The condition must be where a serum calcium times phosphate product is greater than 4 at the commencement of therapy; AND
                                                                                                                                            The treatment must not be used in combination with any other non‑calcium phosphate binding agents.
                                                                                                                                            Patient must be undergoing dialysis for chronic kidney disease.
                                                                       C9762                                                                Hyperphosphataemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures ‑ Streamlined Authority Code 9762
                                                                                                                                            Initiation and stabilisation
                                                                                                                                            The condition must not be adequately controlled by calcium; AND
                                                                                                                                            Patient must have a serum phosphate of greater than 1.6 mmol per L at