Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p229
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 229/476)
Character Range: 2224947–2234094

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.
                                                                       C10077                                                               Non‑functional gastroenteropancreatic neuroendocrine tumour (GEP‑NET)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures ‑ Streamlined Authority Code 10077
                                                                                                                                            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.
                                                                       C15955                                                               Functional carcinoid tumour                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures - Streamlined Authority Code 15955
                                                                                                                                            Continuing treatment
                                                                                                                                            Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                            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.
                                                                       C16024                                                               Acromegaly                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 16024
                                                                                                                                            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 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 lanreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND
                                                                                                                                            The treatment