Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p277
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 277/312)
Character Range: 17211094–17218873

AND
                                                                                                                           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patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND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 must cease if IGF1 is not lower after 3 months of treatment; AND
                                                                                                                           The treatment must not be given concomitantly with PBS-subsidised pegvisomant.
                                                                                                                           In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission.
C16056              P16056         CN16056          Lanreotide                                                             Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures - Streamlined Authority Code 16056
                                                                                                                           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; 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.
C16057              P16057         CN16057          Lanreotide                                                             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; 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