Document ID: chunk:federal_register_of_legislation:F2024L01395:schedule:1:p8
Version: federal_register_of_legislation:F2024L01395
Segment Type: schedule
Provision Reference: sch 1 (pt 8/20)
Character Range: 27147–30922

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patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND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              In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission.
   C16055     Acromegaly                                                                                                                                                                                                               Compliance with Authority Required procedures - Streamlined Authority Code 16055
              Continuing treatment
              Patient must have previously received PBS-subsidised treatment with this drug for this condition; 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patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND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              In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission.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     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.
              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     Functional carcinoid tumour                                                                                                                                                                                              Compliance with Authority Required procedures - Streamlined Authority Code 16057
              Initial treatment
              Must be treated by a