Document ID: chunk:federal_register_of_legislation:F2024L01389:schedule:1:p53
Version: federal_register_of_legislation:F2024L01389
Segment Type: schedule
Provision Reference: sch 1 (pt 53/66)
Character Range: 162919–168312

the condition is no more than 25% of the patient's body surface area to provide 4 weeks of treatment per script.
C16055  P16055  CN16055  Lanreotide                   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patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND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  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