Document ID: chunk:federal_register_of_legislation:F2024L01395:schedule:1:p6
Version: federal_register_of_legislation:F2024L01395
Segment Type: schedule
Provision Reference: sch 1 (pt 6/20)
Character Range: 20342–24124

must be within a framework of medical, social and psychological treatment.
                                        The prescriber must request a quantity sufficient for up to 28 days of supply per dispensing according to the patient's daily dose. Up to 5 repeats will be authorised. The maximum listed quantity or number of repeats must not be prescribed if lesser quantity or repeats are sufficient for the patient's needs.

 1.                Schedule 3, entry for Lanreotide
         1.            omit:
   C7509     Functional carcinoid tumour                                                                                                                                                                                              Compliance with Authority Required procedures ‑ Streamlined Authority Code 7509
             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.
   C7532     Acromegaly                                                                                                                                                                                                               Compliance with Authority Required procedures ‑ Streamlined Authority Code 7532
             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.

          1.            omit:
   C10075     Non‑functional gastroenteropancreatic neuroendocrine tumour (GEP‑NET)                                                        Compliance with Authority Required procedures ‑ Streamlined Authority Code 10075
              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