Document ID: chunk:federal_register_of_legislation:F2024L01395:schedule:1:p9
Version: federal_register_of_legislation:F2024L01395
Segment Type: schedule
Provision Reference: sch 1 (pt 9/20)
Character Range: 30450–34581

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 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 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.
   C16133     Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 16133
              Continuing treatment
              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 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.

 1.                Schedule 3, entry for Mepolizumab
         1.            omit:
   C15344      Uncontrolled severe asthma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Written Authority Required procedures
               Initial treatment - Initial 2 (Change of treatment)
               Must be treated by a medical practitioner who is either a: (i) respiratory physician, (ii) clinical immunologist, (iii) allergist, (iv) general physician experienced in the management of patients with severe asthma.
               Patient must be under the care of the same physician for at least 6 months; OR
               Patient must have been diagnosed by a multidisciplinary severe asthma clinic team; AND
               Patient must have received prior PBS-subsidised treatment with a biological medicine for severe asthma in this treatment cycle; AND
               Patient must not have failed, or ceased to respond to, PBS-subsidised treatment with this drug for severe asthma during the current treatment cycle; AND
               Patient must have had