Document ID: chunk:federal_register_of_legislation:F2025L00062:schedule:1:p46
Version: federal_register_of_legislation:F2025L00062
Segment Type: schedule
Provision Reference: sch 1 (pt 46/51)
Character Range: 141700–146537

tolerance test with maximum serum growth hormone (GH) less than 2.5 micrograms per litre; OR
                                     Patient must have current or historical evidence of an arginine infusion test with maximum serum GH less than 0.4 micrograms per litre; OR
                                     Patient must have current or historical evidence of a glucagon provocation test with maximum serum GH less than 3 micrograms per litre.
                                     Patient must have a mature skeleton.
                                     Somatropin is not PBS-subsidised for patients with Prader-Willi syndrome aged 18 years or older without a documented childhood onset Growth Hormone Deficiency.
                                     The authority application must be in writing and must include:
                                     1. Details of the proposed prescription; AND
                                     2. A completed Severe Growth Hormone Deficiency supporting information form; AND
                                     3. Results of the growth hormone stimulation testing, including the date of testing, the type of test performed, the peak growth hormone concentration, and laboratory reference range for age/gender.

[196] Schedule 4, Part 1, after entry for Circumstances Code "C16252"
insert:
C16261  P16261  CN16261  Enoxaparin                      For prescribing by certain health practitioners
                         Labetalol                       Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner, (iii) an endorsed midwife who is each of: (a) sharing patient care with a medical practitioner for the current pregnancy episode, (b) continuing existing treatment with this drug that was initiated by a medical practitioner.
                         Levothyroxine
                         Metformin
C16264  P16264  CN16264  Pembrolizumab                   Stage IV (metastatic) non-small cell lung cancer (NSCLC)                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures - Streamlined Authority Code 16264
                                                         Initial treatment - 6 weekly treatment regimen
                                                         Patient must not have previously been treated for this condition in the metastatic setting; or
                                                         The condition must have progressed after treatment with only one of (i) tepotinib, (ii) selpercatinib; AND
                                                         Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor or a programmed cell death ligand-1 (PD-L1) inhibitor for non-small cell lung cancer; AND
                                                         Patient must have a WHO performance status of 0 or 1; AND
                                                         The condition must not have evidence of an activating epidermal growth factor receptor (EGFR) gene or an anaplastic lymphoma kinase (ALK) gene rearrangement or a c-ROS proto-oncogene 1 (ROS1) gene arrangement in tumour material; AND
                                                         The treatment must not exceed a total of 4 doses under this restriction.
C16269  P16269  CN16269  Hydroxocobalamin                Anaemias associated with vitamin B12 deficiency
                                                         Patient must have had a gastrectomy; AND
                                                         The treatment must be for prophylaxis;
                                                         Patient must identify as Aboriginal or Torres Strait Islander;
                                                         Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) a nurse practitioner, (iii) an endorsed midwife where patient care is being shared with a medical practitioner.
C16270  P16270  CN16270  Selpercatinib                   Locally advanced or metastatic non-small cell lung cancer                                                                                                                                                                                                                                                                                                                                                                                    Compliance