Document ID: chunk:federal_register_of_legislation:F2025L00062:schedule:1:p45
Version: federal_register_of_legislation:F2025L00062
Segment Type: schedule
Provision Reference: sch 1 (pt 45/51)
Character Range: 137812–142018

or 13.5 years in females) and before chronological age of 18 years; AND
                                     Patient must have a diagnostic insulin tolerance test with maximum serum growth hormone (GH) less than 2.5 micrograms per litre; OR
                                     Patient must have a diagnostic arginine infusion test with maximum serum GH less than 0.4 micrograms per litre; OR
                                     Patient must have a diagnostic glucagon provocation test with maximum serum GH less than 3 micrograms per litre; OR
                                     Patient must have: (a) a chronological age of 18 years or older, (b) established hypothalamic-pituitary disease, (c) at least three documented pituitary hormone deficiencies, (d) an IGF-1 concentration lower than the sex- and age-specific lower limit of normal in a patient.
                                     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. If applicable, results of the growth hormone simulation testing, including the date of testing, the type of test performed, the peak growth hormone concentration, and laboratory reference range for age/gender.

[194] Schedule 4, Part 1, entry for Circumstances Code "C16242"
substitute:
C16242  P16242  CN16242  Somatropin  Severe growth hormone deficiency                                                                                                                                 Compliance with Written Authority Required procedures
                                     Initial treatment of childhood onset growth hormone deficiency in a patient who has received PBS-subsidised treatment as a child
                                     Must be treated by an endocrinologist.
                                     Patient must have a documented childhood onset growth hormone deficiency due to a congenital, genetic or structural cause; AND
                                     Patient must have previously received PBS-subsidised treatment with this drug for this condition as a child.
                                     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.

[195] Schedule 4, Part 1, entry for Circumstances Code "C16243"
substitute:
C16243  P16243  CN16243  Somatropin  Severe growth hormone deficiency                                                                                                                                                                        Compliance with Written Authority Required procedures
                                     Initial treatment of childhood onset growth hormone deficiency in a patient who has received non-PBS subsidised treatment as a child
                                     Must be treated by an endocrinologist.
                                     Patient must have a documented childhood onset growth hormone deficiency due to a congenital, genetic or structural cause; AND
                                     Patient must have previously received non-PBS subsidised treatment with this drug for this condition as a child; AND
                                     Patient must have current or historical evidence of an insulin 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