Document ID: chunk:federal_register_of_legislation:F2024L01730:schedule:1:p21
Version: federal_register_of_legislation:F2024L01730
Segment Type: schedule
Provision Reference: sch 1 (pt 21/30)
Character Range: 59534–64348

Schedule 4, Part 1, entry for Circumstances Code "C16189"
omit entry for Circumstances Code "C16189" and substitute:
C16189  P16189  CN16189  Methylphenidate  Attention deficit hyperactivity disorder                                                                                                       Compliance with Authority Required procedures
                                          Patient must have demonstrated a response to immediate-release methylphenidate hydrochloride with no emergence of serious adverse events; AND
                                          Patient must require continuous coverage over 12 hours; AND
                                          The treatment must not exceed a maximum daily dose of 72 mg of PBS-subsidised treatment with this drug.
                                          Patient must be or have been diagnosed between the ages of 6 and 18 years inclusive.

[146] Schedule 4, Part 1, after entry for Circumstances Code "C16223"
insert:
C16224  P16224  CN16224  Talazoparib   Castration resistant metastatic carcinoma of the prostate                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures
                                       The condition must be associated with a class 4 or 5 BRCA1 or BRCA2 gene mutation; AND
                                       Patient must not have received prior PBS-subsidised novel hormonal drug in any non-metastatic setting of prostate cancer prior to commencing treatment with this drug for this condition; AND
                                       Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance score no higher than 1 prior to treatment initiation; AND
                                       Patient must be undergoing concurrent treatment with enzalutamide, unless an intolerance to enzalutamide requires either a:
                                       (i) temporary cessation, (ii) permanent discontinuation; AND
                                       The treatment must not be a PBS-subsidised benefit beyond disease progression.
C16226  P16226  CN16226  Somatropin    Severe growth hormone deficiency                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Written Authority Required procedures
                                       Initial treatment of late onset growth hormone deficiency
                                       Must be treated by an endocrinologist; AND
                                       Patient must have onset of growth hormone deficiency secondary to organic hypothalamic or pituitary disease diagnosed at chronological age of 18 years or older; or
                                       Patient must have onset of growth hormone deficiency diagnosed after skeletal maturity (bone age greater than or equal to 15.5 years in males 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:
                                       Details of the proposed prescription; AND
                                       A completed Severe Growth Hormone Deficiency supporting information form; AND
                                       If applicable, results of the growth hormone simulation testing, including the date