Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p303
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 303/312)
Character Range: 17401875–17409896

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.
                                                                                                                           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:
                                                                                                                           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.
C16228              P16228         CN16228          Dasatinib                                                              Acute lymphoblastic leukaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures
                                                                                                                           Maintenance of first complete remission
                                                                                                                           Patient must have previously received PBS-subsidised treatment with this drug for this condition; or
                                                                                                                           Patient must have experienced intolerance, not a failure to respond, to continuing PBS-subsidised treatment with imatinib as a first-line therapy for this condition; AND
                                                                                                                           The condition must be expressing the Philadelphia chromosome; or
                                                                                                                           The condition must have the transcript BCR-ABL; AND
                                                                                                                           Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND
                                                                                                                           Patient must be undergoing treatment with this drug that is occurring within the first 24 months from the first administered dose. or
                                                                                                                           Patient must be undergoing treatment with this drug that is occurring beyond the first 24 months from the first administered dose - the patient meets the conditions as outlined below.
                                                                                                                           Conditions for PBS-subsidy beyond 24 months of treatment
                                                                                                                           On the first occasion an authority application extends PBS-subsidy beyond 24 months, confirm