Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p307
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 307/312)
Character Range: 17432047–17441192

The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this PBS indication; AND
                                                                                                                           Patient must not have developed disease progression while receiving treatment with this drug for this condition.
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.
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 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.
C16249              P16249         CN16249          Imatinib                                                               Acute lymphoblastic leukaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures - Streamlined Authority Code 16249
                                                                                                                           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 dasatinib as a first-line therapy for this