Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p361
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 361/381)
Character Range: 13712448–13718751

treatment with androgen deprivation therapy.
                                                                                                                                                                    Prescribing instructions
                                                                                                                                                                    Retain the results of all investigative imaging and prostate-specific antigen (PSA) level measurements on the patient's medical records - do not submit copies of these with this authority application.
                                                                                                                                                                    The PSA level doubling time must be based on at least three PSA levels obtained within a time period of 10 months any time prior to first commencing a novel hormonal drug for this condition. The third reading is to demonstrate that the doubling was durable and must be at least 1 week apart from the second reading.
C12899              P12899         CN12899          Somatropin                                                                                                      Hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Written Authority Required procedures
                                                                                                                                                                    Continuing treatment
                                                                                                                                                                    Patient must have previously received treatment under the PBS S100 Growth Hormone Program under the hypothalamic-pituitary disease secondary to a structural lesion, with hypothalamic obesity driven growth category; AND
                                                                                                                                                                    Patient must not have been on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or
                                                                                                                                                                    Patient must have achieved the 50th percentile growth velocity for bone age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or
                                                                                                                                                                    Patient must have achieved an increase in height standard deviation score for chronological age and sex while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or
                                                                                                                                                                    Patient must have achieved a minimum growth velocity of 4cm/year while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); or
                                                                                                                                                                    Patient must have achieved and maintained mid parental height standard deviation score while on the maximum dose of 7.5mg/m2/week or greater for the most recent treatment period (32 weeks for an initial or recommencement treatment period and 26 weeks for a continuing treatment period, whichever applies); AND
                                                                                                                                                                    Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes; AND
                                                                                                                                                                    Patient must not have an active tumour or evidence of tumour growth or activity; AND
                                                                                                                                                                    Patient must be male and must not have a bone age of 15.5 years or more; or
                                                                                                                                                                    Patient must be female and must not have a bone age of 13.5 years or more;
                                                                                                                                                                    Patient must