Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p61
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 61/161)
Character Range: 14155420–14160736

the Administrative Advice).
                                                                                   Prescribe an appropriate amount of drug (maximum quantity in units) outlined within the 'Notes' section of this restriction.
                                                                                   Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
                                                                                   In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.
C13320              P13320         CN13320          Mecasermin                     Severe growth failure with primary insulin-like growth factor-1 deficiency                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures
                                                                                   Initial treatment
                                                                                   The condition must be caused by severe primary insulin-like growth factor-1 deficiency (IGFD), with IGFD deficiency for the purpose of PBS subsidy defined as a basal IGF-1 level (measured any time prior to initiating treatment with this drug) below the 2.5th percentile adjusted for each of:
                                                                                    (i) age, (ii) gender; AND
                                                                                   The condition must have resulted in the patient experiencing short stature, with short stature for the purpose of PBS subsidy defined as the patient's height (measured any time prior to initiating treatment with this drug) being at least 3 standard deviations below the norm, adjusted for each of:
                                                                                    (i) age, (ii) gender; AND
                                                                                   Patient must have a growth velocity below the 25th percentile for bone age and sex measured over a 12 month interval (or a 6 month interval for an older child); AND
                                                                                   The condition must not be caused by growth hormone deficiency; AND
                                                                                   Patient must have a bone age of less than 13.5 years (females); or
                                                                                   Patient must have a bone age of less than 15.5 years (males); AND
                                                                                   The condition must not be caused by secondary causes of IGFD - prior to initiating treatment with this drug, the treating physician has at least excluded each of the following:
                                                                                    (i) malnutrition, (ii) hypopituitarism, (iii) hypothyroidism, (iv) medication side effects; AND
                                                                                   The treatment must not be in a patient with known epiphyseal closure/growth plate fusion (i.e. the patient is known to have ceased growing); AND
                                                                                   Must be treated by a paediatric endocrinologist; the authority application must be completed by this physician type; or
                                                                                   Must be treated by a paediatrician who has consulted the above mentioned specialist type; the authority application must be completed by this paediatrician;
                                                                                   Patient must be aged from 2 years up until their 18th birthday.
                                                                                   An older child is defined as a male with a chronological age of at least 12 years or a bone age of at least 10 years, or a female with a chronological age of at