Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p325
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 325/381)
Character Range: 13518800–13525459

a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
                                                                                                                                                                    (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
                                                                                                                                                                    (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
                                                                                                                                                                    (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
                                                                                                                                                                    (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
                                                                                                                                                                    (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
                                                                                                                                                                    (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
                                                                                                                                                                    Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.
C12855              P12855         CN12855          Somatropin                                                                                                      Short stature due to short stature homeobox (SHOX) gene disorders                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Written Authority Required procedures
                                                                                                                                                                    Initial treatment
                                                                                                                                                                    Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as a karyotype confirming the presence of a SHOX mutation/deletion without the presence of mixed gonadal dysgenesis; or
                                                                                                                                                                    Patient must have diagnostic results consistent with a SHOX mutation/deletion, defined as mixed gonadal dysgenesis (45X mosaic karyotype with the presence of any Y chromosome material and/or SRY gene positive by FISH study) and have an appropriate plan of management in place for the patient's increased risk of gonadoblastoma; AND
                                                                                                                                                                    Patient must have a current height at or below the 1st percentile for age and sex; 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); or
                                                                                                                                                                    Patient must have an annual growth velocity of 8 cm per year or less if the patient has a bone or chronological age of 2.5 years or less; AND
                                                                                                                                                                    Patient must not have a condition with a known risk of malignancy including chromosomal abnormalities such as Down and Bloom syndromes (excluding gonadoblastoma secondary to mixed gonadal dysgenesis); AND
                                                                                                                                                                    Patient must not have an active tumour or evidence of tumour growth or activity; AND
                                                                                                                                                                    Patient must not have previously received treatment under the PBS S100 Growth Hormone Program; AND
                                                                                                                                                                    Patient must be male and must not have a height greater than or equal to 167.7cm; or
                                                                                                                                                                    Patient must be female and must not have a height