Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p349
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 349/476)
Character Range: 3095573–3103165

developmental state has regressed.
                                                                                                                                            0. Absence of developmental states (1 to 9) listed below:
                                                                                                                                            1. Rolls from side to side on back;
                                                                                                                                            2. Child holds head erect for at least 3 seconds unsupported;
                                                                                                                                            3. Sitting, but with assistance;
                                                                                                                                            4. Sitting without assistance:
                                                                                                                                            (a) Child sits up straight with the head erect for at least 10 seconds;
                                                                                                                                            (b) Child does not use arms or hands to balance body or support position.
                                                                                                                                            5. Hands and knees crawling:
                                                                                                                                            (a) Child alternately moves forward or backwards on hands and knees;
                                                                                                                                            (b) The stomach does not touch the supporting surface;
                                                                                                                                            (c) There are continuous and consecutive movements at least 3 in a row.
                                                                                                                                            6. Standing with assistance:
                                                                                                                                            (a) Child stands in upright position on both feet, holding onto a stable object (e.g. furniture) with both hands and without leaning on object;
                                                                                                                                            (b)The body does not touch the stable object, and the legs support most of the body weight;
                                                                                                                                            (c) Child thus stands with assistance for at least 10 seconds.
                                                                                                                                            7. Standing alone:
                                                                                                                                            (a) Child stands in upright position on both feet (not on the toes) with the back straight;
                                                                                                                                            (b) The leg supports 100% of the child's weight;
                                                                                                                                            (c) There is no contact with a person or object;
                                                                                                                                            (d) Child stands alone for at least 10 seconds.
                                                                                                                                            8. Walking with assistance:
                                                                                                                                            (a) Child is in an upright position with the back straight;
                                                                                                                                            (b) Child makes sideways or forced steps by holding onto a stable object (e.g. furniture) with 1 or both hands;
                                                                                                                                            (c) One leg moves forward while the other supports part of the body weight;
                                                                                                                                            (d) Child takes at least 5 steps in this manner.
                                                                                                                                            9. Walking alone:
                                                                                                                                            (a) Child takes at least 5 steps independently in upright position with the back straight;
                                                                                                                                            (b) One leg moves forward while the other supports most of the body weight;
                                                                                                                                            (c) There is no contact with a person or object.
                                                                                                                                            Confirm which developmental state has regressed by: (i) stating the overall developmental state (1 ‑ 9) the patient was in at the time of gene therapy, or, the best developmental state achieved since gene therapy, and (ii) stating the patient's current overall developmental state (i.e. a number that is lower than stated in (i).
                                                                                                                                            Where the patient has neither regressed from a developmental state nor reached the next developmental state, PBS‑subsidy of this benefit is not available.
                                                                                                                                            The approved Product Information recommended dosing is as follows:
                                                                                                                                            (i) 16 days to less than 2 months of age: 0.15 mg/kg
                                                                                                                                            (ii) 2 months to less than 2 years of age: 0.20 mg/kg
                                                                                                                                            (iii) 2 years of age and older weighing less than 20 kg: 0.25 mg/kg
                                                                                                                                            (iv) 2 years of age and older weighing 20 kg or more: 5