Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p389
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 389/476)
Character Range: 3379832–3384168

per week compared to the mean number of days per week at baseline; OR
                                                                                                                                            Patient must have, as a patient yet to turn 18 years of age, a reduction in the mean weekly parenteral support volume of at least 20% (mL per kg of body weight) relative to baseline; OR
                                                                                                                                            The treatment must be resuming after a break in therapy, but before the break in therapy occurred, a reduction in parenteral support relative to baseline had been occurring to an extent as stated as above.
                                                                                                                                            Refer to the measurement(s) stated in the Initial treatment authority application for the baseline dependence on parenteral support. Determine the current mean use per week of parental support in days (for a patient of any age) and/or the mean volume per week in mL per kg (for a patient yet to turn 18 years of age). State these values in this authority application.
                                                                                                                                            The current mean number of days of parenteral support is calculated as the mean number of days in which any parenteral support is required (parenteral nutrition with or without IV fluids) per week to meet caloric, fluid or electrolyte needs over a 4 week timeframe that best represents the average of the preceding treatment period.
                                                                                                                                            The current mean weekly parenteral support volume is calculated as the mean mL per kg of body weight of parenteral support (parenteral nutrition with or without IV fluids) per week to meet caloric, fluid or electrolyte needs over a 4 week timeframe that best represents the average of the preceding treatment period.
                                                                                                                                            From 1 September 2021
                                                                                                                                            Where the mean weekly volume of parenteral support in terms of mL per kg of body weight for 4 consecutive weeks has not been stated in an Initial treatment authority application for a patient yet to turn 18 years of age, provide in this authority application both:
                                                                                                                                            (i) a known or estimated retrospective baseline value that would have applied to the patient immediately before commencing treatment with this drug, and
                                                                                                                                            (ii) the current value (observed over a 4 week timeframe)
                                                                                                                                            Provide these values for a child only where mean weekly volume is to be used as an alternative response assessment to mean days of parenteral support per week. Otherwise, continue to use mean days per week.
                                                                                                                                            Where treatment is resuming after a break in treatment with this drug, state parenteral support days/volume values as occurring prior to the break instead of current values.
                                                                                                                                            A patient who has turned 18 years of age since their last authority application may be assessed for response using either the mean number of days of parenteral support or mean volume of parenteral support. Any subsequent authority application after this application must be assessed using the mean