Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p388
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 388/476)
Character Range: 3371903–3380175

initial treatment; AND
                                                                                                                                            The treatment must provide no more than the balance of up to 12 months of treatment.
                                                                       C14534                                                               Type III Short bowel syndrome with intestinal failure                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Written Authority Required procedures
                                                                                                                                            Initial treatment
                                                                                                                                            Must be treated by a gastroenterologist; OR
                                                                                                                                            Must be treated by a specialist within a multidisciplinary intestinal rehabilitation unit.
                                                                                                                                            Patient must have short bowel syndrome with intestinal failure following major surgery; AND
                                                                                                                                            Patient must have a history of dependence on parenteral support for at least 12 months; AND
                                                                                                                                            Patient must have received a stable parenteral support regimen for at least 3 days per week in the previous 4 weeks; AND
                                                                                                                                            Patient must not have active gastrointestinal malignancy or history of gastrointestinal malignancy within the last 5 years; AND
                                                                                                                                            The treatment must not exceed 12 months under this restriction; AND
                                                                                                                                            Patient must not have previously received PBS‑subsidised treatment with this drug for this condition.
                                                                                                                                            Provide a baseline value in this authority application of the amount of parenteral support per week, expressed as either:
                                                                                                                                            (i) for a patient of any age, the mean number of days of parenteral support per week
                                                                                                                                            (ii) for a patient yet to turn 18 years of age, the mean volume of parenteral support per week in mL per kg.
                                                                                                                                            Determine the mean over any given 4 week period prior to this authority application. For a patient yet to turn 18 years of age, both (i) and (ii) may be supplied, but provide at least (i).
                                                                                                                                            Assessment of treatment response/non‑response in the 'Continuing treatment' authority application will be compared against the baseline value(s) submitted in this application.
                                                                                                                                            A stable parenteral support regimen is defined as a minimum of 3 days of parenteral support (parenteral nutrition with or without IV fluids) per week for 4 consecutive weeks to meet caloric, fluid or electrolyte needs.
                                                                                                                                            The authority application must be made in writing and must include:
                                                                                                                                            (a) a completed authority prescription form(s); and
                                                                                                                                            (b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
                                                                       C14632                                                               Type III Short bowel syndrome with intestinal failure                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Written Authority Required procedures
                                                                                                                                            Continuing treatment
                                                                                                                                            Must be treated by a gastroenterologist; OR
                                                                                                                                            Must be treated by a specialist within a multidisciplinary intestinal rehabilitation unit.
                                                                                                                                            Patient must have previously received PBS‑subsidised initial treatment with this drug for this condition; AND
                                                                                                                                            Patient must have a reduction in parenteral support frequency of at least one day 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%