Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p11
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 11/162)
Character Range: 14717445–14722975

required until patient has begun puberty.
                                                                                                         In patients where puberty has commenced, radiographic evidence that epiphyses have not closed must be obtained within 6 months of completing an authority application for vosoritide. X-ray and date taken must be documented in the patient's medical records.
C13988              P13988         CN13988          Ustekinumab                                          Moderate to severe ulcerative colitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures
                                                                                                         Initial treatment - Initial 1 (new patient)
                                                                                                         Must be treated by a gastroenterologist (code 87); or
                                                                                                         Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or
                                                                                                         Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND
                                                                                                         Patient must have failed to achieve an adequate response to a 5-aminosalicylate oral preparation in a standard dose for induction of remission for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; AND
                                                                                                         Patient must have failed to achieve an adequate response to azathioprine at a dose of at least 2 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or
                                                                                                         Patient must have failed to achieve an adequate response to 6-mercaptopurine at a dose of at least 1 mg per kg daily for 3 or more consecutive months or have intolerance necessitating permanent treatment withdrawal; or
                                                                                                         Patient must have failed to achieve an adequate response to a tapered course of oral steroids, starting at a dose of at least 40 mg prednisolone (or equivalent), over a 6 week period or have intolerance necessitating permanent treatment withdrawal, and followed by a failure to achieve an adequate response to 3 or more consecutive months of treatment of an appropriately dosed thiopurine agent; AND
                                                                                                         Patient must have a Mayo clinic score greater than or equal to 6; or
                                                                                                         Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); AND
                                                                                                         The treatment must not exceed a single dose to be administered at week 8 under this restriction;
                                                                                                         Patient must be at least 18 years of age.
                                                                                                         The authority application must be made in writing and must include
                                                                                                         (1) a completed authority prescription form; and
                                                                                                         (2) 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), which includes
                                                                                                         (i) the completed current Mayo clinic or partial Mayo clinic calculation sheet including the date of assessment of the patient's condition; and
                                                                                                         (ii) details of prior systemic drug therapy [dosage, date of commencement and duration of therapy].
                                                                                                         All tests and assessments should be performed preferably