Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p166
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 166/476)
Character Range: 1867757–1871985

latest version is located on the website specified in the Administrative Advice), which includes the following:
                                                                                                                                            (i) the completed current Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) 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].
                                                                                                                                            A maximum quantity and number of repeats to provide for an initial course of this drug consisting of 3 doses at 5 mg per kg body weight per dose to be administered at weeks 0, 2 and 6, or to be administered at 8‑weekly intervals for patients who have received prior treatment for an acute severe episode, will be authorised.
                                                                                                                                            All tests and assessments should be performed preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior conventional treatment.
                                                                                                                                            The most recent Mayo clinic, partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) score must be no more than 4 weeks old at the time of application.
                                                                                                                                            An adult patient who has previously received induction therapy with PBS‑subsidised treatment with this drug for an acute severe episode of ulcerative colitis in the last 4 months, and demonstrated an adequate response to induction therapy by achieving and maintaining a partial Mayo clinic scoreless than or equal to 2, with no subscore greater than 1, will not be required to demonstrate failure to prior treatment with a 5‑aminosalicylate oral preparation and one of azathioprine, 6‑mercaptopurine or oral steroids.
                                                                                                                                            A patient, aged 6 to 17 years, who has previously received induction therapy with PBS‑subsidised treatment with this drug for an acute severe episode of ulcerative colitis in the last 4 months, and demonstrated an adequate response to induction therapy by achieving and maintaining a PUCAI score of less than 10 will not be required to demonstrate failure to prior treatment with a 5‑aminosalicylate oral preparation and one of azathioprine, 6‑mercaptopurine or oral steroids.
                                                                                                                                            A partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) assessment of the patient's response to this initial course of treatment must be made following a minimum of 12 weeks of treatment for adalimumab and up to 12 weeks after the first dose (6 weeks following the third dose) for golimumab, infliximab and vedolizumab so that there is adequate time for a response to be demonstrated.
                                                                                                                                            If treatment with any of the above‑mentioned drugs is contraindicated according to the relevant TGA‑approved Product Information, details must be provided at the time of application.
                                                                                                                                            An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4