Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p1
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 1/162)
Character Range: 14657029–14663102

1  Circumstances, purposes and conditions
  The following table sets out:
 (a) circumstances for circumstances codes, for the purposes of section 13 and 23; and
 (b) purposes for purposes codes, for the purposes of sections 15 and 16; and
 (c) for the purposes of section 19, information relating to how authorisation is obtained when the circumstances or conditions for writing a prescription include an authorisation requirement.

Circumstances Code  Purposes Code  Conditions Code  Listed Drug                                          Circumstances and Purposes                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Authority Requirements (part of Circumstances; or Conditions)

C13927              P13927         CN13927          Ustekinumab                                          Moderate to severe ulcerative colitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures
                                                                                                         Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 5 years)
                                                                                                         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 received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
                                                                                                         Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; 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) the details of prior biological medicine treatment including the details of date and duration of treatment.
                                                                                                         An application for a patient who has received PBS-subsidised biological medicine treatment for this condition who wishes to change or recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised biological medicine treatment, within the timeframes specified below.
                                                                                                         An assessment of a patient's response to this initial course of treatment must be conducted between 8 and 16 weeks of therapy.
                                                                                                         Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
                                                                                                         If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive