Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p161
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 161/476)
Character Range: 1840783–1847379

with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
                                                                                                                                            A patient may re‑trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS‑subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
                                                                                                                                            If patients aged 6 to 17 years fail to respond to PBS‑subsidised biological medicine treatment 3 times (twice with one agent) they will not be eligible to receive further PBS‑subsidised biological medicine therapy in this treatment cycle.
                                                                       C12063                                                               Severe Crohn disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Written 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)].
                                                                                                                                            Patient must have received prior PBS‑subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
                                                                                                                                            Patient must not have 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 total of 3 doses to be administered at weeks 0, 2 and 6 under this restriction.
                                                                                                                                            Patient must be aged 18 years or older.
                                                                                                                                            Applications for authorisation must be made in writing and must include:
                                                                                                                                            (a) a completed authority prescription form; and
                                                                                                                                            (b) a completed Crohn Disease PBS Authority Application ‑ Supporting Information Form, which includes the following:
                                                                                                                                            (i) the completed current Crohn Disease Activity Index (CDAI) Score calculation sheet including the date of assessment of the patient's condition if relevant; or
                                                                                                                                            (ii) the reports and dates of the pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant; and
                                                                                                                                            (iii) the date of clinical assessment; and
                                                                                                                                            (iv) 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.
                                                                                                                                            Where the most recent course of PBS‑subsidised biological medicine treatment was approved under an initial treatment restriction, the patient must have been assessed for response to that