Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p463
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 463/476)
Character Range: 3798861–3803936

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.
                                                                       C15930                                                               Severe Crohn disease
                                                                                                                                            Initial treatment - Initial 4 (additional dose at week 10)
                                                                                                                                            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 this drug for this condition in this treatment cycle; AND
                                                                                                                                            Patient must have received 3 doses of initial treatment under either (i) initial 1, (ii) initial 2, (iii) initial 3; AND
                                                                                                                                            Patient must not have achieved an adequate response to this drug after a total of 3 doses of initial treatment under either (i) initial 1, (ii) initial 2, (iii) initial 3 under this restriction; AND
                                                                                                                                            The treatment must not exceed a total of 4 doses to be administered at weeks 0, 2, 6 and 10 under the initial treatment phase.
                                                                                                                                            Patient must be at least 18 years of age.
                                                                                                                                            A maximum quantity and number of repeats to provide for an additional dose of this drug consisting of one vial of 300 mg, with one dose to be administered at week 10, will be authorised.
                                                                                                                                            The assessment of the patient's response to the initial course of treatment must be conducted prior to 10 weeks and a second assessment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
                                                                                                                                            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 further PBS-subsidised treatment 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.
                                                                                                                                            An adequate response to this drug defined as:
                                                                                                                                            a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150