Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p137
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 137/476)
Character Range: 1701937–1709307

patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle.
                                                                                                                                            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.
                                                                       C9602                                                                Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures ‑ Streamlined Authority Code 9602
                                                                                                                                            Subsequent continuing treatment, Whole body
                                                                                                                                            Patient must have previously received PBS‑subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND
                                                                                                                                            Patient must have demonstrated an adequate response to treatment with this drug; AND
                                                                                                                                            The treatment must be as systemic monotherapy (other than methotrexate); AND
                                                                                                                                            Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction.
                                                                                                                                            Patient must be aged 18 years or older.
                                                                                                                                            Must be treated by a dermatologist.
                                                                                                                                            An adequate response to treatment is defined as:
                                                                                                                                            A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.
                                                                                                                                            The measurement of response to the prior course of therapy must be documented in the patient's medical notes.
                                                                                                                                            Determination of response must be based on the PASI assessment of response to the most recent course of treatment with this drug.
                                                                                                                                            If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS‑subsidised treatment with this drug for this condition within this treatment cycle.
                                                                                                                                            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.
                                                                       C9632                                                                Acute severe ulcerative colitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures ‑ Streamlined Authority Code 9632
                                                                                                                                            Must be treated by a gastroenterologist; OR
                                                                                                                                            Must be treated by a consultant physician [internal medicine specialising in gastroenterology, or general medicine specialising in gastroenterology].
                                                                                                                                            Patient must have received an infusion of infliximab for the treatment of this condition as a hospital inpatient no more than two weeks prior to the date of the authority application; AND
                                                                                                                                            Patient must be an adult aged 18 years or older, and prior to initiation of infliximab treatment in hospital must have been experiencing six or more bloody stools per day, plus at least one of the following: (i)