Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p128
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 128/312)
Character Range: 16268808–16274333

on the same affected area as assessed at baseline.
                                                                                                                           An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.
                                                                                                                           To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
                                                                                                                           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.
                                                                                                                           The authority application must be made in writing and must include:
                                                                                                                           (1) a completed authority prescription form(s); 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 the following:
                                                                                                                           (i) the completed current Psoriasis Area and Severity Index (PASI) calculation sheets, and the face, hand, foot area diagrams including the dates of assessment of the patient's condition; and
                                                                                                                           (ii) details of prior biological treatment, including dosage, date and duration of treatment.
                                                                                                                           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.
                                                                                                                           At the time of the authority application, medical practitioners should request to provide for an initial course of this drug for this condition sufficient for up to 28 weeks of therapy, at a dose of 150 mg for weeks 0 and 4, then 150 mg every 12 weeks thereafter.
C15223              P15223         CN15223          Risankizumab                                                           Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Written Authority Required procedures
                                                                                                                           Continuing treatment, Face, hand, foot
                                                                                                                           Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND
                                                                                                                           Patient must have