Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p133
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 133/312)
Character Range: 16294797–16300301

and
                                                                                                                           (ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].
                                                                                                                           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.
                                                                                                                           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.
                                                                                                                           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.
C15237              P15237         CN15237          Risankizumab                                                           Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Written Authority Required procedures
                                                                                                                           Initial treatment - Initial 3, Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years)
                                                                                                                           Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND
                                                                                                                           Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND
                                                                                                                           The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where: (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; AND
                                                                                                                           The treatment must be as systemic monotherapy (other than methotrexate); AND
                                                                                                                           Patient must not receive more than 28 weeks of treatment under this restriction.
                                                                                                                           Patient must be at least 18 years of age.
                                                                                                                           Must be treated by a dermatologist.
                                                                                                                           The most recent PASI assessment must be no more than 4 weeks old at the time of application.
                                                                                                                           The PASI assessment for continuing treatment must