Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p5
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 5/312)
Character Range: 15501674–15507576

prescription form; 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).
                                                                                                                           An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.
                                                                                                                           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.
C14572              P14572         CN14572          Ustekinumab                                                            Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Written Authority Required procedures
                                                                                                                           Initial 3 treatment (Whole body, or, face/hand/foot) - Recommencement of treatment after a break in biological medicine of more than 5 years
                                                                                                                           Must be treated by a dermatologist; AND
                                                                                                                           Patient must not have received PBS-subsidised treatment with a biological medicine for this condition for at least 5 years, if they have previously received PBS-subsidised treatment with a biological medicine for this condition and wish to commence a new treatment cycle; AND
                                                                                                                           The condition must be affecting the whole body - all subsequent authority applications to this application will be made under treatment phases that feature the words 'whole body'; or
                                                                                                                           The condition must be limited to the face/hand/foot - all subsequent authority applications to this application will be made under treatment phases that feature the words 'face, hand, foot'; AND
                                                                                                                           Patient must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; or
                                                                                                                           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; or
                                                                                                                           The treatment must be in combination with methotrexate; AND
                                                                                                                           Patient must not receive more than 28 weeks of treatment under this restriction;
                                                                                                                           Patient must be under 18 years of age.
                                                                                                                           The most recent PASI assessment must be no more than 4 weeks old at the time of application and must be documented in the patient's medical records.
                                                                                                                           The authority application