Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p117
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 117/162)
Character Range: 15269396–15274082

be performed on the same affected area as assessed at baseline.
                                                                                                         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 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.
                                                                                                         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.
C14449              P14449         CN14449          Bimekizumab                                          Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures
                                                                                                         Initial treatment - Initial 1, Whole body or Face, hand, foot (new patient) or Initial 2, Whole body or Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years) or Initial 3, Whole body or Face, hand, foot (recommencement of treatment after a break in biological medicine of more than 5 years) - balance of supply
                                                                                                         Patient must have received insufficient therapy with this drug for this condition under the Initial 1, Whole body (new patient) restriction to complete 24 weeks treatment; or
                                                                                                         Patient must have received insufficient therapy with this drug for this condition under the Initial 2, Whole body (change or recommencement of treatment after a break in biological medicine of less than 5 years) restriction to complete 24 weeks treatment; or
                                                                                                         Patient must have received insufficient therapy with this drug for this condition under the Initial 3, Whole body (recommencement of treatment after a break in biological medicine of more than 5 years) restriction to complete 24 weeks treatment; or
                                                                                                         Patient must have received insufficient therapy with this drug for this condition under the Initial