Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p33
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 33/312)
Character Range: 15652470–15657932

degree of this toxicity must be provided at the time of application.
                                                                                                                           Details of the accepted toxicities including severity can be found on the Services Australia website.
                                                                                                                           The authority application must be made in writing and must include
                                                                                                                           (1) a completed authority 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).
                                                                                                                           The following indicates failure to achieve an adequate response to prior phototherapy/methotrexate/acitretin therapy
                                                                                                                           (a) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling being rated as severe or very severe, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the last pre-requisite therapy; or
                                                                                                                           (b) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot, as assessed, preferably whilst still on treatment, but no longer than 1 month following cessation of the last pre-requisite therapy
                                                                                                                           (i) the name of each prior therapy trialled that meets the above requirements - state at least 2;
                                                                                                                           (ii) the date of commencement and cessation of each prior therapy trialled, as well as the dosage (for drug therapies);
                                                                                                                           (iii) whether failure type (a) or (b) as described above occurred for each prior therapy trialled;
                                                                                                                           (iv) the dates that response assessments were determined.
                                                                                                                           (v) for each of erythema, thickness and scaling, which of these are rated as severe or very severe (at least 2 must be rated as severe/very severe);
                                                                                                                           (vi) the percentage area of skin (combined area of face, hands and feet) affected by this condition (must be at least 30%) prior to treatment with biological medicine.
                                                                                                                           Provide in this authority application, and document in the patient's medical records, each of
                                                                                                                           (i) the name of each prior therapy trialled that meets the above requirements - state at least 2;
                                                                                                                           (ii) the date of commencement and cessation of each prior therapy trialled, as well as the dosage (for drug therapies);
                                                                                                                           (iii) whether failure type (a) or (b) as described above occurred for each prior therapy trialled;
                                                                                                                           (iv) the dates that response assessments were determined.
                                                                                                                           (v) for each of erythema, thickness and scaling, which of these are rated as severe or very severe (at least 2 must be rated as severe/very severe);
                                                                                                                           (vi) the percentage area of skin (combined area of face, hands and feet) affected by this condition (must be at least 30%) prior to treatment with biological medicine.
                                                                                                                           Provide in this authority application at least one of the following to act as a baseline measurement and be referenced in any future authority applications that continue treatment
                                                                                                                           (v)