Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p153
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 153/162)
Character Range: 15437730–15442727

day for at least 6 weeks; AND
                                                                                                         Patient must not receive more than 16 weeks of treatment with etanercept under this restriction;
                                                                                                         Patient must be under 18 years of age.
                                                                                                         Where treatment with any of the above-mentioned drugs was contraindicated according to the relevant TGA-approved Product Information, or where phototherapy was contraindicated, details must be documented in the patient's medical records.
                                                                                                         Where intolerance to phototherapy, methotrexate and/or acitretin developed during the relevant period of use, which was of a severity to necessitate permanent treatment withdrawal, details of the degree of this toxicity must be documented in the patient's medical records.
                                                                                                         Details of the accepted toxicities including severity can be found on the Services Australia website.
                                                                                                         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)