Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p151
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 151/162)
Character Range: 15426083–15432154

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) the PASI score that followed each prior therapy trialled;
                                                                                                         (iv) the date the PASI scores were determined.
                                                                                                         Provide a baseline PASI score to be referenced in any future authority applications that continue treatment. This PASI score may be any of (i) a current PASI score, (ii) a PASI score present prior to, or, after a pre-requisite non-biological medicine.
C14552              P14552         CN14552          Etanercept                                           Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures
                                                                                                         Initial 2 treatment (Face, hand, foot) - Change of treatment
                                                                                                         Must be treated by a dermatologist; AND
                                                                                                         Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
                                                                                                         Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug more than once during the current treatment cycle; AND
                                                                                                         Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment 3 times for this condition within this treatment cycle; AND
                                                                                                         The treatment must be as systemic monotherapy; or
                                                                                                         The treatment must be in combination with methotrexate; AND
                                                                                                         Patient must not receive more than 16 weeks of treatment with this biological medicine under this restriction;
                                                                                                         Patient must be under 18 years of age.
                                                                                                         An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing
                                                                                                         (i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the pre-biological treatment baseline values; or
                                                                                                         (ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the pre-biological treatment baseline value.
                                                                                                         (i) there is an absence of an adequate response to that treatment; or
                                                                                                         (ii) there was an intolerance to that treatment; or
                                                                                                         (iii) there was an adequate response, but a change in treatment has been made for reasons other than the 2 mentioned above.
                                                                                                         In relation to the biological medicine that the patient is changing from, state whether the patient is changing therapy because
                                                                                                         (i) there is an absence of an adequate response to that treatment; or
                                                                                                         (ii) there was an intolerance to that treatment; or
                                                                                                         (iii) there was an adequate response, but a change in treatment has been made for reasons other than the 2 mentioned above.
                                                                                                         The assessment of response to treatment and the reason for changing therapy