Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p152
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 152/162)
Character Range: 15431708–15438284

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 must be provided in this application and documented in the patient's medical records.
C14553              P14553         CN14553          Etanercept                                           Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures
                                                                                                         Initial 4 - Re-treatment (Whole body)
                                                                                                         Must be treated by a dermatologist; AND
                                                                                                         The treatment must be as systemic monotherapy; or
                                                                                                         The treatment must be in combination with methotrexate; AND
                                                                                                         Patient must have a documented history of severe chronic plaque psoriasis of the whole body; AND
                                                                                                         Patient must be undergoing re-treatment with this biological medicine for this PBS indication after an initial adequate response to the most recent treatment course, but has since experienced at least one of the following:
                                                                                                          (i) a disease flare where the PASI score has worsened (increased) by at least 50%, (ii) the current PASI score has returned above 15; AND
                                                                                                         Patient must not have failed more than once to achieve an adequate response with etanercept; 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 a patient has had a treatment break the length of the break is measured from the date the most recent treatment was stopped to the date of the application for further treatment.
C14554              P14554         CN14554          Etanercept                                           Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures
                                                                                                         Initial 1 treatment (Face, hand, foot) - biological medicine-naive patient
                                                                                                         Must be treated by a dermatologist; AND
                                                                                                         Patient must be undergoing treatment for the first time with PBS-subsidised biological medicine for this PBS indication; AND
                                                                                                         The treatment must be as systemic monotherapy; or
                                                                                                         The treatment must be in combination with methotrexate; AND
                                                                                                         Patient must have the plaque or plaques of the face, or palm of hand or sole of foot present for at least 6 months from the time of initial diagnosis; AND
                                                                                                         Patient must have failed to achieve an adequate response to at least 2 of the following 3 treatments:
                                                                                                          (i) phototherapy (UVB or PUVA) for 3 treatments per week for at least 6 weeks; (ii) methotrexate at a dose of at least 10 mg or 10 mg per square metre weekly (whichever is lowest) for at least 6 weeks; (iii) acitretin at a dose of at least 0.4 mg per kg per 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