Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p142
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 142/162)
Character Range: 15383371–15389297

the remainder of a 24-week treatment course with this biological medicine; AND
                                                                                                         The treatment must be as systemic monotherapy; or
                                                                                                         The treatment must be in combination with methotrexate; AND
                                                                                                         Patient must have been assessed for response to treatment after at least 12 weeks treatment with the preceding supply of this biological medicine, but within 8 weeks of the last administered dose; AND
                                                                                                         Patient must have demonstrated an adequate response to treatment; AND
                                                                                                         Patient must not receive more than 8 weeks of treatment with etanercept under this restriction.
                                                                                                         An adequate response to treatment is defined as
                                                                                                         A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.
                                                                                                         The assessment of response to treatment must be documented in the patient's medical records.
                                                                                                         The same body area assessed at the baseline PASI assessment must be assessed for demonstration of response to treatment for the purposes of gaining approval for the remainder of 24 weeks treatment.
C14513              P14513         CN14513          Etanercept                                           Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures
                                                                                                         Initial 1 treatment (Whole body) - 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 lesions 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 this biological medicine 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