Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p150
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 150/162)
Character Range: 15421413–15426531

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 28 weeks of treatment 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 provided at the time of application.
                                                                                                         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 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) A Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably when the patient was on treatment, but no longer than 4 weeks 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) the PASI score that followed each prior therapy trialled;
                                                                                                         (iv) the date the PASI scores were determined.
                                                                                                         A PASI assessment must have been completed for each pre-requisite treatment trialled, preferably when the patient was on treatment, but no longer than 4 weeks following cessation of that pre-requisite treatment. 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