Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p112
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 112/162)
Character Range: 15245576–15250420

once daily for at least 6 weeks; AND
                                                                                                         The treatment must be as systemic monotherapy (other than methotrexate); AND
                                                                                                         Patient must not receive more than 16 weeks of treatment under this restriction;
                                                                                                         Patient must be aged 18 years or older;
                                                                                                         Must be treated by a dermatologist.
                                                                                                         Where treatment with methotrexate, ciclosporin, apremilast, deucravacitinib or acitretin is contraindicated according to the relevant TGA-approved Product Information, or where phototherapy is contraindicated, details must be provided at the time of application.
                                                                                                         Where intolerance to treatment with phototherapy, methotrexate, ciclosporin, apremilast, deucravacitinib 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.
                                                                                                         Regardless of if a patient has a contraindication to treatment with either methotrexate, ciclosporin, apremilast, deucravacitinib, acitretin or phototherapy, the patient is still required to trial 2 of these prior therapies until a failure to achieve an adequate response is met.
                                                                                                         The following criterion indicates failure to achieve an adequate response to prior treatment and must be demonstrated in the patient at the time of the application
                                                                                                         (a) A current Psoriasis Area and Severity Index (PASI) score of greater than 15, as assessed, preferably whilst still on treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.
                                                                                                         (b) A PASI assessment must be completed for each prior treatment course, preferably whilst still on treatment, but no longer than 4 weeks following cessation of each course of treatment.
                                                                                                         (c) The most recent PASI assessment must be no more than 4 weeks old at the time of application.
                                                                                                         The authority application must be made in writing and must include
                                                                                                         (a) a completed authority prescription form(s); and
                                                                                                         (b) a completed Severe Chronic Plaque Psoriasis PBS Authority Application - Supporting Information Form which includes the following
                                                                                                         (i) the completed current and previous Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition; and
                                                                                                         (ii) details of previous phototherapy and systemic drug therapy [dosage (where applicable), date of commencement and duration of therapy].
                                                                                                         To demonstrate a response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
                                                                                                         Where a response assessment is not conducted within the required timeframe, the patient will be