Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p89
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 89/162)
Character Range: 15140822–15145734

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 treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
                                                                                                         Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
                                                                                                         If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle.
                                                                                                         A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the Initial 3 treatment restriction.
C14377              P14377         CN14377          Adalimumab                                           Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Written Authority Required procedures
                                                                                                         Initial treatment - Initial 1, Whole body (new patient)
                                                                                                         Patient must have severe chronic plaque psoriasis where lesions have been present for at least 6 months from the time of initial diagnosis; AND
                                                                                                         Patient must not have received PBS-subsidised treatment with a biological medicine for this condition; AND
                                                                                                         Patient must have failed to achieve an adequate response, as demonstrated by a Psoriasis Area and Severity Index (PASI) assessment, to at least 2 of the following 6 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 weekly for at least 6 weeks; (iii) ciclosporin at a dose of at least 2 mg per kg per day for at least 6 weeks; (iv) acitretin at a dose of at least 0.4 mg per kg per day for at least 6 weeks; (v) apremilast at a dose of 30 mg twice a day for at least 6 weeks; (vi) deucravacitinib at a dose of 6 mg 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 at least 18 years of age;
                                                                                                         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