Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p146
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 146/381)
Character Range: 12473062–12480446

(in writing), Face, hand, foot restriction to complete 24 weeks treatment; AND
                                                                                                                                                                    The treatment must provide no more than the balance of up to 24 weeks treatment available under the above restrictions; AND
                                                                                                                                                                    The treatment must be as systemic monotherapy (other than methotrexate); AND
                                                                                                                                                                    Must be treated by a dermatologist.
C12157              P12157         CN12157          Adalimumab                                                                                                      Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Written Authority Required procedures
                                                                                                                                                                    Subsequent continuing treatment, Whole body
                                                                                                                                                                    Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND
                                                                                                                                                                    Patient must have demonstrated an adequate response to treatment with this drug; AND
                                                                                                                                                                    The treatment must be as systemic monotherapy (other than methotrexate); AND
                                                                                                                                                                    Patient must not receive more than 24 weeks of treatment per subsequent continuing treatment course authorised under this restriction;
                                                                                                                                                                    Patient must be aged 18 years or older;
                                                                                                                                                                    Must be treated by a dermatologist.
                                                                                                                                                                    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 authority application must be made in writing and must include
                                                                                                                                                                    (1) a completed authority prescription form(s); 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) which includes the completed current Psoriasis Area and Severity Index (PASI) calculation sheet including the date of the assessment of the patient's condition.
                                                                                                                                                                    The most recent PASI assessment must be no more than 4 weeks old at the time of application.
                                                                                                                                                                    Approval will be based on the PASI assessment of response to the most recent course of treatment with this drug.
                                                                                                                                                                    An application for the continuing treatment 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 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