Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p135
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 135/161)
Character Range: 14514705–14519921

calculation sheets including the dates of assessment of the patient's condition; and
                                                                                   (ii) details of prior biological treatment, including dosage, date and duration 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.
C13647              P13647         CN13647          Etanercept                     Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Written Authority Required procedures
                                                                                   Initial treatment - Initial 3, Face, hand, foot (re-commencement of treatment after a break in biological medicine of more than 5 years)
                                                                                   Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND
                                                                                   Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND
                                                                                   The condition must be classified as severe due to a plaque or plaques on the face, palm of a hand or sole of a foot where:
                                                                                    (i) at least 2 of the 3 Psoriasis Area and Severity Index (PASI) symptom subscores for erythema, thickness and scaling are rated as severe or very severe; or (ii) the skin area affected is 30% or more of the face, palm of a hand or sole of a foot; 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.
                                                                                   The most recent PASI assessment must be no more than 1 month 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 completed current Psoriasis Area and Severity Index (PASI) calculation sheets and face, hand, foot area diagrams including the dates of assessment of the patient's condition.
                                                                                   It is recommended that an assessment of a patient's response is conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from the completion of the most recent course of treatment.
                                                                                   To demonstrate a response to treatment the application must be accompanied with the assessment of response from the most recent course of biological medicine therapy following a minimum of 12 weeks in therapy. It is recommended that an