Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p125
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 125/161)
Character Range: 14468629–14473605

condition. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
C13598              P13598         CN13598          Etanercept                     Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Written Authority Required procedures
                                                                                   Initial treatment - Initial 2, Face, hand, foot (change or recommencement of treatment after a break in biological medicine of less than 5 years)
                                                                                   Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
                                                                                   Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with 3 biological medicines for this condition within this treatment cycle; AND
                                                                                   Patient must not have already failed, or ceased to respond to, PBS-subsidised treatment with this drug for this condition during the current treatment cycle; 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.
                                                                                   An adequate response to treatment is defined as the plaque or plaques assessed prior to biological treatment showing
                                                                                   (i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom subscores for all 3 of erythema, thickness and scaling, to slight or better, or sustained at this level, as compared to the baseline values; or
                                                                                   (ii) a reduction by 75% or more in the skin area affected, or sustained at this level, as compared to the baseline value for this treatment cycle.
                                                                                   An application for a patient who has received PBS-subsidised treatment with this drug and who wishes to recommence therapy with this drug, must be accompanied by evidence of a response to the patient's most recent course of PBS-subsidised treatment with this drug, within the timeframes specified below.
                                                                                   Where the most recent course of PBS-subsidised treatment with this drug was approved under either of the Initial 1, Initial 2, Initial 3, first or subsequent continuing treatment restrictions, 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. It is recommended that an application for the continuing treatment is submitted to the Department of Human Services no later than 1 month from the date of completion of the most recent course of treatment. This is to ensure continuity of treatment for those who meet the continuing restriction for PBS-subsidised treatment with this drug for this condition. Demonstration of response should