Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p106
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 106/191)
Character Range: 10691061–10701690

weeks treatment available under the above restrictions; AND
                                                                                                                                                                                                                               Must be treated by a dermatologist.
C8879               P8879          CN8879           Etanercept                                                                                                                                                                 Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures
                                                                                                                                                                                                                               Continuing treatment, Whole body or Continuing treatment, Face, hand, foot - balance of supply
                                                                                                                                                                                                                               Patient must have received insufficient therapy with this drug under the first continuing treatment, Whole body restriction to complete 24 weeks treatment; or
                                                                                                                                                                                                                               Patient must have received insufficient therapy with this drug under the first continuing treatment, 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.
C8887               P8887          CN8887           Etanercept                                                                                                                                                                 Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures - Streamlined Authority Code 8887
                                                                                                                                                                                                                               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 measurement of response to the prior course of therapy must be documented in the patient's medical notes.
                                                                                                                                                                                                                               Determination of response must be based on the PASI assessment of response to the most recent course of treatment with this drug.
                                                                                                                                                                                                                               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.
C8891               P8891          CN8891           Ustekinumab                                                                                                                                                                Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Written Authority Required procedures
                                                                                                                                                                                                                               Continuing treatment, Whole body
                                                                                                                                                                                                                               Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; 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