Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p103
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 103/191)
Character Range: 10671151–10679162

Patient must not receive more than 24 weeks of treatment 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 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.
                                                                                                                                                                                                                               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 Psoriasis Area and Severity Index (PASI) calculation sheet and face, hand, foot area diagrams including the date of the assessment of the patient's condition.
                                                                                                                                                                                                                               The most recent PASI assessment must be no more than 1 month 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.
                                                                                                                                                                                                                               The PASI assessment for first continuing or subsequent continuing treatment must be performed on the same affected area assessed at baseline.
                                                                                                                                                                                                                               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.
                                                                                                                                                                                                                               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.
C8866               P8866          CN8866           Omeprazole                                                                                                                                                                 Zollinger-Ellison syndrome                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures - Streamlined Authority Code 8866

                                                    Pantoprazole

C8873               P8873          CN8873           Etanercept                                                                                                                                                                 Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Written Authority Required procedures
                                                                                                                                                                                                                               Subsequent continuing treatment,