Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p124
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 124/476)
Character Range: 1621994–1630575

treatment; OR
                                                                                                                                            Patient must have received insufficient therapy with this drug under the subsequent continuing treatment Authority Required (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).
                                                                                                                                            Must be treated by a dermatologist.
                                                                       C8844                                                                Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures ‑ Streamlined Authority Code 8844
                                                                                                                                            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.
                                                                       C8881                                                                Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Written Authority Required procedures
                                                                                                                                            Subsequent continuing treatment, Face, hand, foot
                                                                                                                                            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 the plaque or plaques assessed prior to biological treatment showing:
                                                                                                                                            (i) a reduction in the Psoriasis Area and Severity Index (PASI) symptom