Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p110
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 110/191)
Character Range: 10725542–10733573

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 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.
                                                                                                                                                                                                                               The PASI assessment for continuing treatment must be performed on the same affected area as assessed at baseline.
                                                                                                                                                                                                                               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.
C8987               P8987          CN8987           Ustekinumab                                                                                                                                                                Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Written Authority Required procedures
                                                                                                                                                                                                                               Continuing treatment, Face, hand, foot
                                                                                                                                                                                                                               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
                                                                                                                                                                                                                               Patient must not receive more than 24 weeks of treatment per 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 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.
                                                                                                                                                                                                                               At the time of the authority application, medical practitioners should request the appropriate number of vials, based on the weight of the patient, to provide sufficient for a single injection. Up to a maximum of 1 repeat will be authorised.
                                                                                                                                                                                                                               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