Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p32
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 32/381)
Character Range: 11689245–11695309

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 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 4 weeks 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 continuing treatment must be performed on the same affected area as assessed at baseline.
                                                                                                                                                                    An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of treatment. This will enable ongoing treatment for those who meet the continuing restriction for PBS-subsidised treatment.
                                                                                                                                                                    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.
C10890              P10890         CN10890          Oxycodone                                                                                                       Severe pain
                                                                                                                                                                    Initial