Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p56
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 56/381)
Character Range: 11861841–11870249

with a biological medicine for this condition; AND
                                                                                                                                                                    Patient must have a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND
                                                                                                                                                                    The condition must have a current Psoriasis Area and Severity Index (PASI) score of greater than 15; AND
                                                                                                                                                                    The treatment must be as systemic monotherapy (other than methotrexate); AND
                                                                                                                                                                    Patient must not receive more than 16 weeks of treatment under this restriction;
                                                                                                                                                                    Patient must be aged 18 years or older;
                                                                                                                                                                    Must be treated by a dermatologist.
                                                                                                                                                                    The most recent PASI assessment must be no more than 4 weeks old at the time of application.
                                                                                                                                                                    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 current Psoriasis Area and Severity Index (PASI) calculation sheets including the dates of assessment of the patient's condition.
                                                                                                                                                                    To demonstrate a response to treatment the application 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 biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
                                                                                                                                                                    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.
C11160              P11160         CN11160          Sorafenib                                                                                                       Advanced Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures - Streamlined Authority Code 11160
                                                                                                                                                                    Initial treatment
                                                                                                                                                                    The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                                                                                                    Patient must have a WHO performance status of 2 or less; AND
                                                                                                                                                                    Patient must have Child Pugh class A; AND
                                                                                                                                                                    The condition must be untreated with systemic therapy.  or
                                                                                                                                                                    Patient must have developed intolerance of a severity necessitating permanent treatment withdrawal, in the absence of disease progression, to any of the following:
                                                                                                                                                                     (i) a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI), (ii) atezolizumab/bevacizumab combination therapy.
C11161              P11161         CN11161          Ustekinumab                                                                                                     Severe chronic plaque psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Written Authority Required procedures
                                                                                                                                                                    Initial treatment -