Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p34
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 34/381)
Character Range: 11702035–11710287

on the same affected area as assessed at baseline.
                                                                                                                                                                    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 and face, hand, foot area diagrams 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.
C10910              P10910         CN10910          Oxycodone                                                                                                       Severe pain
                                                                                                                                                                    Initial PBS treatment after 1 June 2020 where patient has been treated with opioids for less than 12 months
                                                                                                                                                                    Patient must have cancer pain; or
                                                                                                                                                                    The treatment must be for post-operative pain following a major operative procedure; AND
                                                                                                                                                                    Patient must have had or would have inadequate pain management with maximum tolerated doses of non-opioid analgesics.  or
                                                                                                                                                                    Patient must be unable to use non-opioid analgesics due to contraindications or intolerance.
C10917              P10917         CN10917          Atezolizumab                                                                                                    Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures - Streamlined Authority Code 10917
                                                                                                                                                                    Continuing treatment of hepatocellular carcinoma - 3 weekly treatment regimen
                                                                                                                                                                    Patient must be undergoing combination treatment with bevacizumab until disease progression, unless not tolerated; AND
                                                                                                                                                                    Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                    Patient must not have developed disease progression while being treated with this drug for this condition.
                                                                                                                                                                    PBS supply of this drug must be through only one of the two continuing treatment regimens at any given time
C10935              P10935         CN10935          Armodafinil                                                                                                     Narcolepsy                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures
                                                                                                                                                                    Initial 2 - treatment of narcolepsy with cataplexy
                                                    Modafinil                                                                                                       Must be treated by a qualified sleep medicine practitioner or neurologist; AND
                                                                                                                                                                    The treatment must be for use when