Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p35
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 35/381)
Character Range: 11708472–11720603

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 therapy with dexamfetamine sulfate poses an unacceptable medical risk; or
                                                                                                                                                                    The treatment must be for use when intolerance to dexamfetamine sulfate is of a severity to necessitate treatment withdrawal; AND
                                                                                                                                                                    Patient must have experienced excessive daytime sleepiness, recurrent naps or lapses into sleep occurring almost daily for at least 3 months; AND
                                                                                                                                                                    Patient must have a definite history of cataplexy documented in their medical records for auditing purposes; AND
                                                                                                                                                                    Patient must not have any medical or psychiatric disorder that could otherwise account for the hypersomnia.
                                                                                                                                                                    The presence of any one of the following indicates treatment with dexamfetamine sulfate poses an unacceptable medical risk
                                                                                                                                                                    (a) a psychiatric disorder;
                                                                                                                                                                    (b) a cardiovascular disorder;
                                                                                                                                                                    (c) a history of substance abuse;
                                                                                                                                                                    (d) glaucoma;
                                                                                                                                                                    (e) any other absolute contraindication to dexamfetamine sulfate as specified in the TGA-approved Product Information.
C10939              P10939         CN10939          Atezolizumab                                                                                                    Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures - Streamlined Authority Code 10939
                                                                                                                                                                    Initial treatment
                                                                                                                                                                    Patient must be undergoing combination treatment with bevacizumab and atezolizumab until disease progression, unless not tolerated; AND
                                                                                                                                                                    Patient must have a WHO performance status of 0 or 1; AND
                                                                                                                                                                    Patient must not be suitable for transarterial chemoembolisation; AND
                                                                                                                                                                    Patient must have Child Pugh class A; AND
                                                                                                                                                                    The condition must be untreated with systemic therapy.  or
                                                                                                                                                                    Patient must have developed intolerance to a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) of a severity necessitating permanent treatment withdrawal.
C10953              P10953         CN10953          Siponimod                                                                                                       Multiple sclerosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures - Streamlined Authority Code 10953
                                                                                                                                                                    Continuing treatment (including recommencement of treatment)
                                                                                                                                                                    The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND
                                                                                                                                                                    Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                    Patient must not show continuing progression of disability while on treatment with this drug; AND
                                                                                                                                                                    Patient must be ambulatory, with/without assistance/support; AND
                                                                                                                                                                    Patient must have demonstrated compliance with, and an ability to tolerate this therapy.
C10955              P10955         CN10955          Siponimod                                                                                                       Multiple sclerosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures - Streamlined Authority Code 10955
                                                                                                                                                                    Initial treatment
                                                                                                                                                                    The condition must be/have previously been diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of at least one of the brain/spinal cord; or
                                                                                                                                                                    The condition must be/have previously been diagnosed as clinically definite relapsing-remitting multiple sclerosis supported by written certification, which is documented in the patient's medical records, from a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk