Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p36
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 36/381)
Character Range: 11720302–11731570

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 of physical (not psychological) injury to the patient; AND
                                                                                                                                                                    The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND
                                                                                                                                                                    Patient must be ambulatory, with/without assistance/support; AND
                                                                                                                                                                    Patient must have mild disability in at least 3 functional systems.  or
                                                                                                                                                                    Patient must have moderate disability in at least 1 functional system.
                                                                                                                                                                    Functional systems referred to in this restriction are the visual, brain stem, pyramidal, cerebellar, sensory, bowel/bladder and cerebral/cognitive systems.
                                                                                                                                                                    Select a dose and pack size appropriate for the patient's CYP2C9 metabolising enzyme status.
C10967              P10967         CN10967          Armodafinil                                                                                                     Narcolepsy                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures
                                                                                                                                                                    Continuing or change of treatment
                                                                                                                                                                    Patient must have previously received PBS-subsidised treatment with this drug for this condition.  or
                                                                                                                                                                    Patient must have previously received PBS-subsidised treatment with modafinil for this condition.
C10968              P10968         CN10968          Modafinil                                                                                                       Narcolepsy                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures
                                                                                                                                                                    Continuing or change of treatment
                                                                                                                                                                    Patient must have previously received PBS-subsidised treatment with this drug for this condition.  or
                                                                                                                                                                    Patient must have previously received PBS-subsidised treatment with armodafinil for this condition.
C10970              P10970         CN10970          Armodafinil                                                                                                     Narcolepsy                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Written Authority Required procedures
                                                                                                                                                                    Initial 1 - treatment of narcolepsy without 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 mean sleep latency less than or equal to 10 minutes on a Multiple Sleep Latency Test (MSLT); or
                                                                                                                                                                    Patient must have an electroencephalographic (EEG) recording showing the pathologically rapid development of REM sleep; 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.
                                                                                                                                                                    The MSLT must be preceded by nocturnal polysomnography. Sleep prior to the MSLT must be at least 6 hours in duration.
                                                                                                                                                                    The authority application must be made in writing and must include the following
                                                                                                                                                                    (a) a completed authority prescription form; and
                                                                                                                                                                    (b) a completed Narcolepsy Initial PBS authority