Document ID: chunk:federal_register_of_legislation:F2025L00215:schedule:1:p20
Version: federal_register_of_legislation:F2025L00215
Segment Type: schedule
Provision Reference: sch 1 (pt 20/51)
Character Range: 59832–66438

atherosclerotic cardiovascular disease where LDL cholesterol cannot be measured due to hypertriglyceridaemia, may qualify under this authority application if they have a non-HDL in excess of 2.4 millimoles per litre.
C16297  P16297  CN16297  Glatiramer             Multiple sclerosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 16297
                         Interferon beta-1b     Continuing treatment
                         Peginterferon beta-1a  The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis; 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 have demonstrated compliance with, and an ability to tolerate this therapy.
                                                Must be treated by a medical practitioner; OR
                                                Must be treated by a nurse practitioner in consultation with a specialist physician.
C16299  P16299  CN16299  Cladribine             Relapsing remitting multiple sclerosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures - Streamlined Authority Code 16299
                                                Continuing treatment
                                                The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; AND
                                                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 have demonstrated compliance with, and an ability to tolerate, this therapy.
                                                Must be treated by a medical practitioner; OR
                                                Must be treated by a nurse practitioner in consultation with a specialist physician.
                                                The prescriber should request authority approval for the appropriate combination of packs (1, 4 or 6 tablets) to provide sufficient drug for a treatment week based on the weight of the patient in accordance with the TGA approved Product Information. Separate authority prescriptions may be required where the dose for treatment week 5 is different to the dose for treatment week 1.
C16301  P16301  CN16301  Fingolimod             Multiple sclerosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 16301
                         Ofatumumab             Continuing treatment
                         Ozanimod               The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis; AND
                                                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 have demonstrated compliance with, and an ability to tolerate this therapy.
                                                Must be treated by a medical practitioner; OR
                                                Must be treated by a nurse practitioner in consultation with a specialist physician.
C16303  P16303  CN16303  Siponimod              Multiple sclerosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 16303
                                                Continuing treatment (including recommencement of treatment)
                                                The treatment must be the sole PBS-subsidised disease modifying therapy for