Document ID: chunk:federal_register_of_legislation:F2025L00215:schedule:1:p29
Version: federal_register_of_legislation:F2025L00215
Segment Type: schedule
Provision Reference: sch 1 (pt 29/51)
Character Range: 99315–105233

fluorescein angiography; AND
                                                The treatment must be the sole PBS-subsidised therapy for this condition.
                                                Authority approval for initial treatment of each eye must be sought.
                                                The first authority application for each eye must be made via the Online PBS Authorities System (real time assessment) or in writing via HPOS form upload or mail and must include:
                                                (1) Details (date, unique identifying number/code or provider number) of the optical coherence tomography or fluorescein angiogram report.
                                                If the application is submitted through HPOS form upload or mail, it must include:
                                                (a) details of the proposed prescription; and
                                                (b) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
                                                All reports must be documented in the patient's medical records.
C16320  P16320  CN16320  Inclisiran             Familial heterozygous hypercholesterolaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures - Streamlined Authority Code 16320
                                                Continuing treatment with this drug or switching treatment from a monoclonal antibody inhibiting proprotein coverase subtilisin kexin type 9 (PSCK9) for this PBS indication
                                                Patient must have previously received PBS-subsidised treatment with this drug for this condition; OR
                                                Patient must have previously received PBS-subsidised treatment with a monoclonal antibody inhibiting proprotein convertase subtilisin kexin type 9 (PCSK9) for this PBS indication; AND
                                                The treatment must be in conjunction with dietary therapy and exercise; AND
                                                Patient must not be receiving concomitant PBS-subsidised treatment with a monoclonal antibody inhibiting proprotein convertase subtilisin kexin type 9 (PCSK9) for this PBS indication.
                                                Must be treated by a medical practitioner; OR
                                                Must be treated by a nurse practitioner in consultation with a specialist physician.
C16321  P16321  CN16321  Glatiramer             Multiple sclerosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 16321
                         Interferon beta-1b     Initial treatment
                         Peginterferon beta-1a  The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis by magnetic resonance imaging of the brain and/or spinal cord; OR
                                                The condition must be diagnosed as clinically definite relapsing-remitting multiple sclerosis, with written certification provided by a radiologist that a magnetic resonance imaging scan is contraindicated because of the risk of physical (not psychological) injury to the patient; AND
                                                Patient must have experienced at least 2 documented attacks of neurological dysfunction, believed to be due to multiple sclerosis, in the preceding 2 years of commencing a PBS-subsidised disease modifying therapy for this condition; AND
                                                Patient must be ambulatory (without assistance or support).
                                                Must be treated by a medical practitioner; OR
                                                Must be treated by a nurse practitioner in consultation with a specialist physician.
                                                Where applicable, the date of the magnetic resonance imaging scan must be recorded in the patient's medical records.
C16323  P16323  CN16323  Dimethyl fumarate      Multiple sclerosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 16323
                         Diroximel