Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p64
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 64/161)
Character Range: 14170514–14177504

proteinuria (1-2 grams/day or equivalent in children, depending on specialist Wilson disease and renal review), (x) haematuria (if cause unknown), (xi) thrombocytopenia/leukopenia, (xii) bleeding related to thromobocytopenia/leukopenia, (xiii) lupus-like syndrome (haematuria, proteinuria, positive antinuclear antibody), (xiv) arthralgia.
                                                                                   Side effects of penicillamine developing later
                                                                                   (i) nephrotic syndrome, (ii) glomerulonephritis, (iii) total bone marrow aplasia, (iv) skin changes (cutis laxa, elastosis perforans serpiginosa, pemphigus), (v) myasthenia gravis, (vi) polymyositis, (vii) Goodpasture syndrome, (viii) optic neuritis, (ix) proteinuria (1-2 grams/day or equivalent in children, depending on specialist Wilson disease and renal review), (x) haematuria (if cause unknown), (xi) thrombocytopenia/leukopenia, (xii) bleeding related to thromobocytopenia/leukopenia, (xiii) lupus-like syndrome (haematuria, proteinuria, positive antinuclear antibody), (xiv) arthralgia.
                                                                                   At the time of the first authority application for this drug, document the details (date of reaction, severity of reaction, dose of penicillamine, etc) of the penicillamine intolerance, if not already done, in the patient's medical records. Do not supply these details in this authority application.
C13336              P13336         CN13336          Aflibercept                    Central retinal vein occlusion with macular oedema                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures - Streamlined Authority Code 13336
                                                                                   Continuing treatment
                                                    Dexamethasone                  Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND
                                                                                   Patient must have previously received PBS-subsidised treatment with this drug for this condition for the same eye; AND
                                                    Ranibizumab                    The treatment must be the sole PBS-subsidised therapy for this condition.

C13337              P13337         CN13337          Aflibercept                    Subfoveal choroidal neovascularisation (CNV)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Written Authority Required procedures
                                                                                   Initial treatment
                                                    Ranibizumab                    Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND
                                                                                   The condition must be due to pathologic myopia (PM); AND
                                                                                   The condition must be diagnosed by optical coherence tomography; or
                                                                                   The condition must be diagnosed by 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.
                                                                                   (a) A completed authority prescription form; 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).
                                                                                   If the application is submitted through HPOS form upload or mail, it must include
                                                                                   (a) A completed authority prescription form; 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