Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p148
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 148/161)
Character Range: 14582058–14590256

by a physician.
C13769              P13769         CN13769          Brolucizumab                   Subfoveal choroidal neovascularisation (CNV)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Written Authority Required procedures
                                                                                   Initial treatment
                                                                                   Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; AND
                                                                                   The condition must be due to age-related macular degeneration (AMD); AND
                                                                                   Patient must have persistent macular exudation, as determined clinically and/or by optical coherence tomography or fluorescein angiography, despite at least 6 months of PBS-subsidised treatment with:
                                                                                    1. Aflibercept and/or 2. Ranibizumab and/or 3. Faricimab; AND
                                                                                   The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                   Patient must not have previously received PBS-subsidised treatment with this drug 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 the patient's medical records.
C13771              P13771         CN13771          Leflunomide                    Severe active psoriatic arthritis
                                                                                   Patient must have previously received, and failed to achieve an adequate response to, one or more disease modifying anti-rheumatic drugs including methotrexate; or
                                                                                   Patient must be clinically inappropriate for treatment with one or more disease modifying anti-rheumatic drugs including methotrexate; AND
                                                                                   The treatment must be initiated by a physician.
C13774              P13774         CN13774          Daratumumab                    Newly diagnosed systemic light chain amyloidosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures
                                                                                   Continuing treatment from week 25 onwards (administered once every four weeks)
                                                                                   Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                   Must be treated by a haematologist (this does not exclude treatment via a multidisciplinary team, but the PBS authority application must be sought by the treating haematologist); AND
                                                                                   Patient must be undergoing continuing treatment that does not extend treatment duration beyond whichever comes first:
                                                                                    (i) disease progression, (ii) 96 cumulative weeks from the first administered dose, once in a lifetime.
C13839              P13839         CN13839          Nivolumab                      Unresectable Stage III or Stage IV malignant melanoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures - Streamlined Authority Code 13839
                                                                                   Maintenance treatment
                                                                                   Patient must have previously received of up to maximum 4