Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p95
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 95/161)
Character Range: 14302561–14310983

initiate treatment, (ii) continuing treatment is not based on quantified improvements in diagnostic measurements, but will be determined by clinician judgement.
                                                                                   A multidisciplinary team is defined as comprising of at least a specialist respiratory physician, a radiologist and where histological material is considered, a pathologist. If attendance is not possible because of geographical isolation, consultation with a multidisciplinary team is required for diagnosis.
                                                                                   Document in the patient's medical records the qualifying FVC, FEV1/FVC ratio and DLCO measurements. Retain medical imaging in the patient's medical records.
                                                                                   Authority applications must be made via the Online PBS Authorities System (real time assessment), or in writing via HPOS form upload or mail.
                                                                                   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)
C13380              P13380         CN13380          Nintedanib                     Idiopathic pulmonary fibrosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures
                                                                                   Continuing treatment
                                                    Pirfenidone                    Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                   The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                   Must be treated by a medical practitioner who is either:
                                                                                    (i) a respiratory physician, (ii) a specialist physician, (iii) in consultation with a respiratory physician or specialist physician; AND
                                                                                   Patient must not be undergoing PBS-subsidised treatment simultaneously through the following PBS indications:
                                                                                    (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis; AND
                                                                                   Patient must not be undergoing sequential PBS-subsidised treatment through the following PBS indications:
                                                                                    (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis.
C13381              P13381         CN13381          Nintedanib                     Idiopathic pulmonary fibrosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures
                                                                                   Initial treatment 2 - change or recommencement of treatment
                                                    Pirfenidone                    Patient must have previously received PBS-subsidised treatment with nintedanib or pirfenidone for this condition; AND
                                                                                   The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                   Must be treated by a medical practitioner who is either:
                                                                                    (i) a respiratory physician, (ii) a specialist physician, (iii) in consultation with a respiratory physician or specialist physician; AND
                                                                                   Patient must not be undergoing PBS-subsidised treatment simultaneously through the following PBS indications:
                                                                                    (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis; AND
                                                                                   Patient must not be undergoing sequential PBS-subsidised treatment through the following PBS indications:
                                                                                    (i) progressive fibrosing interstitial lung disease, (ii) idiopathic pulmonary fibrosis.
C13384              P13384         CN13384          Aflibercept                    Branch retinal vein occlusion with macular oedema                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         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
                                                                                   Patient must have visual impairment due to macular oedema secondary to branched retinal vein occlusion