Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p94
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 94/161)
Character Range: 14297055–14302939

three months); AND
                                                                                   4. A bone age result performed within the last 12 months; AND
                                                                                   5. The proprietary name (brand), form and strength of somatropin requested, and the number of vials/cartridges required to provide sufficient drug for 16 weeks' worth of treatment (with up to 1 repeat allowed).
                                                                                   Prescribers must keep a copy of any clinical records relating to the prescription, including such records required to demonstrate that the prescription was written in compliance with any relevant circumstances and/or purposes. These records must be kept for 2 years after the date the prescription to which the records relate is written.
                                                                                   In children with diabetes mellitus prescribers must ascertain that a growth failure is not due to poor diabetes control, diabetes control is adequate, and regular screening occurs for diabetes complications, particularly retinopathy.
C13378              P13378         CN13378          Nintedanib                     Idiopathic pulmonary fibrosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Written Authority Required procedures
                                                                                   Initial treatment 1 - new patient
                                                    Pirfenidone                    The condition must be diagnosed through a multidisciplinary team; AND
                                                                                   Patient must have chest high resolution computed tomography (HRCT) consistent with diagnosis of idiopathic pulmonary fibrosis within the previous 12 months; AND
                                                                                   Patient must have a forced vital capacity (FVC) greater than or equal to 50% predicted for age, gender and height; AND
                                                                                   Patient must have a forced expiratory volume in 1 second to forced vital capacity ratio (FEV1/FVC) greater than 0.7; AND
                                                                                   Patient must not have had an acute respiratory infection at the time of FVC measurement; AND
                                                                                   Patient must have diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for haemoglobin equal to or greater than 30%; AND
                                                                                   Patient must not have interstitial lung disease due to other known causes including domestic and occupational environmental exposures, connective tissue disease, or drug toxicity; 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; AND
                                                                                   Patient must be undergoing treatment with this pharmaceutical benefit only where the prescriber has explained to the patient/patient's guardian the following:
                                                                                    (i) that certain diagnostic criteria must be met to be eligible to 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