Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p100
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 100/161)
Character Range: 14332784–14338619

disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Written Authority Required procedures
                                                                                   Initial treatment
                                                                                   The condition must be diagnosed through a multidisciplinary team; AND
                                                                                   The condition must have chest imaging through high resolution computed tomography (HRCT) that is no older than 12 months, to support the diagnosis of the PBS indication; AND
                                                                                   The condition must display, through HRCT, an affected area of no less than 10% (after rounding to the nearest multiple of 5); AND
                                                                                   Patient must have a current (no older than 2 years) forced vital capacity (FVC) measurement of no less than 45% predicted, adjusted for each of:
                                                                                    (i) age, (ii) gender, (iii) height; AND
                                                                                   The condition must be of a progressive nature, observed by, in the 2 years leading up to this authority application, any of:
                                                                                    (i) a worsening in relative FVC% predicted measurement of no less than 10%, (ii) a worsening in relative FVC% predicted measurement in the range 5-10%, combined with worsening of respiratory symptoms, (iii) a worsening in relative FVC% predicted measurement in the range 5-10%, combined with increases in fibrosis observed on HRCT; document at least one of (i) to (iii) in the patient's medical records; 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 that is both:
                                                                                    (i) at least 30% predicted, (ii) no greater than 80% predicted; AND
                                                                                   The condition must not be interstitial lung disease due to idiopathic pulmonary fibrosis (apply under the correct PBS listing if it is); AND
                                                                                   The condition must not be due to reversible causes (e.g. drug toxicity); 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.
                                                                                   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