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Nintedanib, sold under the brand names Ofev and Vargatef, is an oral medication used for the treatment of idiopathic pulmonary fibrosis and along with other medications for some types of non-small-cell lung cancer.
Read the full article on WikipediaIdiopathic pulmonary fibrosis Clinical criteria: Treatment Phase: Initial treatment 1 - new patient 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. Treatment criteria: Must be treated by a prescriber who is either: (i) a respiratory physician, (ii) a specialist physician, (iii) none of the aforementioned prescriber types, but has consulted one of these aforementioned prescriber types, 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 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. Applications for authorisation under this treatment phase 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) details of the proposed prescription; 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).
Progressive fibrosing Interstitial lung disease Clinical criteria: Treatment Phase: 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). Treatment criteria: Must be treated by a prescriber who is either: (i) a respiratory physician, (ii) a specialist physician, (iii) none of the aforementioned prescriber types, but has consulted one of these aforementioned prescriber types, 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. Applications for authorisation under this treatment phase 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) details of the proposed prescription; 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). 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.
“Nintedanib competitively inhibits both nonreceptor tyrosine kinases (nRTKs) and receptor tyrosine kinases (RTKs). NRTK targets of nintedanib include Lck, Lyn, and Src. RTK targets of nintedanib include platelet-derived growth factor receptor (PDGFR) α and β; fibroblast growth factor receptor (FGFR) 1, 2, and 3; vascular endothelial growth factor receptor (VEGFR) 1, 2, and 3; and FLT3. Its use in IPF is predicated on its inhibition of PDGFR, FGFR, and VEGFR, which increase fibroblast proliferation, migration, and transformation.”
“10–15 hrs”
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