Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p280
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 280/312)
Character Range: 17233542–17240309

as a 20% or greater reduction in height of the anterior or mid portion of a vertebral body relative to the posterior height of that body, or, a 20% or greater reduction in any of these heights compared to the vertebral body above or below the affected vertebral body.
                                                                                                                           If treatment with anti-resorptive therapy is contraindicated according to the relevant TGA-approved Product Information, details of the contraindication must be documented in the patient's medical record at the time treatment with this drug is initiated.
                                                                                                                           If an intolerance of a severity necessitating permanent treatment withdrawal develops during the relevant period of use of one anti-resorptive agent, alternate anti-resorptive agents must be trialled so that the patient achieves the minimum requirement of 12 months continuous therapy. Details must be documented in the patient's medical record at the time treatment with this drug is initiated.
                                                                                                                           Anti-resorptive therapies for osteoporosis and their adequate doses which will be accepted for the purposes of administering this restriction are alendronate sodium 10 mg per day or 70 mg once weekly, risedronate sodium 5 mg per day or 35 mg once weekly or 150 mg once monthly, raloxifene hydrochloride 60 mg per day (women only), denosumab 60 mg once every 6 months and zoledronic acid 5 mg per annum.
                                                                                                                           Details of prior anti-resorptive therapy, fracture history including the date(s), site(s), the symptoms associated with the fracture(s) which developed after at least 12 months continuous anti-resorptive therapy and the score of the qualifying BMD measurement must be provided at the time of application.
C16094              P16094         CN16094          Voriconazole                                                           Serious fungal infections                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures
                                                                                                                           Treatment and maintenance therapy
                                                                                                                           The condition must be caused by Scedosporium species; OR
                                                                                                                           The condition must be caused by Fusarium species.
                                                                                                                           Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.
C16096              P16096         CN16096          Posaconazole                                                           Fungal infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Authority Required procedures
                                                                                                                           The condition must be fusariosis; or
                                                                                                                           The condition must be zygomycosis; or
                                                                                                                           The condition must be coccidioidomycosis; or
                                                                                                                           The condition must be chromoblastomycosis; or
                                                                                                                           The condition must be mycetoma; AND
                                                                                                                           Patient must be unable to tolerate alternative therapy; or
                                                                                                                           Patient must have disease refractory to alternative therapy; AND
                                                                                                                           Must be treated by a health practitioner who is any of: (i) a medical practitioner, (ii) an authorised PBS prescriber who is not a medical practitioner, but who is: (a) sharing care of the patient with at least one medical practitioner; (b) intending to share care of the patient with a