Document ID: chunk:federal_register_of_legislation:F2024L01389:schedule:1:p56
Version: federal_register_of_legislation:F2024L01389
Segment Type: schedule
Provision Reference: sch 1 (pt 56/66)
Character Range: 177528–181678

-3.0 or less; AND
                                                      Patient must have had 2 or more fractures due to minimal trauma; AND
                                                      Patient must have experienced at least 1 symptomatic new fracture after at least 12 months continuous therapy with an anti-resorptive agent at adequate doses; AND
                                                      The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                      The treatment must not exceed a lifetime maximum of 12 months of PBS and non-PBS-subsidised therapy; AND
                                                      Patient must not have received treatment with PBS-subsidised teriparatide; or
                                                      Patient must have developed intolerance to teriparatide of a severity necessitating permanent treatment withdrawal within the first 6 months of therapy; AND
                                                      Must be treated by a consultant physician.
                                                      A vertebral fracture is defined 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; 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