Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p273
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 273/312)
Character Range: 17178748–17187340

Density (BMD) T-score of -2.5 or less prior to starting non-PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                           Patient must have had a symptomatic fracture due to minimal trauma prior to starting non-PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                           Patient must have had at least 1 hip or symptomatic vertebral fracture in the 24 months prior to starting non-PBS-subsidised treatment with this drug for this condition; or
                                                                                                                           Patient must have had at least 2 fractures including 1 symptomatic new fracture in the 24 months prior to starting non-PBS-subsidised treatment with this drug for this condition; 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
                                                                                                                           Must be treated by a consultant physician.
                                                                                                                           Details of fracture history including the date(s), site(s), the symptoms associated with the fracture(s) and the score of the qualifying BMD measurement must be provided at the time of application.
                                                                                                                           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.
                                                                                                                           Anti-resorptive therapies for osteoporosis include alendronate sodium, risedronate sodium, raloxifene hydrochloride, denosumab and zoledronic acid.
C16022              P16022         CN16022          Romosozumab                                                            Severe established osteoporosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures
                                                                                                                           Continuing treatment - First-line therapy
                                                                                                                           Patient must have previously received PBS-subsidised treatment with this drug for this condition as first-line therapy; 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
                                                                                                                           Must be treated by a medical practitioner identifying as either: (i) a consultant physician, (ii) a general practitioner.
C16023              P16023         CN16023          Romosozumab                                                            Severe established osteoporosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures
                                                                                                                           Continuing treatment - Second-line therapy
                                                                                                                           Patient must have previously received PBS-subsidised treatment with this drug for this condition as second-line therapy; AND
                                                                                                                           The treatment must not exceed a lifetime maximum of 12 months of PBS and non-PBS-subsidised therapy; AND
                                                                                                                           Must be treated by a medical practitioner identifying as either: (i) a consultant physician, (ii) a general practitioner.
C16024              P16024         CN16024          Lanreotide                                                             Acromegaly                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 16024
                                                                                                                           Initial treatment
                                                                                                                           Must be treated by a specialist practicing in a hospital who is either: (i) an endocrinologist, (ii) an oncologist; or
                                                                                                                           Must be treated by a medical practitioner working under the direct supervision of one of the above mentioned specialist types within a hospital setting; AND
                                                                                                                           The condition must be