Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p284
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 284/312)
Character Range: 17262228–17270655

Severe established osteoporosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures
                                                                                                                           Initial treatment - First-line therapy
                                                                                                                           Patient must not have received PBS-subsidised treatment with any of: (i) anti-resorptive therapy, (ii) teriparatide, (iii) romosozumab; AND
                                                                                                                           Patient must be at very high risk of fracture; AND
                                                                                                                           Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less; AND
                                                                                                                           Patient must have had a symptomatic fracture due to minimal trauma; AND
                                                                                                                           Patient must have had at least 1 hip or symptomatic vertebral fracture in the previous 24 months; or
                                                                                                                           Patient must have had at least 2 fractures including 1 symptomatic new fracture in the previous 24 months; 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.
C16133              P16133         CN16133          Lanreotide                                                             Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures - Streamlined Authority Code 16133
                                                                                                                           Continuing treatment
                                                                                                                           Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                           The condition must be unresectable locally advanced disease or metastatic disease; AND
                                                                                                                           The condition must be World Health Organisation (WHO) grade 1 or 2; AND
                                                                                                                           The treatment must be the sole PBS-subsidised therapy for this condition;
                                                                                                                           Patient must be at least 18 years of age.
                                                                                                                           WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.
                                                                                                                           WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.
C16141              P16141         CN16141          Fluconazole                                                            Cryptococcal meningitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures - Streamlined Authority Code 16141
                                                                                                                           Patient must be unable to take a solid dose form of fluconazole; 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 medical practitioner.
C16145              P16145