Document ID: chunk:federal_register_of_legislation:F2024L01389:schedule:1:p49
Version: federal_register_of_legislation:F2024L01389
Segment Type: schedule
Provision Reference: sch 1 (pt 49/66)
Character Range: 143399–148794

November 2024; AND
                                                      Patient must not have received PBS-subsidised treatment with any of the following prior to initiating non-PBS-subsidised treatment with this drug for this condition: (i) anti-resorptive therapy, (ii) teriparatide, (iii) romosozumab; AND
                                                      Patient must be at very high risk of fracture; AND
                                                      Patient must have had a Bone Mineral 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