Document ID: chunk:federal_register_of_legislation:F2024L01389:schedule:1:p60
Version: federal_register_of_legislation:F2024L01389
Segment Type: schedule
Provision Reference: sch 1 (pt 60/66)
Character Range: 195738–201057

patient with at least one medical practitioner; (b) intending to share care of the patient with a medical practitioner.
C16123  P16123  CN16123  Tirofiban                    High risk of unstable angina                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures - Streamlined Authority Code 16123
                                                      Patient must have new transient or persistent ST-T ischaemic changes; AND
                                                      Patient must have pain lasting longer than 20 minutes; 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.
C16132  P16132  CN16132  Romosozumab                  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