Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p279
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 279/312)
Character Range: 17225599–17233750

The condition must be stable for the prescriber to consider the listed maximum quantity of this medicine suitable for this patient.
                                                                                                                           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.
C16083              P16083         CN16083          Methadone                                                              Opioid dependence                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures - Streamlined Authority Code 16083
                                                                                                                           The treatment must be within a framework of medical, social and psychological treatment.
                                                                                                                           The prescriber must request a quantity (in millilitres) sufficient for up to 28 days of supply per dispensing according to the patient's daily dose. Up to 5 repeats will be authorised. The maximum listed quantity or number of repeats must not be prescribed if lesser quantity or repeats are sufficient for the patient's needs.
C16085              P16085         CN16085          Avelumab                                                               Stage IV (metastatic) Merkel Cell Carcinoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures - Streamlined Authority Code 16085
                                                                                                                           Continuing treatment
                                                                                                                           The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                                                           Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                           Patient must not have developed disease progression while being treated with this drug for this condition; AND
                                                                                                                           The treatment must not exceed a maximum dose of 10 mg per kg every 2 weeks under this restriction. or
                                                                                                                           The treatment must not exceed a dose of 800 mg every 2 weeks under this restriction.
C16087              P16087         CN16087          Romosozumab                                                            Severe established osteoporosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures
                                                                                                                           Initial treatment - Second-line therapy
                                                                                                                           Patient must be at very high risk of fracture; AND
                                                                                                                           Patient must have a bone mineral density (BMD) T-score of -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