Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p3
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 3/381)
Character Range: 11403053–11412914

AND
                                                                                                                                                                    Patient must have previously received PBS-subsidised treatment with this drug for this condition.
                                                                                                                                                                    During the maintenance phase, iPTH should be monitored quarterly (measured at least 12 hours post dose) and dose adjusted as necessary to maintain an appropriate iPTH concentration.
                                                                                                                                                                    During the maintenance phase, prescribers should request approval to allow sufficient supply for 4 weeks treatment up to a maximum of 6 months supply, with doses between 30 and 180 mg per day according to the patient's response and tolerability.
C10068              P10068         CN10068          Cinacalcet                                                                                                      Secondary hyperparathyroidism                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures - Streamlined Authority Code 10068
                                                                                                                                                                    Continuing treatment
                                                                                                                                                                    Patient must have chronic kidney disease; AND
                                                                                                                                                                    Patient must be on dialysis; AND
                                                                                                                                                                    Patient must have achieved a decrease of at least 30% in intact parathyroid hormone (iPTH) concentrations after 6 months treatment.  or
                                                                                                                                                                    Patient must have an intact parathyroid (iPTH) concentration greater than 15 pmol/L and an (adjusted) serum calcium concentration of less than 2.6 mmol/L after 6 months.
                                                                                                                                                                    During the maintenance phase, iPTH should be monitored quarterly (measured at least 12 hours post dose) and dose adjusted as necessary to maintain an appropriate iPTH concentration.
                                                                                                                                                                    During the maintenance phase, prescribers should request approval to allow sufficient supply for 4 weeks treatment up to a maximum of 6 months supply, with doses between 30 and 180 mg per day according to the patient's response and tolerability.
C10073              P10073         CN10073          Cinacalcet                                                                                                      Secondary hyperparathyroidism                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures
                                                                                                                                                                    Initial treatment
                                                                                                                                                                    Must be treated by a nephrologist; AND
                                                                                                                                                                    Patient must have chronic kidney disease; AND
                                                                                                                                                                    Patient must be on dialysis; AND
                                                                                                                                                                    Patient must have failed to respond to conventional therapy; AND
                                                                                                                                                                    Patient must have sustained hyperparathyroidism with iPTH of at least 50 pmol per L.  or
                                                                                                                                                                    Patient must have sustained hyperparathyroidism with iPTH of at least 15 pmol per L and less than 50 pmol per L and an (adjusted) serum calcium concentration at least 2.6 mmol per L.
                                                                                                                                                                    During the titration phase, intact PTH (iPTH) should be monitored 4 weekly (measured at least 12 hours post dose) and dose titrated until an appropriate iPTH concentration is achieved.
                                                                                                                                                                    During the titration phase, prescribers should request approval to allow sufficient supply for 4 weeks treatment at a time, with doses between 30 and 180 mg per day according to the patient's response and tolerability.
C10075              P10075         CN10075          Octreotide                                                                                                      Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures - Streamlined Authority Code 10075
                                                                                                                                                                    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;