Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p54
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 54/476)
Character Range: 1077239–1088216

Severe psoriasis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                      Compliance with Authority Required procedures - Streamlined Authority Code 15361
                                                                                                                                            Management (initiation, stabilisation and review of therapy)
                                                                                                                                            The condition must be ineffective to other systemic therapies; OR
                                                                                                                                            The condition must be inappropriate for other systemic therapies; AND
                                                                                                                                            The condition must have caused significant interference with quality of life.
                                                                                                                                            Must be treated by a medical practitioner who is either: (i) a dermatologist, (ii) a rheumatologist, (iii) general physician; OR
                                                                                                                                            Must be treated by a medical practitioner in consultation with one of the above specialist types who is either an accredited: (i) dermatology registrar, (ii) rheumatology registrar.
                                                                                                                                            For patients who do not demonstrate an adequate response to ciclosporin, a Psoriasis Area and Severity Index (PASI) assessment must be completed, preferably while on treatment, but no longer than 4 weeks following the cessation of treatment. This assessment will be required for patients who transition to 'biological medicines' for the treatment of 'severe chronic plaque psoriasis'.
                                                                                                                                            This assessment must be documented in the patient's medical records.
Cinacalcet                                                             C10063                                                               Secondary hyperparathyroidism                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 10063
                                                                                                                                            Continuing treatment
                                                                                                                                            Must be treated by a nephrologist.
                                                                                                                                            Patient must have chronic kidney disease; AND
                                                                                                                                            Patient must be on dialysis; 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.
                                                                       C10067                                                               Secondary hyperparathyroidism                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures ‑ Streamlined Authority Code 10067
                                                                                                                                            Continuing treatment
                                                                                                                                            Must be treated by a nephrologist.
                                                                                                                                            Patient must have chronic kidney disease; AND
                                                                                                                                            Patient must be on dialysis; 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.
                                                                       C10073                                                               Secondary hyperparathyroidism                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures
                                                                                                                                            Initial treatment
                                                                                                                                            Must be treated by a nephrologist.
                                                                                                                                            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