Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p2
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 2/381)
Character Range: 11391317–11403649

harms of therapy outweigh benefits.
                                                                                                                                                                    Trials of reduction or cessation of therapy should be considered periodically with the intention of maintaining symptom control through non-pharmacological measures wherever possible and/or lowest effective dose therapy.
                                                                                                                                                                    Evidence of patient benefit from therapy, failure of non-pharmacological approaches to manage symptoms in the absence of therapy, and recurrence of symptoms following reduction or cessation of therapy, trialled on at least 1 occasion, must be documented in the patient's medical records.
C10033              P10033         CN10033          Cobimetinib                                                                                                     Unresectable Stage III or Stage IV malignant melanoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures - Streamlined Authority Code 10033
                                                                                                                                                                    Initial treatment
                                                                                                                                                                    Patient must be receiving PBS subsidised vemurafenib concomitantly for this condition.
C10051              P10051         CN10051          Trametinib                                                                                                      Unresectable Stage III or Stage IV malignant melanoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures - Streamlined Authority Code 10051
                                                                                                                                                                    Initial treatment
                                                                                                                                                                    Patient must be receiving PBS-subsidised dabrafenib concomitantly for this condition.
C10061              P10061         CN10061          Lanreotide                                                                                                      Non-functional gastroenteropancreatic neuroendocrine tumour (GEP-NET)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures - Streamlined Authority Code 10061
                                                                                                                                                                    The condition must be unresectable locally advanced disease or metastatic disease; AND
                                                    Octreotide                                                                                                      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 aged 18 years or older.
                                                                                                                                                                    WHO grade 1 of GEP-NET is defined as a mitotic count (10HPF) of less than 2 and Ki-67 index (%) of less than or equal to 2.
                                                                                                                                                                    WHO grade 2 of GEP-NET is defined as a mitotic count (10HPF) of 2-20 and Ki-67 index (%) of 3-20.
C10063              P10063         CN10063          Cinacalcet                                                                                                      Secondary hyperparathyroidism                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures - Streamlined Authority Code 10063
                                                                                                                                                                    Continuing treatment
                                                                                                                                                                    Must be treated by a nephrologist; AND
                                                                                                                                                                    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              P10067         CN10067          Cinacalcet                                                                                                      Secondary hyperparathyroidism                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures - Streamlined Authority Code 10067
                                                                                                                                                                    Continuing treatment
                                                                                                                                                                    Must be treated by a nephrologist; AND
                                                                                                                                                                    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