Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p69
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 69/191)
Character Range: 10284836–10296955

density assessment must be recorded in the patient's medical records.
C6524               P6524          CN6524           Denosumab                                                                                                                                                                  Established osteoporosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures - Streamlined Authority Code 6524
                                                                                                                                                                                                                               Patient must have fracture due to minimal trauma; AND
                                                                                                                                                                                                                               Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.
                                                                                                                                                                                                                               The fracture must have been demonstrated radiologically and the year of plain x-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) scan must be documented in the patient's medical records when treatment is initiated.
                                                                                                                                                                                                                               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.
C6548               P6548          CN6548           Denosumab                                                                                                                                                                  Osteoporosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures - Streamlined Authority Code 6548
                                                                                                                                                                                                                               Patient must be aged 70 years or older;
                                                                                                                                                                                                                               Patient must have a Bone Mineral Density (BMD) T-score of -2.5 or less; AND
                                                                                                                                                                                                                               Patient must not receive concomitant treatment with any other PBS-subsidised anti-resorptive agent for this condition.
                                                                                                                                                                                                                               The date, site (femoral neck or lumbar spine) and score of the qualifying BMD measurement must be documented in the patient's medical records when treatment is initiated.
C6552               P6552          CN6552           Nafarelin                                                                                                                                                                  Endometriosis
                                                                                                                                                                                                                               Initial treatment, for up to 6 months
                                                                                                                                                                                                                               The condition must be visually proven.
C6562               P6562          CN6562           Ipilimumab                                                                                                                                                                 Unresectable Stage III or Stage IV malignant melanoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 6562
                                                                                                                                                                                                                               Induction treatment
                                                                                                                                                                                                                               The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                                                                                                                                                               Patient must not have received prior treatment with ipilimumab; AND
                                                                                                                                                                                                                               The treatment must not exceed a total of 4 doses at a maximum dose of 3 mg per kg every 3 weeks.
                                                                                                                                                                                                                               The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.
C6578               P6578          CN6578           Lenvatinib                                                                                                                                                                 Locally advanced or metastatic differentiated thyroid cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures - Streamlined Authority Code 6578
                                                                                                                                                                                                                               Continuing treatment
                                                                                                                                                                                                                               The condition must be refractory to radioactive iodine; AND
                                                                                                                                                                                                                               Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                                                                               The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                                                                                                                                                               Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST).
C6585               P6585          CN6585           Ipilimumab                                                                                                                                                                 Unresectable Stage III or Stage IV malignant melanoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 6585
                                                                                                                                                                                                                               Re-induction treatment
                                                                                                                                                                                                                               The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                                                                                                                                                               Patient must have progressive disease after achieving an initial objective response to the most recent course