Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p146
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 146/191)
Character Range: 11015663–11025877

P9315          CN9315           Pamidronic acid                                                                                                                                                            Bone metastases                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures - Streamlined Authority Code 9315
                                                                                                                                                                                                                               The condition must be due to breast cancer.
C9317               P9317          CN9317           Zoledronic acid                                                                                                                                                            Hypercalcaemia of malignancy                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures - Streamlined Authority Code 9317
                                                                                                                                                                                                                               Patient must have a malignancy refractory to anti-neoplastic therapy.
C9319               P9319          CN9319           Imatinib                                                                                                                                                                   Malignant gastrointestinal stromal tumour                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures
                                                                                                                                                                                                                               Initial Treatment
                                                                                                                                                                                                                               The condition must be metastatic; or
                                                                                                                                                                                                                               The condition must be unresectable; AND
                                                                                                                                                                                                                               The condition must be histologically confirmed by the detection of CD117 on immunohistochemical staining; AND
                                                                                                                                                                                                                               The treatment must be commenced at a dose not exceeding 400 mg per day; AND
                                                                                                                                                                                                                               The treatment must not exceed 3 months under this restriction.
                                                                                                                                                                                                                               Authority prescriptions for a higher dose will not be approved during this initial 3 month treatment period.
                                                                                                                                                                                                                               Patients with metastatic/unresectable disease who achieve a response to treatment at an imatinib dose of 400 mg per day should be continued at this dose and assessed for response at regular intervals. Patients who fail to achieve a response to 400 mg per day may have their dose increased to 600 mg per day. Authority applications for doses higher than 600 mg per day will not be approved.
                                                                                                                                                                                                                               A response to treatment is defined as a decrease from baseline in the sum of the products of the perpendicular diameters of all measurable lesions of 50% or greater. (Response definition based on the Southwest Oncology Group standard criteria, see Demetri et al. N Engl J Med 2002; 347 472-80.)
                                                                                                                                                                                                                               A pathology report from an Approved Pathology Authority supporting the diagnosis of a gastrointestinal stromal tumour and confirming the presence of CD117 on immunohistochemical staining must be documented in the patient's medical records.
                                                                                                                                                                                                                               Details of the most recent (within 2 months of the application) computed tomography (CT) scan, magnetic resonance imaging (MRI) or ultrasound assessment of the tumour(s), including whether or not there is evidence of metastatic disease must be documented in the patient's medical records.
                                                                                                                                                                                                                               Where the application for authority to prescribe is being sought on the basis of an unresectable tumour, written evidence must be documented in the patient's medical records.
C9321               P9321          CN9321           Nivolumab                                                                                                                                                                  Stage IV clear cell variant renal cell carcinoma (RCC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures - Streamlined Authority Code 9321
                                                                                                                                                                                                                               Maintenance treatment
                                                                                                                                                                                                                               Patient must have previously received of up to maximum 4 doses of PBS-subsidised combined therapy with nivolumab and ipilimumab as induction for this condition; AND
                                                                                                                                                                                                                               The treatment must be as monotherapy for this condition; AND
                                                                                                                                                                                                                               Patient must not have developed disease progression while receiving PBS-subsidised treatment with this drug for this condition.
                                                                                                                                                                                                                               Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four