Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p205
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 205/381)
Character Range: 12889346–12900003

and rilpivirine                                                                                    HIV infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures - Streamlined Authority Code 12636
                                                                                                                                                                    Patient must have previously received PBS-subsidised therapy for this condition; AND
                                                                                                                                                                    The treatment must be the sole PBS-subsidised therapy for this condition.
C12656              P12656         CN12656          Sacituzumab govitecan                                                                                           Unresectable locally advanced or metastatic triple-negative breast cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures - Streamlined Authority Code 12656
                                                                                                                                                                    Initial treatment
                                                                                                                                                                    Patient must have progressive disease following two or more prior systemic therapies, at least one of them in the locally advanced or metastatic setting; AND
                                                                                                                                                                    The condition must be inoperable; AND
                                                                                                                                                                    Patient must have a World Health Organisation (WHO) Eastern Cooperative Oncology Group (ECOG) performance status score no higher than 1 prior to treatment initiation; AND
                                                                                                                                                                    The treatment must be the sole PBS-subsidised therapy for this PBS indication.
C12669              P12669         CN12669          Sacituzumab govitecan                                                                                           Unresectable locally advanced or metastatic triple-negative breast cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures - Streamlined Authority Code 12669
                                                                                                                                                                    Continuing treatment
                                                                                                                                                                    Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                    Patient must not have developed disease progression while being treated with this drug for this condition; AND
                                                                                                                                                                    The treatment must be the sole PBS-subsidised therapy for this PBS indication.
C12685              P12685         CN12685          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 condition must have not achieved a response with this drug at a dose of 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