Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p206
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 206/381)
Character Range: 12899552–12908145

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.
C12691              P12691         CN12691          Daratumumab                                                                                                     Relapsed and/or refractory multiple myeloma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures
                                                                                                                                                                    Continuing treatment of second-line drug therapy from week 25 until disease progression (administered every 4 weeks)
                                                                                                                                                                    Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                    Patient must not have developed disease progression while receiving treatment with this drug for this condition.
                                                                                                                                                                    Progressive disease is defined as at least 1 of the following
                                                                                                                                                                    (a) at least a 25% increase and an absolute increase of at least 5 g per L in serum M protein (monoclonal protein); or
                                                                                                                                                                    (b) at least a 25% increase in 24-hour urinary light chain M protein excretion, and an absolute increase of at least 200 mg per 24 hours; or
                                                                                                                                                                    (c) in oligo-secretory and non-secretory myeloma patients only, at least a 50% increase in the difference between involved free light chain and uninvolved free light chain; or
                                                                                                                                                                    (d) at least a 25% relative increase and at least a 10% absolute increase in plasma cells in a bone marrow aspirate or on biopsy; or
                                                                                                                                                                    (e) an increase in the size or number of lytic bone lesions (not including compression fractures); or
                                                                                                                                                                    (f) at least a 25% increase in the size of an existing or the development of a new soft tissue plasmacytoma (determined by clinical examination or diagnostic imaging); or
                                                                                                                                                                    (g) development of hypercalcaemia (corrected serum calcium greater than 2.65 mmol per L not attributable to any other cause).
                                                                                                                                                                    Oligo-secretory and non-secretory patients are defined as having active disease with less than 10 g per L serum M protein.
C12694              P12694         CN12694          Carfilzomib                                                                                                     Multiple myeloma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures - Streamlined Authority Code 12694
                                                                                                                                                                    Initial treatment - once weekly treatment regimen
                                                                                                                                                                    The condition must be confirmed by a histological diagnosis; AND
                                                                                                                                                                    The treatment must be in combination with dexamethasone; AND
                                                                                                                                                                    Patient must have progressive disease after at least one prior therapy; AND
                                                                                                                                                                    Patient must have undergone or be ineligible for a stem cell transplant; AND
                                                                                                                                                                    Patient must not have previously received this drug for this condition; AND
                                                                                                                                                                    Patient must not receive more than three cycles of treatment under this restriction.
                                                                                                                                                                    Progressive