Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p30
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 30/162)
Character Range: 14815741–14821685

Patient must be undergoing dual combination therapy limited to:
                                                                                                          (i) this drug, (ii) dexamethasone; AND
                                                                                                         Patient must have progressive disease after at least one prior therapy; AND
                                                                                                         Patient must not have previously received 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.
                                                                                                         Refractory disease is defined as less than or equal to a 25% response to therapy, or progression during or within 60 days after completion of therapy
C14026              P14026         CN14026          Ciclosporin                                          Chronic severe dry eye disease with keratitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures
                                                                                                         Initial treatment for up to the first 180 days of treatment
                                                                                                         Patient must have a corneal fluorescein staining (CFS) grade of 4 at treatment initiation, using at least one of:
                                                                                                          (i) the Oxford scale, (ii) the modified Oxford scale, (iii) an equivalent scale to the Oxford scale as determined by the prescriber; AND
                                                                                                         Patient must have an ocular surface disease index (OSDI) score of at least 23 at treatment initiation; AND
                                                                                                         The condition must be inadequately controlled by monotherapy with a preservative free artificial tears substitute; AND
                                                                                                         The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                                         Patient must be undergoing simultaneous treatment with a preservative free artificial tears substitute; AND
                                                                                                         Must be treated by an ophthalmologist or by an accredited ophthalmology registrar in consultation with an ophthalmologist; or
                                                                                                         Must be treated by an optometrist in accordance with Optometry Board of Australia guidelines; AND
                                                                                                         Patient must not be undergoing treatment with this drug under this treatment phase beyond day 180 of treatment;
                                                                                                         Patient must be at least 18