Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p32
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 32/162)
Character Range: 14827710–14833912

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.
C14032              P14032         CN14032          Ciclosporin                                          Chronic severe dry eye disease with keratitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures
                                                                                                         Continuing treatment
                                                                                                         Patient must have received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                         The condition must have improved to an extent that corneal fluorescein staining, using the same scale used at the time of the first authority application, shows an improvement (reduction) by at least 3 grades from baseline (the grade stated in the first authority application) - the improvement need only be demonstrated by staining once only with the first Continuing treatment authority application; AND
                                                                                                         The condition must have improved to an extent that the patient's ocular surface disease index score at the time of this authority application, has improved (reduced) by at least 30% compared to the value stated in the first authority application (i.e. baseline); AND
                                                                                                         The treatment must be the sole PBS-subsidised therapy for this condition; 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.
                                                                                                         Prescribing instructions
                                                                                                         State in the first continuing treatment authority application for this drug
                                                                                                         (i) an improved corneal fluorescein staining grade (a numerical value that has improved by 3 grades from that provided in the first Initial 1 treatment authority application).
                                                                                                         (ii) the ocular surface disease index score at the time of this authority application (a numerical value that is at least 30% lower than that stated in the first Initial 1 treatment authority application).
                                                                                                         State in all continuing treatment authority applications
                                                                                                         (ii) the ocular surface disease index score at the time of this authority application (a numerical value that is at least 30% lower than that stated in the first Initial 1 treatment authority application).
C14034              P14034         CN14034          Abiraterone and methylprednisolone                   Metastatic castration sensitive carcinoma of the prostate                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures
                                                                                                         The treatment must be/have been initiated within 6 months