Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p31
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 31/162)
Character Range: 14821130–14828037

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 years of age.
                                                                                                         Prescribing instruction
                                                                                                         State in the first authority application for this drug, for the purpose of having a baseline measurement to assess response to treatment under the Continuing treatment listing, each of (i) the qualifying corneal fluorescein staining grade (a numerical value no less than 4), (ii) the qualifying ocular surface disease index score (a numerical value no less than 23).
C14027              P14027         CN14027          Pembrolizumab                                        Advanced, metastatic or recurrent endometrial carcinoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Authority Required procedures - Streamlined Authority Code 14027
                                                                                                         Initial treatment
                                                                                                         Patient must have received prior treatment with platinum-based chemotherapy; AND
                                                                                                         The condition must be untreated with each of:
                                                                                                          (i) programmed cell death-1/ligand-1 (PD-1/PDL-1) inhibitor therapy, (ii) tyrosine kinase inhibitor therapy; 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
                                                                                                         Patient must be undergoing combination therapy consisting of:
                                                                                                          (i) pembrolizumab, (ii) lenvatinib; or
                                                                                                         Patient must be undergoing monotherapy with this drug due to a contraindication/intolerance to the other drug in the combination mentioned above, requiring temporary/permanent discontinuation; document the details in the patient's medical records; AND
                                                                                                         Patient must be undergoing treatment with this drug administered once every 3 weeks - prescribe up to 6 repeat prescriptions.  or
                                                                                                         Patient must be undergoing treatment with this drug administered once every 6 weeks - prescribe up to 3 repeat prescriptions.
C14031              P14031         CN14031          Selinexor                                            Relapsed and/or refractory multiple myeloma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures
                                                                                                         Continuing treatment - Dose requirement of 160 mg per week
                                                                                                         Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                         Patient must be undergoing dual combination therapy limited to:
                                                                                                          (i) this drug, (ii) dexamethasone; 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