Document ID: chunk:federal_register_of_legislation:F2025C00119:clause:3_1:p49
Version: federal_register_of_legislation:F2025C00119
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 49/69)
Character Range: 530512–537282

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.
                                                                                                                Provide details of the histological diagnosis of multiple myeloma, prior treatments including name(s) of drug(s) and date of the most recent treatment cycle; the basis of the diagnosis of progressive disease or failure to respond; and which disease activity parameters will be used to assess response once only through the Authority application for lenalidomide.
C14403              P14403         Pembrolizumab                                                                Advanced carcinoma of the cervix                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures ‑ Streamlined Authority Code 14403
                                                                                                                Initial treatment
                                                                                                                The condition must be at least one of (i) persistent carcinoma, (ii) recurrent carcinoma, (iii) metastatic carcinoma of the cervix; AND
                                                                                                                The condition must be unsuitable for curative treatment with either of (i) surgical resection, (ii) radiation; AND
                                                                                                                Patient must have WHO performance status no higher than 1; AND
                                                                                                                Patient must not have received prior treatment for this PBS indication.
                                                                                                                Patient must be undergoing concomitant treatment with chemotherapy, containing a minimum of: (i) a platinum‑based chemotherapy agent, plus (ii) paclitaxel; 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.
C14404              P14404         Pembrolizumab                                                                Advanced carcinoma of the cervix                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures ‑ Streamlined Authority Code 14404
                                                                                                                Continuing treatment
                                                                                                                Patient must have previously received PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                The condition must not have progressed while receiving PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                The treatment must not exceed a total of (i) 24