Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p182
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 182/312)
Character Range: 16598832–16607627

Code 15510
                                                                                                                           Initial treatment
                                                                                                                           The condition must be refractory to radioactive iodine; AND
                                                                                                                           The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                                                           Patient must have symptomatic progressive disease prior to treatment; OR
                                                                                                                           Patient must have progressive disease at critical sites with a high risk of morbidity or mortality where local control cannot be achieved by other measures; AND
                                                                                                                           Patient must have thyroid stimulating hormone adequately suppressed; AND
                                                                                                                           Patient must be one in whom surgery is inappropriate; AND
                                                                                                                           Patient must not be a candidate for radiotherapy with curative intent; AND
                                                                                                                           Patient must have a WHO performance status of 2 or less.
                                                                                                                           Radioactive iodine refractory is defined as:
                                                                                                                           (i) a lesion without iodine uptake on a radioactive iodine (RAI) scan; or
                                                                                                                           (ii) having received a cumulative RAI dose of greater than or equal to 600 mCi; or
                                                                                                                           (iii) progression within 12 months of a single RAI treatment; or
                                                                                                                           (iv) progression after two RAI treatments administered within 12 months of each other.
C15518              P15518         CN15518          Cabozantinib                                                           Locally advanced or metastatic differentiated thyroid cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures - Streamlined Authority Code 15518
                                                                                                                           Transitioning from non-PBS to PBS-subsidised supply - Grandfather arrangements
                                                                                                                           Patient must have previously received non-PBS-subsidised treatment with this drug for this condition prior to 1 August 2024; AND
                                                                                                                           The condition must be refractory to radioactive iodine; OR
                                                                                                                           Patient must be deemed ineligible for treatment with radioactive iodine; AND
                                                                                                                           Patient must have had progressive disease according to Response Evaluation Criteria in Solid Tumours (RECIST) whilst on treatment with a vascular endothelial growth factor (VEGF)-targeted tyrosine kinase inhibitor (TKI) prior to receiving this drug for this indication; OR
                                                                                                                           Patient must have developed intolerance of a severity necessitating permanent treatment withdrawal, in the absence of disease progression, to prior VEGF-targeted TKI therapy prior to receiving this drug for this indication; AND
                                                                                                                           Patient must have had a WHO performance status of no greater than 2 prior to receiving this drug for this indication; AND
                                                                                                                           The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                                                           Patient must have thyroid stimulating hormone adequately suppressed.
                                                                                                                           Radioactive iodine refractory is defined as:
                                                                                                                           (i) a lesion without iodine uptake on a radioactive iodine (RAI) scan; or
                                                                                                                           (ii) having received a cumulative RAI dose of greater than or equal to 600 mCi; or
                                                                                                                           (iii) progression within 12 months of a single RAI treatment; or
                                                                                                                           (iv) progression after two RAI treatments administered within 12 months of each other.
C15526              P15526         CN15526          Gilteritinib                                                           Relapsed or refractory Acute Myeloid Leukaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures
                                                                                                                           Initial treatment
                                                                                                                           The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                                                           The condition must not be acute promyelocytic leukaemia; AND
                                                                                                                           The condition must be internal tandem duplication (ITD) and/or tyrosine