Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p172
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 172/312)
Character Range: 16527941–16534901

or equal to 7.5 mg per day of prednisone or equivalent while on immunomodulatory therapy prior to commencing non-PBS-subsidised treatment; OR
                                                                                                                           Patient must have failed to achieve an adequate response to prior conventional immunomodulatory therapy in patients for whom corticosteroids are not clinically appropriate prior to commencing non-PBS-subsidised treatment; OR
                                                                                                                           Patient must have a documented intolerance of a severity necessitating permanent treatment withdrawal or a contraindication to corticosteroid and immunomodulatory therapy prior to commencing non-PBS-subsidised treatment; AND
                                                                                                                           Patient must have demonstrated or sustained an adequate response to treatment with this drug for this condition if they have received more than 25 weeks of non-PBS-subsidised treatment; AND
                                                                                                                           The treatment must not exceed 24 weeks under this restriction.
                                                                                                                           Must be treated by an ophthalmologist, rheumatologist or immunologist with expertise in uveitis; OR
                                                                                                                           Must be treated by a medical practitioner who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion.
                                                                                                                           Vision threatening disease is defined as at least 1 of the following:
                                                                                                                           (a) A decrease in visual acuity of at least 10 letters using an ETDRS chart or equivalent;
                                                                                                                           (b) A 2-step increase in anterior chamber cells or vitreous haze;
                                                                                                                           (c) New retinal vasculitis;
                                                                                                                           (d) New retinal or choroidal lesions;
                                                                                                                           (e) Other signs of disease progression including visual field changes or electroretinogram changes
                                                                                                                           An adequate response to treatment is defined as:
                                                                                                                           (a) Sustained reduction in inflammation defined as a 2-step decrease from baseline in Standardisation of Uveitis Nomenclature (SUN) criteria for anterior chamber or vitreous haze; or
                                                                                                                           (b) Sustained quiescence of inflammation defined as Standardisation of Uveitis Nomenclature (SUN) criteria less than or equal to 0.5+ anterior chamber or vitreous haze, absence of active vitreous or retinal lesions or vitreous cells; or
                                                                                                                           (c) Sustained corticosteroid sparing effect, allowing reduction in prednisone to less than 7.5 mg daily; or
                                                                                                                           (d) Reduction in frequency of ocular attacks to less than or equal to 1 per year (patients with Behcet's disease only)
C15454              P15454         CN15454          Cabozantinib                                                           Locally advanced or metastatic differentiated thyroid cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures - Streamlined Authority Code 15454
                                                                                                                           Initial treatment
                                                                                                                           The condition must be refractory to radioactive iodine; OR
                                                                                                                           Patient must be deemed ineligible for treatment with radioactive iodine; AND
                                                                                                                           Patient must have 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) 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; AND
                                                                                                                           Patient must have a WHO performance status of no higher than 2; AND
                                                                                                                           The treatment must be