Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p84
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 84/191)
Character Range: 10457631–10472792

patient or the patient's family (in the case of paediatric patients) and the treating physician(s) must report a benefit in the clinical status of the patient.
                                                                                                                                                                                                                               Further reassessments must be undertaken and documented at six-monthly intervals. Therapy with this drug should cease if there is not general agreement of benefit as there is always the possibility of harm from unnecessary use.
C7374               P7374          CN7374           Deferasirox                                                                                                                                                                Chronic iron overload                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures
                                                                                                                                                                                                                               Initial treatment
                                                                                                                                                                                                                               Patient must not be transfusion dependent; AND
                                                                                                                                                                                                                               The condition must be thalassaemia.
C7375               P7375          CN7375           Deferasirox                                                                                                                                                                Chronic iron overload                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures
                                                                                                                                                                                                                               Initial treatment
                                                                                                                                                                                                                               Patient must be transfusion dependent; AND
                                                                                                                                                                                                                               Patient must not have a malignant disorder of erythropoiesis.
C7385               P7385          CN7385           Deferasirox                                                                                                                                                                Chronic iron overload                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures
                                                                                                                                                                                                                               Initial treatment
                                                                                                                                                                                                                               Patient must be red blood cell transfusion dependent; AND
                                                                                                                                                                                                                               Patient must have a serum ferritin level of greater than 1000 microgram/L; AND
                                                                                                                                                                                                                               Patient must have a malignant disorder of haemopoiesis; AND
                                                                                                                                                                                                                               Patient must have a median life expectancy exceeding five years.
C7386               P7386          CN7386           Ocrelizumab                                                                                                                                                                Multiple sclerosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures - Streamlined Authority Code 7386
                                                                                                                                                                                                                               Continuing treatment
                                                                                                                                                                                                                               Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                                                                               Patient must not show continuing progression of disability while on treatment with this drug; AND
                                                                                                                                                                                                                               The treatment must be the sole PBS-subsidised disease modifying therapy for this condition; AND
                                                                                                                                                                                                                               Patient must have demonstrated compliance with, and an ability to tolerate this therapy; AND
                                                                                                                                                                                                                               Must be treated by a neurologist.
C7431               P7431          CN7431           Everolimus                                                                                                                                                                 Tuberous sclerosis complex (TSC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures - Streamlined Authority Code 7431
                                                                                                                                                                                                                               Continuing treatment
                                                                                                                                                                                                                               The condition must be subependymal giant cell astrocytomas (SEGAs) associated with TSC; or
                                                                                                                                                                                                                               The condition must be visceral tumours associated with TSC; AND
                                                                                                                                                                                                                               The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                                                                                                                                                               Patient must have received an initial authority prescription for this drug for this condition; AND
                                                                                                                                                                                                                               Patient must have demonstrated a response to prior treatment.
C7432               P7432          CN7432           Everolimus                                                                                                                                                                 Stage IV clear cell variant renal cell carcinoma (RCC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures - Streamlined Authority Code 7432
                                                                                                                                                                                                                               Continuing treatment beyond 3 months
                                                                                                                                                                                                                               Patient must have received an initial authority prescription for this drug for this condition; AND
                                                                                                                                                                                                                               Patient must have stable or responding disease according to the Response Evaluation Criteria In Solid Tumours (RECIST); AND
                                                                                                                                                                                                                               The treatment must be the sole PBS-subsidised therapy for this condition.
                                                                                                                                                                                                                               A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.
C7433               P7433          CN7433           Axitinib                                                                                                                                                                   Stage IV clear cell variant renal cell carcinoma (RCC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures - Streamlined Authority Code 7433
                                                                                                                                                                                                                               Continuing treatment beyond