Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p203
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 203/312)
Character Range: 16756974–16765558

medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
                                                                                                                           Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
                                                                                                                           The authority application must be made in writing and must include:
                                                                                                                           (1) details of the proposed prescription(s); and
                                                                                                                           (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice) which includes:
                                                                                                                           (i) the Hurley stage grading; and
                                                                                                                           (ii) the AN count.
                                                                                                                           Details of two completed prescriptions should be submitted with every initial application for this drug.
                                                                                                                           One prescription should be for the induction doses, containing a quantity of 8 doses of 150 mg and no repeats and the second prescription should be for 2 doses of 150 mg and 3 repeats.
                                                                                                                           This restriction is intended for induction dosing only.
C15772              P15772         CN15772          Budesonide                                                             Mild to moderate Crohn disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures - Streamlined Authority Code 15772
                                                                                                                           The condition must affect the ileum; OR
                                                                                                                           The condition must affect the ascending colon; OR
                                                                                                                           The condition must affect the ileum and ascending colon.
                                                                                                                           The total duration of therapy should be no more than 10 weeks in any single course.
C15774              P15774         CN15774          Cabozantinib                                                           Stage IV renal cell carcinoma (RCC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures - Streamlined Authority Code 15774
                                                                                                                           Initial treatment
                                                                                                                           The condition must be each of: (i) classified as having an intermediate to poor survival risk score according to the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC), (ii) untreated with a tyrosine kinase inhibitor; OR
                                                                                                                           Patient must have progressive disease according to the Response Evaluation Criteria in Solid Tumours (RECIST) despite treatment with a tyrosine kinase inhibitor, irrespective of the current IMDC survival risk score; AND
                                                                                                                           Patient must have a WHO performance status of 2 or less; AND
                                                                                                                           The treatment must be the sole PBS-subsidised therapy for this condition.
                                                                                                                           Patient must be undergoing treatment with this drug for the first time at the time of the first PBS prescription.
C15775              P15775         CN15775          Cabozantinib                                                           Stage IV renal cell carcinoma (RCC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures - Streamlined Authority Code 15775
                                                                                                                           Continuing treatment
                                                                                                                           Patient must have previously received PBS-subsidised treatment with 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