Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p95
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 95/191)
Character Range: 10588602–10600598

The treatment must be adjunctive to ongoing maximum tolerated dose (MTD) of stimulant (dexamfetamine, methylphenidate or lisdexamfetamine); AND
                                                                                                                                                                                                                               Patient must be experiencing residual moderate to severe ADHD symptoms resulting in impaired functioning (social, academic or occupational), present in at least one setting (home, nursery/school/college/work, friends or family homes or other environment);
                                                                                                                                                                                                                               Patient must be or have been diagnosed between the ages of 6 and 17 years inclusive.
C8555               P8555          CN8555           Ipilimumab                                                                                                                                                                 Stage IV clear cell variant renal cell carcinoma (RCC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures - Streamlined Authority Code 8555
                                                                                                                                                                                                                               Induction treatment
                                                                                                                                                                                                                               The condition must not have previously been treated; AND
                                                                                                                                                                                                                               The condition must be classified as intermediate to poor risk according to the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC); AND
                                                                                                                                                                                                                               Patient must have a WHO performance status of 2 or less; AND
                                                                                                                                                                                                                               The treatment must be in combination with PBS-subsidised treatment with nivolumab as induction therapy for this condition.
                                                                                                                                                                                                                               Induction treatment with ipilimumab must not exceed a total of 4 doses at a maximum dose of 1 mg per kg every 3 weeks.
                                                                                                                                                                                                                               The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.
C8584               P8584          CN8584           Lenvatinib                                                                                                                                                                 Advanced (unresectable) Barcelona Clinic Liver Cancer Stage B or Stage C hepatocellular carcinoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures - Streamlined Authority Code 8584
                                                                                                                                                                                                                               Continuing treatment
                                                                                                                                                                                                                               The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                                                                                                                                                               Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                                                                               Patient must not develop disease progression while receiving treatment with this drug for this condition.
C8585               P8585          CN8585           Guanfacine                                                                                                                                                                 Attention deficit hyperactivity disorder                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                 Compliance with Authority Required procedures - Streamlined Authority Code 8585
                                                                                                                                                                                                                               Continuing treatment
                                                                                                                                                                                                                               Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                                                                               The treatment must be adjunctive to ongoing maximum tolerated dose (MTD) of stimulant (dexamfetamine, methylphenidate or lisdexamfetamine).
C8588               P8588          CN8588           Axitinib                                                                                                                                                                   Stage IV clear cell variant renal cell carcinoma (RCC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures
                                                                                                                                                                                                                               Initial treatment
                                                                                                                                                                                                                               Patient must have progressive disease according to the Response Evaluation Criteria in Solid Tumours (RECIST) following prior treatment with a tyrosine kinase inhibitor; 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.
                                                                                                                                                                                                                               Patients who have developed intolerance to a tyrosine kinase inhibitor of a severity necessitating permanent treatment withdrawal are eligible to receive PBS-subsidised treatment with this drug.
                                                                                                                                                                                                                               A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.
C8606               P8606          CN8606           Tiotropium                                                                                                                                                                 Severe asthma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 8606
                                                                                                                                                                                                                               Must be treated by a