Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p165
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 165/191)
Character Range: 11173334–11185537

or gastro-oesophageal junction                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures - Streamlined Authority Code 9571
                                                                                                                                                                                                                               Continuing treatment
                                                                                                                                                                                                                               Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                                                                               Patient must not have progressive disease; AND
                                                                                                                                                                                                                               The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.
C9573               P9573          CN9573           Trastuzumab                                                                                                                                                                Metastatic (Stage IV) HER2 positive adenocarcinoma of the stomach or gastro-oesophageal junction                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures - Streamlined Authority Code 9573
                                                                                                                                                                                                                               Initial treatment
                                                                                                                                                                                                                               Patient must have evidence of human epidermal growth factor receptor 2 (HER2) positivity as demonstrated by immunohistochemistry 2+ or more in tumour material; AND
                                                                                                                                                                                                                               Patient must have evidence of HER2 gene amplification as demonstrated by in situ hybridisation results based on more than 6 copies of HER2 in the same tumour tissue sample; AND
                                                                                                                                                                                                                               Patient must have evidence of HER2 gene amplification as demonstrated by in situ hybridisation results based on the ratio of HER2 to chromosome 17 being more than 2 in the same tumour tissue sample; AND
                                                                                                                                                                                                                               Patient must commence treatment in combination with platinum based chemotherapy and capecitabine; or
                                                                                                                                                                                                                               Patient must commence treatment in combination with platinum based chemotherapy and 5 fluorouracil; AND
                                                                                                                                                                                                                               Patient must not have previously received this drug for this condition; AND
                                                                                                                                                                                                                               Patient must not have received prior chemotherapy for this condition; AND
                                                                                                                                                                                                                               Patient must have a WHO performance status of 2 or less; AND
                                                                                                                                                                                                                               The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.
                                                                                                                                                                                                                               Cardiac function must be tested by echocardiography (ECHO) or multigated acquisition (MUGA), prior to initiating treatment with this drug for this condition.
C9589               P9589          CN9589           Alemtuzumab                                                                                                                                                                Multiple sclerosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                       Compliance with Authority Required procedures - Streamlined Authority Code 9589
                                                                                                                                                                                                                               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
                                                                                                                                                                                                                               Patient must not receive more than one PBS-subsidised treatment per year; 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.
C9590               P9590          CN9590           Deferiprone                                                                                                                                                                Iron overload                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 9590
                                                                                                                                                                                                                               Patient must have thalassaemia major; AND
                                                                                                                                                                                                                               Patient must be one in whom desferrioxamine therapy has proven ineffective.
C9591               P9591          CN9591           Dornase alfa                                                                                                                                                               Cystic fibrosis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                          Compliance with Authority Required procedures - Streamlined Authority Code 9591
                                                                                                                                                                                                                               Patient must have a severe clinical course with frequent respiratory exacerbations or chronic respiratory symptoms (including chronic or recurrent cough,