Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p142
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 142/191)
Character Range: 10972359–10984185

agonists has failed; or
                                                                                                                                                                                                                               The treatment must be in a patient who is unfit for or unwilling to undergo surgery and where radiotherapy is contraindicated; AND
                                                                                                                                                                                                                               The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after lanreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND
                                                                                                                                                                                                                               The treatment must cease if IGF1 is not lower after 3 months of treatment; AND
                                                                                                                                                                                                                               The treatment must not be given concomitantly with PBS-subsidised pegvisomant.
                                                                                                                                                                                                                               In a patient treated with radiotherapy, lanreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission.
C9262               P9262          CN9262           Octreotide                                                                                                                                                                 Acromegaly                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures - Streamlined Authority Code 9262
                                                                                                                                                                                                                               The condition must be controlled with octreotide immediate release injections; AND
                                                                                                                                                                                                                               The treatment must cease in a patient treated with radiotherapy if there is biochemical evidence of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND
                                                                                                                                                                                                                               The treatment must cease if IGF1 is not lower after 3 months of treatment; AND
                                                                                                                                                                                                                               The treatment must not be given concomitantly with PBS-subsidised lanreotide or pegvisomant for this condition.
                                                                                                                                                                                                                               In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission
C9267               P9267          CN9267           Valaciclovir                                                                                                                                                               Cytomegalovirus infection and disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 9267
                                                                                                                                                                                                                               Prophylaxis
                                                                                                                                                                                                                               Patient must have undergone a renal transplant; AND
                                                                                                                                                                                                                               Patient must be at risk of cytomegalovirus disease.
C9268               P9268          CN9268           Zoledronic acid                                                                                                                                                            Multiple myeloma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures - Streamlined Authority Code 9268

C9274               P9274          CN9274           Imatinib                                                                                                                                                                   Chronic eosinophilic leukaemia or Hypereosinophilic syndrome                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures
                                                                                                                                                                                                                               Initial treatment
                                                                                                                                                                                                                               Patient must have confirmed evidence of carrying the FIP1L1-PDGFRA fusion gene; AND
                                                                                                                                                                                                                               The treatment must not exceed a maximum dose of 400 mg per day.
                                                                                                                                                                                                                               A pathology report confirming the presence of the FIP1L1-PDGFRA fusion gene, a full blood examination report and details of organ involvement requiring treatment, including a copy of the radiology, nuclear medicine, respiratory function or anatomical pathology reports as appropriate must be documented in the patient's medical records.
C9276               P9276          CN9276           Imatinib                                                                                                                                                                   Myelodysplastic or myeloproliferative disorder                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures
                                                                                                                                                                                                                               Initial treatment
                                                                                                                                                                                                                               Patient must have confirmed evidence of a platelet-derived growth factor receptor (PDGFR) gene re-arrangement by standard karyotyping; or
                                                                                                                                                                                                                               Patient must have confirmed evidence of a platelet-derived growth factor receptor (PDGFR) gene re-arrangement by fluorescence in situ hybridization (FISH); or
                                                                                                                                                                                                                               Patient must have confirmed evidence of a platelet-derived growth factor receptor (PDGFR) gene re-arrangement by PDGFRB fusion gene transcript; AND
                                                                                                                                                                                                                               Patient must have previously failed an adequate trial of conventional