Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p92
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 92/191)
Character Range: 10553890–10564065

of remission (normal IGF1) after octreotide has been withdrawn for at least 4 weeks (8 weeks after the last dose); AND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                                                           In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission
C8165               P8165          CN8165           Octreotide                                                                                                                                                                 Acromegaly                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures - Streamlined Authority Code 8165
                                                                                                                                                                                                                               The condition must be active; AND
                                                                                                                                                                                                                               Patient must have persistent elevation of mean growth hormone levels of greater than 2.5 micrograms per litre; AND
                                                                                                                                                                                                                               The treatment must be after failure of other therapy including dopamine agonists; or
                                                                                                                                                                                                                               The treatment must be as interim treatment while awaiting the effects of radiotherapy and where treatment with dopamine 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 octreotide has been withdrawn for at least 4 weeks; AND
                                                                                                                                                                                                                               The treatment must cease if IGF1 is not lower after 3 months of treatment at a dose of 100 micrograms 3 time daily; 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
C8183               P8183          CN8183           Trifluridine with tipiracil                                                                                                                                                Metastatic colorectal cancer                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures - Streamlined Authority Code 8183
                                                                                                                                                                                                                               Continuing treatment
                                                                                                                                                                                                                               Patient must have previously been treated with PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                                                                               Patient must not develop progressive disease whilst receiving PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                                                                               The treatment must be the sole PBS-subsidised therapy for this condition.
C8197               P8197          CN8197           Octreotide                                                                                                                                                                 Acromegaly                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Authority Required procedures - Streamlined Authority Code 8197
                                                                                                                                                                                                                               Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                                                                               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