Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p93
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 93/191)
Character Range: 10563364–10575145

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                                                           In a patient treated with radiotherapy, octreotide should be withdrawn every 2 years in the 10 years after radiotherapy for assessment of remission
C8198               P8198          CN8198           Octreotide                                                                                                                                                                 Vasoactive intestinal peptide secreting tumour (VIPoma)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures - Streamlined Authority Code 8198
                                                                                                                                                                                                                               Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                                                                               Patient must have achieved symptom control on octreotide immediate release injections; AND
                                                                                                                                                                                                                               The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.
                                                                                                                                                                                                                               Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.
C8208               P8208          CN8208           Octreotide                                                                                                                                                                 Functional carcinoid tumour                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures - Streamlined Authority Code 8208
                                                                                                                                                                                                                               Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                                                                               Patient must have achieved symptom control on octreotide immediate release injections; AND
                                                                                                                                                                                                                               The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 3 months therapy at a dose of 30 mg every 28 days and having allowed adequate rescue therapy with octreotide immediate release injections.
                                                                                                                                                                                                                               Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.
C8214               P8214          CN8214           Dolutegravir with rilpivirine                                                                                                                                              HIV infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 8214
                                                                                                                                                                                                                               Initial treatment
                                                                                                                                                                                                                               Patient must be virologically suppressed on a stable antiretroviral regimen for at least 6 months; AND
                                                                                                                                                                                                                               The treatment must be the sole PBS-subsidised therapy for this condition.
C8226               P8226          CN8226           Dolutegravir with rilpivirine                                                                                                                                              HIV infection                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 8226
                                                                                                                                                                                                                               Continuing treatment
                                                                                                                                                                                                                               Patient must have previously received PBS-subsidised therapy with this drug for this condition; AND
                                                                                                                                                                                                                               The treatment must be the sole PBS-subsidised therapy for this condition.
C8262               P8262          CN8262           Everolimus                                                                                                                                                                 Refractory seizures associated with tuberous sclerosis complex                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures - Streamlined Authority Code 8262
                                                                                                                                                                                                                               Continuing treatment
                                                                                                                                                                                                                               Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                                                                               Patient must have maintained a response to the PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                                                                               The treatment must be in combination with at least one anti-epileptic drug; AND
                                                                                                                                                                                                                               Patient must not be a candidate for curative surgery.
C8263               P8263          CN8263           Everolimus                                                                                                                                                                 Refractory seizures associated with tuberous