Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p144
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 144/191)
Character Range: 10993783–11006314

carcinoid tumour                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures - Streamlined Authority Code 9289
                                                                                                                                                                                                                               The condition must be causing intractable symptoms; AND
                                                                                                                                                                                                                               Patient must have experienced on average over 1 week, 3 or more episodes per day of diarrhoea and/or flushing, which persisted despite the use of anti-histamines, anti-serotonin agents and anti-diarrhoea agents; AND
                                                                                                                                                                                                                               Patient must be one in whom surgery or antineoplastic therapy has failed or is inappropriate; AND
                                                                                                                                                                                                                               The treatment must cease if there is failure to produce a clinically significant reduction in the frequency and severity of symptoms after 2 months' therapy.
                                                                                                                                                                                                                               Dosage and tolerance to the drug should be assessed regularly and the dosage should be titrated slowly downwards to determine the minimum effective dose.
C9290               P9290          CN9290           Thalidomide                                                                                                                                                                Multiple myeloma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures - Streamlined Authority Code 9290

C9296               P9296          CN9296           Imatinib                                                                                                                                                                   Chronic eosinophilic leukaemia or Hypereosinophilic syndrome                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures - Streamlined Authority Code 9296
                                                                                                                                                                                                                               Continuing treatment
                                                                                                                                                                                                                               Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                                                                               Patient must have achieved and maintained a complete haematological response; AND
                                                                                                                                                                                                                               The condition must not have progressed while receiving PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                                                                               The treatment must not exceed a maximum dose of 400 mg per day.
                                                                                                                                                                                                                               A full blood examination report which demonstrates a complete haematological response, with a normal eosinophil count and a statement that the disease has not progressed on imatinib therapy must be documented in the patient's medical records.
C9298               P9298          CN9298           Nivolumab                                                                                                                                                                  Unresectable Stage III or Stage IV malignant melanoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 9298
                                                                                                                                                                                                                               Continuing treatment
                                                                                                                                                                                                                               The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                                                                                                                                                               Patient must have previously been issued with an authority prescription for this drug for this condition; AND
                                                                                                                                                                                                                               Patient must have stable or responding disease.
                                                                                                                                                                                                                               Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen.
C9299               P9299          CN9299           Nivolumab                                                                                                                                                                  Stage IV clear cell variant renal cell carcinoma (RCC)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                   Compliance with Authority Required procedures - Streamlined Authority Code 9299
                                                                                                                                                                                                                               Continuing treatment
                                                                                                                                                                                                                               Patient must have previously received PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                                                                                                                               Patient must not have developed disease progression while being treated with this drug for this condition; AND
                                                                                                                                                                                                                               The treatment must be the sole PBS-subsidised therapy for this condition.
                                                                                                                                                                                                                               Patients must only receive a maximum of 240 mg every two weeks or 480 mg every four weeks under a weight based or flat dosing regimen.
C9302               P9302          CN9302           Deferasirox                                                                                                                                                                Chronic iron overload                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 9302
                                                                                                                                                                                                                               Continuing treatment
                                                                                                                                                                                                                               Patient must be transfusion dependent; AND