Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p138
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 138/191)
Character Range: 10925871–10939231

this condition; AND
                                                                                                                                                                                                                               Patient must have demonstrated a response to the PBS-subsidised treatment; 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 800 mg per day.
                                                                                                                                                                                                                               Evidence that the disease has not progressed on imatinib therapy must be documented in the patient's medical records.
C9216               P9216          CN9216           Nivolumab                                                                                                                                                                  Recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 9216
                                                                                                                                                                                                                               Initial treatment
                                                                                                                                                                                                                               Patient must have a WHO performance status of 0 or 1; AND
                                                                                                                                                                                                                               The treatment must be the sole PBS-subsidised therapy for this condition; AND
                                                                                                                                                                                                                               The condition must have progressed within 6 months of the last dose of prior platinum based chemotherapy; AND
                                                                                                                                                                                                                               Patient must not have received prior treatment with a programmed cell death-1 (PD-1) inhibitor for this condition.
                                                                                                                                                                                                                               The patient's body weight must be documented in the patient's medical records at the time treatment is initiated.
                                                                                                                                                                                                                               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.
C9222               P9222          CN9222           Deferasirox                                                                                                                                                                Chronic iron overload                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 9222
                                                                                                                                                                                                                               Continuing treatment
                                                                                                                                                                                                                               Patient must not be transfusion dependent; AND
                                                                                                                                                                                                                               The condition must be thalassaemia; AND
                                                                                                                                                                                                                               Patient must have previously received PBS-subsidised therapy with deferasirox for this condition.
C9223               P9223          CN9223           Doxorubicin - pegylated liposomal                                                                                                                                          Kaposi sarcoma                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                           Compliance with Authority Required procedures - Streamlined Authority Code 9223
                                                                                                                                                                                                                               The condition must be AIDS-related; AND
                                                                                                                                                                                                                               Patient must have a CD4 cell count of less than 200 per cubic millimetre; AND
                                                                                                                                                                                                                               The condition must include extensive visceral involvement.
C9224               P9224          CN9224           Lipegfilgrastim                                                                                                                                                            Chemotherapy-induced neutropenia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                         Compliance with Authority Required procedures - Streamlined Authority Code 9224
                                                                                                                                                                                                                               Patient must be receiving chemotherapy with the intention of achieving a cure or a substantial remission; AND
                                                                                                                                                                                                                               Patient must be at greater than 20% risk of developing febrile neutropenia.  or
                                                                                                                                                                                                                               Patient must be at substantial risk (greater than 20%) of prolonged severe neutropenia for more than or equal to seven days.
C9228               P9228          CN9228           Deferiprone                                                                                                                                                                Iron overload                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures - Streamlined Authority Code 9228
                                                                                                                                                                                                                               Patient must have thalassaemia major; AND
                                                                                                                                                                                                                               Patient must be one in whom desferrioxamine therapy has proven ineffective.
C9232               P9232          CN9232           Octreotide                                                                                                                                                                 Vasoactive intestinal peptide secreting tumour (VIPoma)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures - Streamlined Authority Code 9232
                                                                                                                                                                                                                               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