Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p156
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 156/191)
Character Range: 11099331–11109542

condition; AND
                                                                                                                                                                                                                               Patient must not have progressive disease while receiving PBS-subsidised treatment with this drug for this condition.
C9470               P9470          CN9470           Inotuzumab ozogamicin                                                                                                                                                      Acute lymphoblastic leukaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Written Authority Required procedures
                                                                                                                                                                                                                               Induction treatment
                                                                                                                                                                                                                               The condition must be relapsed or refractory B-precursor cell ALL, with an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less; AND
                                                                                                                                                                                                                               Patient must have received intensive combination chemotherapy for initial treatment of ALL or for subsequent salvage therapy; AND
                                                                                                                                                                                                                               Patient must not have received more than 1 line of salvage therapy; AND
                                                                                                                                                                                                                               Patient must have previously received a tyrosine kinase inhibitor (TKI) if the condition is Philadelphia chromosome positive; AND
                                                                                                                                                                                                                               The condition must be CD22-positive; AND
                                                                                                                                                                                                                               The condition must have more than 5% blasts in bone marrow; AND
                                                                                                                                                                                                                               The treatment must not be more than 3 treatment cycles under this restriction in a lifetime.
                                                                                                                                                                                                                               This drug is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.
                                                                                                                                                                                                                               The authority application must be made in writing and must include
                                                                                                                                                                                                                               (1) two completed authority prescription forms;
                                                                                                                                                                                                                               (2) a completed Acute Lymphoblastic Leukaemia PBS Authority Application - Supporting Information Form; and
                                                                                                                                                                                                                               (3) evidence that the condition is CD22-positive; and
                                                                                                                                                                                                                               (4) date of most recent chemotherapy, and if this was the initial chemotherapy regimen or salvage therapy, including what line of salvage; and
                                                                                                                                                                                                                               (5) a copy of the most recent bone marrow biopsy report of no more than one month old at the time of application.
                                                                                                                                                                                                                               The treatment must not exceed 0.8mg per m2 for the first dose of a treatment cycle (Day 1), and 0.5mg per m2 for subsequent doses (Days 8 and 15) within a treatment cycle.
                                                                                                                                                                                                                               Treatment with this drug for this condition must not exceed 6 treatment cycles in a lifetime.
C9473               P9473          CN9473           Etanercept                                                                                                                                                                 Severe active juvenile idiopathic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Written Authority Required procedures
                                                                                                                                                                                                                               Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)
                                                                                                                                                                                                                               Must be treated by a rheumatologist; or
                                                                                                                                                                                                                               Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND
                                                                                                                                                                                                                               Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND
                                                                                                                                                                                                                               Patient must have a break in treatment of 24 months or more from the most recently approved PBS-subsidised biological medicine for this condition; or
                                                                                                                                                                                                                               Patient must not have received PBS-subsidised biological medicine for at least 5 years if they failed or ceased to respond to PBS-subsidised biological medicine treatment 3 times in their last treatment cycle; AND
                                                                                                                                                                                                                               The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or
                                                                                                                                                                                                                               The condition must have a C-reactive protein (CRP) level greater than 15