Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p15
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 15/312)
Character Range: 15554065–15561748

be eligible to receive further PBS-subsidised treatment with this drug for this condition.
                                                                                                                           A patient who has demonstrated a response to a course of rituximab must have a PBS-subsidised biological therapy treatment-free period of at least 22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine.
C14587              P14587         CN14587          Blinatumomab                                                           Measurable residual disease of precursor B-cell acute lymphoblastic leukaemia (Pre-B-cell ALL)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Authority Required procedures
                                                                                                                           Continuing treatment of previously measurable residual disease of Pre-B-cell ALL
                                                                                                                           Must be treated by a physician experienced in the treatment of haematological malignancies; AND
                                                                                                                           Patient must have previously received PBS-subsidised initial treatment with this drug for this condition; AND
                                                                                                                           Patient must have achieved a complete remission; AND
                                                                                                                           The condition must be negative for measurable residual disease using the same method used to determine initial PBS eligibility; AND
                                                                                                                           Patient must not have developed disease progression while receiving treatment with this drug for this condition; AND
                                                                                                                           The treatment must not be more than 2 treatment cycles under this restriction in a lifetime.
                                                                                                                           For all subsequent cycle starts and re-initiation (e.g. if treatment is interrupted for four or more hours), supervision by a health care professional or hospitalisation is recommended.
                                                                                                                           An amount of 784 microgram will be sufficient for a continuous infusion of blinatumomab over 28 days in each cycle.
                                                                                                                           Blinatumomab is not PBS-subsidised if it is administered to an in-patient in a public hospital setting.
                                                                                                                           Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent.
C14588              P14588         CN14588          Blinatumomab                                                           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
                                                                                                                           The condition must not be present in the central nervous system or testis; AND
                                                                                                                           Patient must have previously received a tyrosine kinase inhibitor (TKI) if the condition is Philadelphia chromosome positive; 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
                                                                                                                           The condition must be one of the following:
                                                                                                                            (i) untreated with this drug for measurable residual disease, (ii) treated with this drug for measurable residual disease, but the condition has not relapsed within 6 months of completing that course of treatment; AND
                                                                                                                           The condition must have more than 5% blasts in bone marrow; AND
                                                                                                                           The treatment must not be more than 2 treatment cycles under this restriction in a lifetime.
                                                                                                                           According to the TGA-approved Product Information, hospitalisation is recommended at minimum for the first 9 days of