Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p31
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 31/312)
Character Range: 15641370–15647004

pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
                                                                                                                           The assessment of response to treatment must be documented in the patient's medical records and must be no more than 4 weeks old at the time of the authority application.
                                                                                                                           Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.
                                                                                                                           If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.
                                                                                                                           If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.
C14631              P14631         CN14631          Blinatumomab                                                           Measurable residual disease of precursor B-cell acute lymphoblastic leukaemia (Pre-B-cell ALL)                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                        Compliance with Written Authority Required procedures
                                                                                                                           Initial treatment of 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 an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; AND
                                                                                                                           The condition must not be present in the central nervous system or testis; AND
                                                                                                                           Patient must have achieved complete remission following intensive combination chemotherapy for initial treatment of acute lymphoblastic leukaemia (ALL) or for subsequent salvage therapy; AND
                                                                                                                           Patient must have measurable residual disease based on measurement in bone marrow, documented after an interval of at least 2 weeks from the last course of systemic chemotherapy given as intensive combination chemotherapy treatment of ALL/as subsequent salvage therapy, whichever was the later, measured using flow cytometry/molecular methods; 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 3 days of the first cycle and the first 2 days of the second cycle.
                                                                                                                           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 mcg will be sufficient for a continuous infusion of blinatumomab over 28 days in each cycle.
                                                                                                                           Blinatumomab is not