Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p163
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 163/191)
Character Range: 11156112–11166972

neurologist.  or
                                                                                                                                                                                                                               Must be treated by an orthopaedic surgeon.  or
                                                                                                                                                                                                                               Must be treated by a rehabilitation specialist.  or
                                                                                                                                                                                                                               Must be treated by a plastic surgeon.  or
                                                                                                                                                                                                                               Must be treated by a geriatrician.
                                                                                                                                                                                                                               Standard management includes physiotherapy and/or oral spasticity agents.
C9549               P9549          CN9549           Dasatinib                                                                                                                                                                  Acute lymphoblastic leukaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures
                                                                                                                                                                                                                               Continuing treatment
                                                                                                                                                                                                                               The condition must be expressing the Philadelphia chromosome; or
                                                                                                                                                                                                                               The condition must have the transcript BCR-ABL; AND
                                                                                                                                                                                                                               Patient must have previously received PBS-subsidised treatment with this drug for this condition as second-line therapy following treatment with imatinib; AND
                                                                                                                                                                                                                               The condition must not have progressed.
C9553               P9553          CN9553           Tocilizumab                                                                                                                                                                Severe active juvenile idiopathic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Written Authority Required procedures
                                                                                                                                                                                                                               Continuing treatment
                                                                                                                                                                                                                               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 received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND
                                                                                                                                                                                                                               Patient must have demonstrated an adequate response to treatment with this drug; AND
                                                                                                                                                                                                                               Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction;
                                                                                                                                                                                                                               Patient must be aged 18 years or older.
                                                                                                                                                                                                                               An adequate response to treatment is defined as
                                                                                                                                                                                                                               an ESR no greater than 25 mm per hour or a CRP level no greater than 15 mg per L or either marker reduced by at least 20% from baseline;
                                                                                                                                                                                                                               AND either of the following
                                                                                                                                                                                                                               (a) an active joint count of fewer than 10 active (swollen and tender) joints; or
                                                                                                                                                                                                                               (b) a reduction in the active (swollen and tender) joint count by at least 50% from baseline; or
                                                                                                                                                                                                                               (c) a reduction in the number of the following active joints, from at least 4, by at least 50%
                                                                                                                                                                                                                               (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or
                                                                                                                                                                                                                               (ii) shoulder, cervical spine and/or hip (assessed as 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).
                                                                                                                                                                                                                               Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response will 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 demonstrated on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker will be used to determine response.
                                                                                                                                                                                                                               The authority application must be made in writing and must include
                                                                                                                                                                                                                               (1) completed authority prescription form(s); and
                                                                                                                                                                                                                               (2) a completed Juvenile Idiopathic Arthritis PBS Authority Application - Supporting Information