Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p149
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 149/191)
Character Range: 11045601–11055758

for this condition; AND
                                                                                                                                                                                                                               The treatment must be the sole PBS-subsidised anti-HER2 therapy for this condition; AND
                                                                                                                                                                                                                               The treatment must not be used in a patient with a left ventricular ejection fraction (LVEF) of less than 45% and/or with symptomatic heart failure.
                                                                                                                                                                                                                               A patient who has progressive disease when treated with this drug is no longer eligible for PBS-subsidised treatment with this drug.
                                                                                                                                                                                                                               The treatment must not exceed a lifetime total of one continuous course.
C9369               P9369          CN9369           Blinatumomab                                                                                                                                                               Acute lymphoblastic leukaemia                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Compliance with Authority Required procedures
                                                                                                                                                                                                                               Consolidation treatment
                                                                                                                                                                                                                               Patient must have previously received PBS-subsidised induction treatment with this drug for this condition; AND
                                                                                                                                                                                                                               Patient must have achieved a complete remission; or
                                                                                                                                                                                                                               Patient must have achieved a complete remission with partial haematological recovery; AND
                                                                                                                                                                                                                               The treatment must not be more than 3 treatment cycles under this restriction in a lifetime; AND
                                                                                                                                                                                                                               Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug.
C9377               P9377          CN9377           Etanercept                                                                                                                                                                 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