Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p22
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 22/312)
Character Range: 15592883–15598938

response to treatment the application must be accompanied with the assessment of response, conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most recent course of biological medicine. It is recommended that an application for the continuing treatment be submitted no later than 4 weeks from the date of completion of the most recent course of treatment. This is to ensure treatment continuity for those who meet the continuing restriction.
                                                                                                                           Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
                                                                                                                           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.
C14604              P14604         CN14604          Abatacept                                                              Severe active rheumatoid arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures - Streamlined Authority Code 14604
                                                                                                                           Subsequent continuing treatment
                                                    Golimumab                                                              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 under the First continuing treatment restriction; or
                                                                                                                           Patient must have received this drug under this treatment phase as their most recent course of PBS-subsidised biological medicine; AND
                                                                                                                           Patient must have demonstrated an adequate response to treatment with this drug; AND
                                                                                                                           Patient must not receive more than 24 weeks of treatment under this restriction; AND
                                                                                                                           The treatment must be given concomitantly with methotrexate at a dose of at least 7.5 mg weekly;
                                                                                                                           Patient must be at least 18 years of age.
                                                                                                                           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) a reduction in the total active (swollen and tender) joint count by at least 50% from baseline, where baseline is at least 20 active joints; or
                                                                                                                           (b) 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 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).
                                                                                                                           The assessment of response to treatment must be documented