Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p208
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 208/476)
Character Range: 2088898–2094687

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.
                                                                                                                                            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.
                                                                                                                                            At the time of the authority application, medical practitioners should request the appropriate quantity of vials to provide sufficient drug, based on the weight of the patient, for a single infusion at a dose of 3 mg per kg.
                                                                                                                                            Up to a maximum of 3 repeats will be authorised.
                                                                                                                                            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.
                                                                                                                                            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.
                                                                       C14638                                                               Severe active rheumatoid arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures ‑ Streamlined Authority Code 14638
                                                                                                                                            First continuing treatment
                                                                                                                                            Must be treated by a rheumatologist; OR
                                                                                                                                            Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis.
                                                                                                                                            Patient must have received this drug as their most recent course of PBS‑subsidised biological medicine treatment for this condition; OR
                                                                                                                                            Patient must have received this drug in the subcutaneous form as their most recent course of PBS‑subsidised biological medicine for this condition under the infliximab subcutaneous form continuing restriction; 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