Document ID: chunk:federal_register_of_legislation:F2025C00124:clause:3_1:p195
Version: federal_register_of_legislation:F2025C00124
Segment Type: clause
Provision Reference: sch 3 cl 1 (pt 195/476)
Character Range: 2018868–2026946

application, the same marker must be used to determine response.
                                                                                                                                            The date of the most recent treatment course, methotrexate dose, joint count and CRP and/or ESR must be documented in the patient's medical records. These values will be used for patients who transition to subcutaneous form of infliximab.
                                                                                                                                            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.
                                                                                                                                            If the requirement for concomitant treatment with methotrexate cannot be met because of a contraindication and/or severe intolerance, details must be documented in the patient's medical records.
                                                                                                                                            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.
                                                                       C14507                                                               Severe active rheumatoid arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures
                                                                                                                                            First continuing treatment ‑ balance of supply
                                                                                                                                            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 insufficient therapy with this drug for this condition under the first continuing treatment restriction to complete 24 weeks treatment; AND
                                                                                                                                            The treatment must provide no more than the balance of up to 24 weeks treatment.
                                                                       C14544                                                               Severe active rheumatoid arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Authority Required procedures
                                                                                                                                            Initial treatment ‑ Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)
                                                                                                                                            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 previously received PBS‑subsidised treatment with a biological medicine for this condition; AND
                                                                                                                                            Patient must have a break in treatment of 24 months or more from the most recent PBS‑subsidised biological medicine for this condition; AND
                                                                                                                                            Patient must not have failed to respond to previous PBS‑subsidised treatment with this drug for this condition; AND
                                                                                                                                            Patient must not have already failed/ceased to respond to PBS‑subsidised biological medicine treatment for this condition 5 times; AND
                                                                                                                                            The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; OR
                                                                                                                                            The condition must have a C‑reactive protein (CRP) level greater than 15 mg per L; AND
                                                                                                                                            The condition must have either: (a) a total active joint count of at least 20 active (swollen and tender) joints; (b) at least 4 active major joints; AND
                                                                                                                                            Patient must not receive more than 22 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.
                                                                                                                                            Major