Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p133
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 133/162)
Character Range: 15340972–15346575

clinical immunologist with expertise in the management of rheumatoid arthritis; AND
                                                    Baricitinib                                          Patient must have received insufficient therapy with this drug for this condition under the Initial 1 (new patient) restriction to complete 16 weeks treatment; or
                                                                                                         Patient must have received insufficient therapy with this drug for this condition under the Initial 2 (change or recommencement of treatment after a break in biological medicine of less than 24 months) restriction to complete 16 weeks treatment; or
                                                    Etanercept                                           Patient must have received insufficient therapy with this drug for this condition under the Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months) to complete 16 weeks of treatment; AND
                                                                                                         The treatment must provide no more than the balance of up to 16 weeks treatment available under the above restrictions.
                                                    Golimumab

                                                    Tocilizumab

                                                    Tofacitinib

                                                    Upadacitinib

C14493              P14493         CN14493          Adalimumab                                           Severe active rheumatoid arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Written Authority Required procedures
                                                                                                         First continuing treatment
                                                    Baricitinib                                          Must be treated by a rheumatologist; or
                                                                                                         Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND
                                                    Certolizumab pegol                                   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
                                                    Etanercept                                           Patient must not receive more than 24 weeks of treatment under this restriction;
                                                                                                         Patient must be at least 18 years of age.
                                                    Tocilizumab                                          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;
                                                    Tofacitinib                                          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).
                                                                                                         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