Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p131
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 131/162)
Character Range: 15331238–15336931

determine response.
                                                                                                         The authority application must be made in writing and must include
                                                                                                         (1) a completed authority prescription form; and
                                                                                                         (2) a completed authority application form relevant to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice).
                                                                                                         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.
C14486              P14486         CN14486          Adalimumab                                           Severe active rheumatoid arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Written Authority Required procedures
                                                                                                         Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)
                                                    Baricitinib                                          Must be treated by a rheumatologist; or
                                                                                                         Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND
                                                    Etanercept                                           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
                                                    Tocilizumab                                          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
                                                    Tofacitinib                                          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
                                                    Upadacitinib                                         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 16 weeks of treatment under this restriction;
                                                                                                         Patient must be at least 18 years of age.
                                                                                                         Major joints are defined as (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).
                                                                                                         All measures of joint count and ESR and/or CRP must be no more than 4 weeks old at the time of initial application.
                                                                                                         If the requirement to demonstrate an elevated ESR or CRP cannot be met, the application must state the reasons why this criterion cannot be satisfied. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a