Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p158
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 158/162)
Character Range: 15461139–15467389

or
                                                                                                         The treatment must be in combination with methotrexate; AND
                                                                                                         Patient must have been assessed for response to treatment after at least 12 weeks treatment with the preceding supply of this biological medicine; AND
                                                                                                         Patient must have demonstrated an adequate response to treatment; AND
                                                                                                         Patient must not receive more than 24 weeks of treatment per continuing treatment course authorised under this restriction.
                                                                                                         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).
                                                                                                         An adequate response to treatment is defined as
                                                                                                         A Psoriasis Area and Severity Index (PASI) score which is reduced by 75% or more, or is sustained at this level, when compared with the baseline value for this treatment cycle.
                                                                                                         The assessment of response to treatment must be provided in this application and documented in the patient's medical records.
                                                                                                         The same body area assessed at the baseline PASI assessment must be assessed for demonstration of response to treatment for the purposes of gaining approval for the remainder of 24 weeks treatment.
C14560              P14560         CN14560          Abatacept                                            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)
                                                                                                         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 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 16 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 joints are defined as (i) elbow, wrist, knee and/or ankle (assessed as swollen and tender); and/or (ii) shoulder and/or hip (assessed