Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p13
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 13/312)
Character Range: 15544339–15550666

22 weeks, immediately following the second infusion, before swapping to an alternate biological medicine.
C14583              P14583         CN14583          Abatacept                                                              Severe active rheumatoid arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Written Authority Required procedures
                                                                                                                           Initial treatment - Initial 2 (change or recommencement of treatment after a break in biological medicine of less 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 received prior PBS-subsidised treatment with a biological medicine for this condition; or
                                                                                                                           Patient must have received prior PBS-subsidised treatment with a biological medicine under the paediatric Severe active juvenile idiopathic arthritis/Systemic juvenile idiopathic arthritis indication; 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
                                                                                                                           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.
                                                                                                                           Patients who have received PBS-subsided treatment for paediatric Severe active juvenile idiopathic arthritis or Systemic juvenile idiopathic arthritis where the condition has progressed to Rheumatoid arthritis may receive treatment through this restriction using existing baseline scores.
                                                                                                                           Where a patient is changing from a biosimilar medicine for the treatment of this condition, the prescriber must provide baseline disease severity indicators with this application, in addition to the response assessment outlined below.
                                                                                                                           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;
                                                                                                                           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).
                                                                                                                           An application for a patient who is either changing treatment from another biological medicine to this drug or recommencing therapy with this drug after a treatment break of less than 24 months, must be accompanied with details of the evidence of a response to the patient's most recent course of PBS-subsidised biological medicine, within