Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p1
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 1/312)
Character Range: 15482082–15488924

1  Circumstances, purposes and conditions
  The following table sets out:
 (a) circumstances for circumstances codes, for the purposes of section 13 and 23; and
 (b) purposes for purposes codes, for the purposes of sections 15 and 16; and
 (c) for the purposes of section 19, information relating to how authorisation is obtained when the circumstances or conditions for writing a prescription include an authorisation requirement.

Circumstances Code  Purposes Code  Conditions Code  Listed Drug                                                            Circumstances and Purposes                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                            Authority Requirements (part of Circumstances; or Conditions)

C14568              P14568         CN14568          Adalimumab                                                             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; 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;
                                                                                                                           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 reasons why this criterion cannot be satisfied must be documented in the patient's medical records. Treatment with prednisolone dosed at 7.5 mg or higher daily (or equivalent) or a parenteral steroid within the past month (intramuscular or intravenous methylprednisolone or equivalent) is an acceptable reason.
                                                                                                                           Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints),