Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p18
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 18/312)
Character Range: 15571479–15577538

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 be used to determine response.
                                                                                                                           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.
C14591              P14591         CN14591          Certolizumab pegol                                                     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 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction;
                                                                                                                           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