Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p100
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 100/312)
Character Range: 16097113–16104207

with the same biological medicine in courses of up to 24 weeks providing they continue to sustain an adequate response. It is recommended that a patient be reviewed in the month prior to completing their current course of treatment.
C15126              P15126         CN15126          Certolizumab pegol                                                     Non-radiographic axial spondyloarthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Authority Required procedures
                                                                                                                           Initial treatment - Initial 2 (Change or re-commencement of treatment after a break in biological medicine of less than 5 years)
                                                                                                                           Patient must have received prior PBS-subsidised treatment with a biological medicine for this condition in this treatment cycle; AND
                                                                                                                           The condition must not have responded inadequately to biological medicine on 4 occasions within the same treatment cycle; AND
                                                                                                                           Patient must not have failed PBS-subsidised therapy with this biological medicine for this PBS indication more than once in the current treatment cycle; AND
                                                                                                                           Patient must not receive more than 18 to 20 weeks of treatment, depending on the dosage regimen, under this restriction; AND
                                                                                                                           Must be treated by a rheumatologist.  or
                                                                                                                           Must be treated by a clinical immunologist with expertise in the management of non-radiographic axial spondyloarthritis.
                                                                                                                           An application for Initial 2 treatment must indicate whether the patient has demonstrated an adequate response (an absence of treatment failure), failed or experienced an intolerance to the most recent supply of biological medicine treatment.
                                                                                                                           A new baseline Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score and C-reactive protein (CRP) level may be provided at the time of this application.
                                                                                                                           An adequate response to therapy with this biological medicine is defined as a reduction from baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score by 2 or more units (on a scale of 0-10) and 1 of the following
                                                                                                                           (a) a CRP measurement no greater than 10 mg per L; or
                                                                                                                           (b) a CRP measurement reduced by at least 20% from baseline.
                                                                                                                           The assessment of the patient's response to the most recent supply of biological medicine must be conducted following a minimum of 12 weeks of treatment.
                                                                                                                           BASDAI scores and CRP levels must be documented in the patient's medical records.
                                                                                                                           The assessment of the patient's response to the initial course of treatment must be conducted following a minimum of 12 weeks of treatment and no later than 4 weeks from the cessation of that treatment course. If the response assessment is not conducted within these timeframes, the patient will be deemed to have failed this course of treatment in this treatment cycle.
                                                                                                                           The following must be provided at the time of application and documented in the patient's medical records
                                                                                                                           (a) the BASDAI score; and
                                                                                                                           (b) the C-reactive protein (CRP) level.
C15127              P15127         CN15127          Secukinumab                                                            Non-radiographic axial spondyloarthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Written Authority Required procedures
                                                                                                                           Initial treatment - Initial 1 (New