Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p166
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 166/381)
Character Range: 12600942–12609702

to their 13th birthday if male;
                                                                                                                                                                    Patient must have had onset of signs/symptoms of central precocious puberty prior to their 9th birthday if female.  or
                                                                                                                                                                    Patient must have had onset of signs/symptoms of central precocious puberty prior to their 10th birthday if male.
C12392              P12392         CN12392          Certolizumab pegol                                                                                              Non-radiographic axial spondyloarthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures
                                                                                                                                                                    Continuing treatment - balance of supply
                                                    Secukinumab                                                                                                     Patient must have received insufficient therapy with this drug for this condition under the continuing treatment restriction to complete 24 weeks treatment; AND
                                                                                                                                                                    The treatment must provide no more than the balance of up to 24 weeks therapy available under Continuing treatment; 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.
C12399              P12399         CN12399          Tocilizumab                                                                                                     Severe active juvenile idiopathic arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                               Compliance with Written Authority Required procedures
                                                                                                                                                                    Initial treatment - Initial 4 (Temporary listing - change of treatment from another biological medicine to tocilizumab after resolution of the critical shortage of tocilizumab)
                                                                                                                                                                    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 been receiving PBS-subsidised treatment with tocilizumab for this condition prior to 1 November 2021; AND
                                                                                                                                                                    Patient must have been receiving PBS-subsidised treatment with a biological medicine for this condition in place of tocilizumab due to the critical supply shortage of tocilizumab; AND
                                                                                                                                                                    Patient must not receive more than 16 weeks of treatment under this restriction;
                                                                                                                                                                    Patient must be aged 18 years or older.
                                                                                                                                                                    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).
                                                                                                                                                                    If a patient has received 12 weeks or more of therapy with the alternative biological medicine as their most recent treatment, evidence of a response must be provided.
                                                                                                                                                                    If a prescriber wishes to switch therapy back to tocilizumab upon resolution of the shortage, evidence demonstrating a response to the alternative biological medicine is not required, if the patient has not completed 12 weeks of treatment. Prescribers must note on the change/recommencement authority application form that the patient is unable to demonstrate response due to insufficient treatment length and the patient is switching to tocilizumab as the shortage has been resolved.
                                                                                                                                                                    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) an active joint count