Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p61
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 61/312)
Character Range: 15810511–15818366

mesenteric lymphadenopathy or fat streaking in the mesentery.
                                                                                                                           Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the continuing treatment restriction. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.
C14711              P14711         CN14711          Upadacitinib                                                           Severe Crohn disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Authority Required procedures
                                                                                                                           Extended induction period (optional) from weeks 12 to 24
                                                                                                                           Must be treated by a gastroenterologist (code 87); or
                                                                                                                           Must be treated by a consultant physician [internal medicine specialising in gastroenterology (code 81)]; or
                                                                                                                           Must be treated by a consultant physician [general medicine specialising in gastroenterology (code 82)]; AND
                                                                                                                           Patient must have experienced an inadequate therapeutic benefit following at least one of:
                                                                                                                            (i) dosing with 45 mg daily in the initial 12-week induction period, (ii) dosing with 15 mg daily;
                                                                                                                           Patient must be at least 18 years of age.
C14713              P14713         CN14713          Adalimumab                                                             Ankylosing spondylitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                Compliance with Written Authority Required procedures
                                                                                                                           First continuing treatment
                                                    Etanercept                                                             Patient must have received this drug as their most recent course of PBS-subsidised biological medicine treatment for this condition; AND
                                                                                                                           Patient must have demonstrated an adequate response to treatment with this drug; AND
                                                                                                                           Patient must not receive more than 24 weeks of treatment under this restriction;
                                                                                                                           Patient must be at least 18 years of age;
                                                                                                                           Must be treated by a rheumatologist.  or
                                                                                                                           Must be treated by a clinical immunologist with expertise in the management of ankylosing spondylitis.
                                                                                                                           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).
                                                                                                                           An adequate response is defined as an improvement from baseline of at least 2 units (on a scale of 0-10) in the BASDAI score combined with at least 1 of the following
                                                                                                                           (a) an ESR measurement no greater than 25 mm per hour; or
                                                                                                                           (b) a CRP measurement no greater than 10 mg per L; or
                                                                                                                           (c) an ESR or CRP measurement reduced by at least 20% from baseline.
                                                                                                                           Where only 1 acute phase reactant measurement is supplied in the first application for PBS-subsidised treatment, that same marker must be measured and used to assess all future responses to treatment.
                                                                                                                           The assessment of response to treatment must be documented in the patient's medical records.
                                                                                                                           An application for the continuing treatment must be accompanied with the assessment of response conducted following a minimum of 12 weeks of therapy and no later than 4 weeks from cessation of the most