Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p59
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 59/312)
Character Range: 15800148–15806085

have an adequate response to this drug defined as a reduction in Crohn Disease Activity Index (CDAI) Score to a level no greater than 150 if assessed by CDAI or if affected by extensive small intestine disease; or
                                                                                                                           Patient must have an adequate response to this drug defined as (a) an improvement of intestinal inflammation as demonstrated by:
                                                                                                                            (i) blood: normalisation of the platelet count, or an erythrocyte sedimentation rate (ESR) level no greater than 25 mm per hour, or a C-reactive protein (CRP) level no greater than 15 mg per L; or (ii) faeces: normalisation of lactoferrin or calprotectin level; or (iii) evidence of mucosal healing, as demonstrated by diagnostic imaging findings, compared to the baseline assessment; or (b) reversal of high faecal output state; or (c) avoidance of the need for surgery or total parenteral nutrition (TPN), if affected by short gut syndrome, extensive small intestine or is an ostomy patient;
                                                                                                                           Patient must be at least 18 years of age.
                                                                                                                           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).
                                                                                                                           In relation to the immediately preceding supply of this biological medicine, provide at least one of the following which is not more than 4 weeks from the last administered dose
                                                                                                                           (i) the Crohn Disease Activity Index (CDAI) score, including the date the score was calculated on; or
                                                                                                                           (ii) the unique serial/identifying number and date(s) of pathology or diagnostic imaging test(s) used to assess response to therapy for patients with short gut syndrome, extensive small intestine disease or an ostomy, if relevant.
C14710              P14710         CN14710          Upadacitinib                                                           Severe Crohn disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                  Compliance with Written Authority Required procedures
                                                                                                                           Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 5 years)
                                                                                                                           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 received prior PBS-subsidised treatment with a biological medicine for this condition; AND
                                                                                                                           Patient must have had a break in treatment of 5 years or more from the most recently approved PBS-subsidised biological medicine for this condition; AND
                                                                                                                           Patient must have confirmed severe Crohn disease, defined by standard clinical, endoscopic and/or imaging features, including histological evidence, with the diagnosis confirmed by a gastroenterologist or a consultant physician; AND
                                                                                                                           Patient must have a Crohn Disease Activity Index (CDAI) Score of greater than or equal to 300 that is no more than