Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p141
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 141/381)
Character Range: 12440165–12447867

by a prescriber who is either:
                                                                                                                                                                     (i) a gastroenterologist, (ii) a hepatologist; or
                                                                                                                                                                    Must be treated by an eligible practitioner type who has consulted at least one of the above mentioned specialist types, with agreement reached that the patient should be treated with this pharmaceutical benefit on this occasion; AND
                                                                                                                                                                    Patient must be undergoing concurrent treatment with ursodeoxycholic acid, following this authority application; or
                                                                                                                                                                    Patient must be undergoing treatment with this drug as monotherapy following this authority application, because combination treatment with ursodeoxycholic acid is not tolerated; AND
                                                                                                                                                                    Patient must have received treatment with this drug for this PBS indication prior to 1 September 2021; AND
                                                                                                                                                                    Patient must have experienced an inadequate response to ursodeoxycholic acid, despite treatment with ursodeoxycholic acid for at least 52 weeks at a therapeutic dose, prior to initiating treatment with this drug; or
                                                                                                                                                                    Patient must have experienced an intolerance to ursodeoxycholic acid of a severity requiring permanent treatment discontinuation, prior to initiating treatment with this drug; AND
                                                                                                                                                                    Patient must not have/be each of:
                                                                                                                                                                     (i) severe liver disease, (ii) immunocompromised; AND
                                                                                                                                                                    Patient must have had, prior to initiating treatment with this drug, an alkaline phosphatase (ALP) level of at least 1.67 times the upper limit of normal (ULN) having accounted for each of:
                                                                                                                                                                     (i) age, (ii) gender, (iii) laboratory to laboratory variances in the definition of 'normal', despite treatment with ursodeoxycholic acid for at least 52 cumulative weeks; or
                                                                                                                                                                    Patient must have had, prior to initiating treatment with this drug, a total bilirubin level between 1 to 2 times the ULN, despite treatment with ursodeoxycholic acid for at least 52 cumulative weeks; or
                                                                                                                                                                    Patient must have had, prior to initiating treatment with this drug, abnormal readings of at least one of:
                                                                                                                                                                     (i) alkaline phosphatase (ii) total bilirubin, in the presence of an intolerance of a severity requiring treatment discontinuation with ursodeoxycholic acid;
                                                                                                                                                                    Patient must be aged 18 years or older.
                                                                                                                                                                    Document and retain in the patient's medical records the qualifying baseline laboratory reading for the purpose of assessing response to treatment under the 'Continuing treatment' restriction.
C12147              P12147         CN12147          Adalimumab                                                                                                      Complex refractory Fistulising Crohn disease                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                              Compliance with Written Authority Required procedures
                                                                                                                                                                    Initial treatment - Initial 1 (new patient or 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 confirmed 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 an externally