Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p84
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 84/381)
Character Range: 12065921–12072986

treatment with this drug, unless the patient has experienced a serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment.
                                                                                                                                                                    If a patient fails to demonstrate a response to treatment with this drug they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition within this treatment cycle. Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
C11763              P11763         CN11763          Adalimumab                                                                                                      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 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 4 weeks old at the time of application; or
                                                                                                                                                                    Patient must have a documented history of intestinal inflammation and have diagnostic imaging or surgical evidence of short gut syndrome if affected by the syndrome or has an ileostomy or colostomy; or
                                                                                                                                                                    Patient must have a documented history and radiological evidence of intestinal inflammation if the patient has extensive small intestinal disease affecting more than 50 cm of the small intestine, together with a Crohn Disease Activity Index (CDAI) Score greater than or equal to 220 and that is no more than 4 weeks old at the time of application; AND
                                                                                                                                                                    Patient must have evidence of intestinal inflammation; or
                                                                                                                                                                    Patient must be assessed clinically as being in a high faecal output state; or
                                                                                                                                                                    Patient must be assessed clinically as requiring surgery or total parenteral nutrition (TPN) as the next therapeutic option, in the absence of this drug, if affected by short gut syndrome, extensive small intestine disease or is an ostomy patient; 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) two completed authority prescription forms; and
                                                                                                                                                                    (2) a completed authority application form relevant