Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p96
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 96/381)
Character Range: 12143569–12150583

Serious adverse reaction of a severity resulting in the necessity for permanent withdrawal of treatment is not considered as a treatment failure.
                                                                                                                                                                    A patient who fails to demonstrate a response to treatment with this drug under this restriction will not be eligible to receive further PBS-subsidised treatment with this drug in this treatment cycle. A patient may re-trial this drug after a minimum of 5 years have elapsed between the date the last prescription for a PBS-subsidised biological medicine was approved in this cycle and the date of the first application under a new cycle under the initial 3 treatment restriction.
                                                                                                                                                                    If patients aged 6 to 17 years fail to respond to PBS-subsidised biological medicine treatment 3 times (twice with one agent) they will not be eligible to receive further PBS-subsidised biological medicine therapy in this treatment cycle.
C11855              P11855         CN11855          Adalimumab                                                                                                      Moderate to severe ulcerative colitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     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)]; or
                                                                                                                                                                    Must be treated by a paediatrician; or
                                                                                                                                                                    Must be treated by a specialist paediatric gastroenterologist; AND
                                                                                                                                                                    Patient must have previously received 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 a Mayo clinic score greater than or equal to 6 if an adult patient; or
                                                                                                                                                                    Patient must have a partial Mayo clinic score greater than or equal to 6, provided the rectal bleeding and stool frequency subscores are both greater than or equal to 2 (endoscopy subscore is not required for a partial Mayo clinic score); or
                                                                                                                                                                    Patient must have a Paediatric Ulcerative Colitis Activity Index (PUCAI) Score greater than or equal to 30 if aged 6 to 17 years;
                                                                                                                                                                    Patient must be 6 years of age 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 to the indication and treatment phase (the latest version is located on the website specified in the Administrative Advice), which includes
                                                                                                                                                                    (i) the completed current Mayo clinic or partial Mayo clinic or Paediatric Ulcerative Colitis Activity Index (PUCAI) calculation sheet including the date of assessment of the patient's condition; and
                                                                                                                                                                    (ii) the details of prior biological medicine treatment including the details of date and duration of