Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p93
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 93/381)
Character Range: 12126406–12133282

response to be demonstrated.
                                                                                                                                                                    The measurement of response to the prior course of therapy must be documented in the patient's medical notes.
                                                                                                                                                                    If treatment with any of the above-mentioned drugs is contraindicated according to the relevant TGA-approved Product Information, details must be provided at the time of application.
                                                                                                                                                                    An assessment of a patient's response to this initial course of treatment must be conducted following a minimum of 12 weeks of therapy and no later than 4 weeks prior the completion of this course of treatment.
                                                                                                                                                                    Where a response assessment is not conducted within the required timeframe, the patient will be deemed to have failed to respond to 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.
                                                                                                                                                                    Details of the accepted toxicities including severity can be found on the Services Australia website.
C11853              P11853         CN11853          Adalimumab                                                                                                      Moderate to severe ulcerative colitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                     Compliance with Authority Required procedures
                                                                                                                                                                    Subsequent continuing treatment
                                                                                                                                                                    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 this drug for this condition under the First continuing treatment restriction; AND
                                                                                                                                                                    Patient must have demonstrated or sustained an adequate response to treatment by having a partial Mayo clinic score less than or equal to 2, with no subscore greater than 1 while receiving treatment with this drug; or
                                                                                                                                                                    Patient must have demonstrated or sustained an adequate response to treatment by having a Paediatric Ulcerative Colitis Activity Index (PUCAI) score less than 10 while receiving treatment with this drug if aged 6 to 17 years;
                                                                                                                                                                    Patient must be 6 years of age or older.
                                                                                                                                                                    Patients who have failed to maintain a partial Mayo clinic score of less than or equal to 2, with no subscore greater than 1, or, patients who have failed to maintain a Paediatric Ulcerative Colitis Activity Index (PUCAI) score of less than 10 (if aged 6 to 17 years) with continuing treatment with this drug, will not be eligible to receive further PBS-subsidised treatment with this drug.
                                                                                                                                                                    Patients are eligible to receive continuing treatment