Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p83
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 83/381)
Character Range: 12060950–12066335

platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or
                                                                                                                                                                    (ii) faeces higher than normal lactoferrin or calprotectin level; or
                                                                                                                                                                    (iii) diagnostic imaging demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.
                                                                                                                                                                    Evidence of intestinal inflammation includes
                                                                                                                                                                    (i) blood higher than normal platelet count, or, an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour, or, a C-reactive protein (CRP) level greater than 15 mg per L; or
                                                                                                                                                                    (ii) faeces higher than normal lactoferrin or calprotectin level; or
                                                                                                                                                                    (iii) diagnostic imaging demonstration of increased uptake of intravenous contrast with thickening of the bowel wall or mesenteric lymphadenopathy or fat streaking in the mesentery.
                                                                                                                                                                    Where fewer than 2 repeats are requested at the time of the application, authority approvals for sufficient repeats to complete a maximum of 16 weeks of treatment with adalimumab may be requested under the balance of supply restriction.
                                                                                                                                                                    All assessments, pathology tests and diagnostic imaging studies must be made within 4 weeks of the date of application and should be performed preferably whilst still on conventional treatment, but no longer than 4 weeks following cessation of the most recent prior treatment.
                                                                                                                                                                    If treatment with any of the specified prior conventional drugs is contraindicated according to the relevant TGA-approved Product Information, please provide details at the time of application.
                                                                                                                                                                    If intolerance to treatment develops during the relevant period of use, which is of a severity necessitating permanent treatment withdrawal, details of this toxicity must be provided at the time of application.
                                                                                                                                                                    Details of the accepted toxicities including severity can be found on the Services Australia website.
                                                                                                                                                                    Any one of the baseline criteria may be used to determine response to an initial course of treatment and eligibility for continued therapy, according to the criteria included in the first or subsequent continuing treatment restrictions. However, the same criterion must be used for any subsequent determination of response to treatment, for the purpose of eligibility for continuing PBS-subsidised therapy.
                                                                                                                                                                    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