Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p23
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 23/312)
Character Range: 15598556–15604348

pain in passive movement and restriction of passive movement, where pain and limitation of movement are due to active disease and not irreversible damage such as joint destruction or bony overgrowth).
                                                                                                                           The assessment of response to treatment must be documented in the patient's medical records and must be no more than 4 weeks old at the time of the authority application.
                                                                                                                           Where the baseline active joint count is based on total active joints (i.e. more than 20 active joints), response must be determined according to the reduction in the total number of active joints. Where the baseline is determined on total number of major joints, the response must be determined on the total number of major joints. If only an ESR or CRP level is provided with the initial application, the same marker must be used to determine response.
                                                                                                                           If a patient has either failed or ceased to respond to a PBS-subsidised biological medicine for this condition 5 times, they will not be eligible to receive further PBS-subsidised treatment with a biological medicine for this condition.
                                                                                                                           If a patient fails to demonstrate a response to treatment with this drug under this restriction they will not be eligible to receive further PBS-subsidised treatment with this drug for this condition.
                                                                                                                           If the requirement for concomitant treatment with methotrexate cannot be met because of a contraindication and/or severe intolerance, details must be documented in the patient's medical records.
C14608              P14608         CN14608          Budesonide                                                             Eosinophilic oesophagitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures
                                                                                                                           Initial treatment - Induction of remission
                                                                                                                           Patient must have a history of symptoms of oesophageal dysfunction; AND
                                                                                                                           Patient must have eosinophilic infiltration of the oesophagus, demonstrated by oesophageal biopsy specimens obtained by endoscopy confirming the presence of at least 15 eosinophils in at least one high power field (hpf); corresponding to approximately 60 eosinophils per mm2 hpf; AND
                                                                                                                           Patient must not receive more than 90 days of treatment under this restriction; AND
                                                                                                                           Must be treated by a prescriber who is either:
                                                                                                                            (i) gastroenterologist, (ii) surgeon experienced in the management of patients with eosinophilic oesophagitis, (iii) physician experienced in the management of patients with eosinophilic oesophagitis.
                                                                                                                           Applications for treatment of this condition must be received within 12 weeks of biopsy.
                                                                                                                           Symptoms of oesophageal dysfunction include at least one of the following dysphasia, odynophagia, transient or self-cleared food impaction, chest pain, epigastric discomfort, vomiting/regurgitation.
                                                                                                                           Diagnostic sensitivity increases with the number of biopsies and can be optimised, where necessary, by taking at least eight biopsies (minimum of four collected from each of the mid and distal segments, with the distal segment biopsies taken at least 5 cm above the gastroesophageal junction).
                                                                                                                           After prescribing the Initial induction treatment with budesonide, a histologic assessment must be conducted within 48