Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p24
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 24/312)
Character Range: 15603959–15610895

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 weeks of initiating treatment to determine the patient's eligibility for continuing therapy.
                                                                                                                           The histologic assessment should be conducted no later than 2 weeks prior to completing the PBS-subsidised First continuing maintenance treatment course to avoid an interruption of supply for continuing therapy.
C14610              P14610         CN14610          Budesonide                                                             Eosinophilic oesophagitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures
                                                                                                                           First continuing treatment - until remission is confirmed
                                                                                                                           Patient must have previously received PBS-subsidised initial treatment with this drug for this condition; AND
                                                                                                                           Patient must have demonstrated an adequate response to treatment with this drug for this condition; AND
                                                                                                                           Patient must not receive more than 36 weeks 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, (iv) medical practitioner who has consulted at least one of the above-mentioned prescriber types.
                                                                                                                           Histologic assessment should be based on the peak eosinophils count derived, where necessary, from the evaluation of at least eight oesophageal 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).
                                                                                                                           The histologic assessment should, where possible, be performed by, or in consultation with, the same physician or surgeon who confirmed the patient's diagnosis of eosinophilic oesophagitis. This assessment must be conducted within 48 weeks of initiating treatment to determine the patient's eligibility for continuing treatment. The histologic assessment should be conducted no later than 2 weeks prior to the patient completing the PBS-subsidised First continuing treatment course to avoid an interruption of supply for continuing therapy. Where a histologic assessment is not undertaken, the patient will not be eligible for ongoing treatment.
                                                                                                                           The result of the histological assessment must be documented in the patient's medical records.
                                                                                                                           First application for the subsequent continuing treatment of this condition must be received within 12 weeks of the histologic assessment.
C14619              P14619         CN14619          Budesonide                                                             Eosinophilic oesophagitis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                             Compliance with Authority Required procedures
                                                                                                                           Subsequent continuing treatment - Maintenance of remission
                                                                                                                           Patient must have previously received PBS-subsidised treatment with this drug for this condition under the First continuing treatment restriction; AND
                                                                                                                           Patient must have documented evidence of having achieved histologic remission while receiving Initial and First continuing PBS-subsidised treatment with this drug for this condition, defined as a peak eosinophil count of less than 5 eosinophils per high power field (hpf), corresponding to less than 16