Document ID: chunk:federal_register_of_legislation:F2025C00158:clause:4_1:p25
Version: federal_register_of_legislation:F2025C00158
Segment Type: clause
Provision Reference: sch 4 cl 1 (pt 25/312)
Character Range: 15610631–15616700

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 eosinophils per mm2 hpf on oesophageal biopsy; AND
                                                                                                                           The condition must not have progressed while being treated with this drug; 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.
C14622              P14622         CN14622          Certolizumab pegol                                                     Severe active rheumatoid arthritis                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                                    Compliance with Written Authority Required procedures
                                                                                                                           Initial treatment - Initial 3 (recommencement of treatment after a break in biological medicine of more than 24 months)
                                                                                                                           Must be treated by a rheumatologist; or
                                                                                                                           Must be treated by a clinical immunologist with expertise in the management of rheumatoid arthritis; AND
                                                                                                                           Patient must have previously received PBS-subsidised treatment with a biological medicine for this condition; AND
                                                                                                                           Patient must have a break in treatment of 24 months or more from the most recent PBS-subsidised biological medicine for this condition; AND
                                                                                                                           Patient must not have failed to respond to previous PBS-subsidised treatment with this drug for this condition; AND
                                                                                                                           Patient must not have already failed/ceased to respond to PBS-subsidised biological medicine treatment for this condition 5 times; AND
                                                                                                                           The condition must have an elevated erythrocyte sedimentation rate (ESR) greater than 25 mm per hour; or
                                                                                                                           The condition must have a C-reactive protein (CRP) level greater than 15 mg per L; AND
                                                                                                                           The condition must