Listing of Pharmaceutical Benefits (NHL) - Schedule 4 part 1

Eosinophilic oesophagitis

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) a prescriber who is not any of the aforementioned prescriber types, but who has consulted at least one of the aforementioned 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.