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

Eosinophilic oesophagitis

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 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.