Jorveza® (budesonide) is an orally disintegrating tablet for the treatment of eosinophilic oesophagitis (EoE) in adults, that was first listed on the Pharmaceutical Benefits Scheme (PBS) on 1 May 2022. Several changes have been made to PBS prescribing criteria (from 1 November 2023) that should enable easier access to Jorveza for all patients with EoE, particularly those being treated in the public health system, but also in regional or remote areas where access to a Gastroenterologist may be limited. These changes have now been recommended by the Pharmaceutical Benefits Advisory Committee (PBAC) and implemented by PBS, with prescribing criteria changes to be implemented on 1 November 2023. 

ASCIA made a submission in January 2023  to support the main changes requested:

• For ‘other specialists experienced in the management of EoE’ to be able to prescribe Jorveza (whilst respecting the need for histological confirmation of the condition prior to initiating treatment - through endoscopic tissue sample collection and analysis. 
• The requirement for re-examination by endoscopy at 8 -10 weeks to confirm remission was considered too rigid (particularly within the public health system) meaning that some patients were unable to access treatment simply due to these scheduling of endoscopy limitations.

In summary these changes affect three treatment ‘phases’ as listed below. The new ‘First Continuing Treatment’ phase allows patients to stay on treatment (if it is providing a benefit) whilst waiting for the 2^nd histology for confirmation of remission, and should ensure doctors feel confident to commence treatment without being concerned by when they can schedule the 2^nd endoscopy.

Treatment Phase 1: Initial treatment - Induction of remission

Clinical criteria:

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.

Treatment criteria:

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

**NEW** Treatment Phase 2: First continuing treatment - until remission is confirmed

Clinical criteria:

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.

Treatment criteria:

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.

Treatment Phase 3: Subsequent continuing treatment - Maintenance of remission

Clinical criteria:

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 eosinophils per mm² hpf on oesophageal biopsy,

AND

The condition must not have progressed while being treated with this drug.

Treatment criteria:

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.

These changes should  provide benefits to patients with  EoE by improving ease of access to Jorveza as the only TGA registered and PBS reimbursed treatment for EoE.

This news item was issued on 26 October 2023 by Jill Smith, CEO of ASCIA, the peak professional body of clinical immunology/allergy specialists in Australia and New Zealand.