JORVEZA

Key points

Favourable opinion for reimbursement in the treatment of eosinophilic oesophagitis (EoE) in adults, only in patients not responding to PPIs.

Unfavourable opinion for reimbursement in patients responding to PPIs.

What therapeutic improvement ?

Therapeutic improvement in the treatment of adult patients with eosinophilic oesophagitis (EoE), only in patients not responding to PPIs.

Role in the care pathway ?

The management of patients may be medicinal and/or dietary. No medicinal product currently has an MA in EoE. When a medicinal treatment is proposed, the drugs recommended and used off-label are PPIs and topical corticosteroids as a spray or viscous solution to be swallowed (primarily fluticasone and budesonide). These treatments have a suspensive effect only, with the condition systematically recurring when they are stopped. Only an avoidance/reintroduction protocol for foods potentially implicated, which is complex and difficult to implement, may represent a long-term curative treatment.

Role of the medicinal product in the care pathway

JORVEZA (budesonide orodispersible tablets) is a second-line treatment that should be reserved for adult patients not having responded to PPIs used off-label, the only population for which its efficacy and safety have been documented versus placebo. In fact, JORVEZA (budesonide) has been assessed in studies that exclusively included patients in whom a clinical and histological response to PPIs had been excluded following treatment for at least 4 weeks with a dose that had to be at least the standard dose in accordance with the SPC.

JORVEZA (budesonide) is currently the only medicinal product and, in particular, the only corticosteroid, to have an MA in France in the treatment of EoE and it is consequently the corticosteroid of choice in this indication.

The role of JORVEZA (budesonide) compared to the medicinal products currently prescribed off-label - PPIs and swallowed corticosteroid sprays - cannot be defined in the absence of direct comparative data. In comparison with the other corticosteroids used off-label, JORVEZA (budesonide) presents the advantage of having a more appropriate delivery form.

To date, only comparative data versus placebo after 48 weeks are available, a duration that is too short in this chronic disease that generally progresses slowly over several years. Consequently, the benefit of maintaining JORVEZA (budesonide) as long-term treatment to prevent progression to oesophageal fibrosis or stenosis has not been demonstrated. Furthermore, there are uncertainties with respect to the benefit of this type of maintenance treatment taken continuously compared to intermittent treatment. A study that aims to document this aspect is ongoing.