1.2 This recommendation is not intended to affect treatment with budesonide ODT that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.
Why the committee made these recommendations
Although budesonide ODT has a marketing authorisation for both inducing and maintaining remission in eosinophilic oesophagitis, at the time this appraisal started it was only licensed for induction. So, the company's evidence is for inducing remission only (with treatment of up to 12 weeks) and the committee is unable to make recommendations for maintenance treatment.
There is currently no standard care for inducing remission in eosinophilic oesophagitis. Fluticasone is one treatment option, but it is an asthma treatment that is not easy to use for eosinophilic oesophagitis. Dietary changes are also an option, for example the 6‑food elimination diet, which involves cutting out the known allergens milk, eggs, nuts, wheat, soy and seafood from your diet. These treatments can be difficult to access and adhere to. And people often have no treatment at all, so there is an unmet need for this condition.
Clinical trial evidence shows that budesonide ODT improves the signs and symptoms of eosinophilic oesophagitis compared with placebo. There is no direct evidence for budesonide ODT compared with fluticasone or the 6‑food elimination diet and the results of an indirect comparison with these treatments are very uncertain.
The cost-effectiveness estimates vary and are also very uncertain. However, the most likely estimates are within what NICE considers a cost-effective use of NHS resources. Therefore, it is recommended for inducing remission in eosinophilic oesophagitis in adults.