1 Recommendations
1.1
Targeted-release budesonide is recommended as an option for treating primary immunoglobulin A nephropathy (IgAN) when there is a risk of rapid disease progression in adults with a urine protein-to-creatinine ratio of 1.5 g/g or more. Targeted-release budesonide is recommended only if:
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it is an add-on to optimised standard care including the highest tolerated licensed dose of angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARBs), unless these are contraindicated
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the company provides it according to the commercial arrangement.
1.2
This recommendation is not intended to affect treatment with targeted-release budesonide 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
Standard care for IgAN includes lifestyle and dietary changes, and ACE inhibitors or ARBs. Targeted-release budesonide would be used as an add-on to optimised standard care with ACE inhibitors or ARBs.
Clinical trial evidence suggests that targeted-release budesonide plus standard care is more effective than standard care alone. Also, it is the first licensed treatment that specifically treats the condition, increasing the likelihood that people may avoid or delay the need for dialysis or a kidney transplant.
The most likely cost-effectiveness estimate for targeted-release budesonide is within the range that NICE considers an acceptable use of NHS resources. So it is recommended.