Targeted-release budesonide for treating primary IgA nephropathy

  • Technology appraisal guidance
  • TA1128
  • Published: 
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1 Recommendations

1.1

Targeted-release budesonide can be used as an option to treat primary immunoglobulin A nephropathy (IgAN) in adults when:

  • they have:

    • a urine protein-to-creatinine ratio (UPCR) of 90 mg/mmol or more or

    • a protein excretion of 1.0 g/day or more, and

  • it is used as an add-on to optimised standard care that includes, unless contraindicated:

    • the highest tolerated licensed dose of renin-angiotensin system inhibitors (RASi) or

    • a dual endothelin angiotensin-receptor antagonist (DEARA), and

  • 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 healthcare professional consider it appropriate to stop.

What this means in practice

Targeted-release budesonide must be funded in the NHS in England for the condition and population in the recommendations, if it is considered the most suitable treatment option. Targeted-release budesonide must be funded in England within 90 days of final publication of this guidance.

There is enough evidence to show that targeted-release budesonide provides benefits and value for money, so it can be used routinely across the NHS in this population.

NICE has produced tools and resources to support the implementation of this guidance.

Why these recommendations were made

This evaluation reviews the evidence for targeted-release budesonide for treating primary IgAN (NICE technology appraisal guidance 937). It considers use of targeted-release budesonide in a broader population than it was recommended for in that evaluation, including using a lower UPCR threshold.

Usual treatment for primary IgAN includes optimised standard care. This has changed since the previous evaluation and now includes RASi or DEARA, with or without a sodium-glucose cotransporter-2 inhibitor (SGLT2i). Targeted-release budesonide is used as an add-on to optimised standard care.

Clinical trial evidence shows that targeted-release budesonide plus optimised standard care increases how long people have before their condition gets worse compared with optimised standard care alone.

There are uncertainties in the economic model. This is because standard care in the trial did not include DEARA or SGLT2i treatments, which are currently used in the NHS.

But, the most likely cost-effectiveness estimates are below the range that NICE considers an acceptable use of NHS resources. So, targeted-release budesonide can be used.

For all the evidence, see the committee papers. For more information on streamlined evaluations, see NICE's manual on health technology evaluations.