IgA nephropathy drives 10-12% of incident UK end-stage renal disease, a burden NICE built into its budesonide and sparsentan case.

IgA nephropathy is an immune-mediated glomerulonephritis caused by mesangial deposition of galactose-deficient IgA1, driving progressive proteinuria and declining eGFR. The UK Renal Registry identifies IgAN as the UK's second most common primary glomerulonephritis after membranous nephropathy, with an estimated 10,000-15,000 UK patients and approximately 500 new diagnoses a year confirmed via kidney biopsy. IgAN accounts for 10-12% of incident UK end-stage renal disease, roughly 1,000-1,200 UK ESRD cases annually. A network of approximately 80 NHS specialist nephrology centres performs the confirmatory biopsies, giving the UK a comparatively high diagnosis rate.

The Renal Association's IgAN guideline, aligned with KDIGO 2021, directs optimal ACEi/ARB therapy for three to six months before considering novel agents, targeting blood pressure below 130/80mmHg and a UPCR below 0.5g/g. Corticosteroid immunosuppression remains controversial following the STOP-IgAN trial's null result in high-risk patients, with SGLT2 inhibition now being explored. Both novel agents have since cleared NICE technology appraisal: targeted-release budesonide under TA937, updated by TA1128 in 2026, and sparsentan under TA1074 in June 2025, following MHRA approval of sparsentan in April 2025, moving IgAN novel-agent access from a Named Patient Programme into mainstream NHS commissioning.

Two novel agents cleared NICE; the eligible population sits behind ACEi/ARB failure first.

Five questions this report answers:

Q1 - What is the size of the UK IgAN population eligible for novel agents after ACEi/ARB fails?

Q2 - What is the NHS economic case for novel IgAN agents built on ESRD cost offset?

Q3 - How do the budesonide (TA937/TA1128) and sparsentan (TA1074) NICE recommendations compare on funding?

Q4 - How many NHS nephrology centres perform the biopsies that confirm an IgAN diagnosis?

Q5 - Why did the STOP-IgAN trial leave corticosteroid use controversial in high-risk patients?

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Mike || Global Pharma Commercial Marketing Head

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