NICE accepted a 5–8 year modelled ESRD delay as the cost-effectiveness case behind budesonide's TA937, and applies the same ACEi/ARB gate to sparsentan, narrowing the UK's 10,000–15,000 IgA nephropathy patients to a 3,000–5,000 novel-agent-eligible pool worth up to £140–180M a year to the NHS.
Budesonide (Tarpeyo, Calliditas/AstraZeneca) is NICE-recommended and NHS-funded under TA937, with eligibility subsequently expanded by TA1128 (February 2026). Its NefIgArd trial data showed a 31% reduction in urine protein-to-creatinine ratio and a 3.87 mL/min/year eGFR-slope benefit; the economic case NICE accepted turns on that eGFR benefit translating into a meaningful delay to end-stage renal disease — at a median GFR of 60 mL/min/year at diagnosis, the modelled ESRD delay is 5–8 years. NHS renal replacement therapy costs an estimated £37,000 a year in dialysis, so a 5–8 year delay implies £185,000–£296,000 in NHS savings per patient against a drug cost of £175,000–£360,000 over the same period at a WAC of £35,000–£45,000 a year, a case NICE judged close to breakeven and cleared with a Patient Access Scheme discount understood to be in the 20–35% range off WAC against its standard £20,000–£30,000/QALY threshold.
Before either novel agent could qualify for funding, NICE's guidance requires patients to have completed ACEi/ARB optimisation for at least three months, with a target proteinuria below 0.5 g/g and blood pressure below 130/80mmHg, per Renal Association and KDIGO guidelines — a standard-of-care gate that an estimated 70% of the 10,000–15,000 UK IgAN patient pool partially clears, leaving 3,000–5,000 patients with persistent proteinuria above 0.5–1.0 g/g as the addressable novel-agent population. At £35,000–£45,000 a year across that population, potential NHS annual spend reaches £140–180 million, a budget-impact scale that carries a Patient Access Scheme or Commercial Access Agreement on both agents regardless of clinical case. Sparsentan (Filspari, Travere) received MHRA marketing authorisation in April 2025 and NICE's final recommendation in May 2025; its PROTECT trial confirmatory data showed a smaller eGFR decline (−2.0 mL/min/year vs −4.7 for placebo) and superior proteinuria reduction (−49.8% vs budesonide's −31%), a competitive position it now holds as an NHS-available alternative within the same cost-effectiveness envelope as budesonide.
UK IgA nephropathy agent NICE and NHS status
| Drug (Brand / INN) | NICE HTA Route | NICE Recommendation & PAS | NHS Access Channel | Cost-Effectiveness Position | Key Payer Risk |
|---|---|---|---|---|---|
| Tarpeyo (budesonide, targeted) | Standard Technology Appraisal — TA937, updated by TA1128 (Feb 2026) | NICE-recommended with PAS; TA1128 expanded eligibility | NHS-funded; routine commissioning | ESRD-delay model accepted near breakeven with ~20–35% PAS off WAC to clear £20K–£30K/QALY | Long-term durability beyond NefIgArd's confirmatory window still maturing |
| Filspari (sparsentan) | NICE appraisal concluded May 2025 | MHRA-approved (Apr 2025); NICE-recommended (May 2025) | NHS-funded; routine commissioning | Superior proteinuria reduction (−49.8% vs −31%) — priced within budesonide's cost-effectiveness envelope | Eligibility runs behind the same ACEi/ARB SoC gate as budesonide |
Sources: NICE IgAN economic model framework (GID appraisal documentation); NHS renal replacement therapy tariff, 2023–24; NefIgArd trial eGFR and UPCR data; Renal Association IgA Nephropathy guideline, 2023; NICE TA937 (budesonide), since updated by TA1128, Feb 2026; NICE final guidance on sparsentan, May 2025; NICE TA775 (dapagliflozin for CKD), since updated by TA1075; KDIGO 2021 guideline; PROTECT trial 2-year confirmatory data, 2024; UK Renal Registry IgAN patient flow model, 2023.
What this assessment answers
Every section answers a named commercial question your team is asking, scoped to your asset.
Delivers
- ESRD-delay modelling breakdown (eGFR slope, dialysis cost offset, breakeven analysis) as accepted by NICE
- PAS discount terms (understood at 20–35% off WAC) that cleared the standard TA threshold
- how TA1128's February 2026 eligibility expansion changes the addressable population
Delivers
- Renal Association/KDIGO SoC pathway analysis
- eligible-population sizing (10,000–15,000 total UK IgAN patients narrowing to 3,000–5,000 post-optimisation)
- NHS budget-impact modelling for the now-settled eligible population
Delivers
- Head-to-head evidence comparison (proteinuria reduction, eGFR preservation)
- sparsentan's NICE recommendation terms relative to budesonide's TA937/TA1128 precedent
- competitive pricing position within the NHS cost-effectiveness envelope
Custom assessment delivered in 72 hours.
Commission This AssessmentWhat's inside
- How budesonide (Tarpeyo) secured NICE recommendation and NHS funding under TA937, with eligibility since expanded by TA1128 in February 2026
- Why sparsentan (Filspari) moved from MHRA approval (April 2025) to NICE recommendation (May 2025) within the same cost-effectiveness envelope
- How NefIgArd's 3.87 mL/min/year eGFR-slope benefit was modelled into a 5-8 year delay to end-stage renal disease, the basis of NICE's accepted case
- Why NHS dialysis savings of £185,000-296,000 per patient against a £175,000-360,000 drug cost left the case near breakeven, requiring a 20-35% PAS discount
- The mandatory three-month ACEi/ARB optimisation gate, per Renal Association and KDIGO guidelines, before either novel agent qualifies for NHS funding
- How this standard-of-care gate narrows the UK's 10,000-15,000 IgAN patient pool to 3,000-5,000 addressable novel-agent patients
- PROTECT's superior proteinuria reduction (-49.8% vs budesonide's -31%) and smaller eGFR decline (-2.0 mL/min/year vs -4.7 for placebo)
- How sparsentan now competes as an NHS-available alternative within the same cost-effectiveness envelope as budesonide
- Why potential NHS annual spend of £140-180 million across the fully ACEi/ARB-optimised eligible population triggers PAS or Commercial Access Agreement scrutiny
- How this budget-impact scale shapes payer risk on both agents regardless of the underlying clinical case
- How Scotland's SMC and Wales's AWMSG assess budesonide and sparsentan against NICE's now-established English precedent for both agents
- What a devolved-nation divergence from NICE's TA937/TA1128 and sparsentan recommendations would mean for UK-wide access planning
Included with every brief
How AXLRx builds this assessment
Prepared by MoatRx analysts.
This assessment is built from NICE's IgAN economic modelling framework, NHS renal replacement therapy tariff data, published NefIgArd and PROTECT trial results, and Renal Association/KDIGO guideline documentation defining the standard-of-care gate.
Key sources: NICE IgAN economic model framework (GID appraisal documentation); NHS RRT tariff, 2023–24; NefIgArd trial eGFR and UPCR data; Renal Association IgA Nephropathy guideline, 2023; NICE TA937 (budesonide), since updated by TA1128, Feb 2026; NICE final guidance on sparsentan, May 2025; NICE TA775 (dapagliflozin for CKD), since updated by TA1075; KDIGO 2021 guideline; PROTECT trial 2-year confirmatory data, 2024; UK Renal Registry IgAN patient flow model, 2023; NICE budget impact methodology. Devolved-nation positions (Scotland's SMC, Wales's AWMSG) are assessed against NICE's now-established English precedent for both agents.
- NICE ESRD-delay cost-effectiveness modelling verified against the NICE IgAN economic model framework and NHS RRT tariff, 2023–24
- NefIgArd trial eGFR-slope and UPCR data verified against published NefIgArd trial results
- ACEi/ARB and SGLT2i standard-of-care gate verified against the Renal Association IgA Nephropathy guideline, 2023, NICE TA775 (since updated by TA1075), and KDIGO 2021
- Eligible-population sizing verified against the UK Renal Registry IgAN patient flow model, 2023
- Sparsentan PROTECT trial data verified against published 2-year confirmatory trial results, 2024
- Budesonide's TA937/TA1128 status and sparsentan's MHRA approval (April 2025) and NICE recommendation (May 2025) verified against live NICE.org.uk and MHRA publications
Frequently asked questions
Commission this assessment
AXLRx IgA Nephropathy Payer & HTA is built for market access, HEOR, and pricing teams navigating NICE's accepted ESRD-delay cost-effectiveness case and the ACEi/ARB standard-of-care gate in the UK IgAN market. Custom assessment in 72 hours.
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