NICE accepted an eGFR-slope-to-ESRD-delay model as the value case behind budesonide's TA937 and sparsentan's TA1074, not the proteinuria reduction each trial headlined, and the mandatory ACEi/ARB and SGLT2 inhibitor gate narrows the UK's 10,000 to 15,000 IgAN patients to a 3,000 to 5,000 eligible pool worth up to £140 to 180M a year to the NHS.
NICE has already set the IgA nephropathy value template twice, and the pattern is consistent enough to build against. Targeted-release budesonide (Tarpeyo in the US, Kinpeygo in Europe; Calliditas/AstraZeneca) cleared Technology Appraisal TA937 in December 2023, with TA1128 expanding eligibility in February 2026 to a urine protein-to-creatinine ratio of 90 mg/mmol or protein excretion of 1.0 g/day. Sparsentan (Filspari, Travere/CSL Vifor) followed under TA1074 in May 2025 after MHRA marketing authorisation in April 2025. In both appraisals the cost-effectiveness case NICE accepted turned on eGFR slope translating into a delay to end-stage renal disease, not on the proteinuria reduction that reads as each drug's headline efficacy result. Budesonide's NefIgArd data showed a 31% urine protein-to-creatinine ratio reduction and a 3.87 mL/min/year eGFR-slope benefit; it was the eGFR figure, converted into a modelled 5 to 8 year ESRD delay at a median GFR of 60 mL/min at diagnosis, that carried the economic argument. A new entrant that leads its submission with proteinuria is building on the wrong surrogate.
The population that pricing math applies to is defined before any drug is scored. NICE's guidance requires ACEi/ARB optimisation for at least three months, alongside the SGLT2 inhibitor backbone NICE established for chronic kidney disease under dapagliflozin's TA775 (updated by TA1075), with a target proteinuria below 0.5 g/g and blood pressure below 130/80 mmHg, per Renal Association and KDIGO 2021 guidance. That optimised-supportive-care gate is what narrows the 10,000 to 15,000 UK IgAN pool to the 3,000 to 5,000 patients with persistent proteinuria who remain novel-agent-eligible. At a WAC of £35,000 to 45,000 a year across that population, potential NHS annual spend reaches £140 to 180 million, a budget-impact scale that carried a Patient Access Scheme understood at 20 to 35% off WAC on both agents regardless of clinical case. Our model treats the surrogate-acceptance question and the supportive-care-gate population as the two constraints a new submission must clear before the economic model is even run.
UK IgA nephropathy NICE precedent — both value cases won on eGFR slope, not proteinuria, behind the same optimised-supportive-care gate
| Agent (Brand / INN) | NICE Appraisal | Accepted Value Surrogate | Eligibility Gate | Reusable Precedent for New Entrant |
|---|---|---|---|---|
| Tarpeyo / Kinpeygo (targeted-release budesonide) | TA937 (Dec 2023), eligibility expanded by TA1128 (Feb 2026) | eGFR-slope-to-ESRD-delay model (3.87 mL/min/yr benefit), not the 31% UPCR reduction | ACEi/ARB optimised; UPCR at or above 90 mg/mmol under TA1128 | Sets the eGFR-slope surrogate NICE will price on and the 20 to 35% PAS band off WAC |
| Filspari (sparsentan) | TA1074, NICE-recommended May 2025 (MHRA approval Apr 2025) | Same eGFR-slope ESRD-delay envelope; PROTECT eGFR decline of 2.0 vs 4.7 mL/min/yr on placebo | Same ACEi/ARB optimisation gate; UPCR at or above 0.75 g/g | Confirms the surrogate is repeatable; parity pricing on superior proteinuria reduction |
| Dapagliflozin (SGLT2 inhibitor) | TA775 (Mar 2022), updated by TA1075, for chronic kidney disease | Supportive-care backbone, not a novel-agent value case | Part of the optimisation gate required before novel-agent eligibility | Defines the optimised-supportive-care comparator floor a new IgAN agent must beat |
Sources: NICE TA937 (targeted-release budesonide, Dec 2023), updated by TA1128 (Feb 2026); NICE TA1074 (sparsentan, May 2025); NICE TA775 (dapagliflozin for CKD, Mar 2022), updated by TA1075; NefIgArd trial eGFR and UPCR data; PROTECT trial 2-year confirmatory data, 2024; NHS renal replacement therapy tariff, 2023–24; Renal Association IgA Nephropathy guideline, 2023; KDIGO 2021 guideline; UK Renal Registry IgAN patient flow, 2023.
What this model answers
Every section answers a named commercial question your team is asking, scoped to your asset.
Delivers
- How TA937 and TA1074 both converted eGFR slope, not urine protein-to-creatinine ratio, into the modelled ESRD delay that carried the value case
- Why a proteinuria-led submission is building on a surrogate NICE has twice declined to price on directly
- The surrogate-endpoint defence a new eGFR-slope or proteinuria dataset needs before the economic model is run
Delivers
- The three-month ACEi/ARB optimisation and SGLT2 inhibitor backbone (dapagliflozin TA775, updated by TA1075) NICE requires before novel-agent eligibility
- How the persistent-proteinuria threshold above 0.5 to 1.0 g/g defines the addressable pool the £140 to 180M budget-impact ceiling is built on
- Where the optimised-supportive-care comparator sets the cost-effectiveness floor a new agent must beat
Delivers
- The 20 to 35% PAS discount band off a £35,000 to 45,000 WAC that cleared budesonide's £20,000 to 30,000 per QALY threshold
- Why IgAN's prevalence disqualifies it from the ultra-rare Highly Specialised Technology track and forces the harder standard TA threshold
- The devolved-nation sequencing across NICE, the SMC, and the AWMSG once an English precedent is set
Custom model delivered in 72 hours.
Commission This ModelWhat's inside
- Why the surrogate NICE will price on, eGFR slope rather than proteinuria, is the first thing a new IgAN submission must solve
- Pressure-tested against the TA937 and TA1074 value cases before the rest of the model is built out
- NICE's standard Technology Appraisal route and why IgAN's prevalence keeps it off the ultra-rare Highly Specialised Technology track
- TA937 and TA1128 (budesonide) and TA1074 (sparsentan) precedent, and the SMC and AWMSG devolved positions that follow the English decision
- Population defined by the mandatory ACEi/ARB and SGLT2 inhibitor optimisation gate, narrowing 10,000 to 15,000 patients to 3,000 to 5,000
- Comparator set as optimised supportive care, and outcomes anchored on eGFR slope converted to ESRD delay
- The 3-test defence framework applied to an eGFR-slope value case versus a proteinuria-led one
- Why NICE accepted the eGFR-to-ESRD-delay conversion for both prior agents and how a new dataset must map to it
- 5-module, 15-check self-assessment against submission readiness
- Testing the dossier against the eGFR-slope surrogate, the utility values, and the ESRD-delay model structure NICE accepted
- Surrogate-acceptance risk, supportive-care-gate population risk, and durability-beyond-confirmatory-window risk scored separately by likelihood and impact
- Submission-blocking versus manageable classification for each gap
- The ESRD-delay model, the £37,000 a year dialysis-cost offset, and the PAS discount mechanics behind the £20,000 to 30,000 per QALY threshold
- Milestone timeline incorporating the ACEi/ARB and SGLT2 inhibitor optimisation window and the £140 to 180M budget-impact ceiling
- The open HEOR and surrogate-endpoint questions your team must close before the dossier is finalised
Included with every brief
How AXLRx builds this model
Prepared by MoatRx analysts.
Every AXLRx HTA strategy model is built from primary HTA-body sources: NICE technology appraisals and final guidance documents, not secondary summaries. Every surrogate-endpoint and comparator claim is pressure-tested through the 3-test defence framework before being accepted.
UK IgA nephropathy HTA sources: NICE TA937 (targeted-release budesonide, December 2023), updated by TA1128 (February 2026); NICE TA1074 (sparsentan, May 2025); NICE TA775 (dapagliflozin for chronic kidney disease, March 2022), updated by TA1075; NefIgArd and PROTECT trial results; the Renal Association IgA Nephropathy guideline 2023 and KDIGO 2021 defining the optimised-supportive-care gate; NHS renal replacement therapy tariff 2023 to 24; and the UK Renal Registry IgAN patient flow, 2023.
- NICE TA937 (budesonide, December 2023) and its expansion under TA1128 (February 2026) verified live against nice.org.uk guidance pages this session
- NICE TA1074 (sparsentan) recommendation, May 2025, verified live against nice.org.uk and the marketing-authorisation announcement this session
- NICE TA775 (dapagliflozin for CKD, March 2022) and its update TA1075 verified live against nice.org.uk as the SGLT2 inhibitor supportive-care backbone this session
- The eGFR-slope-to-ESRD-delay basis of both accepted value cases verified against the NICE IgAN economic model framework and NHS RRT tariff, 2023 to 24
- The ACEi/ARB and SGLT2 inhibitor optimisation gate and the 10,000 to 15,000 down to 3,000 to 5,000 eligible-population narrowing verified against the Renal Association 2023 guideline, KDIGO 2021, and the UK Renal Registry IgAN patient flow, 2023
Frequently asked questions
Commission this model
AXLRx delivers nephrology HTA strategy models built for market access and HEOR teams navigating NICE's IgA nephropathy value precedent and its optimised-supportive-care gate. Custom model in 72 hours.
Specify your indication, HTA bodies, and comparator scope.
AXLRx analyst confirms the surrogate-endpoint case, comparator set, and eligibility-gate scope before building.
Research-verified HTA strategy model in 72 hours with optional analyst readout.