Budesonide and sparsentan must clear NICE's standard £20,000-30,000/QALY bar, since IgA Nephropathy is too common for the ultra-rare HST track.

An estimated 10,000-15,000 UK IgA Nephropathy patients are managed within a well-established NHS renal biopsy network of roughly 80 specialist nephrology centres; the UK Renal Registry tracks approximately 8,000 diagnosed cases. Kidney biopsy is required for diagnosis under Renal Association guidelines, and ACE inhibitor/ARB optimisation to target blood pressure below 130/80 and UPCR below 0.5g/g is NHS standard of care before novel agent consideration, a structural 3-6 month delay gate ahead of eligibility for either novel therapy.

Both budesonide (Tarpeyo, Calliditas/AstraZeneca) and sparsentan (Filspari, Travere) are accessed via Named Patient Programme at UK nephrology centres while their NICE technology appraisals progress. Because IgA Nephropathy prevalence is too high for the ultra-rare NICE Highly Specialised Technology track, both will be appraised under the standard TA process at the standard £20,000-30,000/QALY threshold, a materially harder bar than the £100,000-300,000/QALY threshold used for genuinely ultra-rare conditions. Both manufacturers will need to model end-stage renal disease cost offsets (dialysis at roughly £37,000/year; transplant at £22,000-40,000 in year one) convincingly to clear NICE's cost-effectiveness requirement.

Both drugs must model dialysis-cost offsets to clear a materially harder QALY bar.

Five questions this report answers:

Q1 - What NICE appraisal evidence would move budesonide or sparsentan from Named Patient access to NHS commissioning?

Q2 - How does the NHS ACEi/ARB optimisation requirement gate eligibility for novel IgA Nephropathy agents?

Q3 - Which of the ~80 UK nephrology centres are using budesonide or sparsentan ahead of NICE decisions?

Q4 - How do dialysis costs of roughly £37,000 a year factor into NICE's cost-offset modelling?

Q5 - Why does the mandatory ACEi/ARB optimisation period create a 3-6 month delay gate?

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Mike || Global Pharma Commercial Marketing Head

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