Finerenone gets NICE backing for HFpEF and HFmrEF: what the final draft guidance means for primary care

Intended for UK healthcare professionals only.

NICE has backed finerenone as the second disease-modifying option for this group

NICE has published final draft guidance recommending finerenone as an option for treating symptomatic chronic heart failure with preserved or mildly reduced ejection fraction (HFpEF/HFmrEF) in adults, within its marketing authorisation for a left ventricular ejection fraction of 40% or above.

This is a significant moment for a patient group with few disease-modifying options. Finerenone is now the second type of disease-modifying treatment recommended for this form of heart failure, following SGLT2 inhibitors. NICE estimates that nearly 280,000 people in England may be eligible — approximately half of the 635,000 people with heart failure who have preserved or mildly reduced ejection fraction.

The benefit is fewer hospital admissions, not longer survival

The recommendation is based on the FINEARTS-HF trial: a phase 3 randomised controlled trial of 6,001 adults aged 40 and older with an ejection fraction of 40% or more. Participants received either finerenone or placebo alongside standard care. The key results were:²

• Primary composite endpoint (total worsening heart failure events and cardiovascular death): rate ratio 0.84 (95% CI 0.75–0.95, p=0.007) — a 16% relative reduction

• Total worsening heart failure events (hospitalisations and urgent visits): rate ratio 0.82 (95% CI 0.71–0.94)

• Cardiovascular death: hazard ratio 0.93 (95% CI 0.78–1.11) — not statistically significant

• All-cause mortality: hazard ratio 0.93 (95% CI 0.83–1.06) — not statistically significant

The committee noted that the treatment effect was driven primarily by a reduction in worsening heart failure events rather than by lower mortality. The benefit is therefore best understood as keeping patients out of hospital, rather than extending life.

The comparison with spironolactone remains unresolved

A common question during the appraisal was how finerenone compares to spironolactone — a steroidal mineralocorticoid receptor antagonist (MRA) already used, though inconsistently, in this patient group. There is no head-to-head trial. The company's indirect comparison and real-world evidence analyses were considered too uncertain to establish relative efficacy. However, neither analysis suggested that finerenone was less effective than spironolactone.

The committee used a basket comparator reflecting the mix of treatments finerenone would replace in practice — predominantly standard care, with a small proportion of spironolactone use. The cost-effectiveness estimate remained robust: the base-case incremental cost-effectiveness ratio (ICER) compared to standard care was £12,764 per QALY gained, well within NICE's acceptable threshold. The list price is £36.68 for a pack of 28 tablets.¹

Tolerability is what makes finerenone attractive in primary care

For primary care, the practical picture is shaped as much by tolerability as by efficacy. Clinical experts advising the committee noted that finerenone is generally better tolerated than spironolactone — an important consideration for older, frailer, and multimorbid patients, where steroidal MRA use has historically been low and frequently discontinued.

The key prescribing considerations for primary care are:

• Tolerability: lower risk of anti-androgenic effects such as gynaecomastia compared with spironolactone; hyperkalaemia risk judged by clinical experts to be broadly similar or slightly lower

• Monitoring: check serum potassium and renal function before starting and during treatment

• Dosing: follow the summary of product characteristics rather than assuming doses from trial titration protocols

• Guideline fit: finerenone sits within the 2025 update to NG106, which recommends an MRA for HFpEF/HFmrEF alongside an SGLT2 inhibitor³

• CKD overlap: finerenone is already recommended under TA877 for chronic kidney disease with type 2 diabetes — some patients will have overlapping indications⁴

This is final draft guidance, not the final word

One important caveat: this is final draft guidance, not yet published final guidance. NICE plans to publish the final technology appraisal in August 2026. Following publication, NHS commissioners in England will have 90 days to make finerenone routinely available. Until then, it remains a recommendation in waiting rather than a funded option — it is worth checking local formulary status before relying on it in a consultation.

References

1. National Institute for Health and Care Excellence. Finerenone for treating chronic heart failure with preserved or mildly reduced ejection fraction [ID6514]. Final draft guidance. July 2026. Available at: nice.org.uk/guidance/indevelopment/gid-ta11651

2. Solomon SD, McMurray JJV, Vaduganathan M, et al. Finerenone in heart failure with mildly reduced or preserved ejection fraction. N Engl J Med. 2024;391(16):1475–85. Available at: doi.org/10.1056/NEJMoa2407107

3. National Institute for Health and Care Excellence. Chronic heart failure in adults: diagnosis and management. NICE guideline [NG106]. 2025. Available at: nice.org.uk/guidance/ng106

4. National Institute for Health and Care Excellence. Finerenone for treating chronic kidney disease in type 2 diabetes. Technology appraisal guidance [TA877]. 2023. Available at: nice.org.uk/guidance/ta877