NICE has recommended finerenone (Kerendia, Bayer) in final draft guidance as a treatment option for adults with symptomatic chronic heart failure with preserved or mildly reduced ejection fraction.
The nonsteroidal mineralocorticoid receptor antagonist (MRA) is only the second disease-modifying treatment recommended for this form of heart failure, after SGLT2 inhibitors.
New Option for a Common Form of Heart Failure
An estimated 635,000 people in England have chronic heart failure. Of these, roughly half have preserved or mildly reduced ejection fraction (left ventricular ejection fraction ≥ 41%). Symptoms include breathlessness, fatigue, and ankle swelling, and the condition often coexists with chronic kidney disease, diabetes, and other cardiovascular conditions.
Heart failure accounted for about 100,000 hospital admissions in England in 2023-2024, with an average stay of about 10 days, making it a leading cause of avoidable hospitalisation. Current treatment for heart failure with preserved ejection fraction may include dapagliflozin or empagliflozin, spironolactone, and diuretics. For mildly reduced ejection fraction, an angiotensin-converting enzyme inhibitor or angiotensin II receptor blocker plus a beta-blocker may also be used.
Helen Knight, director of medicines evaluation at NICE, said: “Heart failure can have a profound effect on people's daily lives, often leading to repeated hospital admissions and a reduced quality of life.” She added that the final draft guidance means there is “a further effective treatment available on the NHS for people with this type of heart failure” and said finerenone could help patients “live well for longer” while reducing their risk of needing unplanned emergency treatment.
Why Finerenone Matters
As a nonsteroidal MRA, finerenone may offer advantages over steroidal options such as spironolactone. Clinical experts consulted during the NICE appraisal noted a lower risk for antiandrogenic side effects and a more tolerable profile for older, frail patients with multiple comorbidities. The drug may also be more suitable for those with hypotension or chronic kidney disease, for whom steroidal MRAs may be unsuitable or poorly tolerated.
Finerenone is available as 10-mg and 20-mg tablets. The starting dose is based on baseline estimated glomerular filtration rate, as specified in the Summary of Product Characteristics.
Fewer Worsening Heart Failure Events
The recommendation is based on the phase 3 FINEARTS-HF trial, which included 6001 adults aged 40 years or older with chronic heart failure and a left ventricular ejection fraction of 40% or higher. Participants received finerenone plus standard care (n = 3003) or placebo plus standard care (n = 2998).
Finerenone significantly reduced the risk for the primary composite endpoint of total worsening heart failure events and cardiovascular death compared with placebo (rate ratio, 0.84; P = .007). The benefit was driven primarily by a reduction in worsening heart failure events (rate ratio, 0.82; 95% CI, 0.71-0.94), while cardiovascular mortality did not significantly differ between the treatment groups (hazard ratio, 0.93; 95% CI, 0.78-1.11). All-cause mortality also numerically favoured finerenone, but the difference was not significant (hazard ratio, 0.93; 95% CI, 0.83-1.06).
NICE noted that finerenone has not been directly compared with spironolactone in this population, and indirect evidence comparing the two remains uncertain.
NHS Implementation and Cost
The list price of finerenone is £36.68 per 28-tablet pack (excluding VAT).
NHS commissioners in England must make the treatment available within 90 days of final publication. Clinicians can initiate treatment immediately for eligible patients when clinically appropriate.
NICE estimates that up to 280,000 people in England could be eligible for treatment. Final guidance is expected in August 2026.
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