NICE Backs Finerenone for HFpEF and HFmrEF

NICE has backed finerenone as a new treatment option for adults with symptomatic chronic heart failure and preserved or mildly reduced ejection fraction. The recommendation expands the limited range of disease-modifying therapies available for this common form of heart failure, although its main demonstrated benefit is reducing worsening heart failure events rather than mortality.

A New Disease-Modifying Treatment Option

The National Institute for Health and Care Excellence (NICE) has recommended finerenone, marketed as Kerendia by Bayer, as a treatment option for adults with symptomatic chronic heart failure with preserved or mildly reduced ejection fraction.

The recommendation, issued in final draft guidance, applies to patients with a left ventricular ejection fraction of at least 41%. Finerenone would become only the second disease-modifying treatment recommended by NICE for this heart failure population, following sodium–glucose cotransporter-2 inhibitors such as dapagliflozin and empagliflozin.

Chronic heart failure affects an estimated 635,000 people in England, and approximately half have preserved or mildly reduced ejection fraction. Common symptoms include breathlessness, fatigue, reduced exercise tolerance, and ankle swelling. Many patients also have chronic kidney disease, diabetes, hypertension, or other cardiovascular conditions.

Evidence from FINEARTS-HF

The recommendation is primarily supported by results from the phase 3 FINEARTS-HF trial. The study included 6,001 adults aged 40 years or older with symptomatic chronic heart failure and a left ventricular ejection fraction of at least 40%.

Participants received either finerenone plus standard care or placebo plus standard care. Finerenone reduced the rate of the primary composite endpoint of total worsening heart failure events and cardiovascular death by 16% compared with placebo.

The treatment effect was mainly driven by fewer worsening heart failure events, including hospital admissions and urgent visits requiring intravenous therapy. Finerenone reduced these events by approximately 18%.

However, cardiovascular mortality did not differ significantly between the finerenone and placebo groups. All-cause mortality was also numerically lower with finerenone, but the difference was not statistically significant.

Comparison with Spironolactone

Finerenone is a selective, nonsteroidal mineralocorticoid receptor antagonist. Unlike steroidal MRAs such as spironolactone, it has a lower potential for antiandrogenic adverse effects, including gynaecomastia and sexual dysfunction.

Clinical experts consulted by NICE suggested that finerenone may be a useful option for older or frail patients and for those with multiple comorbidities who cannot tolerate steroidal MRAs. It may also be considered in selected patients with chronic kidney disease or lower blood pressure.

Nevertheless, NICE highlighted that finerenone has not been directly compared with spironolactone in patients with HFpEF or HFmrEF. Evidence from indirect comparisons remains uncertain, so the two treatments should not be considered clinically interchangeable based on current data.

Safety and Clinical Use

Finerenone is available as 10-mg and 20-mg tablets. The starting dose is determined by baseline estimated glomerular filtration rate.

As with other mineralocorticoid receptor antagonists, finerenone can increase serum potassium. Kidney function and potassium levels should therefore be assessed before treatment and monitored regularly, particularly in patients with chronic kidney disease or those receiving other medicines that increase potassium.

Potential NHS Impact

NICE estimates that up to 280,000 people in England could be eligible for finerenone. The list price is £36.68 per 28-tablet pack, excluding VAT.

Once the final guidance is published, NHS commissioners in England will be required to make finerenone available within 90 days. Final NICE guidance is expected in August 2026.

 Source

Medscape