NICE recommends finerenone (Kerendia) for adults with chronic heart failure and LVEF ≥40%, supported by Phase 3 FINEARTS-HF trial results.
Written By: Amit Kumar Bharti, BPharm
Reviewed By: Pharmacally Editorial Team
The National Institute for Health and Care Excellence (NICE) has published final draft technology appraisal guidance recommending finerenone (Kerendia) as a treatment option for adults with symptomatic chronic heart failure and a left ventricular ejection fraction (LVEF) of 40% or greater.
If finalized, the guidance will expand NHS treatment options for people with heart failure with preserved or mildly reduced ejection fraction (HFpEF/HFmrEF), a population that has historically had relatively few evidence-based disease-modifying therapies.
Addressing an Unmet Need in Heart Failure
HFpEF and HFmrEF occur when the heart contracts normally but do not relax and fill efficiently during the diastolic phase, reducing its ability to supply enough blood to meet the body’s needs. Patients commonly experience breathlessness, fatigue, and ankle swelling, often resulting in repeated hospital admissions and reduced quality of life. Many also have chronic kidney disease, diabetes, or hypertension, making treatment more challenging.
Commenting on the recommendation, 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. Not only does finerenone have the potential to help them live well for longer, but it could also save the NHS money and free up space by reducing their risk of having to go to hospital for unplanned emergency treatment.”
Dr. Carol Whelan, Consultant Cardiologist and Heart Failure Lead at the Royal Free Hospital in London, also welcomed the recommendation, describing patients with HFpEF and HFmrEF as a historically underserved population that could benefit from an additional evidence-based treatment option.
Phase 3 FINEARTS-HF Trial
NICE’s recommendation is supported by results from the pivotal Phase 3 FINEARTS-HF trial (NCT04435626), a randomized, double-blind, placebo-controlled study involving 6,001 adults with symptomatic heart failure and an LVEF of 40% or greater.
Compared with placebo, finerenone reduced the relative risk of the primary composite endpoint of cardiovascular death and total (first and recurrent) worsening heart failure events by 16% over a median follow-up of 32 months. The benefit was primarily driven by an 18% reduction in worsening heart failure events, including unplanned hospitalizations and urgent heart failure visits. Clinical benefits were consistent across prespecified patient subgroups.
Finerenone is a non-steroidal mineralocorticoid receptor antagonist (MRA) with greater receptor selectivity than traditional steroidal MRAs. Although its pharmacological profile may improve tolerability for some patients, routine monitoring of serum potassium and renal function remains essential during treatment.
NHS Impact and Next Steps
According to NICE, around 635,000 people in England are living with heart failure, with approximately half having preserved or mildly reduced ejection fraction. Up to 280,000 patients could become eligible for finerenone if the guidance is finalized.
Treatment is expected to be initiated under specialist supervision, with ongoing prescribing and biochemical monitoring potentially delivered through shared-care arrangements between specialist and primary care services where local NHS pathways are in place.
The safety profile observed in FINEARTS-HF was consistent with previous finerenone studies, with hyperkalemia occurring more frequently than with placebo, reinforcing the need for regular monitoring.
NICE expects to publish its final technology appraisal guidance in August 2026. Once finalized, eligible NHS organizations will be required to make finerenone available in accordance with NICE funding and implementation requirements, providing an additional evidence-based treatment option for adults with symptomatic chronic heart failure and an LVEF of 40% or greater.
References
About the Writer
Amit Kumar Bharti (LinkedIn) is a pharmacy graduate from DPSRU, Delhi and healthcare writer with a strong interest in pharmaceutical research, medical writing, and evidence-based healthcare communication. He is passionate about translating complex scientific and medical information into clear, accurate, and engaging content for healthcare professionals and the pharmaceutical industry. His focus includes emerging therapies, clinical research, and recent advances in medicine.