The National Institute for Health and Care Excellence (NICE) in the UK has issued its final draft guidance recommending Bayer’s innovative non-steroidal mineralocorticoid receptor antagonist (MRA), Kerendia (finerenone), for use within the National Health Service (NHS) in England. This pivotal decision paves the way for English patients suffering from chronic heart failure (CHF) with preserved or mildly reduced ejection fraction (HFpEF or HFmrEF) to access a novel treatment option. The agency anticipates publishing its final guidance in August 2026, at which point Kerendia will become available, marking a significant advancement in the management of a condition that remains one of the leading causes of avoidable hospitalisations across England.
This recommendation underscores a critical effort to address the substantial burden of heart failure, a complex and debilitating condition affecting hundreds of thousands of individuals in the UK. Heart failure with preserved ejection fraction (HFpEF) and mildly reduced ejection fraction (HFmrEF) have historically presented significant therapeutic challenges, with limited treatment options specifically proven to improve outcomes for these patient cohorts. Kerendia’s approval offers new hope, promising to enhance patient quality of life, reduce hospitalisation rates, and alleviate pressure on the NHS.
Understanding Chronic Heart Failure and the Unmet Need
Chronic heart failure is a progressive condition where the heart is unable to pump enough blood to meet the body’s needs. It affects approximately 635,000 people across England, with roughly half of these patients living with HFpEF or HFmrEF. In HFpEF, the heart muscle contracts normally, but the ventricles do not relax properly or are too stiff to fill with blood effectively between beats. HFmrEF represents an intermediate category, where ejection fraction is between 41-49%. These forms of heart failure are often associated with comorbidities such as hypertension, diabetes, obesity, and chronic kidney disease, making management particularly complex.
The societal and economic impact of heart failure is immense. Between 2023 and 2024, heart failure was linked to approximately 100,000 hospitalisations in England, highlighting its status as a major driver of unplanned emergency admissions. These hospitalisations not only impose a considerable financial strain on the NHS, estimated to be billions of pounds annually, but also significantly diminish patients’ quality of life, leading to frequent readmissions, functional limitations, and increased mortality. Patients often experience symptoms such as breathlessness, fatigue, and swelling, which severely impact their daily activities and overall well-being. The lack of specific, highly effective treatments for HFpEF/HFmrEF has long represented a significant unmet medical need, leaving clinicians with fewer tools to manage these challenging cases compared to heart failure with reduced ejection fraction (HFrEF).
Kerendia: A New Therapeutic Mechanism
Kerendia, with its active ingredient finerenone, is a non-steroidal, selective mineralocorticoid receptor antagonist (MRA). Its mechanism of action distinguishes it from older, steroidal MRAs like spironolactone and eplerenone. Finerenone works by blocking the overactivation of mineralocorticoid receptors, which are implicated in the pathogenesis of heart failure. This overactivation contributes to vascular inflammation, fibrosis (scarring) in the muscular layer of the heart wall, and sodium retention in the kidneys. By targeting these pathways, Kerendia effectively reduces myocardial scarring and inflammation, which are key drivers of heart failure progression, and lessens the burden on the heart by diminishing the retention of excess fluid.
A significant advantage of Kerendia’s non-steroidal nature and high selectivity is its improved safety profile. Traditional steroidal MRAs can interfere with sex hormone activity, leading to side effects such as gynecomastia (breast enlargement) in men and menstrual irregularities in women, which can impact patient adherence. Bayer designed finerenone to be more selective, resulting in a lower incidence of these sex hormone-related side effects. This differentiation potentially allows for broader applicability across a wider patient population. NICE estimates that around 280,000 people across England could be eligible for treatment with Kerendia, a testament to its potential reach and differentiated profile.
NICE’s Evaluation and Broader Implications
NICE’s recommendation follows a rigorous evaluation process, which assesses the clinical effectiveness and cost-effectiveness of new medicines for use within the NHS. The agency’s decision is based on comprehensive clinical trial data demonstrating Kerendia’s ability to reduce the risk of cardiovascular death and heart failure hospitalisations in patients with HFpEF and HFmrEF. While specific trial names were not provided in the initial brief, such a recommendation would typically be supported by large-scale, placebo-controlled studies, such as the FINEARTS-HF trial, which evaluated finerenone in patients with symptomatic HFpEF.
This is not Kerendia’s first foray into the NHS. In 2023, NICE previously recommended finerenone for use in adult patients with stage 3 or 4 chronic kidney disease (CKD) linked to type 2 diabetes, provided they exhibited a presence of the blood protein albumin in their urine. This earlier approval highlighted Kerendia’s dual benefits in cardiorenal protection, demonstrating its versatility and importance in managing complex comorbid conditions. Its expanded role to include heart failure with preserved or mildly reduced ejection fraction further solidifies its position as a critical therapeutic agent in chronic disease management.
Helen Knight, NICE’s director of medicines evaluation, articulated the dual benefits of this recommendation. She emphasised that Kerendia holds the potential to significantly improve the quality of life for patients struggling with chronic heart failure. Furthermore, she noted the substantial economic advantage for the NHS, stating that the drug offers the chance to "save the NHS money and free up space" by diminishing the risk of hospitalisation for unplanned emergency treatment. This highlights NICE’s commitment to not only clinical efficacy but also to the sustainable use of NHS resources.
The Evolving Landscape of Heart Failure Treatment in England
The arrival of Kerendia into the NHS treatment arsenal for HFpEF/HFmrEF joins an increasingly sophisticated array of medications. Prior to this, the primary treatment strategies for these patient groups often focused on symptom management and controlling comorbidities. In 2023, NICE also gave the green light to SGLT2 inhibitors like Boehringer Ingelheim and Eli Lilly’s Jardiance (empagliflozin) and AstraZeneca’s Forxiga (dapagliflozin) for CHF with preserved or mildly reduced ejection fraction. These drugs, originally developed for type 2 diabetes, have shown remarkable cardiovascular and renal benefits, revolutionising heart failure treatment.
The current "treatment arsenal" for heart failure now includes:
- SGLT2 Inhibitors: (e.g., empagliflozin, dapagliflozin) are foundational, reducing cardiovascular death and heart failure hospitalisations.
- Mineralocorticoid Receptor Antagonists (MRAs): (e.g., spironolactone, eplerenone, and now finerenone) target hormonal pathways involved in heart failure progression. Kerendia offers a non-steroidal, more selective option.
- Loop Diuretics: Used to manage fluid overload and alleviate symptoms like oedema and breathlessness.
- Angiotensin Receptor-Neprilysin Inhibitors (ARNIs) / ACE Inhibitors / Beta-blockers: Primarily used in heart failure with reduced ejection fraction (HFrEF) but may be considered for other forms based on specific patient profiles and comorbidities.
Kerendia’s addition means clinicians will have another powerful tool, especially for patients who may not tolerate steroidal MRAs or for whom additional cardiorenal protection is desired. This expanded choice allows for a more personalised approach to treatment, tailoring regimens to individual patient needs and risk factors. The move reflects a broader trend in cardiology towards multimodal therapy, where different drug classes are combined to target various pathophysiological pathways involved in heart failure, leading to more comprehensive and effective management.
Reactions from Stakeholders and Future Outlook
Bayer, the manufacturer of Kerendia, is expected to welcome NICE’s recommendation as a significant milestone. While specific statements from Bayer were not provided in the original text, it is standard practice for pharmaceutical companies to express their satisfaction and reiterate their commitment to improving patient outcomes. Such a recommendation validates years of research and development, underscoring the company’s role in bringing innovative treatments to market. It also represents a substantial commercial opportunity, given the large eligible patient population in England.
Patient advocacy organisations, such as the British Heart Foundation and other groups supporting individuals with chronic conditions, will undoubtedly laud this development. Improved access to effective treatments directly translates to better quality of life, reduced symptom burden, and a renewed sense of hope for patients and their families. This approval addresses a long-standing call from patient groups for more dedicated and effective treatments for HFpEF/HFmrEF.
Healthcare professionals, including cardiologists, nephrologists, and general practitioners, are likely to welcome Kerendia’s inclusion in the NHS formulary. The availability of a new, well-tolerated MRA that can be used across a broad spectrum of patients offers greater flexibility in managing complex cases, particularly those with comorbidities such as type 2 diabetes and chronic kidney disease. It allows for a more integrated approach to managing cardiorenal syndromes, which are increasingly recognised as interconnected conditions.
Chronology of Key Developments:
- 2023: Kerendia (finerenone) receives NICE approval for use in adult patients with stage 3 or 4 chronic kidney disease linked to type 2 diabetes, contingent on albuminuria. SGLT2 inhibitors (Jardiance, Forxiga) also gain NICE approval for chronic heart failure with preserved or mildly reduced ejection fraction.
- March 2026: The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and NICE launch an aligned pathway designed to expedite the medicines regulation process. This initiative aims to accelerate patient access to innovative treatments by streamlining regulatory and health technology assessment processes.
- Current (Implied date of article): NICE issues its final draft guidance recommending Kerendia for chronic heart failure with preserved or mildly reduced ejection fraction in England.
- August 2026: NICE is expected to publish its final guidance, leading to the official availability of Kerendia on the NHS for this new indication.
The recommendation of Kerendia for heart failure with preserved or mildly reduced ejection fraction in England represents a crucial step forward in the fight against a debilitating and widespread condition. By expanding the therapeutic options available to hundreds of thousands of patients, the NHS is poised to improve clinical outcomes, reduce the burden of hospitalisations, and enhance the overall quality of life for those living with chronic heart failure. This decision, underpinned by robust evidence and strategic health technology assessment, underscores a commitment to innovation and patient-centred care within the UK’s healthcare system, setting a positive precedent for future advancements in cardiology.
