Bayer has welcomed final draft guidance from NICE recommending finerenone for adults in England and Wales with symptomatic chronic heart failure and a left ventricular ejection fraction of 40% or above.
The decision means the non-steroidal mineralocorticoid receptor antagonist can now be accessed through NHS pathways for patients with heart failure with mildly reduced ejection fraction and heart failure with preserved ejection fraction.
Dr Carol Whelan, Consultant Cardiologist and HF Lead at the Royal Free Hospital in London, said: “Heart failure with preserved ejection fraction or mildly reduced ejection fraction represents a substantial and growing challenge for patients, clinicians and the NHS.
“Too many patients experience repeated hospital admissions, poor quality of life and an unacceptably high risk of death.”
She added: “As our population ages and the burden on patients and the healthcare system continues to rise, improving outcomes for this large and historically underserved patient population is increasingly important.
“The NICE recommendation of finerenone is therefore a welcome development, providing clinicians with an additional evidence-based treatment option that could help address an important unmet need in heart failure care.”
Heart failure affects more than one million people in the UK, with prevalence in England projected to rise by 92% to nearly 2 million by 2040. Around half of patients are estimated to have an ejection fraction of 40% or above, with heart failure with preserved ejection fraction accounting for a substantial proportion and placing sustained pressure on NHS services.
The NICE decision follows MHRA authorisation earlier this year and is based on results from the phase 3 FINEARTS-HF study in 6,001 adults.
Finerenone reduced the risk of cardiovascular death and total heart failure events by 16% over 32 months compared with placebo, with consistent benefits across all pre-specified subgroups. The treatment was generally well tolerated.
Tomer Feffer, CEO, Bayer UK & Ireland, said: “We are delighted that NICE has recommended finerenone for patients with symptomatic chronic heart failure and LVEF ≥40%, marking an important milestone in expanding treatment options for people living with this complex and challenging condition.”
