Empagliflozin (Jardiance®) receives positive NICE recommendation for the treatment of symptomatic chronic heart failure with reduced ejection fraction
Bracknell, UK, 4 February 2022 – The National Institute for Health and Care Excellence (NICE) has announced that empagliflozin (Jardiance®) will be recommended as a clinical and cost effective treatment option for adult patients with symptomatic chronic heart failure with reduced ejection fraction (HFrEF) as an add-on to optimised standard care.[i] Published today, the positive Final Appraisal Document (FAD) means that adults with HFrEF in England and Wales will soon be able to access empagliflozin via the NHS. NICE states that treatment should be initiated on the advice of a heart failure specialist, and monitored by the most appropriate healthcare professional.
Heart failure affects an estimated 920,000 people in the UK, most of whom (64%) have HFrEF.[ii],[iii] Heart failure is one of the leading causes of avoidable hospitalisations, associated with considerable NHS resource utilisation and a detrimental impact on patients’ quality of life and life expectancy.[iv] The NICE recommendation was based on results from the EMPEROR-Reduced trial in which empagliflozin on top of standard of care showed a significant 25 percent relative risk reduction in the primary composite endpoint versus placebo of cardiovascular death or hospitalisation due to heart failure (co;nfidence interval 0.65-0.86; P<0.001), absolute risk reduction 5.2%.[v] Safety data were consistent with the known safety profile from previous trials and post marketing experience.[vi]
Professor Simon Williams, Past Chair of The British Society for Heart Failure, the professional association for heart failure care in the UK, commented: “Each year over one million hospital visits in England alone include a heart failure diagnosis as the cause or contributing factor. Heart failure is a complex long term condition, rarely existing in isolation and can be the final destination for a considerable number of cardiovascular diseases. This positive recommendation for empagliflozin by NICE now provides a potentially important new treatment option for adults with symptomatic chronic HFrEF, which may help in avoiding hospitalisations and possibly reduce the growing pressures on our health service.”
Nick Hartshorne-Evans, CEO of the Pumping Marvellous Foundation, the leading patient organisation for people living with heart failure added: “Without effective treatment and management options, heart failure can be a life-limiting condition with a considerable impact on the daily quality of life for the people who live with it, their families and carers. Many people with heart failure eventually struggle with simple everyday tasks, such as household chores or walking short distances. Despite recent advances, there remains a significant need for beneficial treatment options and we welcome today’s recommendation as positive news for those living with symptomatic chronic heart failure.”
Heart failure is a chronic, long term and potentially fatal condition which occurs when the heart does not pump blood around the body as effectively as it should.[vii] Heart failure with reduced ejection fraction means the heart cannot contract normally.[viii] People with heart failure often experience breathlessness and fatigue, which can severely impact their quality of life.[ix],[x] The prevalence of heart failure is now similar to the four most common cancers combined (breast, prostate, lung and bowel cancer).[xi] While heart failure can be treated and managed, it is a progressive condition, and delayed diagnosis can lead to more severe heart failure at the point of diagnosis.4
Dr Douglas Clark, Head of Medical Affairs at Boehringer Ingelheim UK & Ireland, said: “We’re delighted with NICE’s positive FAD recommendation which means that empagliflozin will be available through the NHS to adults in England and Wales living with symptomatic chronic heart failure with reduced ejection fraction. The Boehringer Ingelheim and Lilly Alliance remains committed to ensuring clinicians and the thousands of people living with heart failure are able to benefit from new treatment options.”