Empagliflozin (Jardiance®) receives positive NICE recommendation for treatment of symptomatic chronic heart failure with preserved or mildly reduced ejection fraction

Empagliflozin (Jardiance^®) receives positive NICE recommendation for treatment of symptomatic chronic heart failure with preserved or mildly reduced ejection fraction

• The National Institute for Health and Care Excellence (NICE) has issued its final draft guidance, recommending empagliflozin (Jardiance^®) as an option for the treatment of symptomatic chronic heart failure with preserved or mildly reduced ejection fraction in adults.[i]
• Up to one million people in the UK have heart failure[ii] and around 50% have preserved or mildly reduced ejection fraction[iii]
• This decision is aligned to reimbursement recommendations by authorities in Ireland and Scotland[iv]^,[v]

Bracknell, UK, 5 October 2023 – The National Institute for Health and Care Excellence (NICE) has today announced that empagliflozin (Jardiance^®) is recommended for use as an option for treating symptomatic chronic heart failure with preserved or mildly reduced ejection fraction in adults.¹ Empagliflozin is licensed for use in the treatment of adults with symptomatic chronic heart failure regardless of ejection fraction, alongside existing indications in chronic kidney disease and type 2 diabetes.[vi]

This recommendation will expand the use of empagliflozin, which was previously recommended by NICE in March 2022 for treating symptomatic chronic heart failure in adults with reduced ejection fraction, as part of optimised standard of care.[vii] The positive Final Draft Guidance (FDG) from NICE means that empagliflozin will be accessible through the NHS to all eligible adult patients with symptomatic chronic heart failure in England and Wales, regardless of ejection fraction.1

Professor Ahmet Fuat, Education and Research Lead at the Primary Care Cardiovascular Society said: "The Primary Care Cardiovascular Society are delighted that NICE has now provided a draft recommendation for empagliflozin as another option for treating symptomatic chronic heart failure with preserved and mildly reduced ejection fraction in adults. Until recently, unlike heart failure with reduced ejection fraction, there have been limited treatment options for this group of patients, despite the trend of increasing prevalence of symptomatic chronic heart failure with preserved and mildly reduced ejection fraction.”

Nick Hartshorne-Evans, Chief Executive and Founder of the Pumping Marvellous Foundation, the leading patient organisation for people living with heart failure, said: “The approval of empagliflozin represents a positive step for people living with heart failure in England and Wales, approximately half of whom have heart failure with preserved or mildly reduced ejection fraction. We are delighted that this decision brings another treatment option to people living with this severe long-term condition that significantly impacts their day-to-day activities.”

This NICE recommendation was based on results from the EMPEROR-Preserved Phase III clinical trial, which demonstrated that empagliflozin achieved its primary composite endpoint (cardiovascular death or hospitalisation for heart failure) in adults with an ejection fraction of more than 40%, compared to placebo, both added to background therapy.^[viii]

“Heart failure generally is a challenging yet treatable condition which, critically, needs to be identified and managed early to mitigate the incipient risks for patients. It is essential that patients have early access to treatments that have been proven to reduce the risks of hospitalisation or cardiac events, which we know have considerable impact on people’s lives and long-term outcomes,” said Professor Roy Gardner, Chair of the British Society for Heart Failure (BSH) and Consultant Cardiologist, Heart Failure Specialist at the Golden Jubilee National Hospital, Glasgow. “With respect to heart failure with preserved ejection fraction and mildly reduced ejection fraction, phenotypes of the heart failure spectrum that until recently did not have a meaningful treatment option, this NICE recommendation should be welcomed by those managing the condition and all those affected by it.”

Symptomatic chronic heart failure with preserved ejection fraction occurs when the left ventricle of the heart is unable to relax and properly fill with blood, resulting in less blood being available to be pumped out to the body.11^,9 Heart failure with reduced ejection fraction is when the left ventricle of the heart is not able to contract effectively, therefore the heart cannot pump with enough force.^[ix] Heart failure with mildly reduced ejection fraction shares features with both heart failure with reduced and preserved ejection fraction.11 This serious, long-term condition is one of the leading causes of avoidable hospitalisations, associated with considerable NHS resource utilisation.[x]

“In line with the UK Government’s Life Sciences Vision, NHS Long Term Plan and Major Conditions Strategy, we are committed to improving patient outcomes for the large population of people living with the interconnected cardio-renal-metabolic conditions by providing effective treatment options,” said Dr Christoph Zehendner, Medical Director, Boehringer Ingelheim UK and Ireland. “This positive NICE recommendation marks another important milestone for empagliflozin and follows the recent MHRA approval in chronic kidney disease in September 2023.”

Ms Poppy Brooks, Chair of the British Society for Heart Failure (BSH) Nurse Forum and Lead Advanced Practitioner for cardiac support services at Royal Devon University Healthcare Trust added: “People living with heart failure with preserved ejection fraction and mildly reduced ejection fraction have historically been an underserved patient population with poor outcomes, an absence of treatment options and variable access to specialist heart failure nurses whose role is integral in their ongoing care. Whilst we welcome this recommendation by NICE, we worry that burgeoning heart failure nurse caseloads may affect the access patients have to new choices in treatment. In addition to increasing the heart failure specialist workforce, we also need to educate, train and support healthcare professionals across the healthcare ecosystem to work with us in the care of this patient cohort.” 

[i] NICE. Empagliflozin for treating chronic heart failure with preserved or mildly reduced ejection fraction [ID3945] Available at: https://www.nice.org.uk/guidance/indevelopment/gid-ta10946. Accessed: October 2023.

[ii] British Heart Foundation UK Factsheet. April 2023. Available at: https://www.bhf.org.uk/what-we-do/our-research/heart-statistics. Accessed: October 2023.

^[iii] NICE. Heart Failure – Chronic: How common is it? Available at: https://cks.nice.org.uk/topics/heart-failure-chronic/background-information/prevalence/ Accessed: October 2023.

[iv] National Centre for Pharmacoeconomics NCPE Ireland. Empagliflozin (Jardiance®). HTA ID: 22068. Available at: https://www.ncpe.ie/13280-2/ Accessed: October 2023.

[v] Scottish Medicines Consortium. Empagliflozin (Jardiance). SMC 2523. Available at: https://www.scottishmedicines.org.uk/medicines-advice/empagliflozin-jardiance-full-smc2523/ Accessed: October 2023.

[vi] Jardiance® (empagliflozin) tablets. Summary of Product Characteristics.

[vii] NICE. Empagliflozin for treating chronic heart failure with reduced ejection fraction

Technology appraisal guidance [TA773] Published: 09 March 2022 https://www.nice.org.uk/guidance/ta773 Accessed: October 2023.

[viii] Anker SD, Butler J, Filippatos JP et al. Empagliflozin in heart failure patients with a preserved ejection fraction. N Engl J Med. 2021;385(16):1451-1461.

^[ix] American Heart Association. Ejection Fraction Heart Failure Measurement. Available at: https://www.heart.org/en/health-topics/heart-failure/diagnosing-heart-failure/ejection-fraction-heart-failure-measurement. Accessed: October 2023.

[x] British Heart Foundation. Heart failure: A Blueprint for Change. 2020. Available at:

https://www.bhf.org.uk/-/media/files/health-intelligence/heart-failure-a-blueprint-for-change.pdf?la=en&rev=f89dedb7c933452e8086cc063ff98c26&hash=98E3BEADD6A46974EF0AAD86044B8DC5314F4E2B. Accessed: October 2023.