Bracknell, UK, 8 February 2023 – The Boehringer Ingelheim and Lilly Alliance is disappointed that the National Institute for Health and Care Excellence (NICE) has not recommended empagliflozin (Jardiance^®) for the treatment of adults with symptomatic chronic heart failure with preserved or mildly reduced ejection fraction.[i] There are currently no clinically proven medications recommended by NICE for people with this condition, despite the Medicines and Healthcare products Regulatory Agency (MHRA) approval for empagliflozin to treat symptomatic chronic heart failure regardless of ejection fraction in June 2022. Reimbursement has already been granted for empagliflozin to treat patients with heart failure and mildly reduced or preserved ejection fraction (above 40%) in other countries outside the UK.

“We are disappointed that the draft NICE guidance does not recommend empagliflozin for this highly underserved patient population who are living with a disease that impacts not only their quality of life but also their life expectancy,” commented Dr Christoph Zehendner, Medical Director, Boehringer Ingelheim UK and Ireland. “Patients in the UK do not currently have NICE-endorsed access to an evidence based and MHRA approved treatment for symptomatic chronic heart failure with ejection fraction above 40%. We will continue to work closely with NICE with the determination to ensure that patients living with symptomatic chronic heart failure with mildly reduced or preserved ejection fraction can benefit from empagliflozin.”

Empagliflozin received a marketing authorisation from the MHRA as the UK’s first effective treatment for symptomatic chronic heart failure regardless of ejection fraction. This was based on results from the EMPEROR-Preserved Phase III clinical trial, the first of its kind to achieve its primary composite endpoint (cardiovascular death or hospitalisation for heart failure) in adults with an ejection fraction of more than 40%, treated with empagliflozin compared to placebo, both added to background therapy.^[ii]

Heart failure affects over 900,000 people in the UK and occurs when the heart does not pump blood around the body as effectively as it should.[iii] This serious, long-term condition is one of the leading causes of avoidable hospitalisations, associated with considerable NHS resource utilisation.[iv] Of those affected, approximately half of all heart failure patients have a preserved ejection fraction.[v]

NICE’s Appraisal Consultation Document for empagliflozin in the treatment of adults with symptomatic chronic heart failure with ejection fraction of more than 40% can be changed after further consultation and feedback from the Boehringer Ingelheim and Lilly Alliance, other consultees and commentators.

Empagliflozin received a positive recommendation from NICE in March 2022 for treating adults with symptomatic chronic heart failure with reduced ejection fraction as an add-on to optimised standard of care.[vi] In Ireland, empagliflozin is recommended for reimbursement by the National Centre for Pharmacoeconomics (NCPE) for treating adults with heart failure regardless of ejection fraction.[vii]^,[viii]

[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/documents

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

[iii] British Heart Foundation UK Factsheet. July 2021. Available at: https://www.bhf.org.uk/what-we-do/our-research/heart-statistics. Accessed: February 2023.

[iv] British Heart Foundation. Heart failure: A Blueprint for Change. 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: February 2023.

[v] Dunlay SM, Roger VL, Redfield MM. Epidemiology of heart failure with preserved ejection fraction. Nature Reviews Cardiology.2017;14:591-602.

[vi] 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

[vii] National Centre for Pharmacoeconomics NCPE Ireland. Empagliflozin (Jardiance®). HTA ID: 21030. Available at Empagliflozin (Jardiance®). HTA ID: 21030 | National Centre for Pharmacoeconomics (ncpe.ie)

[viii] National Centre for Pharmacoeconomics NCPE Ireland. Empagliflozin (Jardiance®). HTA ID: 22068. Available at: Empagliflozin (Jardiance®). HTA ID: 22068 | National Centre for Pharmacoeconomics (ncpe.ie).

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