NICE fails to recommend Boehringer Ingelheim and Lilly Alliance’s empagliflozin

The treatment has been developed to treat certain chronic heart failure patients and is approved elsewhere

In a blow to patients who currently lack recommended treatment options for chronic heart failure with preserved or mildly reduced ejection fraction, Boehringer Ingelheim and Lilly Alliance’s empagliflozin has not received a positive recommendation from the National Institute for Health and Care Excellence (NICE).

As yet there are no clinically proven medications recommended by NICE for patients with the condition, despite the Medicines and Healthcare products Regulatory Agency (MHRA) approval for empagliflozin – also known as Jardiance – to treat symptomatic chronic heart failure regardless of ejection fraction last year.

Reimbursement has already been established for empagliflozin involving patients with heart failure and mildly reduced or preserved ejection fraction – above 40% – across other countries outside the UK. Meanwhile, in Ireland, empagliflozin is recommended for reimbursement by the National Centre for Pharmacoeconomics (NCPE) for treating adults with heart failure regardless of ejection fraction.

Dr Christoph Zehendner, medical director at Boehringer Ingelheim UK and Ireland, was disappointed by the guidance: “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%.”

He added: “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.”

NICE’s Appraisal Consultation Document for empagliflozin can still can be changed after further feedback and consultation from Boehringer Ingelheim and Lilly Alliance, along with other consultees and commentators.

Heart failure currently impacts over 900,000 people in the UK and occurs when the heart fails to pump blood around the body as effectively as it should. It remains a long-term condition and is one of the leading causes of avoidable hospitalisations, while also being associated with considerable NHS resource utilisation.

Among patients with the condition, approximately half of all heart failure patients have a preserved ejection fraction.