NICE blocks wider use of Jardiance, Forxiga in heart failure

Eli Lilly and Boehringer Ingelheim's Jardiance and AstraZeneca's Forxiga have not been recommended for NHS use as a treatment for symptomatic chronic heart failure (CHF) with preserved or mildly reduced ejection fraction in new draft guidance.

The two drugs have already been backed for CHF with reduced ejection fraction, with Forxiga (dapagliflozin) getting a green light from NICE in 2021 and Jardiance (empagliflozin) following suit last year, but the health technology assessment (HTA) agency has baulked at broadening use of the SGLT2 inhibitors.

In both draft guidances – which are open for comment until 1 March – NICE's appraisal committee acknowledged that clinical testing has shown that the drugs reduce the combined risk of dying from cardiovascular causes or likelihood of first hospitalisation for heart failure in patients with this category of CHF when added to standard care.

However, it added that it is not clear whether they reduce the likelihood of dying from either any cause or from cardiovascular causes in this setting, and there are "uncertainties" in the modelling of the economic benefits the drugs deliver, making cost-effectiveness hard to determine.

Boehringer and Lilly said they were disappointed by the decision, particularly as there are currently no clinically proven medications recommended by NICE for people with preserved or mildly reduced ejection fraction CHF.

They pointed out that 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.

Jardiance was approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in June 2022 to treat symptomatic CHF regardless of ejection fraction, based on the results of the phase 3 EMPEROR-Preserved clinical trial.

Meanwhile, Forxiga was cleared by the MHRA across all ejection fractions in the UK last December, on the strength of the late-stage DELIVER trial, and AZ's drug also secured EU approval for that indication last week.

Commenting on the Jardiance decision, Dr Christoph Zehendner, medical director of Boehringer Ingelheim UK and Ireland, noted that HF with mildly reduced and preserved ejection fraction represents a "highly underserved patient population who are living with a disease that impacts not only their quality of life but also their life expectancy."

Heart failure affects more than 900,000 people in the UK 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 have a preserved ejection fraction.