NICE has recommended the extension of dapagliflozin as a treatment option for symptomatic chronic heart failure in patients with preserved or mildly reduced ejection fraction.
In final draft guidelines, the committee said it had reviewed evidence from AstraZeneca that adding dapagliflozin (Forxiga) to standard care with diuretics reduces the combined risk of dying from cardiovascular causes or hospital admission with heart failure.
The committee noted in its decision that hospitalisations for heart failure with preserved or mildly reduced ejection fraction place a substantial burden on the NHS and this is the first NICE-recommended treatment for this type of heart failure.
This follows EU approval of dapagliflozin across all ejection fractions in heart failure in February 2023.
More than 550,000 people in England have heart failure and around 50% have preserved or mildly reduced ejection fraction, of whom up to 150,000 would be eligible for treatment with dapagliflozin, NICE said.
Figures show 94,185 hospitalisations in England for heart failure in 2019/20, making it one of the leading causes of avoidable hospitalisations.
And around a quarter of people with heart failure die within the first year and over half within five years.
Positive global study for dapagliflozin
Results from the DELIVER trial considered by NICE (a global study but with no UK patients) showed dapagliflozin plus standard care reduced the composite outcome of cardiovascular death or worsening heart failure by 18% over a median follow-up of 2.3 years.
The committee said the population in the trial were about 10 years younger than would be expected in real-world the but said results were generalisable to NHS clinical practice.
An economic analysis took into account hospitalisations but also GP appointments, the final draft guidance said. Overall it found cost effectiveness to be below £20,000 per quality of life year gained – below the NICE threshold for an acceptable use of NHS resources.
Helen Knight, director of medicines evaluation at NICE, said: ‘Until now there have been no treatments available to delay or slow the progression of this type of heart failure.
‘The committee heard from patient and clinical experts who described how the lack of research and available treatments in this area led to a lack of hope and support that impacts the quality of life and mental health of people with the condition.
‘And we know that chronic heart failure also places a significant burden on the NHS through hospitalisations.’
She added: ‘Today’s draft guidance means that for the first time there is an effective treatment available on the NHS for people with this type of heart failure.
‘Not only does dapagliflozin have the potential to help them live well for longer, but it could also save the NHS money and free up space by reducing their risk of having to go to hospital for unplanned emergency treatment.’