Up to 150,000 patients in England will soon benefit from a new treatment for chronic heart failure – a move that could save the NHS money and free-up hospital beds.
AztraZeneca’s dapagliflozin is the first National Institute for Health and Care Excellence (NICE) recommended treatment for adults with symptomatic chronic heart failure with preserved or mildly reduced ejection fraction.
This happens when the left side of the heart doesn’t fill properly with blood during the diastolic (filling) phase. As a result, the heart is unable to pump enough blood to meet the body’s needs, causing symptoms including difficulty breathing, tiredness, and ankle swelling.
More than 550,000 people in England have heart failure and around 50% have preserved or mildly reduced ejection fraction. Around 150,000 of these would be eligible for treatment with dapagliflozin, says NICE.
Figures published by England’s health cost watchdog, reveal there were 94,185 hospitalisations in England for heart failure in 2019/20, making it one of the leading causes of avoidable treatment admissions.
Around a quarter of people with heart failure die within the first year and over half within five years.
Globally, heart failure affects approximately 64 million people and is associated with substantial morbidity and mortality. Chronic heart failure is the leading cause of hospitalisation for those over the age of 65.
In its draft guidance, NICE said it has reviewed evidence from AstraZeneca that adding dapagliflozin – which is also known as Forxiga – to standard care with diuretics (which help rid the body of salt and water) reduces the combined risk of dying from cardiovascular causes or hospital admission with heart failure.
Results from a DELIVER trial conducted by AstraZeneca in 20 countries including Europe, Asia, and North America, but not the UK, considered by NICE, showed that 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.
In its written decision, the committee said: “The clinical experts noted that the trial population was about 10 years younger than they would expect in clinical practice, but overall they considered the trial to be generalisable to NHS clinical practice.
“The committee questioned whether DELIVER would be generalisable to UK clinical practice because it did not include anyone from the UK. The clinical experts noted that the North American population in DELIVER is likely generalisable to UK clinical practice. They noted that, because there are no disease-modifying treatments available for heart failure with preserved or mildly reduced ejection fraction, the
standard care treatment arms would be similar across the countries included in the trial.
“The committee concluded that the results from DELIVER were broadly generalisable to NHS clinical practice.”
The committee also took into account hospitalisations as well as GP appointments, and found that overall cost effectiveness was below £20,000 per quality of life year gained, less than the NICE threshold for an acceptable use of NHS resources.
Summing up, the committee concluded “that when its preferred assumptions are incorporated, dapagliflozin is a cost-effective use of NHS resources. Therefore, the committee recommended dapagliflozin for treating symptomatic chronic heart failure with preserved or mildly reduced ejection fraction.”
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.
“We’re committed to bring the best care to people fast, while at the same time ensuring value for money for the taxpayer.”
She added that the 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.”
When NICE recommends a treatment ‘as an option’, the NHS must make sure it is available. This means that, if a patient has symptomatic chronic heart failure with preserved or mildly reduced ejection fraction and the doctor responsible for their care thinks that dapagliflozin is the right treatment, it should be available for use, in line with NICE’s recommendations.
In February this year, dapagliflozin was approved for extended use in the European Union for chronic heart failure across the full spectrum of left ventricular ejection fraction.
The approval by the EU followed the positive opinion in December 2022 of the Committee for Medicinal Products for Human Use and was based on the favourable results from the DELIVER Phase III trial comparing dapagliflozin with a placebo
At the time Mene Pangalos, executive vice president, BioPharmaceuticals R&D, AstraZeneca, said: “This broader indication for Forxiga for the treatment of symptomatic chronic heart failure across the full ejection fraction range will help more patients to benefit from this well-tolerated and guideline-directed treatment.
“We are redefining treatment of cardiorenal diseases with Forxiga’s demonstration of life-saving benefits, underscoring AstraZeneca’s commitment to provide innovative solutions that can help address the complexities of heart failure across the spectrum of the disease.”
