The National Institute for Health and Care Excellence (NICE) has extended its recommended indications for dapagliflozin (Forxiga, AstraZeneca) to include adults with symptomatic chronic heart failure with preserved or mildly reduced ejection fraction. The drug is already recommended for treating heart failure with a reduced ejection fraction, as is empagliflozin.
In its final draft guidance, NICE said that the new indication would benefit up to 150,000 people in England. Dapagliflozin is the first NICE-recommended treatment for this population - with heart failure with preserved or only mildly reduced ejection fraction - for whom there had previously been no disease-modifying treatments.
Explaining its decision, the regulator said that current standard care for these patients included loop diuretics plus treatment for co-morbidities, but that while these may manage symptoms, they do not reduce hospitalisations for heart failure.
The manufacturers of dapagliflozin submitted clinical evidence from the DELIVER randomised, double-blind, phase 3 clinical trial comparing dapagliflozin plus standard care with placebo plus standard care in adults 40 years and over with heart failure with preserved or mildly reduced ejection fraction.
Reduced Risk of Worsening Heart Failure or Cardiovascular Death
The study was done in 20 countries from Europe, Asia and North America, and showed that dapagliflozin reduced the combined risk of worsening heart failure or cardiovascular death among this group of patients
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She added: "Today’s draft guidance means that for the first time there is an effective treatment available on the NHS for people with this type of heart failure.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."
NICE said that more than 550,000 people in England have heart failure, of whom by its definitions:
- 40% or less have reduced ejection fraction
- 41% to 49% have mildly reduced ejectionfraction
- 50% or more have preserved ejection fraction
Leading Cause of Avoidable Hospitalisation
These categories "exist on a continuum", and of the 50% or so with preserved or mildly reduced ejection fraction, up to 150,000 would now be eligible for treatment with dapagliflozin, NICE said. It noted that there were 94,185 hospitalisations for heart failure in England in 2019/20, making it "one of the leading causes of avoidable hospitalisations". Around a quarter of people with heart failure die within the first year and over half die within 5 years.
Current standard treatment for heart failure with preserved or mildly reduced ventricular ejection fraction is usually a diuretic, and most patients also have treatments for comorbidities, including angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blockers (ARBs), betablockers or mineralocorticoid receptor antagonists (MRAs).
NICE said that, following consultation on its original draft guidance, along with new statistical and economic analyses from the company, its independent appraisal committee was now able to recommend dapagliflozin as a cost-effective use of NHS resources.
Professor Sir Nilesh Samani, medical director of the British Heart Foundation, told Medscape News UK: "This is welcome news for the many patients with heart failure with preserved ejection fraction, for whom we have not had treatments that improve both symptoms and prognosis."
Also asked to comment by Medscape News UK, John McMurray, professor of medical cardiology at the University of Glasgow and DELIVER trial investigator, said: "Dapagliflozin has the potential to help patients and help ease the pressures on the health service in the UK, as demonstrated in DELIVER, the largest randomised clinical trial in patients with heart failure and mildly reduced or preserved ejection fraction.
"This is great news for patients and an exciting turning point in the battle against heart failure given the unmet treatment need and the absence, until now, of treatments reducing mortality/ morbidity endpoints in these patients."
The list price of 10 mg dapagliflozin is £36.59 per 28-tablet pack, excluding VAT, making a usual annual cost of dapagliflozin treatment of £477.30.
NICE expects to publish final guidance on dapagliflozin on 21 June 2023.
