1 Recommendations
1.1 Dapagliflozin is recommended as an option for treating symptomatic chronic heart failure with reduced ejection fraction in adults, only if it is used as an add-on to optimised standard care with:
-
angiotensin-converting enzyme (ACE) inhibitors or angiotensin‑2 receptor blockers (ARBs), with beta blockers, and, if tolerated, mineralocorticoid receptor antagonists (MRAs), or
-
sacubitril valsartan, with beta blockers, and, if tolerated, MRAs.
1.2 Start treatment of symptomatic heart failure with reduced ejection fraction with dapagliflozin on the advice of a heart failure specialist. Monitoring should be done by the most appropriate healthcare professional.
1.3 These recommendations are not intended to affect treatment with dapagliflozin that was started in the NHS before this guidance was published. People having treatment outside these recommendations may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.
Why the committee made these recommendations
People with heart failure with reduced ejection fraction may have symptoms that are not controlled well enough despite being on the most appropriate (optimised) treatment. Standard care includes an ACE inhibitor or an ARB, with beta blockers and, if tolerated, an MRA. Alternatively, people may be offered sacubitril valsartan, with beta blockers and, if tolerated, MRAs, if symptoms continue on ACE inhibitors or ARBs.
A clinical trial compared dapagliflozin as an add-on treatment to standard care (based on an ACE inhibitor, ARB or sacubitril valsartan) with standard care alone. Evidence from the trial shows that dapagliflozin lowers the risk of dying from cardiovascular causes, and reduces the likelihood of hospitalisation or an urgent outpatient visit because of heart failure.
There are no trials directly comparing dapagliflozin with sacubitril valsartan. An indirect comparison shows dapagliflozin is likely to be as effective at reducing the risk of death from cardiovascular causes.
The cost-effectiveness estimates are within what NICE normally considers an acceptable use of NHS resources. So dapagliflozin is recommended as an add-on to optimised standard care for symptomatic chronic heart failure with reduced ejection fraction.
People whose symptoms continue or worsen on optimised doses of standard care based on ACE inhibitors or ARBs can only start sacubitril valsartan under the supervision of a specialist with access to a multidisciplinary team. So dapagliflozin should only be started on advice from a heart failure specialist in primary, secondary or community care.