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New HTA Decisions in England
March 2021
Drug name
FORXIGA® (dapagliflozin)
Company
AstraZeneca
Decision date
24/12/2020
Therapeutic area
Cardiovascular conditions
Therapeutic sub area
Heart failure
Decision
Recommended with restrictions
Indication
Dapagliflozin is recommended as an option for treating symptomatic chronic heart failure with reduced ejection fraction in adults.
Decision Detail
It is recommended 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. 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.
Summary
DAPA HF, a double-blind randomised clinical trial comparing dapagliflozin plus standard care with placebo plus standard care, provided the clinical evidence. The committee concluded that dapagliflozin is clinically effective compared with placebo and reduces the risk of cardiovascular events and all cause mortality when added to standard care. 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 committee's preferred ICER for dapagliflozin was £7,264 per QALY gained as an add-on to optimised standard care based on ACE inhibitors or ARBs. The committee then considered the population taking dapagliflozin as an add-on to optimised standard care based on sacubitril valsartan and noted that its preferred ICER for this population would be under £10,000 per QALY gained. 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.