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    Has all of the relevant evidence been taken into account?

  • Question on Document

    Are the summaries of clinical and cost effectiveness reasonable interpretations of the evidence?

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    Are the recommendations sound and a suitable basis for guidance to the NHS?

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    Are there any aspects of the recommendations that need particular consideration to ensure we avoid unlawful discrimination against any group of people on the grounds of race, gender, disability, religion or belief, sexual orientation, age, gender reassignment, pregnancy and maternity?
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Draft guidance consultation

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1 Recommendations

1.1 Empagliflozin is not recommended, within its marketing authorisation, for treating symptomatic chronic heart failure with preserved or mildly reduced ejection fraction in adults.

1.2 This recommendation is not intended to affect treatment with empagliflozin that was started in the NHS before this guidance was published. People having treatment outside this recommendation 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

Current standard care for heart failure with preserved or mildly reduced ejection fraction is loop diuretics and treatment for other conditions the person may have. These manage symptoms but do not reduce hospitalisations for heart failure.

Clinical trial evidence shows that empagliflozin plus standard care reduces the combined risk of dying from cardiovascular causes or likelihood of first hospitalisation for heart failure compared with placebo plus standard care. It is not clear whether empagliflozin plus standard care reduces the likelihood of dying from either any cause or from cardiovascular causes.

There are uncertainties in the economic modelling because of the approach used to model how long people live. It is also uncertain whether the outcomes predicted by the model align with the clinical trial outcomes. Because of this, the cost-effectiveness estimates are uncertain and above what NICE considers a cost-effective use of NHS resources. So, empagliflozin is not recommended.