1 Recommendations

1.1

Empagliflozin is recommended as an option for treating chronic kidney disease (CKD) in adults, only if:

it is an add-on to optimised standard care including the highest tolerated licensed dose of angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARBs), unless these are contraindicated, and
people have an estimated glomerular filtration rate of:
- 20 ml/min/1.73 m² to less than 45 ml/min/1.73 m² or
- 45 ml/min/1.73 m² to 90 ml/min/1.73 m² and either:
  - a urine albumin-to-creatinine ratio of 22.6 mg/mmol or more, or
  - type 2 diabetes.

1.2

If people with the condition and their clinicians consider empagliflozin to be 1 of a range of suitable treatments (including dapagliflozin), after discussing the advantages and disadvantages of all the options, use the least expensive. Take account of administration costs, dosage, price per dose and commercial arrangements

1.3

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 these recommendations were made

Management of CKD aims to slow its progression. Standard care is lifestyle and dietary changes, and usually ACE inhibitors or ARBs. Empagliflozin is an oral treatment for CKD. The company proposes that empagliflozin would be used as an add-on to optimised standard care with ACE inhibitors or ARBs. Some people take dapagliflozin as an add-on to standard care. The company proposes that empagliflozin would be used in a similar but slightly broader population to dapagliflozin. This does not include everyone who it is licensed for.

Clinical trial evidence suggests that empagliflozin plus standard care is more effective than standard care alone. But the main clinical trial did not include people with CKD with an estimated glomerular filtration rate of less than 20 ml/min/1.73 m². And people with an estimated glomerular filtration rate between 45 ml/min/1.73 m² and 90 ml/min/1.73 m² were only included if they also had a urine albumin-to-creatinine ratio of 22.6 g/mmol or more. There are no clinical trials directly comparing empagliflozin with dapagliflozin in people with CKD. Results of an indirect comparison suggest that empagliflozin has a similar effectiveness to dapagliflozin, and it likely has similar safety.

CKD can progress more quickly in some ethnic minority groups and, in people with type 2 diabetes, it progresses more quickly in people under 55. This was acknowledged but could not be considered in the decision making.

The cost-effectiveness estimates for empagliflozin compared with standard care are within the range NICE normally considers an acceptable use of NHS resources. Also, a cost comparison suggests that empagliflozin has similar costs to dapagliflozin. So, empagliflozin is recommended.

For all evidence see the committee papers. To see what NICE did for dapagliflozin, see the committee discussion section in NICE's technology appraisal guidance on dapagliflozin for treating chronic kidney disease.