1 Recommendations

1 Recommendations

1.1 Dapagliflozin is recommended as an option for treating chronic kidney disease (CKD) in adults. It is recommended 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 (eGFR) of 25 ml/min/1.73 m2 to 75 ml/min/1.73 m2 at the start of treatment and:

    • have type 2 diabetes or

    • have a urine albumin-to-creatinine ratio (uACR) of 22.6 mg/mmol or more.

1.2 This recommendation is not intended to affect treatment with dapagliflozin 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

Management of CKD aims to slow disease progression. Standard care is lifestyle and dietary changes, and usually ACE inhibitors or ARBs. Dapagliflozin is an oral treatment for CKD. The company proposes that dapagliflozin would be used as an add-on to optimised standard care with ACE inhibitors or ARBs, which is narrower than its marketing authorisation.

Clinical trial evidence suggests that dapagliflozin plus standard care is more effective than standard care alone. The main clinical trial only included people with an eGFR of 25 ml/min/1.73 m2 to 75 ml/min/1.73 m2 and a uACR of 22.6 mg/mmol to 565 mg/mmol. Evidence is available for dapagliflozin from a different clinical trial for people with CKD and type 2 diabetes and with a uACR of less than 22.6 mg/mmol. There is no clinical trial evidence available for dapagliflozin in people with CKD without type 2 diabetes and with a uACR of less than 22.6 mg/mmol.

For the groups for which there is good enough clinical evidence, the cost-effectiveness estimates are within the range that NICE considers an acceptable use of NHS resources. So, dapagliflozin is recommended for these groups as an add-on to optimised standard care including ACE inhibitors or ARBs.

  • National Institute for Health and Care Excellence (NICE)