1 Recommendations

1.1

Dapagliflozin can be used as an option to treat chronic kidney disease (CKD) in adults, if:

it is an add-on to optimised standard care including the highest tolerated licensed dose of angiotensin-converting enzyme (ACE) inhibitors or angiotensin‑2 receptor antagonists, unless these are contraindicated, and
people have an estimated glomerular filtration rate (eGFR) 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 healthcare professional consider dapagliflozin to be 1 of a range of suitable treatments (including empagliflozin), after discussing the advantages and disadvantages of all the options, the least expensive should be used. Administration costs, dosages, price per dose and commercial arrangements should all be taken into account.

1.3

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 healthcare professional consider it appropriate to stop.

What this means in practice

Dapagliflozin must be funded in the NHS in England for the condition and population in the recommendations, if it is considered the most suitable treatment option. Dapagliflozin must be funded in England within 30 days of final publication of this guidance.

There is enough evidence to show that dapagliflozin provides benefits and value for money, so it can be used routinely across the NHS in this population.

NICE has produced tools and resources to support the implementation of this guidance.

Why these recommendations were made

This evaluation is a review of NICE's technology appraisal guidance on dapagliflozin for treating CKD (TA775). It also reviews new data submitted by the company as part of this evaluation.

Standard care for CKD includes lifestyle and dietary changes, and usually an ACE inhibitor or angiotensin‑2 receptor antagonist. Some people take dapagliflozin or empagliflozin as an add-on to optimised standard care with an ACE inhibitor or angiotensin‑2 receptor antagonist. The company has proposed that dapagliflozin should be available for the same population as empagliflozin. Empagliflozin is used in a similar but broader population to dapagliflozin, but this still does not include everyone who dapagliflozin is licensed for.

In the original evaluation, clinical trial evidence suggested that dapagliflozin with standard care is more effective than standard care alone. Dapagliflozin has not been directly compared with empagliflozin in a clinical trial, but an indirect treatment comparison considered in NICE's technology appraisal guidance on empagliflozin for treating CKD suggested that they have similar effectiveness and safety. In this evaluation, the clinical evidence presented by the company does not suggest that dapagliflozin is less effective than empagliflozin in people with CKD. Also, both treatments work in a similar way so are likely to have similar clinical effectiveness and safety for the population considered for this evaluation.

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

A cost comparison suggests that the costs for dapagliflozin are similar to those for empagliflozin. So, dapagliflozin can be used in the same population as empagliflozin.

For all evidence, see the committee papers. For more information on NICE's evaluation of empagliflozin, see NICE's technology appraisal guidance on empagliflozin for treating CKD.