NICE recommends empagliflozin (Jardiance®) for the treatment of adults with chronic kidney disease
- The National Institute for Health and Care Excellence (NICE) has issued Final Draft Guidance recommending empagliflozin (Jardiance®) as an option for the treatment of eligible adults with chronic kidney disease (CKD).[i]
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Empagliflozin would be the first and only SGLT2 inhibitor recommended by NICE for CKD patients without both type 2 diabetes and albuminuria* (specifically in patients with eGFR 20 to <45 ml/min/1.73m2), subject to publication of the final guidance.
- It is estimated that CKD affects up to 7.2 million people in the UK, more than 1 in 10 of the population, costing the NHS a substantial £6.4 billion in direct annual costs.[ii]
[Definitions: estimated glomerular filtration (eGFR) is a measure of kidney function and determines the stage of kidney disease; albuminuria is where protein (albumin) is abnormally present in the urine and can be a sign of kidney disease; *albuminuria defined as urine albumin-to-creatinine ratio (uACR) of ≥22.6 mg/mmol]
Bracknell, UK, 17 November 2023 – The National Institute for Health and Care Excellence (NICE) has issued its Final Draft Guidance (FDG) recommending empagliflozin (Jardiance®) as an option for the treatment of eligible adults with chronic kidney disease (CKD). 1 NICE has applied a streamlined process to this assessment of empagliflozin – an approach that is speeding up final recommendations compared with NICE’s usual appraisal process.[iii]
“The NICE Final Draft Guidance to recommend empagliflozin for the treatment of eligible patients living with chronic kidney disease is a positive step and will also be welcomed in primary care because we currently have limited treatment options” said Dr Kevin Fernando, GPwSI CVRM and Medical Education. “CKD is a pressing concern for healthcare professionals, therefore it is important that we identify and effectively manage the disease at an early stage to slow the progression and avoid future complications including the need for dialysis or kidney transplantation.”
“We are very pleased to see that the range of SGLT2 inhibitors being recommended for patients with chronic kidney disease is broadening” commented Dr Aisling McMahon, Executive Director of Research and Policy at Kidney Research UK. “In June this year, our report Kidney disease: A public health emergency, warned that growing numbers of patients needing dialysis over the next ten years risked overwhelming the NHS unless urgent action was taken. It recommended this class of medication be made more widely available to CKD patients, as part of a package of measures urgently needed to save patients’ lives and prevent more people descending into kidney failure and requiring dialysis. The NICE recommendation of empagliflozin for patients in England and Wales would be an important step in the right direction.”
The NICE recommendation has the potential to advance the standard of care for the treatment of CKD, and may help relieve the burden on healthcare systems by reducing the risk of CKD hospitalisations,[iv] or disease progression which can ultimately lead to a need for dialysis or kidney transplantation.2 With existing indications in type 2 diabetes and heart failure,[v] empagliflozin could help manage the risks of cardio-renal-metabolic conditions, which are often interconnected.[vi]
Empagliflozin is recommended by NICE as an option for treating 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-receptor blockers (ARBs), 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 (uACR) of 22.6 mg/mmol or more, or
- type 2 diabetes.1
The eGFR is a key indicator of renal function based on blood readings of a patient’s serum creatinine level, age, sex and race.[vii] Kidney damage is graded into 5 stages based on an individual's eGFR result.7 Alongside eGFR, urine albumin-to-creatinine ratio (uACR) is also used to plan the management of CKD by healthcare professionals.7,[viii]
Dr Christoph Zehendner, Medical Director, Boehringer Ingelheim UK & Ireland added: “This positive NICE endorsement marks another milestone for people living with CKD who will soon have access to the benefits of empagliflozin. Cardio-renal-metabolic diseases are interconnected and affect a large population of people in the UK, and we are committed to delivering transformative life-improving treatments that make a meaningful difference to patients’ lives.”
[i] NICE. Empagliflozin for treating chronic kidney disease ID6131. Available at: https://www.nice.org.uk/guidance/indevelopment/gid-ta11170 Accessed: November 2023
[ii] Kidney Research UK, Kidney disease: A UK public health emergency. The health economics of
kidney disease to 2033. June 2023. Available at: https://www.kidneyresearchuk.org/wp-content/uploads/2023/06/Economics-of-Kidney-Disease-full-report_accessible.pdf Accessed:
November 2023
[iii] NICE. Taking a proportionate approach to technology appraisals Available at: https://www.nice.org.uk/about/what-we-do/proportionate-approach-to-technology-appraisals Accessed: November 2023
[iv] The EMPA-KIDNEY Collaborative Group. Empagliflozin in Patients with Chronic Kidney Disease. N Engl J Med. 2023; 388:117-127.
[v] Jardiance® (empagliflozin) Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/5441/smpc. Accessed: November 2023
[vi] Arnold SV, Kosiborod M, Wang J et al. Burden of cardio-renal-metabolic conditions in adults with type 2 diabetes within the Diabetes Collaborative Registry. Diabetes Obes Metab. 2018;20(8):2000-2003.
[vii] UK Kidney Association, About eGFR. Available at: https://ukkidney.org/health-professionals/information-resources/uk-eckd-guide/about-egfr Accessed: November 2023
[viii] UK Kidney Association, Proteinuria. Available at: https://ukkidney.org/health-professionals/information-resources/uk-eckd-guide/proteinuria Accessed: November 2023
[ix] Data on File (EMP 23-26)
[x] Data on File (EMP 23-22)
