NICE publishes guidance recommending Bayer’s Kerendia® (finerenone) as an option for treating adult patients with chronic kidney disease associated with type 2 diabetes

• Kerendia^® (finerenone) is now available through NHS England as an option for treating chronic kidney disease (CKD) (stage 3 and 4 with albuminuria) associated with type 2 diabetes (T2D) in adults¹
• Finerenone is the only licenced oral non-steroidal mineralocorticoid receptor antagonist for the treatment of CKD associated with T2D that has been recommended by NICE²
• NICE recommendation is based on evidence from the pivotal Phase III FIDELIO-DKD study demonstrating the efficacy and safety profile of finerenone on kidney outcomes in patients with CKD associated with T2D^3,4
• Appraisal Committee highlights the unmet need for additional treatment options for CKD associated with T2D in the Guidance¹

Reading, 23^rd March 2023 – Today, the National Institute for Health and Care Excellence (NICE) has published a new guidance (TA877) recommending the use of finerenone (10mg and 20mg) by NHS England as an option for treating chronic kidney disease (CKD) (stage 3 and 4 with albuminuria) associated with type 2 diabetes in adults.¹ Finerenone is recommended as an add-on to optimised standard care, which should include, unless they are unsuitable, the highest tolerated licensed doses of angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARBs), and sodium–glucose cotransporter-2 (SGLT2) inhibitors, for people who have an estimated glomerular filtration rate (eGFR) of 25 ml/min/1.73 m² or more.¹

Publication of the NICE guidance on finerenone is based on the results of the pivotal Phase III FIDELIO-DKD study investigating the efficacy and safety profile of finerenone on kidney (primary composite endpoint) and cardiovascular (secondary composite endpoint) outcomes in 5,734 adult patients with CKD associated with T2D.³ The study showed that finerenone significantly reduced the risk of the primary composite renal outcome of time to kidney failure, a sustained decrease of estimated glomerular filtration rate (eGFR) ≥ 40% from baseline over a period of at least four weeks, or death from renal causes by 18% (relative risk reduction, absolute risk reduction 3.3%, HR 0.82 [95% CI, 0.73-0.93; p=0.001]) over a median duration of follow-up of 2.6 years compared to placebo (17.8% in finerenone group vs. 21.1% in placebo group experienced a primary composite renal outcome) when added to maximum tolerated dose of an ACE inhibitor or ARB.³ Based on an absolute between-group difference of 3.4% [95% CI, 0.6–6.2] at 36 months, the number needed to treat to prevent a primary composite renal event was 29 [95% CI, 16–166].³ In FIDELIO-DKD, there was a 14% relative risk reduction (absolute risk reduction, 1.8%; HR 0.86 [95% CI, 0.75-0.99; p=0.03]) in the key secondary cardiovascular endpoint, a composite of time to cardiovascular death, non-fatal myocardial infarction, non-fatal stroke or hospitalisation for heart failure, in those receiving finerenone compared to placebo (13% vs. 14.8%, respectively, experienced a key secondary cardiovascular event) over a median duration of 2.6 years follow-up.³ Finerenone was generally tolerated in the study.³ Hyperkalaemia events were the most frequently reported adverse reaction that occurred in 18.3% (516) of finerenone-treated patients (n= 2,827), compared with 9.0% (255) of placebo-treated patients (n=2,831). In patients treated with finerenone, most hyperkalaemia events were mild to moderate and resolved.³

Dr Kieran McCafferty, Consultant Nephrologist Barts Health NHS Trust, said: “People with chronic kidney disease associated with type 2 diabetes have significant risk of progression to kidney failure or premature death, particularly due to increased risk of cardiovascular disease compared with people with CKD alone. There has long been an unmet need for additional treatment options for people with CKD associated with T2D, especially as the residual risk of kidney disease progression and cardiovascular events remains high despite current therapies.¹ The NICE recommendation of finerenone is therefore very welcome news and provides physicians with an important add-on option for protecting our patients by delaying kidney disease progression.”  

Dr Raj Thakkar, GP, Present Elect and CKD Lead, Primary Care Cardiovascular Society (PCCS), said: “Chronic kidney disease is one of the most common and burdensome complications of high-risk conditions including diabetes and hypertension.⁵ Without early identification and optimisation of treatment, CKD progresses over time leading to accelerated adverse renal and cardiovascular outcomes including end-stage kidney disease and coronary disease, heart failure, valve disease, stroke, and peripheral vascular disease. Building on the NICE guidance, the PCCS is developing a quality improvement programme to support colleagues to systematically and proactively identify and manage CKD in the primary care setting.” 

Alison Railton, head of policy and external affairs, Kidney Research UK, said: “Chronic kidney disease associated with type 2 diabetes is now the leading cause of kidney failure in the UK.⁶ It has a debilitating impact on patients’ lives yet is still not recognised as a major health condition. Today’s recommendation from NICE provides an additional treatment option and is good news for thousands of patients living with this long-term condition across the nation.”

In the UK, it is estimated that over 4.4 million people are living with type 2 diabetes, including almost one million undiagnosed,⁷ and as many as 40% of people with type 2 diabetes – approximately 1.76 million people, could eventually develop CKD in T2D.⁸

A recent survey of patients with CKD associated with T2D (in the UK, France, Italy, Germany, and Spain), developed by the European Kidney Patients Federation in collaboration with Bayer AG, which included 100 UK patients, highlights that a CKD diagnosis not only has a profound physical impact on patients, but can also affect all aspects of a patient’s life including career, finances, and mental health.⁹ Results show that respondents in the UK were the most likely to have experienced depression (67% vs. 57% overall) with CKD in T2D.⁹ Findings of the survey, published on this year’s ahead of World Kidney Day 8^th March, also reveal that delays in CKD diagnosis are common across countries and there is a lack of awareness of CKD and its symptoms among T2D patients⁹ – in the UK, half of the respondents knew nothing about CKD prior to their diagnosis, despite the known link between T2D and CKD.⁹

“We are thrilled that finerenone is now made available to eligible adults in England who live with chronic kidney disease associated with type 2 diabetes, a condition that is associated with poor health outcomes for patients and high expenditure to the NHS services when managing the end-stage complications of CKD. We will continue to support the NHS and healthcare professionals to bring this treatment option to benefit more patients,” said Dr Antonio Payano, Senior Bayer Representative, Head of Pharmaceuticals at Bayer UK & Ireland. “Given the rising prevalence of T2D, we are fully committed to raising awareness of CKD among T2D patients and working with physicians on CKD knowledge sharing to help improve diagnosis and empower patients for better outcomes.”

Publication of the NICE guidance on finerenone follows authorisation of Kerendia^® (finerenone) (10mg and 20mg) in Great Britain by The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK in March 2022 for the treatment of chronic kidney disease (stage 3 and 4 with albuminuria) associated with type 2 diabetes in adults.