NICE approves new drug for chronic kidney disease and diabetes 

The National Institute for Health and Care Excellence (NICE) has recommended a new medicine for adults with chronic kidney disease (CKD) and type 2 diabetes mellitus (T2DM).

Finerenone (Kerendia; Bayer), a non-steroidal mineralocorticoid receptor antagonist, has been recommended as an option for treating stage 3 and 4 CKD (with albuminuria) associated with T2DM in adults, a move described as “an important advance in therapies” by the chair of the Renal Pharmacy Group.

It is recommended only as an add-on to optimised standard care and if the person has an estimated glomerular filtration rate of 25mL/min/1.73 m² or more.

According to the NICE guidance, published on 23 March 2023, current standard care for CKD in people with T2DM includes angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARBs) and sodium-glucose cotransporter-2 (SGLT2) inhibitors,

“Finerenone would be added to ACE inhibitors and ARBs if they are not working well enough,” the guidance states.

“It could be offered before, after, or with SGLT2 inhibitors.”

CKD is a long-term condition involving abnormal kidney function or structure. It is affected by comorbidities, particularly T2DM. The excess glucose in T2DM can further affect kidney function and accelerate CKD progression. The aim of treatment is to slow progression of disease.

NICE’s recommendation is based on the findings from a phase III, randomised, double-blind, placebo-controlled trial, which enrolled more than 5,000 adults. Its results suggested that — in addition to standard care with and without SGLT2 inhibitors — finerenone improved kidney function and helped to slow the worsening of CKD compared with placebo.

The main adverse event of finerenone observed in the trial was hyperkalaemia but the NICE guidance committee agreed that it was mild “in most cases”.

In addition, the cost-effectiveness estimates, while uncertain, were all within the range considered by NICE to be an acceptable use of NHS resources.

The guidance says that finerenone was likely to be prescribed in secondary care to begin with but would eventually be prescribed in primary care, once experience with the treatment had grown.

Commenting on the findings, Clare Morlidge, lead renal pharmacist at the Lister hospital in Stevenage and chair of the Renal Pharmacy Group, pointed out that CKD was a “significant health burden” in the UK and many of these patients will have diabetic kidney disease.

“In 2020, there were around 3.5 million people in the UK living with CKD,” she said.

“By 2040, CKD will be the fifth commonest cause of death worldwide, so preventing progression of CKD is hugely important along with preventing cardiovascular death in this population, many of whom will be managed in primary care.

“The addition of finerenone as an option for treatment is an important advance in therapies.”

Morlidge added that reducing progression of CKD would have “huge positive implications” for the NHS spend on dialysis and transplantation.

“Not to mention the positive impact on patients’ quality of life,” she added.

“The addition of finerenone to the standard of care will provide an option to further delay kidney disease progression. The challenge will be proactively identifying patients especially those that are not known to the nephrology team. The majority of these patients will be managed in primary care and can continue to be managed here.

“Pharmacists will have a role in identifying and counselling these patients,” she said.

• This article was amended on 5 April 2023 to confirm the fact that finerenone is a non-steroidal mineralocorticoid receptor antagonist