The UK’s National Institute for Health and Care Excellence (NICE) has published new technology appraisal guidance on the use of finerenone in the treatment of chronic kidney disease (CKD) patients with type 2 diabetes. The guidance recommends the drug, which follows on from its acceptance for use in the National Health Service (NHS) in Scotland by the Scottish Medicines Consortium (SMC) in late 2022. The NICE announcement has been shared by Bayer, who produce the drug under the name Kerendia.
Setting out the conditions under which the drug should be prescribed, the NICE guidance recommends it for type 2 diabetes patients with stage 3 or 4 CKD with albuminuria. However, it stipulates that this should only be done “as an add-on to optimised standard care”. This care, it explains, should include “the highest tolerated licensed doses” of angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARBs), as well as of sodium-glucose cotransporter‑2 (SGLT2) inhibitors. The patient should also have an estimated glomerular filtration rate (eGFR) of 25ml/min/1.73m2 or more.
“This recommendation is not intended to affect treatment with finerenone that was started in the NHS before this guidance was published,” its authors add. They state further that those already being treated outside of this guidance before its publication may continue “until they and their NHS clinician consider it appropriate to stop”.
Those authors, including chair Charles Crawley (Cambridge University Hospitals NHS Trust, Cambridge, UK), explain: “The clinical evidence suggests that finerenone improves kidney function and helps to slow the worsening of the disease compared with placebo.” They note that this applies both with and without SGLT2 inhibitors, with which there has not yet been a direct comparative study. This leads the authors to state that finerenone cannot yet be recommended “instead of them”. On cost-effectiveness, they add that “estimates are uncertain” but fall within the bounds of acceptable cost for NHS use.
At the heart of the recommendation is the guideline team’s view that “there is an unmet need for treatment options for CKD associated with type 2 diabetes”. This is due to a “residual risk” of continued progression of the disease—as well as complications such as peripheral vascular disease—for this patient population even when receiving current standard care. The existing options fall short of satisfying their needs, the authors suggest, particularly in those patients where SGLT2 inhibitors are not considered appropriate.
The discussion of the guideline committee made reference to the FIDELIO-DKD study results published in The New England Journal of Medicine (NEJM) in 2020. That trial was a phase 3 randomised, double-blind, placebo-controlled, multicentre clinical trial of 5,734 adult patients with type 2 diabetes and CKD, randomised 1:1 to receive either oral finerenone or placebo, while additional evidence is also cited from the FIGARO trial and FIDELITY pooled results analysis.
The NICE recommendation means finerenone “should be available for use” as part of NHS treatment within three months of its 23 March 2023 publication date—a limit which has been passed as of 23 June 2023.
