Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Chronic kidney disease
Treatment: Kerendia 20 mg (milligrams) tablet
The insurer denied coverage for Kerendia 20 mg tablet.
The denial is upheld.

Kerendia is medically necessary per standard of care if the patient is being treated with standard therapy [i.e. ("that is") Angiotensin receptor blockers (ARB)].

Finerenone (Kerendia) is Food and Drug Administration (FDA) approved for reduction of the progression of kidney function impairment and cardiovascular events in patients with type 2 diabetes and chronic kidney disease (CKD) and who are treated with standard therapy.

In the Finerenone in Reducing Kidney Failure and Disease Progression in Diabetic Kidney Disease (FIDELIO-DKD) trial, 5734 patients with type 2 diabetes and either severely increased albuminuria or moderately increased albuminuria plus retinopathy were randomly assigned to finerenone (10 to 20 mg [milligrams] once daily) or placebo. All patients were taking a maximal, or maximally tolerated, dose of an angiotensin converting enzyme (ACE) inhibitor or ARB at baseline. At 2.6 years, finerenone decreased the incidence of a 40 percent or larger decline in estimated glomerular filtration rate (eGFR) (16.9 versus 20.3 percent) and non-significantly reduced the rates of all-cause mortality (7.7 versus 8.6 percent), and end stage kidney disease (ESKD) (7.3 versus 8.3 percent), which included an eGFR < (less than) 15 and the need for chronic dialysis. Hyperkalemia occurred more frequently with finerenone (18.3 versus 9.0 percent), although only a small number of patients discontinued randomized therapy due to this complication (2.3 versus 0.9 percent). [1]

A similar trial tested the effects of finerenone in 7437 patients with diabetic kidney disease who had less severe kidney disease (moderately increased albuminuria with an eGFR 25 to 90 or severely increased albuminuria with an eGFR > [greater than] 60). Compared with placebo, finerenone reduced the risk of heart failure hospitalization (3.2 versus 4.4 percent), and non-significantly lowered the rate of kidney failure (1.7 versus 1.2 percent) and all-cause mortality (9.0 versus 10.1 percent). The benefits of finerenone appeared to be similar, and possibly stronger, among the minority of patients who were also taking a Sodium-glucose co-transporter 2 (SGLT2) inhibitor or glucagon-like peptide-1 (GLP-1) receptor agonist. Hyperkalemia was more common with finerenone (10.8 versus 5.3 percent). [2]

The member is not being treated with standard therapy prior to Kerendia and this request is not medically necessary per available evidence-based literature. As discussed in Up to Date, "Among patients with type 2 diabetes who have measured or estimated albuminuria greater than or equal to 30 mg/day despite an ACE inhibitor (or ARB) and an SGLT2 inhibitor, we suggest treatment with a nonsteroidal selective mineralocorticoid receptor antagonist (MRA, specifically finerenone), where available, provided the patient has a serum potassium less than or equal to 4.8 and eGFR greater than or equal to 25."

Based on the above, the insurer's denial must be upheld. The health care plan did act reasonably, with sound medical judgment, and in the best interest of the patient. 

The medical necessity for Kerendia 20 mg tablet is not substantiated.