Appeal type: Medical necessity
Decision: Overturned

Diagnosis: Chronic Kidney Disease
Treatment: Kerendia
The insurer denied Kerendia.
The determination is overturned.

This is a patient with a history of diabetes mellitus (DM), hypertension (HTN), and chronic kidney disease (CKD) stage 3a with microalbuminuria who is currently managed with Farxiga and lisinopril. The provider is prescribing Karendia (finerenone) 10 milligrams (mg) daily for further management of her diabetic nephropathy. She has a creatinine of 1.22 and an albumin to creatinine ratio of 128.8 milligrams per gram (mg/g). The health plan states that for Kerendia to be approved the patient has to meet the following criteria: (1) an estimated glomerular filtration rate (GFR) between 25-60 milliliters per minute (ml/min) with a urinary albumin creatinine ratio of 30-300 mg/g with diabetic retinopathy or (2) an estimated glomerular filtration rate (GFR) between 25-75 ml/min with a urinary albumin creatinine ratio of 300-5000mg/g. The patient request was denied as the patient did not have documented diabetic retinopathy. 

The requested use of Kerendia is medically necessary for this patient. Based on the available large, randomized control data this patient has type II DM with stage 3a CKD and microalbuminuria which makes her a candidate to receive Kerendia. Karendia is a non-steroidal mineralocorticoid receptor antagonist (MRA) indicated to reduce the risk of sustained estimated glomerular filtration rate (eGFR) decline, end stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D). It has been studied in two large randomized controlled studies.
The Finerenone in Reducing Kidney Failure and Disease Progression in Diabetic Kidney Disease (FIDELIO-DKD) trial was a randomized, double-blind, placebo-controlled, multicenter trial in adult participants with CKD associated with type 2 diabetes mellitus (T2DM). The inclusion criteria were defined as either having a urine albumin creatinine ratio (UACR) of 30 to 300 mg/g, eGFR of 25 to 60 mL/min/1.73 square meter (m2) and diabetic retinopathy, or as having an urine albumin-creatinine ration (UACR) of greater than or equal to (>=)300 mg/g and an eGFR of 25 to 75 mL/min/1.73 m2. In FIDELIO-DKD, the baseline mean eGFR was 44 mL/min/1.73 m2 and median UACR was 852 mg/g. All participants needed to have a serum potassium of less than or equal to (<=) 4.8 milliequivalents per liter (mEq/L) and were required to be on maximum tolerated dose of an angiotensin converting enzyme inhibitor (ACEi) or angiotensin II receptor blockers (ARB) before being randomized to finerenone or placebo. This trial showed that finerenone slowed the progression of diabetic kidney disease. The FIGARO-DKD trial was a randomized, double-blind, placebo-controlled, multicenter trial in 7437 adult participants with predominantly stage 3 or 4 CKD associated with T2DM. The inclusion criteria were defined as UACR of 30 to < 300 mg/g and an eGFR of 25 to 90 mL/min/1.73 m2 (stage 2 to 4 CKD) or a UACR of 300 to 5000 mg/g and an eGFR of at least 60 mL/min/1.73 m2 (stage 1 or 2 CKD). In this trial, 45 percent (%) of participants had established cardiovascular disease, baseline mean eGFR was 68 mL/min/1.73 m2 and the median UACR was 308 mg/g. All patients were required to be on a maximum tolerated dose of an ACEi or ARB before being randomized to finerenone or placebo. FIGARO-DKD showed that finerenone lowered the risk of primary cardiovascular composite outcome of cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke, or hospitalization for heart failure. The health plan's criteria only take the first trial into account and include the necessity of having diabetic retinopathy in order for drug approval. However, the more recent study shows a benefit without the inclusion of diabetic retinopathy. Diabetic retinopathy alone should not be used to determine candidacy for finereone usage as long as the other criteria are met.