Diagnosis: Hypercholesterolemia and hypertriglyceridemia.
Treatment: Icosapent ethyl (Vascepa).
The insurer denied coverage for icosapent ethyl (Vascepa).
The denial is upheld.

This is a patient with a past medical history of hypertension and hyperlipidemia. On examination, blood pressure was 152/95 millimeters of mercury (mmHg). No abnormal findings were noted. The patient was treated with metoprolol, amlodipine, lisinopril and atorvastatin 20 milligrams (mg) daily. Lipid panel revealed hypercholesterolemia and hypertriglyceridemia: Total cholesterol 240mg/deciliter (dl), triglycerides (TG) 222mg/dl, low-density lipoprotein (LDL) 168mg/dl, high-density lipoprotein (HDL) 28mg/dl.

The American Heart Association (AHA) defines moderate elevation of TG levels as those between 200-400mg/dl. (Reference 1) The guidelines recommend intensive statin therapy for the treatment of moderate to severe hypertriglyceridemia as well as Omega 3 fatty acid treatment. (Reference 2) There have been conflicting trial results demonstrating the efficacy of omega 3 fatty acids in reducing atherosclerotic cardiovascular disease (ASCVD) risk in those with hypertriglyceridemia. However, these findings were largely due to differing patient enrollment and differing doses of omega 3 fatty acids. The REDUCE-IT (Reduction of Cardiovascular Events With Icosapent Ethyl-Intervention Trial) was a prospective double blind placebo controlled trial that enrolled patients with high cardiovascular risk. All patients had statin resistant hypertriglyceridemia. Among patients with elevated triglyceride levels despite the use of statin, the risk of ischemic events and cardiovascular death was significantly lower in the patients treated with Vascepa. (Reference 3) Current AHA guidelines recommend the use of Vascepa in patients with cardiovascular risk or established cardiovascular disease. Provided documentation does not demonstrate a history or risk of ASCVD.

In conclusion, Vascepa is not medically necessary for this gentleman with no history of diabetes and no history of ASCVD.

The health plan acted reasonably, with sound medical judgment, and in the best interest of the patient.

The insurer's denial of coverage for icosapent ethyl (Vascepa) is upheld. Medical necessity is not substantiated.