Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Coronary artery disease (CAD)

The insurer denied coverage for Vascepa. The denial was upheld.

This patient is a female with a cardiac history of hypertension, atherosclerotic cardiovascular disease (ASCVD) and is status post coronary artery bypass graft (CABG) X2. The patient also has hyperlipidemia. The patient's cardiologist stated that despite statin therapy with atorvastatin 10 mg and Rosuvastatin 20 mg, the patient's triglycerides remain above goal. She is diabetic and is therefore at a high risk of cardiac events. Based on data from the REDUCE-IT study, Vascepa may reduce this risk of cardiac events. 

The patient presented to her physician's office because she was experiencing chest pain. The history of present illness stated that she presented for a scheduled follow-up. She continued to experience random stereotyped episodes of transient palpitations, followed by warmth from the chest to the head with a sense of presyncope. The episodes lasted a few seconds. The pain had never occurred with activity. They were not related to sudden postural change. There was no dyspnea, orthopnea or paroxysmal nocturnal dyspnea (PND). She denied palpitations, claudication and had minimal dependent edema.

An article was written in 2013 to review the pharmacology, pharmacokinetics, clinical trial data, adverse effects, and formulary considerations of icosapent ethyl for the treatment of high triglyceride (TG) levels. A literature search was done with keywords Vascepa, icosapent ethyl, AMR101, and eicosapentaenoic acid of articles up to July 2013, along with the package insert for Vascepa and current guidelines for hypertriglyceridemia. Two phase-III, placebo-controlled, randomized, double-blind, 12-week clinical trials were included in this review: the MARINE trial and ANCHOR study. The MARINE trial consisted of mainly overweight Caucasian men with fasting TG >500 and <2000 mg/dL taking 4 g/day icosapent ethyl, 2 g/day, or placebo. The ANCHOR study consisted of mainly overweight Caucasians with type-2 diabetes mellitus on statin therapy, with fasting TG >200 and <500 mg/dL taking 4 g/day icosapent ethyl, 2 g/day, or placebo. The MARINE trial showed a placebo-corrected median decrease in TG of 33.1% for patients receiving 4 g/day icosapent ethyl, with no significant change in low-density lipoprotein cholesterol (LDL-C) levels. TG was reduced by 19.7% in those taking 2 g/day. The ANCHOR study showed a placebo-corrected decrease in TG of 21.5% with a 6.3% decrease in LDL-C for patients taking 4 g/day icosapent ethyl as add-on to statin therapy. TG was reduced by 10.1% in those taking 2 g/day. The main adverse effect observed was joint pain (2.3%). They conclude that Icosapent ethyl is effective in reducing TG levels without increasing LDL-C, and has efficacy similar to other TG-lowering therapies with fewer adverse effects or interactions. (1)

This patient did have coronary artery disease (CAD) with previous bypass surgery. A recent lipid profile showed that her HDL was high, which is protective, and her LDL was slightly elevated. Most important was that her triglyceride, which is under discussion, was perfectly normal or in fact low at 57, which did not make her a candidate for Vascepa. As recently as 2017, the first author of the REDUCE-IT study stated that to date, no large, multinational, randomized clinical trial has proved that lowering triglycerides on top of statin therapy improves cardiovascular outcomes. The literature cited makes it clear that Vascepa is not considered medically necessary for this patient. Therefore, the denial of coverage for Vascepa should be upheld.

The insurer acted reasonably, and with sound medical judgment, and in the patient's best interest.

Based on the above, the medical necessity for Vascepa is not substantiated.  The insurer's denial is upheld.