Appeal type: Medical necessity
Decision: Overturned

Diagnosis: CAD (coronary artery disease).
Treatment: Vascepa.
The insurer denied the Vascepa.
The denial is overturned.

The patient is a male with a long history of CAD (coronary artery disease), including CABG (coronary artery bypass graft) and PCIs (percutaneous coronary interventions). He continues to smoke and had COVID. He is on optimal medical therapy, including high dose atorvastatin. Patient did have evidence of TG (triglycerides) of 190. Tricor was also prescribed.

Coverage for the request for Vascepa was denied by the health plan. The denial explanation was that the patient was not on maximum statin therapy for at least 12 weeks.

Yes, the requested Vascepa is medically necessary.
Based on a review of the medical records and major society statements, it is evidenced that the patient does meet criteria, as he is on 89 mg (milligrams) of atorvastatin per day, with a triglyceride of 190.

Per the American College of Cardiology (ACC) Consensus Statement:

For patients with clinical ASCVD (atherosclerotic cardiovascular disease) and LDL-C (low density lipoprotein cholesterol) < [greater than] 70 mg/dL (milligrams per deciliter) and with persistent fasting triglycerides 150 and < [greater than] 500 mg/dL (milligrams per deciliter) who are on maximally tolerated statin therapy, the clinician should readdress lifestyle and medication adherence and reconsider possible secondary causes of hypertriglyceridemia. In the absence of these factors, it may be reasonable to add IPE (icosapent ethyl) as the next step.

The addition of IPE (icosapent ethyl) for those with clinical ASCVD (atherosclerotic cardiovascular disease) is supported not only by the achievement of the primary and secondary endpoints in the total study population of REDUCE-IT, but by the results reported in the prespecified secondary prevention subgroup.

The American Heart Association (AHA) Science Advisory released an advisory statement identifying icosapent ethyl as the first non-LDL (low density lipoprotein)-focused lipid therapy to demonstrate CV (cardiovascular) benefit. IPE (icosapent ethyl) was further recommended to be considered first-line therapy for patients with T2DM (type 2 diabetes mellitus) and CAD (coronary artery disease) whose triglycerides remain elevated (> [greater than] 135) despite maximally tolerated statin and lifestyle changes.

An American Association of Clinical Endocrinologists (AACE) Consensus Statement recommends to add icosapent ethyl 4 grams/day if high ASCVD (atherosclerotic cardiovascular disease) risk on maximally tolerated statins and TG (triglycerides) 135-499.

Per the American Diabetes Association (ADA) Standards of Medical Care in Diabetes:

ADA (American Diabetes Association) gives icosapent ethyl level "A" recommendation for patients with diabetes and ASCVD (atherosclerotic cardiovascular disease) or other CV (cardiovascular) risk factors on a statin with controlled LDL-C (low density lipoprotein cholesterol) and elevated TG (triglycerides) (135-499).

Per a National Lipid Association (NLA) Scientific Statement, Class I, Level B-R (STRONG) recommendation for the CV (cardiovascular) risk-lowering effects of icosapent ethyl for high-risk and very-high-risk patients with TG (triglyceride) 135-499 on statin therapy.

Therefore, given the above, the requested Vascepa is medically necessary.

No, the health plan did not act reasonably, with sound medical judgment, and in the best interest of the patient.
Based on the response to question 2, the patient has met criteria for Vascepa.