Appeal type: Medical necessity
Decision: Upheld

Diagnosis: Elevated Triglycerides.
Treatment: Vacepa.
The insurer denied the Vascepa.
The determination is upheld.

The patient has elevated triglycerides. The patient was prescribed Vascepa. The medication was denied because the patient did not have a history of atherosclerotic cardiovascular disease (ASCVD), or diabetes or 2 risk factors for ASCVD. It was also noted that he should be on a statin and his low density lipoprotein (LDL) should be below 100 milligrams per deciliter (mg/dl). The triglyceride level should be above 150. His lipid panel at the time of denial was not available.

According to an office visit note by his cardiologist, the patient was suffering from exertional fatigue. He has diabetes and he is on Crestor. The patient was taking fish oil and simvastatin and and his lipids were much better. The patient's cousin had bypass surgery. The patient was on losartan, however, there was no diagnosis of hypertension listed in his records.

He was on Crestor and his cholesterol was 102, triglycerides 311, high density lipoprotein (HDL) 32, low density lipoprotein (LDL) 8, and HbA1C 8.7. He was on simvastatin 20 and fish oil 2000 twice daily (bid), his cholesterol was 122, triglycerides 158, HDL 44, LDL 51, and Hba1C was 7.3. The patient underwent 3 stress nuclear stress tests, all of which were normal. At issue is the medical necessity of Vascepa.

The requested health service/treatment of Vascepa is not medically necessary for this patient.

This patient does not meet Food and Drug Administration (FDA) approved indications for Vascepa. He does not have ASCVD (3 normal stress nuclear tests). He has diabetes, but does not have any other coronary risk factors. Having a cousin with coronary artery bypass grafting (CABG) at young age is not a coronary risk factor. Based on FDA approved indications for Vascepa, a patient with diabetes mellitus (DM) has to have two more coronary risk factors. The patient does not meet FDA approved indications for Vascepa.

The FDA approved indications for Vascepa applicable to this patient are: "Vascepa (icosapent ethyl) is indicated as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (greater than or equal to [>=] 150 milligrams per deciliter (mg/dL)) and established cardiovascular disease or diabetes mellitus and 2 or more additional risk factors for cardiovascular disease". The approval was done based on REDUCE-IT trial which revealed improved cardiovascular mortality and morbidity in the patients with ASCVD, or diabetes with two more coronary risk factors and triglycerides (TGL) above 150 mg/dl. FDA approval was based on this single trial.

Per the first reference below, "Use of omega-3-fatty acids has in general not been shown to decrease ASCVD events. In contrast, the 2019 REDUCE-IT trial [Reduction of Cardiovascular Events With Icosapent Ethyl-Intervention Trial, which assessed the effects of 4 grams of icosapent ethyl (Vascepa) in high risk patients with persistently elevated triglycerides despite statin therapy, demonstrated a dramatic risk reduction (hazard ratio [HR] 0.75) in ASCVD events over a mean of 4.9 years. It is unclear whether the benefits seen in this trial are related to the higher eicosapentaenoic (EPA) dosage of 4 grams, the specific formulation chosen, the selected study population, or in part the possible deleterious effects of the mineral oil used as a placebo". (1)