Vascepa denials in California external review

What the reviewers wrote

Where the denial was overturned

Nature of Statutory Criteria/Case Summary: The patient is a female with bilateral leg discomfort, swelling, and weakness; left leg greater than right. Per the records, she has used compression stockings. The patient has not had a deep vein thrombosis or arterial disease. A venous duplex ultrasound showed left great saphenous vein reflux and right deep venous reflux. The patient has hyperlipidemia. The records noted an elevated triglyceride level of 575 on. She has had elevated homocysteine levels and is pre-diabetic. The patient has been treated with fenofibrate. The patient has requested coverage for Vascepa and left great saphenous vein ablation. The Health Plan denied the requests and reported the requested medication and requested services are not medically necessary for the treatment of this patient.

Nature of Statutory Criteria/Case Summary: An enrollee has requested Vascepa for treatment of her hypertension, hyperlipidemia and hypertriglyceridemia. Findings: The physician reviewer found that per the submitted records, this patient is at risk for coronary heart disease. The patient’s laboratory report includes very high triglycerides, and increased liver enzyme tests while on low intensity statin medication. In this circumstance where a patient presents with very high triglycerides, in spite of maximum tolerated statin medication, additional treatment to reduce triglyceride levels is clinically reasonable and appropriate. Standard accepted practice in the medical community supports treatment options of medications which are directed at reducing triglycerides. These medications include fibrates, nicotinic acid, and fish oil.

Where the denial was upheld

Nature of Statutory Criteria/Case Summary: An enrollee has requested authorization and coverage for Vascepa for treatment of the enrollee who has a history of coronary artery disease and dyslipidemia. Findings: The physician reviewer found that there is a lack of support in the documentation provided for the requested medication in this clinical setting. In this circumstance, treatment of hypertriglyceridemia is being considered to help reduced overall cardiovascular risk. Randomized trials have not directly compared most agents for the reduction of cardiovascular risk in patients with hypertriglyceridemia.

Findings: The physician reviewer found that Nature of Statutory Criteria/Case Summary: A patient has requested authorization and coverage for Vascepa (icosapent ethyl).The records document that this patient has a history of diabetes mellitus, hyperlipidemia, including hypertriglyceridemia, and elevated apolipoprotein B. There is no documentation of a prior clinical cardiovascular event. Coronary artery calcium scoring suggests atherosclerotic cardiovascular disease risk, and overall cardiovascular risk is elevated. The most recent lipid panel shows significantly elevated low-density lipoprotein cholesterol in the setting of diabetes mellitus, supporting the need for aggressive lipid-lowering therapy.The patient has not tolerated statin therapy due to myalgias.

These outcomes describe eligible cases completed through California DMHC’s Independent Medical Review program. They do not estimate the chance that an internal appeal, an external review in another jurisdiction, or your individual case will succeed. Use the record to identify evidence patterns involving Vascepa, then check the rights and deadlines that apply to your plan.