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Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.
DESCRIPTIONLovaza® (omega-3-acid ethyl esters) is a prescription fish oil product which contains both eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), and is indicated as an adjunct to diet to reduce triglycerides in adult patients with severe (> 500 mg/dL) hypertriglyceridemia.
Hypertriglyceridemia is an excess of triglycerides in the blood. Mild to moderate hypertriglyceridemia increases the risk of cardiovascular disease and severe hypertriglyceridemia increases the risk of pancreatitis. According to the Third Report of the National Cholesterol Education Program Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (NCEP ATP III), triglyceride levels of 150-199 mg/L are considered borderline-high, while levels of 200-499 mg/dL are considered high and >500 mg/dL are considered very high. The Endocrine Society has modified the NCEP ATP III classification of hypertriglyceridemia to include very severe hypertriglyceridemia (>2,000 mg/dL) and severe triglyceridemia (1,000-1,999 mg/dL). Patients with very severe hypertriglyceridemia are at risk for pancreatitis.
The Endocrine Society Clinical Practice Guideline for the Evaluation and Treatment of Hypertriglyceridemia recommends treatment with a fibrate as first-line therapy for the reduction of triglycerides in patients at risk for pancreatitis. Fibrates, niacin and n-3 fatty acids are recommended alone or in combination with statins for the treatment of patients with moderate to severe triglyceride levels.
Previous use of samples or vouchers/coupons will not be considered for authorization.
Lovaza will be approved the following criteria are met:
POLICY EXCEPTIONSLovaza prior authorization is not required for Federal Employee Program (FEP) and State Health Plan members.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.
01/01/2014: New policy added.
07/31/2015: Code Reference section updated for ICD-10.
10/26/2015: Policy section updated to state: Previous use of samples or vouchers/coupons will not be considered for authorization.
05/27/2016: Policy number added. Investigative definition updated in Policy Guidelines.
06/13/2016: Approved by Pharmacy & Therapeutics (P&T) Committee.
SOURCE(S)1. Rosenson R. Approach to the patient with hypertriglyceridemia. UptoDate. Last updated February 7, 2013, Available from http://www.uptodate.com
2. Lovaza® [package insert]. Research Triangle Park (NC): GlaxoSmithKline.
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.
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