Omega-3 Fatty Acid Products

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1 Omega-3 Fatty Acid Products Policy Number: Last Review: 7/2016 Origination: 6/2014 Next Review: 7/2017 Policy Blue Cross and Blue Shield of Kansas City (Blue KC) will provide coverage for the Omega-3 Fatty Acid products Lovaza and Vascepa when it is determined to be medically necessary because the following criteria are met. When Policy Topic is covered Recommended Authorization Criteria Coverage of omega-3 fatty acid products (Lovaza and Vascepa) is recommended in those who meet the following criteria: Food and Drug Administration (FDA)-Approved Indication 1. Hypertriglyceridemia with Triglyceride (TG) Levels 500 mg/dl. Approve if the patient meets the following criteria (A and B): A) The patient has a fasting baseline (pretreatment) triglyceride (TG) level of 500 mg/dl; AND B) The patient meets one of the following criteria (i or ii): i. The patient has tried, or is currently receiving, one of the following products: niacin (immediate-release or extended-release), a fibrate (e.g., gemfibrozil, fenofibrate, fenofibric acid), or a statin (e.g., atorvastatin, simvastatin); OR ii. The patient has tried one over-the-counter (OTC) omega-3 fatty acid product (e.g., fish oil supplements) and has not achieved adequate efficacy according to the prescribing physician. Lovaza and Vascepa are indicated as an adjunct to diet to reduce TG levels in adult patients with severe ( 500 mg/dl) hypertriglyceridemia. 1-4 TG levels 500 mg/dl are rare, occurring in only 1% to 2% of patients. 5 Guidelines that discuss hypertriglyceridemia from the AACE, and the Endocrine Society, as well as a scientific statement from the AHA, note that many agents lower TGs as monotherapy (e.g., fibrates, niacin, statins), and that TG-lowering and lipid-altering agents are used in combination for some patients. 5-7 Oftentimes patients with hypertriglyceridemia have other lipid abnormalities and may be receiving additional therapies to improve the overall lipid profile or for synergistic effects to obtain lipid goals. Additionally, other lipid-altering therapies have proven clinical benefits beyond improving the lipid profile (e.g., statins have been shown to reduce the risk of CV events). Omega-3 fatty acid supplements are available as OTC preparations. Some products are more concentrated than others and some have been verified through the US Pharmacopeial Convention (USP) to assure that the supplement does not contain harmful substances and that good manufacturing practices have been followed. In the professional opinion of specialist physicians reviewing the data, we have adopted these criteria. Other Uses with Supportive Evidence 2. Hypertriglyceridemia with Triglyceride (TG) Levels of 150 mg/dl to < 500 mg/dl. Approve if the patient meets the following criteria (A and B):

2 A) The patient has a fasting baseline (pretreatment) triglyceride (TG) level of 150 mg/dl to < 500 mg/dl; AND B) The patient meets one of the following criteria (i or ii): i. The patient has tried or is currently receiving, one of the following products: niacin (immediate-release or extended-release), a fibrate (e.g., gemfibrozil, fenofibrate, fenofibric acid), or a statin (e.g., atorvastatin, simvastatin); OR ii. The patient has tried one over-the-counter (OTC) omega-3 fatty acid product (e.g., fish oil supplements) and has not achieved adequate efficacy according to the prescribing physician. Lovaza and Vascepa have been studied in patients with TG levels 200 mg/dl and < 500 mg/dl in patients who had persistently high TGs despite treatment with statin therapy and proper dietary modifications. 8-9 In these short-term trials lasting 6 to 12 weeks in duration, the addition of omega-3 fatty acid therapy led to further reductions in TG levels. 8-9 Guidelines that discuss hypertriglyceridemia from the AACE, and the Endocrine Society, as well as a scientific statement from the AHA, note that many other agents lower TGs as monotherapy (e.g., fibrates, niacin, statins,), and that TG-lowering and lipid-altering agents are used in combination for some patients. 5-7 Oftentimes patients with hypertriglyceridemia have other lipid abnormalities and may be receiving additional therapies to improve the overall lipid profile or for synergistic effects to obtain lipid goals. Additionally, other lipid-altering therapies have proven clinical benefits beyond improving the lipid profile (e.g., statins have been shown to reduce the risk of CV events). Omega-3 fatty acid supplements are also available as OTC preparations. Some products are more concentrated than others and some have been verified through the USP to assure that the supplement does not contain harmful substances and that good manufacturing practices have been followed. In the professional opinion of specialist physicians reviewing the data, we have adopted these criteria. When Policy Topic is not covered Conditions Not Recommended for Approval Omega-3 fatty acid products (Lovaza and Vascepa) have not been shown to be effective, or there are limited or preliminary data or potential safety concerns that are not supportive of general approval for the following conditions. (Note: This is not an exhaustive list of Conditions Not Recommended for Approval.) 1. Coverage is not recommended for circumstances not listed in the Recommended Authorization Criteria. Criteria will be updated as new published data are available. Considerations The Omega-3 Fatty Acid products Lovaza and Vascepa require prior authorization through the pharmacy services department. This Blue Cross and Blue Shield of Kansas City policy Statement was developed using available resources such as, but not limited to: Hayes Medical Technology Directory, Food and Drug Administration (FDA) approvals, Facts and Comparisons, National specialty guidelines, Local medical policies of other health plans, Medicare (CMS), Local providers. Description of Procedure or Service Lovaza and Vascepa are indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe ( 500 mg/dl) hypertriglyceridemia. 1-2 Lovaza is a combination of ethyl esters of omega-3 fatty acids, principally eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA). 1 The daily dose of Lovaza is 4 g/day taken as a single 4-gram dose (four capsules) or as two 2-gram doses (two capsules given twice daily [BID]). Each 1-gram capsule of Lovaza contains at least 900 mg of ethyl esters of omega-3 fatty acids sourced from fish oils (approximately 465 mg of EPA and 375 mg of DHA). 1 Vascepa is an ethyl ester of the omega-3 fatty acid EPA. 2 The daily dose of Vascepa is 4 g/day taken as two 1-gram capsules BID with food. 2 The safety and effectiveness in pediatric patients have not been established for either of these agents. With omega-3 fatty acid products, common

3 adverse events (AEs) include dyspepsia, eructation, taste perversion, and arthralgia. Both agents have it noted in their prescribing information that the effects on the risk for pancreatitis, as well as the effect on cardiovascular (CV) mortality and morbidity, have not been determined. Of note Epanova (omega- 3-carboxylic acid capsules) and Omtryg (omega-3-acid ethyl esters A capsules) are two other omega- 3 fatty acid products that were approved by the FDA with similar indications but have not been marketed yet. 3-4 They are not discussed further in this document. Rationale Guidelines/Scientific Statements American Heart Association (AHA) In 2011, the AHA published a scientific statement regarding TGs and CV disease. 5 Approximately 31% of patients in the US have TG values 150 mg/dl. Very high TG values ( 500 mg/dl) only occur in 1% to 2% of patients. TG levels associated with a risk of TG-induced pancreatitis are usually 1,000 mg/dl. Many lipid-lowering therapies decrease TG levels. As monotherapy, fibrates have demonstrated the strongest TG reduction (30% to 50%), followed by immediate-release niacin (20% to 50%), omega-3 methyl esters (20% to 50%), extended-release niacin (10% to 30%), statins (10% to 30%) and Zetia (ezetimibe tablets) [5% to 10%]. Therapeutic lifestyle changes (e.g., proper nutrition, exercise and weight loss [if needed]) can reduce TG values by up to 50%. If patients have elevated low-density lipoprotein cholesterol (LDL-C) and elevated TG levels, statin therapy may be beneficial. Use of 4 g of marine-derived omega-3 polyunsaturated fatty acid (PUFA) per day decreased serum TG concentrations by approximately 25% to 30%, along with increases of 5% to 10% in LDL-C and 1% to 3% in high-density lipoprotein cholesterol (HDL-C). There is an approximate 5% to 10% reduction in TGs for every 1 g of EPA/DHA consumed and efficacy appears greater in patients with higher pretreatment TG levels.

4 American Association of Clinical Endocrinologists (AACE) In 2012, the AACE developed guidelines for the management of dyslipidemia and prevention of atherosclerosis. 6 TG levels < 150 mg/dl are optimal for patients. Fibrates are recommended for the treatment of severe hypertriglyceridemia (TG > 500 mg/dl). Niacin can be used for TG reduction, increasing HDL-C, and reducing LDL-C. For both medications, adjunctive use of 2 to 4 g/day of omega-3 fish oil can be used, if needed, to obtain TG goals. Omega-3 fatty acid (fish oil) supplementation is effective in reducing TG, with studies showing reductions of 30% to 50%. Also, combination therapy with niacin or fibrates with statins may be appropriate for patients with hypertriglyceridemia and related low HDL-C. Considerations with statin therapy include monitoring of liver function, and awareness that myalgias and muscle weakness occur in some patients. Some statins have a potential for drug-drug interactions; myopathy or rhabdomyolysis may occur in rare cases, but the risk is increased when given with certain medications. Albeit rare, fibrates (i.e., gemfibrozil, fenofibrate, fenofibric acid) may lead to myopathy and rhabdomyolysis; the risk is increased when used with a statin (interaction less likely with fenofibrate or fenofibric acid). Fibrates may increase serum creatinine levels and are associated with gastrointestinal (GI) symptoms. Niacin has the potential for frequent skin flushing, pruritus, abdominal discomfort, hepatoxicity, nausea and peptic ulcers. Niacin may also have effects on serum glucose (diabetes) at higher dosages, as well as increases in uric acid levels, which may lead to gout. Endocrine Society In 2012, the Endocrine Society 7 published a clinical practice guideline regarding the evaluation and treatment of hypertriglyceridemia. Lifestyle changes, including dietary counseling, physical activity, and weight reduction (if needed) are essential in the treatment of mild to moderate hypertriglyceridemia. The guidelines note that fibrates should be strongly considered for patients with severe and very severe hypertriglyceridemia and should be considered in those with moderate hypertriglyceridemia. Fibrates decrease TG levels by 30% to 50%. At doses of 500 to 2,000 mg/day, niacin lowers TGs by 10% to 30%, increases HDL-C by 10% to 40%, and lowers LDL-C by 5% to 20%. Niacin can lead to cutaneous flushing, hepatotoxicity (which is dose dependent), and impairments in glucose tolerance. Long-chain marine omega-3 fatty acids (EPA and DHA) lower fasting and postprandial TG levels in a dose-dependent manner. Approximately 3 to 4 g/day of EPA plus DHA reduce TG levels by 20% to 50%. Reductions in TG levels can increase the levels of LDL-C. No studies using high-dose omega-3 fatty acids in hypertriglyceridemia have shown beneficial CV outcomes. Omega-3 fatty acids (e.g., Lovaza) may be considered for treating TG levels > 1,000 mg/dl. Over-the-counter (OTC) preparations of omega-3 fatty acids have variable quantities of EPA and DHA ranging from 20% to 50%, depending on the products. The nutrition labels should be evaluated to calculate the number of capsules required. Lovaza, at a dose of four capsules, lowers TG levels by 30% to 50%. AEs with large doses of omega-3 fatty acids include fishy taste and burping. Statins have modest TG-lowering effects (10% to 15%), which appear to be dose dependent. High doses of statins (atorvastatin 80 mg or Crestor [rosuvastatin tablets] 40 mg) can lower plasma TG levels by 25% to 30%. Statin monotherapy should not be used first-line to reduce TG levels in patients with severe or very severe hypertriglyceridemia (> 1,000 mg/dl). Adding statin therapy may be considered to reduce CV risk in patients with mild to moderate hypertriglyceridemia (TG > 150 mg/dl and < 1,000 mg/dl). Of note, fibrates, niacin, omega-3 fatty acids, and statins all have different mechanisms of action in reducing TG levels, and also correct other dyslipidemias. There is potential for combination use considering complementary mechanisms of action. References 1. Lovaza capsules [prescribing information]. Research Triangle Park, NC: GlaxoSmithKline; May Vascepa capsules [prescribing information]. Bedminster, NJ: Amarin; June Epanova capsules [prescribing information]. Wilmington, DE: AstraZeneca Pharmaceuticals; May Omtryg [prescribing information]. Arlington, CA: Trygg Pharma; April Miller M, Stone NJ, Ballantyne C, et al. Triglycerides and cardiovascular disease: a scientific statement from the American Heart Association. Circulation. 2011;123: Available at Accessed on 5, 2016.

5 6. Jellinger PS, Smith DA, Mehta AE, et al, for the AACE Task Force for the Management of Dyslipidemia and Prevention of Atherosclerosis. American Association of Clinical Endocrinologists guidelines for management of dyslipidemia and prevention of atherosclerosis. Endocrin Pract. 2012;18(Suppl 1):1-78. Available at Accessed on April 5, Berglund L, Brunzell JD, Goldberg AC, et al. Evaluation and treatment of treatment of hypertriglyceridemia: an endocrine society clinical practice guideline. J Clin Endocrinol Metab. 2012;97(9): Davidson MH, Stein EA, Bays HE, et al, for the COMBination of prescription Omega-3 with Simvastatin (COMBOS) investigators. Efficacy and tolerability of adding prescription omega-3 fatty acids 4 g/d to simvastatin 40 mg/d in hypertriglyceridemic patients: an 8-week, randomized, doubleblind, placebo-controlled study. Clin Ther. 2007;29(7): Ballantyne CM, Bays HE, Kastelein JJ, et al. Efficacy and safety of eicosapentaenoic acid ethyl ester (AMR 101) therapy in statin-treated patients with persistent high triglycerides (from the ANCHOR) study. Am J Cardiol. 2012;110(7): Billing Coding/Physician Documentation Information Pharmacy benefit Additional Policy Key Words Policy Number: Policy Implementation/Update Information 06/ / /2016 New Policy titled Omega-3 Fatty Acid Products Annual Review no changes made Annual review- no changes made to policy statement State and Federal mandates and health plan contract language, including specific provisions/exclusions, take precedence over Medical Policy and must be considered first in determining eligibility for coverage. The medical policies contained herein are for informational purposes. The medical policies do not constitute medical advice or medical care. Treating health care providers are independent contractors and are neither employees nor agents Blue KC and are solely responsible for diagnosis, treatment and medical advice. No part of this publication may be reproduced, stored in a retrieval system or transmitted, in any form or by any means, electronic, photocopying, or otherwise, without permission from Blue KC.

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