Subject: Antilipidemic Agents, Miscellaneous

Status	Drug	PR-B/D	PR	PR-QL	PR-AL	ST	M EX‡	TOC§
C	cholestyramine
C	colestipol granule packets, tablets
C	fenofibrate
C	gemfibrozil
C	Lovaza®  (omega-3-acid ethyl esters)		X
C	Niacor™ (niacin)
C	Niaspan®  (niacin ER)
C	prevalite
C	Tricor®  (fenofibrate)
NC	Antara®  (fenofibrate)						X
NC	Colestid®  (colestipol)						X
NC	Lipex®  (policosanol)						X
NC	Lipofen®  (fenofibrate)						X
NC	Lofibra®  (fenofibrate)						X
NC	Lopid®  (gemfibrozil)						X
NC	Questran®/Questran Light®  (cholestyramine)						X
NC	Triglide®  (fenofibrate)						X
NC	Welchol®  (colesevelam)						X
Note: Criteria for Lipitor, lovastatin, and Zocor are discussed in the Pharmacy Clinical Policy Bulletin: HMG CoA Reductase Inhibitors

Policy:

1. Precertification Criteria

Under some plans, including plans that use an open formulary, Lovaza is subject to precertification.   If precertification requirements apply Aetna considers Lovaza to be medically necessary for those members who meet both of the following precertification criteria:

A.  A documented diagnosis of hypertriglyceridemia (greater than 500 mg/dL)

OR

B.  If triglycerides less than 500 mg/dL, contraindication to fenofibrate because of hepatic dysfunction, including primary biliary cirrhosis, and unexplained, persistent liver function abnormality; severe renal dysfunction; preexisting gallbladder disease; or hypersensitivity to fenofibrate.


2. Medical Exception Criteria

Antara, Colestid, Lipex, Lipofen, Lofibra, Lopid, Questran/Questran Light, Triglide, and Welchol are currently Not Covered Part D drugs under the Aetna Medicare Prescription Drug Plan.*  Therefore, they are excluded from coverage for members enrolled in prescription drug benefit plans that use a closed formulary, unless a medical exception is granted.  Aetna considers Antara, Colestid, Lipex, Lipofen, Lofibra, Lopid, Niacor, Questran/Questran Light, Triglide and Welchol to be medically necessary for those members who meet the following criteria:

For Antara, Colestid, Lipex, Lipofen, Lofibra, Lopid, Questran/Questran Light, Triglide, and Welchol

A.  A documented:

• Contraindication to one covered antilipidemic agent OR
• Intolerance to one covered antilipidemic agent OR
• Allergy to one covered antilipidemic agent OR
• Failure of an adequate trial of one month of one covered antilipidemic agent

Place of Service:

Outpatient

The above policy is based on the following references:

1. DrugPoints® System ( www.statref.com) Thomson Micromedex, Greenwood Village, CO. Updated periodically.
2. AHFS Drug Information® with AHFSfirstReleases®. ( www.statref.com), American Society Of Health-System Pharmacists®, Bethesda, MD. Updated periodically.
3. DRUGDEX® System [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically.
4. Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. Updated periodically.
5. PDR® Electronic Library™ [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically.
6. Fick DM, Cooper JW, Wade WE, et al.  Updating the Beers criteria for potentially inappropriate medication use in older adults.  Arch Intern Med. 2003;163:2716-24.
7. Zahn C, Sangl J, Bierman AS, et al.  Potentially inappropriate medication use in the community-dwelling elderly.  JAMA.  2001;286:2823-29.
8. WS, et al. Safety and efficacy of Omacor in severe hypertriglyceridemia. J Cardiovasc Risk 1997;4(5-6): 385-91.
9. Borthwick L (UK Study Group). The effects of an omega-3 ethyl ester concentrate on blood lipid concentrations in patients with hyperlipidaemia. Clin Drug Invest 1998;15(5) 397-404.
10. Durrington PN, et al. An omega-3 polyunsaturated fatty acid concentrate administered for one year decreased triglycerides in simvastatin treated patients with coronary heart disease and persisting hypertriglyceridaemia.  Heart 2001;85:544-548.
11. Calabresi L, et al. Omacor in familial combined hyperlipidemia: effects on lipids and low density lipoprotein subclasses. Atherosclerosis 2000;148(2):387-96.
12. van Dam M, et al. Efficacy of concentrated n-3 fatty acids in hypertriglyceridaemia: a comparison with gemfibrozil. Clin Drug Invest 2001;21(3):175-181.
13. Lungershausen YK, et al. Reduction of blood pressure and plasma triglycerides by omega-3 fatty acids in treated hypertensives. J Hypertens 1994;12(9): 1041-5.
14. Johansen O, et al. n-3 fatty acids do not prevent restenosis after coronary angioplasty: results from the CART study. J Am Coll Cariol 1999;33:1619-26.
15. Donadio jr. JV, et al., A randomized trial of high dose compared with low dose omega-3 fatty acids in severe IgA nephropathy. J Am Soc Nephrol 2001;12:791-799.
16. Hogg RJ, Waldo B. Advances in treatment: immunoglobulin A nephropathy. Semi Nephrol 1996;16(6):511-6.
17. Donadio JV, Grande JP. The role of fish oil/omega-3 fatty acids in the treatment of IgA nephropathy. Semin Nephrol 2004; 24(3): 225-43.
18. Parinyasiri U, et al. Effect of fish oil on oxidative stress, lipid profile and renal function in IgA nephropathy. J Med Assoc Thai 2004;87(2):143-9.
19. GISSI-Prevention Investigators. Dietary supplementation with n-3 polyunsaturated fatty acids and vitamin E after myocardial infarction: results of the GISSI-prevention trial. Lancet 1999;354:447-455.
20. Chan DC, et al. Regulatory effects of HMG CoA reductase inhibitor and fish oils on apolipoprotein B-100 kinetics in insulin-resistant obese male subjects with dyslipidemia.  Diabetes 2002;51: 2377-2386.
21. Pownall HJ, et al. Correlation of serum triglyceride and its reduction by omega-3 fatty acids with lipid transfer activity and the neutral lipid compositions of high-density and low-density lipoprotein.  Atheroscerlosis 1999; 143(2): 285-97.
22. Stalenhoef AFH, et al. The effect of concentrated n-3 fatty acids versus gemfibrozil on plasma lipoproteins, low density lipoprotein heterogeneity and oxidazability in patients with hypertriglyceridemia.  Atherosclerosis 2000;153: 129-138.
23. Nordoy A, Bonaa KH, et al.  Effects of simvastatin and omega-3 fatty acids on plasma lipoproteins and lipid peroxidation in patients with combined hyperlipidaemia.  Journal of Internal Medicine 1998; 243: 163-170.
24. Nordoy A, Hansen JB, et al. Effects of atorvastatin and omega-3 fatty acids on LDL subtractions and postprandial hyperlipidemia.  Nutr Metab Cardiovas Dis 2001; 11:7-16.
25. Nordoy A, Bonaa KH, et al. Effect of omega-3 fatty acids and simvastatin on hemostatic risk factors and postprandial hyperlipidemia in patients with combined hyperlipemia.  Arterioscler Thromb Vasc Biol 2000; 20:259-265. 
26. Grundy SM, et al-for the Coordinating Committee of the National Cholesterol Education Program (NCEP). Implication of recent clinical trials for the national cholesterol education program adult treatment panel III guidelines. Circulation 2004;110:227-239.
27. Aronow WS. Treatment of high-risk older persons with lipid-lowering drug therapy. Am J Ther. 2008;15(2):102-7.
28. Zambon A, Cusi K. The role of fenofibrate in clinical practice. Diab Vasc Dis Res. 2007;4:S15-20.
29. Saha SA, Kizhakepunnur LG, Bahekar A, Arora RR. The role of fibrates in the prevention of cardiovascular disease--a pooled meta-analysis of long-term randomized placebo-controlled clinical trials. Am Heart J. 2007;154(5):943-53.
30. Davidson MH, Armani A, McKenney JM, Jacobson TA. Safety considerations with fibrate therapy. Am J Cardiol. 2007;99(6A):3C-18C.

 

ARCHIVE VERSION

Property of Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

July 31, 2009