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Pharmacy Clinical Policy Bulletins

Subject: Antilipidemic Agents - other

Class Edit Summary*
Status Drug PR PR-QL PR-AL ST M EX‡
P cholestyramine          
P fenofibrate          
P gemfibrozil          
P prevalite          
P Antara™ (fenofibrate)          
P Tricor® (fenofibrate)          
P Welchol® (colesevelam)          
P Niaspan® (niacin ER)          
NP Lopid® (gemfibrozil)          
FE Colestid® (colestipol)         X
FE Lipex® (policosanol)         X
FE Lofibra® (fenofibrate)         X
FE Omacor® (omega-3-acid ethyl esters)         X
FE Questran® / Questran® Light (cholestyramine)         X
FE Triglide™ (fenofibrate)         X
FE Vanachol® (Policosanol-DHA-EPA-Vit B6-Cobalamin-Folic Acid)         X

*P = Preferred; FE = Formulary Excluded; NP = Nonpreferred
PR = Precertification; QL = Quantity Limits; AL = Age Limits; ST = Step-Therapy
‡M EX = Medical Exception - This means the physician or health care professional must obtain a medical exception from Aetna, in order for the medication to be eligible for coverage. Medical Exception criteria apply to Formulary Excluded drugs for members enrolled in or covered by closed benefits plans, and also apply to Step-Therapy drugs in cases where a member's physician believes it is medically necessary for the member to use a step-therapy drug in the first instance without a trial of the prerequisite alternative drug(s).

Important Note

This Pharmacy Clinical Policy Bulletin expresses Aetna's determination of whether certain services or supplies are medically necessary. Aetna has reached these conclusions based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors). Aetna expressly reserves the right to revise these conclusions as clinical information changes, and welcomes further relevant information. Each benefits plan defines which services are covered, which are excluded, and which are subject to dollar caps or other limits. Members and their health care providers will need to consult the member's benefits plan to determine if there are any exclusions or other benefit limitations applicable to this service or supply. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered (that is, will be paid for by Aetna) for a particular member. The member's benefits plan determines coverage. Some plans exclude coverage for services or supplies that Aetna considers medically necessary. If there is a discrepancy between this policy and a member's plan of benefits, the benefits plan will govern. In addition, coverage may be mandated by applicable legal requirements of a state, the federal government or CMS for Medicare and Medicaid members. CMS's Coverage Issues Manual can be found on the following website: http://cms.hhs.gov/manuals/pub06pdf/pub06pdf.asp.

Policy

  1. Medical Exception Criteria

    Colestid, Lipex, Lofibra, Omacor, Questran/Questran Light ,Triglide and Vanichol are currently listed on the Aetna Formulary Exclusions List.* 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 Colestid, Lipex, Lofibra, Omacor, Questran/Questran Light, Triglide and Vanichol to be medically necessary for those members who meet the following criteria:

    1. A documented:
      • Contraindication to one preferred antilipidemic agent OR,
      • Intolerance to one preferred antilipidemic agent OR,
      • Allergy to one preferred antilipidemic agent OR,
      • Failure of an adequate trial of one month of one preferred antilipidemic agent

*Information regarding Aetna's Preferred Drug List, Formulary Exclusions list, Precertification and Step-Therapy lists is available on our website. In addition, members should refer to their plan documents and may call the toll-free telephone number on their ID card for information regarding their benefits. Health care professionals also may obtain information by calling the Pharmacy Management Precertification Unit at 1-800-414-2386, or they can register to use our password-protected provider website. Visit www.aetna.com, select "Doctors & Hospitals" and choose "Physician Self-Service." Once registration is completed, health care professionals may use our online Precertification/medical exception email request form.

The lists above are subject to change. Not all programs - for example step-therapy, precertification, and quantity limits - are available in all service areas (for example, step-therapy does not apply to fully insured New Jersey members).

Many medications on the Preferred Drug List are subject to manufacturer rebate arrangements between Aetna and the manufacturer of those medications. If the member's prescription benefits plan has a deductible or copay levels based on a percentage of Aetna's contracted rate with the participating pharmacy, the contracted rate does not include or reflect any manufacturer rebate arrangements between Aetna and the medication manufacturer. In prescription plans with a deductible or copayment or coinsurance tiers, use of drugs from the Preferred Drug List generally will result in lower costs to members. However, where the prescription plan utilizes a deductible or copayments or coinsurance calculated on a percentage basis, there could be some circumstances in which a preferred drug would cost the member more than a nonpreferred drug because (1) the negotiated pharmacy payment rate for the preferred drug may be more than the negotiated pharmacy payment rate for the nonpreferred drug, and (2) rebates received by Aetna from drug manufacturers are not reflected in the cost of a prescription drug obtained by a member. The Preferred Drug List is subject to change.

In evaluating clinically and therapeutically similar drugs for selection for the Preferred Drug List, Aetna reviews the costs of drugs and takes into account rebates negotiated between Aetna and drug manufacturers. Consequently, a drug may be included on the Preferred Drug list that is more expensive than a nonpreferred alternative before any rebates Aetna may receive from a drug manufacturer are taken into account. In addition, certain drugs may be chosen for "preferred" status because of their clinical or therapeutic advantages or level of acceptance among physicians even though they cost more than nonpreferred alternatives. The net cost to a self-funded plan sponsor for covered prescriptions will vary based on (1) the terms of Aetna's arrangements with participating pharmacies; (2) the amount of the member's copayment, coinsurance or deductible obligation under the terms of the plan; and (3) the percentage, if any, of rebates to which the plan sponsor is entitled under its agreement with Aetna. As a result, a self-funded plan sponsor's actual claim expense per prescription for a particular preferred drug may in some circumstances be higher than for a nonpreferred alternative.

For members in Texas, additions to the 2006 Preferred Drug List will be effective no later than January 1, 2006. In accordance with state law, fully insured members in Texas who are receiving coverage for medications that are removed from the Preferred Drug List during the plan year will continue to have those medications covered at the same benefit level until their plan's renewal date.

This definition of precertification is not the same as the definition used by Texas law. Our use of the term "precertification" relates to the prior authorization of your services by Aetna, based on our decision of whether the service is medically necessary. Precertification is not a guarantee of payment or "verification" as defined by Texas law.

California HMO members enrolled in a closed formulary benefits plan who are receiving coverage for medications that are moved to the Formulary Exclusions List, and California HMO members who are receiving coverage for medications added to the Precertification or Step-Therapy lists, will continue to have those medications covered, for as long as the treating physician continues prescribing them. This coverage, in accordance with state law, is only provided when the drug is appropriately prescribed and is considered safe and effective for treating the member's medical condition.

Nothing in this section shall preclude the prescribing health care professional from prescribing another drug covered by the plan that is medically appropriate for the enrollee, nor shall anything in this section be construed to prohibit generic drug substitutions.

Place of Service:

    Outpatient

The above policy is based on the following references:

  1. Gouni-Berthold I, Berthold HK. Policosanol: clinical pharmacology and therapeutic significance of a new lipid-lowering agent. Am Heart J. 2002;143:356-65.
  2. Pepping J. Policosanol. Am J Health Syst Pharm. 2003;60(11):1112-5.
  3. Expert Panel on Detection, Evaluation and Treatment of High Blood Cholesterol in Adults. Executive Summary of the Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). JAMA, May 16, 2001;285(19):2486-2497.
  4. NIH Consensus Development Panel on Triglyceride, High-Density Lipoprotein, and Coronary Heart Disease. Triglyceride, High-density lipoprotein and coronary heart disease. JAMA 1993; 269:505-10.
  5. Shviro I, Leitersdorf E. Targeted prevention of coronary artery disease: Pharmacological considerations in multimodality treatment. Cardiology 1996; 87:469-475.
  6. Frick MH, Flo O, Haapak et al: Helsinki heart study: primary prevention trial with gemfibrozil in middle aged men with dyslipidemia. N Engl J Med 1987; 317:1237-1245.
  7. Huttunen JK, Mannien V, Manttari M, Koskinen P, Romo M, Tenkanen L, Heinonen OP, Frick MH: The Helsinki Heart Study: central findings and clinical implications. Ann Med 1991, 23:155-159.
  8. Jen SL, Chen JW, Lee WL, Wang SP. Efficacy and safety of fenofibrate or gemfibrozil on serum lipid profiles in Chinese patients with type IIb hyperlipidemia; a single-blind, randomized, and cross-over study. Chin Med J. 1997;59-217-24.
  9. Fruchart JC, Brewer HB, Leitersdorf E. Consensus for the use of fibrates in the treatment of dyslipoproteinemia and coronary heart disease. Am J Cardiol. 1998;81:912-917.
  10. Gotto AM. Triglyceride: the forgotten risk factor. Circulation. 1998;97:1027-28.
  11. Criqui MH. Triglycerides and cardiovascular disease: a focus on clinical trials. Eur Heart J. 1998;19(suppl A):A36-A39.
  12. American Diabetes Association - Position Statement, Management of Dyslipidemia in Adults with Diabetes, Diabetes Care, January 2003;26(supp 1):S83-S86.
  13. Steiner G, Coronary Artery Disease in Diabetes: Results of the Diabetes Atherosclerosis Intervention Study (DIAS), Drug Benefit Trends, April 2001;13(supp. A): 15-21.
  14. Robins, SJ, The Veterans Affairs High-Density Lipoprotein Intervention Trial (VA-HIT): Low HDL, Diabetes, and the Benefit of Fibrate Therapy, Drug Benefit Trends, April 2001;13(supp. A): 23-27.
  15. Smith, SC, et al., AHA/ACC Guidelines for Preventing Heart Attack and Death in Patients with Atherosclerotic Cardiovascular Disease: 2001 Update. A Statement for Healthcare Professionals From the American Heart Association and the American College of Cardiology, Circulation, 2001;104:1577-1579.
  16. Report of the Working Group on Hypercholesterolemia and Other Dyslipidemias, Recommendations for the Management and treatment of dyslipidemia, CMAJ, May 16, 2000; 162(10):1441-7
  17. Knapp, HH, et al., Efficacy and Safety of Combination Simvastatin and Colesevelam in Patients with Primary Hypercholesterolemia, Am J Med, 2001; 110:352-360.
  18. Donovan, JM et al., Drug Interactions with Colesevelam Hydrochloride, a Novel, Potent Lipid-Lowering Agent, Cardiovascular Drugs and Therapy 2001; 14:681-690.
  19. Davidson, MH et al., Low-Dose Combination Therapy with Colesevelam Hydrochloride and Lovastatin Effectively Decreases Low-Density Lipoprotein Cholesterol in Patients with Primary Hypercholesterolemia, Clin Cardiol. June 2001; 24:467-474.
  20. Insull, W, et al., Effectiveness of Colesevelam Hydrochloride in Decreasing LDL cholestero in Patients with Primary Hypercholesterolemia: A 24-Week Randomized Controlled Trial, Mayo Clin Proc, October 2001; 76:971-982.
  21. Colesevelam Hydrochloride: A Novel Bile Acid-Binding Resin, Ann Pharmacother. 2001; 35:898-907.
  22. Sacks FM, Implications of Clinical Trial Results for the Reemerging Role of Fibrates, Drug Benefit Trends, April 2001;13(supp. A):29-34.
  23. Caslake, MJ, et al., Atherogenic Lipoprotein Phenotype in Non-Insulin Dependent Diabetes: Reversal with Micronized Fenofibrate. Diabetic Medicine. 1997; 14(supp 1):S12.
  24. Christov, V, Zlateva S. Treatment of Dyslipoproteinemias in NIDDM Patients with Fenofibrate. Cardiovascular Drugs & Therapy, 1997;11(E2):331
  25. Morgan, JM. et al., Treatment Effect of Niaspan, a Controlled-release Niacin, in Patients With Hypercholesterolemia: A Placebo-controlled Trial. J Cardiovasc Pharmacol Therapeut 1(3):195-202, 1996.
  26. Knopp, RH., et al., Equivalent Efficacy of a Time-Release From of Niacin (Niaspan) Given Once-a-Night Versus Plain Niacin in the Management of Hyperlipidemia. Metabolism, 1998;47(9):1097-1104.
  27. Olin BR, editor. Drugs Facts and Comparisons (electronic online version). St. Louis: J.B. Lippincott Company, 2005.
  28. USPDI Drug Information for the HealthCare Professional (online through Stat!Ref). Thomson MICROMEDEX, Greenwood Village, Colorado; 2005.
  29. McEvoy GK, editor. AHFS Drug Information (online through Stat!Ref). American Society of Health-Systems Pharmacists, Bethesda, Maryland; 2005.
  30. Lipex Product Information. Dormel Laboratories. 2002.
  31. Lofibra Product Information. Gate Pharmaceutical. 2002.
  32. Questran Product Information. Bristol Labs, Princeton NJ. June 1999.
  33. Colestid Tablets product package labeling, Pharmacia & Upjohn Company, Kalamazoo, MI. February 1999
  34. Medical Economics, Inc., PDR Electronic Library. Thomson Medical Economics, Montvale, NJ; 2003.
  35. Antara Product Information. Reliant Pharmaceuticals, Inc., Liberty Corner, NJ. October 2004.
  36. Lofibra Product Information. Gate Pharmaceuticals, Sellersville, PA. July 2003.
  37. Lopid Product Information. Parke-Davis/Pfizer Inc, New York, NY. October 2003.
  38. Triglide Product Information. Skye Pharma, San Diego, CA. January 2005.
  39. American Diabetes Association - Position Statement, Standards of Medical Care in Diabetes. Diabetes Care. 2005;28(supp 1):S15-S17.

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.

January 1, 2006