Under some plans, including plans that use an open or closed formulary, Fibricor issubject to step-therapy. Aetna considers Fibricor to be medically necessary for those members who meet the following step-therapy criteria:
A documented trial of one month of one of the following agents – fenofibrate, gemfibrozil, Antara, Tricoror Trilipix – alternatives on the Preferred Drug List
If it is medically necessary for a member to be treated initially with a medication subject to step-therapy, the member’s treating physician may contact the Aetna Pharmacy Management Precertification Unit to request coverage as a medical exception. (See criteria under section II below.)
Medical Exception Criteria
Fibricor is currently listed on the Aetna Formulary Exclusions and Aetna Step-Therapy Lists.* Therefore, Fibricor is excluded from coverage for members enrolled in prescription drug benefit plans that use a closed formulary or that require step-therapy criteria, unless a medical exception is granted. Aetna considers Fibricor to be medically necessary for those members who meet the following criteria:
Colestid, Fenoglide, Lipex, Lipofen, Lofibra, Lopid, Questran/Questran Light , and Triglide and 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, Fenoglide, Lipex, Lipofen, Lofibra, Lopid, Questran/Questran Light and Triglide to be medically necessary for those members who meet the following criteria:
For Fibricor
A. A documented:
Contraindication to one of the following preferred alternatives - fenofibrate, gemfibrozil, Antara, Tricor or Trilipix OR,
Intolerance to one of the following preferred alternatives - fenofibrate, gemfibrozil, Antara, Tricor or Trilipix OR,
Allergy to one of the following preferred alternatives - fenofibrate, gemfibrozil, Antara, Tricor or Trilipix OR,
Failure of an adequate trial of one month of one of the following preferred alternatives - fenofibrate, gemfibrozil, Antara, Tricor or Trilipix
For Colestid, Fenoglide, Lipex, Lipofen, Lofibra, Lopid, Questran/Questran Light and Triglide
A. 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
Place of Service:
Outpatient
The above policy is based on the following references:
Gouni-Berthold I, Berthold HK. Policosanol: clinical pharmacology and therapeutic significance of a new lipid-lowering agent. Am Heart J. 2002;143:356-65.
DrugPoints® System ( www.statref.com) Thomson Micromedex, Greenwood Village, CO. Updated periodically.
AHFS Drug Information® with AHFSfirstReleases®. ( www.statref.com), American Society Of Health-System Pharmacists®, Bethesda, MD. Updated periodically.
DRUGDEX® System [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically.
Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. Updated periodically.
Pepping J. Policosanol. Am J Health Syst Pharm. 2003;60(11):1112-5.
Shviro I, Leitersdorf E. Targeted prevention of coronary artery disease: Pharmacological considerations in multimodality treatment. Cardiology 1996; 87:469-475.
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.
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.
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.
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.
Gotto AM. Triglyceride: the forgotten risk factor. Circulation. 1998;97:1027-28.
Criqui MH. Triglycerides and cardiovascular disease: a focus on clinical trials. Eur Heart J. 1998;19(suppl A):A36-A39.
American Diabetes Association – Position Statement, Management of Dyslipidemia in Adults with Diabetes, Diabetes Care, January 2003;26(supp 1):S83-S86.
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.
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.
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.
Knapp, HH, et al., Efficacy and Safety of Combination Simvastatin and Colesevelam in Patients with Primary Hypercholesterolemia, Am J Med, 2001; 110:352-360.
Donovan, JM et al., Drug Interactions with Colesevelam Hydrochloride, a Novel, Potent Lipid-Lowering Agent, Cardiovascular Drugs and Therapy 2001; 14:681-690.
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.
Insull, W, et al., Effectiveness of Colesevelam Hydrochloride in Decreasing LDL cholesterol in Patients with Primary Hypercholesterolemia: A 24-Week Randomized Controlled Trial, Mayo Clin Proc, October 2001; 76:971-982.
Colesevelam Hydrochloride: A Novel Bile Acid-Binding Resin, Ann Pharmacother. 2001; 35:898-907.
Sacks FM, Implications of Clinical Trial Results for the Reemerging Role of Fibrates, Drug Benefit Trends, April 2001;13(supp. A):29-34.
Caslake, MJ, et al., Atherogenic Lipoprotein Phenotype in Non-Insulin Dependent Diabetes: Reversal with Micronized Fenofibrate.Diabetic Medicine. 1997; 14(supp 1):S12.
Christov, V, Zlateva S. Treatment of Dyslipoproteinemias in NIDDM Patients with Fenofibrate. Cardiovascular Drugs & Therapy, 1997;11(E2):331
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.
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.
American Diabetes Association – Position Statement, Standards of Medical Care in Diabetes. Diabetes Care. 2005;28(supp 1):S15-S17.
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.
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.
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.
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.
ATP III Guidelines At-A-Glance Quick Desk Reference. Available at www.nhlbi.nih.gov/guidelines/cholesterol/atglance.pdf. Accessed October 13, 2005.
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.
Grundy SM, Cleeman JI, Bairey CN, et al. for the Coordinating Committee of the National Cholesterol Edcation Program. Implications of recent clinical trials for the National Cholesterol Education Program Adult Treatment Panel III guidelines.Circulation. 2004;110:227-39.
Ascaso JF, Fernandez-Cruz A, Gonzalez Santos P, et al for the HDL Forum. Significance of high density lipoprotein-cholesterol in cardiovascular risk prevention: recommendations of the HDL Forum. Am J Cardiovasc drugs. 2004;4:299-314.
Prisant LM. Clinical trials and lipid guidelines for type II diabetes. J Clin Pharmacol. 2004;44:423-30.
Sharpe M, Ormrod D, Jarvis B. Micronized fenofibrate in dyslipidemia: a focus on plasma high-density lipoprotein cholesterol (HDL-C) levels. Am J Cardiovasc Drugs. 2002;2:125-32.
Wierzbicki AS, Mikhailidis DP, Wray R, et al. Statin-fibrate combination: therapy for hyperlipidemia: a review. Curr Med Res Opin. 2003;19:155-68.
SC, Allen J, Blair SN, et al. AHA/ACC Guidelines for secondary prevention for patients with coronary and other atherosclerotic vascular disease: 2006 update. Circulation. 2006;113:2363-2372.
Copyright 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.
*P = Preferred
FE = Formulary Excluded
NP = Nonpreferred
PR = Precertification
QL = Quantity Limits
AL = Age Limits
ST = Step-Therapy
‡M EX = Medical Exception
*The lists above are subject to change. Not all programs - for example step-therapy, precertification, and quantity limits - are available in all service areas.
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