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Pharmacy Clinical Policy Bulletins
Aetna Medicare Prescription Drug Plan
Subject: Antilipidemic Agents – HMG CoA Reductase Inhibitors

Status Drug PR-B/D PR PR-QL PR-AL ST M EX‡ TOC§
C Crestor®  (rosuvastastin)     X        
C Lipitor®  (atorvastatin)     X        
C lovastatin     X        
C pravastatin     X        
C simvastatin     X        
C Vytorin®  (simvastatin/ ezetimibe)     X        
NC Advicor®  (lovastatin/ niacin ER)     X     X  
NC Altoprev®  (lovastatin ER)     X   X X  
NC Caduet®  (atorvastatin/ amlodipine)     X   X X  
NC Lescol®  (fluvastatin)     X   X X  
NC Lescol XL®  (fluvastatin ER)     X   X X  
NC Mevacor®  (lovastatin)     X   X X  
NC Pravachol®  (pravastatin)     X   X X  
NC Zocor®  (simvastatin)     X   X X  
Calcium channel blocker
C amlodipine     X        
C Norvasc®  (amlodipine)     X        
Note: Criteria for Norvasc/amlodipine are discussed in Pharmacy Clinical Policy Bulletin: Calcium Channel Blockers, Dihyldropyridines 


Policy:

  1. Precertification Criteria

    2. Under some plans, including plans that use an open or closed formulary, Advicor, Altoprev, Caduet, Crestor, Lescol, Lipitor, lovastatin, Mevacor, Pravachol, pravastatin, simvastatin, Vytorin, and Zocor are subject to precertification.  If precertification requirements apply Aetna considers Advicor, Altoprev, Caduet, Crestor, Lescol, Lipitor, lovastatin, Mevacor, Pravachol, pravastatin, simvastatin, Vytorin, and Zocor to be medically necessary for those members who meet the following precertification criteria:

    According to the manufacturer, the HMG CoA reductase inhibitors can be dosed up to a maximum daily dose at the interval(s) as indicated in the table below. A quantity of each drug will be considered medically necessary as indicated in the table below:

    Drug Maximum Daily Dose/ Dosing Interval Dosage Strength Quantity Limits
    Advicor 2000/40 mg/ once or twice daily 500/20mg, 750/20mg, 1000/20mg, 1000/40mg Up to 60 tablets in 30 days
    Altoprev 60 mg/ once daily 10mg, 20mg Up to 30 tablets in 30 days
    Altoprev 60 mg/ once daily 40mg Up to 30 tablets in 30 days
    Altoprev 60 mg/ once daily 60mg Up to 30 tablets in 30 days
    Caduet 10/80 mg/ once daily 2.5/10, 2.5/20, 2.5/40, 5/10, 5/20, 5/40, 5/80, 10/10, 10/20, 10/40, 10/80 Up to 30 tablets in 30 days
    Crestor 40 mg/ once daily 5, 10, 20mg Up to 30 tablets in 30 days
    Crestor 40 mg/ once daily 40mg Up to 30 tablets in 30 days
    Lescol 80 mg/ twice daily 20mg, 40mg Up to 60 tablets in 30 days
    Lescol XL 80 mg/ once daily 80mg Up to 30 tablets in 30 days
    Lipitor 80 mg/ once daily 10, 20, 40mg Up to 30 tablets in 30 days
    Lipitor 80 mg/ once daily 80mg Up to 30 tablets in 30 days
    lovastatin 80 mg/ twice daily 10mg, 20mg Up to 60 tablets in 30 days
    lovastatin 80 mg/ twice daily 40mg Up to 60 tablets in 30 days
    Mevacor 80 mg/ twice daily 10mg, 20mg Up to 60 tablets in 30 days
    Mevacor 80 mg/ twice daily 40mg Up to 60 tablets in 30 days
    pravastatin Pravachol 80 mg/ once daily 10 mg, 20 mg, 40 mg, 80mg Up to 30 tablets in 30 days
    Vytorin 10 mg/80 mg/ once daily 10-10, 10-20, 10-40, and 10-80 mg Up to 30 tablets in 30 days
    simvastatin 80 mg/ once daily 5,10,20,40mg Up to 30 tablets in 30 days
    simvastatin Zocor 80 mg/ once daily 80mg Up to 30 tablets in 30 days


    For coverage of additional quantities, a member's treating physician must request prior authorization through the Aetna Pharmacy Management Precertification Unit.  Additional quantities of HMG CoA reductase inhibitors will be considered medically necessary for those members who meet ANY of the following criteria:

    • Member requires a dose including half tablets OR
    • Member's dose is being titrated by physician (3-month limit) OR
    • Member has had intolerance to drug administered as a single daily dose OR
    • Member has failed combination therapy and requires higher dose of HMG CoA Reductase Inhibitor (for highest dosage strength of each drug only) OR
    • Member's physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for use of a higher dose


  2. Step Therapy Criteria

    3. Under some plans, including plans that use an open or closed formulary, Altoprev, Caduet, Lescol, Lescol XL, Mevacor, Pravachol and Zocor are subject to step-therapy.  Aetna considers these drugs to be medically necessary for those members who meet the step-therapy criteria as specified below:

    For Altoprev and Mevacor
    A documented trial of one month of the preferred generic alternative lovastatin (any strength).

    For Lescol and Lescol XL
    A documented trial of one month of Crestor, Lipitor (at a dose of 40mg/day or higher), lovastatin (at a dose of 20mg/day or higher), pravastatin, simvastatin (at a dose of 40mg/day or higher) or Vytorin - alternatives on the Aetna Medicare Preferred Drug List.

    For Caduet
    A documented trial of one month of concurrent use of both amlodipine or Norvasc and one of the following:  Lipitor, Vytorin (any dose) OR Crestor OR simvastatin (at a dose of 40mg/day or higher) - alternatives on the Aetna Medicare Preferred Drug List.

    For Pravachol
    A documented trial of one month of the preferred generic equivalent pravastatin (any strength).

    For Zocor
    A documented trial of one month of the preferred generic equivalent simvastatin (any strength)

    If it is medically necessary for a member to be initially treated 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 at 1-800-414-2386. (See criteria under section III below.)

  3. Medical Exception Criteria

    4. Advicor, Altoprev, Caduet, Lescol, Lescol XL, Mevacor, Pravachol and Zocor 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 Advicor, Altoprev, Caduet, Lescol, Lescol XL, Mevacor, Pravachol and Zocor to be medically necessary for those members who meet ANY of the following criteria:

    For Lescol and Lescol XL

    A. Member has a documented

    • Contraindication to Crestor, Lipitor, lovastatin, pravastatin, simvastatin or Vytorin OR
    • Intolerance to Crestor, Lipitor , lovastatin, pravastatin, simvastatin or Vytorin OR
    • Allergy to Crestor, Lipitor, lovastatin, pravastatin, simvastatin or Vytorin OR
    • Failure of an adequate trial of one month of Crestor, Lipitor (at a dose of 40mg/day or higher), lovastatin (at a dose of 20mg or higher), pravastatin,  simvastatin (at a dose of 40mg/day or higher) or Vytorin

    OR

    B. Member is receiving another medication with a potentially clinically significant drug interaction with Crestor, Lipitor, lovastatin, pravastatin, simvastatin or Vytorin

    • Potentially interacting drugs include, but are not limited to: gemfibrozil (Lopid), fenofibrate (Tricor), niacin (dose > 1 gram/day); verapamil; amiodarone (Cordarone); cyclosporine (Neoral, Sandimmune); itraconazole (Sporanox); ketoconazole (Nizoral); danazol; erythromycin; clarithromycin (Biaxin); telithromycin (Ketek); nefazodone (Serzone); warfarin (Coumadin); HIV reverse transcriptor inhibitors: such as Zerit (stavudine or d4T) and HIV protease inhibitors: such as amprenavir (Agenerase), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir (Kaletra), nelfinavir (Viracept), ritonavir (Norvir), saquinavir (Fortovase, Invirase); tipranavir (Aptivus).


    For Altoprev and Mevacor

    A.    Member has a documented

    • Contraindication to the preferred generic alternative lovastatin OR
    • Intolerance to the preferred generic alternative lovastatin OR
    • Allergy to the preferred generic alternative lovastatin OR
    • Failure of an adequate trial of one month of the preferred generic alternative lovastatin (any strength)


    For Advicor

    A.   Member has a documented

    • Contraindication to Crestor, fenofibrate, gemfibrozil, Lipitor, lovastatin, pravastatin, simvastatin, Tricor or Vytorin OR
    • Intolerance to Crestor, fenofibrate, gemfibrozil, Lipitor, lovastatin, pravastatin, simvastatin, Tricor or Vytorin OR
    • Allergy to Crestor, fenofibrate, gemfibrozil, Lipitor, lovastatin, pravastatin, simvastatin, Tricor or Vytorin OR
    • Failure of an adequate trial of one month of Crestor, fenofibrate, gemfibrozil, Lipitor, lovastatin, pravastatin, simvastatin, Tricor or Vytorin OR
    • Member is already receiving lovastatin and niacin ER for antilipidemic therapy (Advicor only)


    For Pravachol

    A.    Member has a documented

    • Contraindication to the preferred generic equivalent pravastatin OR
    • Intolerance to the preferred generic equivalent pravastatin OR
    • Allergy to the preferred generic equivalent pravastatin OR
    • Failure of an adequate trial of one month of the preferred generic equivalent pravastatin (any strength)


    For Zocor

    A.   Member has a documented

    • Contraindication to the preferred generic equivalent simvastatin OR
    • Intolerance to the preferred generic equivalent simvastatin OR
    • Allergy to the preferred generic equivalent simvastatin OR
    • Failure of an adequate trial of one month of the preferred generic equivalent simvastatin (any strength)


    For Caduet

    A.     Member is already receiving amlodipine or Norvasc AND atorvastatin/Lipitor for antihypertensive and   
             antilipidemic therapy.
    OR

    B.      Member is documented to be currently on Caduet.

    OR

    C.    Member is receiving amlodipine or Norvasc and has a documented:

    • Contraindication to one of the preferred alternatives, Crestor, simvastatin or Vytorin  OR
    • Intolerance to one of the preferred alternatives, Crestor, simvastatin or Vytorin  OR
    • Allergy to one of the preferred alternatives, Crestor, simvastatin or Vytorin  OR
    • Failure of an adequate trial of one month of one of the preferred alternatives, Crestor, simvastatin (at a dose of 40mg/day or higher) or Vytorin 

Place of Service:

Outpatient

The above policy is based on the following references:
  1. 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.
  2. Pasternack, R, Adult Treatment Panel II versus Adult Treatment Panel III: What Has changed and Why?, Amer. Journal of Cardiology, March 7, 2002; 89(5A):3C-7C.
  3. Isaacsohn, J, et al., The Impact of the National Cholesterol Education Program Adult Treatment Panel III Guidelines on Drug Development, Amer. Journal of Cardiology, March 7, 2002; 89(5A):45C-49C.
  4. Stein, EA, Managing Dyslipidemia in the High-Risk Patient, Amer. Journal of Cardiology, March 7, 2002; 89(5A):50C-57C.
  5. Metz, CA, Alternate-Day Dosing of HMG-CoA Reductase Inhibitors for Cholesterol Reduction, Ann Pharmacother, 2001;35:496-500.
  6. Klungel, OF, et al., Lipid-Lowering Drug Use and Cardiovascular Events After Myocardial Infarction, Ann Pharmacother, May 2002; 36:751-7.
  7. Jellinger, PS, Chairman, The American Association of Clinical Endocrinologists Medical Guidelines for Clinical Practice for the Diagnosis and Treatment of Dyslipidemia and Prevention of Atherogenesis, Endocrine Practice, March/April 2000; 6(2):162-213.
  8. Lousberg, TR, et al., A Comparison of Clinical Outcome Studies Among Cholesterol Lowering Agents, Ann Pharmacother, December 2001; 35:1599-607.
  9. Lablanche, Jean-Marc, Achieving LDL-C Target Levels: The Role of Statins, Current Medical Research and Opinion, 2001; 16(4):285-295.
  10. Davidson MH, Jacobson TA. How statins work: the development of cardiovascular isease and its treatment with 3-hydroxy-3-methylglutaryl coenzyme A reductase inhfibotrs. Medscape, Clinical Updates. http://www.medscape.com/viewprogram/608?src=search.
  11. Pedersen, T & Gaw A, Statins-Similarities and Differences.   Am J Managed Care.  2001; 7(5 Suppl):S132-S137.
  12. Abramowicz M, ed.   The Medical Letter.  Choice of Lipid-Regulating  Drugs. May 28, 2001; 43(1105):43-48.
  13. 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.
  14. Smith SC, Blair SN, Criqui MH, Fletcher GF, Fuster V et. al.  Preventing heart attack and death in patients with coronary disease (AHA Medical/Scientific Statement; Consensus Panel Statement).  Circulation 1995; 92:2-4.
  15. Pedersen TR. Primary prevention of cardiovascular disease: implications of lipid-lowering trials.  J Hypertens. 1996;14(suppl 5):S195-S200.
  16. Grundy SM. Consensus statement: role of therapy with “statins” in patients with hypertriglyceridemia.  Am J Cardiol. 1998;81(4A):1B-6B.
  17. Stein EA, Lane M, Laskarzewski P.   Comparison of statins in hypertriglyceridemia.   Am J Cardiol.    1998;81(4A):66B-69B.
  18. Knopp RH.  Drug treatment of lipid disorders.  N Eng J Med. 1999;341:498-511. 
  19. Smith SC.  Review of recent clinical trials of lipid lowering in coronary artery disease.   Am J Cardiol. 1997;80(8B):10H-13H.
  20. Williamson DR, Pharand C.  Statins in the prevention of coronary heart disease.  Pharmacotherapy. 1998;18:242-54.  
  21. Grundy SM, Balady GJ, Criqui MH, et al.  Guide to primary prevention of cardiovascular diseases.  Circulation.  1997;95:2329-31.  
  22. Kong SX, Crawfard SY, Gandhi SK, et al.  Efficacy of 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitors in the treatment of patients with hypercholesterolemia: a meta-analysis of clinical trials.  Clin Ther 1997;19:778-97.
  23. Flexner C, Piscitelli S. AIDS drug administration and interactions.  In: AIDS Therapy, Dolin R, Masur H, Saag S eds. Churchill Livingstone, New York, in press, 1998.
  24. Lennernas H, Fager G.  Pharmacodynamics and pharmacokinetics of the HMG-CoA reductase inhibitors; similarities and differences.  Clin Pharmacokinet. 1997;32:403-25.
  25. Flockhart DA.  Clinically used drugs metabolized by cytochrome P450. http://medicine.iupui.edu/flockhart; 6/23/99.
  26. Centers for Disease Control and Prevention.  Report of the NIH panel to define principles of therapy of HIV infection and guidelines for the use of antiretroviral agents in HIV-infected adults and adolescents.  MMWR 1998;47(No. RR-5): 43-82.
  27. Davidson, MH, Safety Profiles for the HMG-CoA Reductase Inhibitors, Treatment and Trust, Adis Drugs, 2001; 61(2):197-206.
  28. The HMG-CoA reductase inhibitors-new safety concerns?  Drug Ther Perspect.  2001; 17(24):11-15.
  29. Altoprev product package labeling, Andrx Laboratories, Inc, Fort Lauderdale, FL.  August 2004.
  30. Lipitor product information, Parke-Davis, Morris Plains, NJ.  July 2004.
  31. Lescol product information, Novartis Pharmaceuticals, East Hanover, NJ. October 2001.
  32. Pravachol product information, Bristol-Myers Squibb, Princeton, NJ.  March 2003. 
  33. Zocor product information, Merck & Co., West Point, PA.  February 2004.
  34. Mevacor product information, Merck & Co., West Point, PA, April 2001.
  35. Crestor Product Information.  AstraZeneca Pharmaceuticals LP, Wilmington, DE.  March 2005.
  36. Vytorin Product Package Labeling, Merck/Schering-Plough Pharmaceuticals, North Wales, PA. November 2004.
  37. Baycol Information, FDA/CDER. 8/8/2001.  http://www.fda.gov/cder/drug/infopage/baycol/default.htm.
  38. Zocor Product Information.  Merck & Co., Inc. Whitehouse Station, NJ.  May 2002.
  39. Olin BR, editor. Drugs Facts and Comparisons (electronic online version). St. Louis: J.B. Lippincott Company, 2004.
  40. USPDI Drug Information for the HealthCare Professional (online through Stat!Ref). Thomson MICROMEDEX, Greenwood Village, Colorado; 2004.
  41. McEvoy GK, editor. AHFS Drug Information (online through Stat!Ref). American Society of Health-Systems Pharmacists, Bethesda, Maryland; 2004.
  42. Medical Economics, Inc., PDR Electronic Library. Thomson Medical Economics, Montvale, NJ; 2003.
  43. Ballantyne CM, Blazing MA, King TR, et al.  Efficacy and safety of ezetimibe co-administered with simvastatin compared with atorvastatin in adults with hypercholesterolemia.  Am J Cardiol.  2004;93:1487-94.
  44. Feldman T, Koren M, Insull Jr W, et al.  Treatment of high-risk patients with ezetimibe plus simvastatin co-administration versus simvastatin alone to attain National Cholesterol Education Program Adult Treatment Panel III low-density lipoprotein cholesterol goals.   Am J Cardiol.  2004;93:1481-86.
  45. Gagne, C, Bays HE, Weiss SR, et al., Efficacy and safety of ezetimibe added to on going statin therapy for treatment of patients with primary hypercholesterolemia.  Am J Cardiol, Nov. 15, 2002; 90:1084-1091.
  46. Caron, MF, Ezetimibe, A novel cholesterol absorption inhibitor, Formulary, December 2002; 37:628-33.
  47. Dujovne CA, Ettinger MP, McNeer JF, Lipka LJ, Lebeaut AP, Suresh R, Yang B, Beltri EP, Efficacy and safety of a potent new selective cholesterol absorption inhibitor, ezetimibe, in patients with primary hypercholesterolemia.  Am J Cardiol, Nov. 15, 2002; 90:1092-1097.
  48. Gupta EK, Ito MK, Ezetimibe: The First in a Novel Class of Selective Cholesterol-Absorption Inhibitors, Heart Disease, 2002;4(6):399-409.
  49. Lipka L, Kerzner B, Corbelli J, Sharp S, Melani L, LeBeaut A, et al., Results of ezetimibe co-administered with lovastatin n 548 patients with primary hypercholesterolemia, J Am Coll Cardiol 2002; 30(suppl B):430B.
  50. Melani L, Mills R, Hassman D, Lipetz R, Lipka L, LeBeaut A, et al., Ezetimibe co-administered with pravastatin in 538 patients with primary hypercholesterolemia, J Am Coll Cardiol 2002; 39(suppl B):139B.
  51. Bays HE, Moore PB, Frehobl MA, Rosenblatt S, Toth PD, Dujovne CA, et al., Effectiveness and tolerability of ezetimibe in patients with primary hypercholesterlemia: pooled analysis of two Phase II studies, Clin Therapeutics 2001; 23(8):1209-1229.
  52. Ballantyne C, Houri J, Notarbartolo A, Melani l, Lipka L, LeBeaut A, et al., Ezetimibe co-administered with atorvastatin in 628 patients with primary hypercholesterolema. Poster presented at 2002 American College of Cardiology Annual Meeting: Chicago, IL.
  53. 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.
  54. Zahn C, Sangl J, Bierman AS, et al.  Potentially inappropriate medication use in the community-dwelling elderly.  JAMA.  2001;286:2823-29.
  55. 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 II guidelines.  J Am Coll Cardiol. 2004;44:720-32.
  56. Anon.  Safety of aggressive statin therapy.  Med Lett Drugs Ther.  2004;46(1196):93-95.
  57. Galson SK.  Communication from Steven K Galson, Acting Director, Center for drug Evaluation and Research, FDA, to Sidney M. Wolfe, MD, Health Research Group, Public Citizen.  March 11, 2005.
  58. Schuster H, Fox JC.  Investigating cardiovascular risk reduction – the rosuvastatin GALAXY programme.  Expert Opin Pharmacother.  2004;5:1187-1200.
  59. Nissen SE, Tuzcu EM, Schoenhagen P, et al., REVERSAL Investigators.  Statin therapy, LDL cholesterol, C-reactive protein, and coronary artery disease.  N Eng J Med.  2005;352:29-38.
  60. Ridker PM, Cannon CP, Morrow D, et al., PROVE IT-TIMI 22 Investigators.  C-reactive protein levels and outcomes after statin therapy.  N Eng J Med.  2005;352:20-8.
  61. deLemos JA, Blazing MA, Wiviott SK, et al, for the A to Z Investigators.  Early intensive vs a delayed conservative simvastatin strategy in patients with cute coronary syndromes; phase Z of the A to Z trial.  JAMA.  2004;292:1307-16.
  62. 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.  J Am Coll Cardiol. 2004;44:720-32.
  63. Goldberg AC, Sapre A, Liu J, et al.  Efficacy and safety of ezetimibe coadministered with simvastatin in patients with primary hypercholesterolemia: a randomized, double-blind placebo-controlled trial.  Mayo Clin Proc.  2004;79:620-9.
  64. Davidson, ME, et al for the Ezetimibe Study Group, Ezetimibe Coadministered with Simvastatin in Patients with Primary Hypercholesterolemia. J Am College Cardiology.  2002; 40:2125-34.
  65. Bays HE, Ose L, Fraser N, et al.  Ezetimibe/simvastatin therapy is more effective than simvastatin alone at reducing remnant-like particle cholesterol.  J Am Coll Cardiol.  2004;43(5 suppl A):481A.
  66. Gaudiani L, Lewin A, Meneghini L, et al.  Efficacy and safety of ezetimibe coadministered with simvastatin versus simvastatin alone in thiazolidinedione-treated patients with type 2 diabetes mellitus.  J Am Coll Cardiol.  2004;43(5 Suppl A):479A.
  67. Gagne C, Gaudet D, Bruckert E, et al., Efficacy and safety of ezetimibe co-administered with atorvastatin or simvastatin in patients with homozygous familial hypercholesterolemia.  Circulation. 2002; 105:2469-2475.
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.

September 10, 2007
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