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Pharmacy Clinical Policy Bulletins
Aetna Non-Medicare Prescription Drug Plan
Subject: Antiplatelet Agents

Status Drug PR PR-QL PR-AL ST M EX‡
P anagrelide          
P cilostazol          
P clopidogrel          
P dipyridamole          
P hydroxyurea          
P ticlopidine          
P Aggrenox™  (dipyridamole w/ ASA)          
P Plavix®  (clopidogrel))          
FE Pletal®  (cilostazol)       X X
FE Agrylin®  (anagrelide)         X


Policy:

  1. Step Therapy Criteria

    2. Under some plans, including plans that use an open or closed formulary, Pletal is subject to step-therapy.  Aetna considers Pletal to be medically necessary for those members who meet the following step-therapy criterion:


    A documented trial of one month of the corresponding preferred generic alternative cilostazol.


    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 at 1-800-414-2386. (See criteria under section II below.)

  2. Medical Exception Criteria

    3. Pletal is currently listed on the Aetna Formulary Exclusion and Step-Therapy lists.* Therefore, Pletal is excluded from coverage for members enrolled in prescription drug benefit plan that uses a closed formulary or that requires step-therapy criteria, unless a medical exception is granted. Aetna considers Pletal to be medically necessary for those members who meet the criteria specified below:

    Agrylin is currently listed on the Aetna Formulary Exclusion list. Therefore, Agrylin is excluded from coverage for members enrolled in a prescription drug benefit plan that uses a closed formulary unless a medical exception is granted. Aetna considers Agrylin to be medically necessary for those members who meet the criteria specified below.


    For Pletal

    A.  A documented:

    • Contraindication to the preferred generic alternative cilostazol OR
    • Intolerance to the  preferred generic alternative cilostazol OR
    • Allergy to the  preferred generic alternative cilostazol OR
    • Failure of an adequate trial of one month of the  preferred generic alternative cilostazol


    For Agrylin

    A. A documented:

    • Contraindication to a preferred alternative OR
    • Intolerance to a preferred alternative OR
    • Allergy to a preferred alternative OR
    • Failure of an adequate trial of one month of a preferred alternative

Place of Service:

Outpatient

The above policy is based on the following references:
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  2. Gilbert HS.  Modern treatment strategies in polycythemia vera.  Semin Hematol. 2003;40 (suppl 1):26-29.
  3. Solberg LA.  Therapeutic options for essential thrombocythemia and polycythemia vera.  Semin Oncol. 2002;29(suppl 10):10-15.
  4. USP DI® Drug Information For The Health Care Professional - 26th Ed. (online from www.statref.com) Thomson Micromedex, Greenwood Village, CO. 2006
  5. AHFS Drug Information® with AHFSfirstReleases®. (online from www.statref.com), American Society Of Health-System Pharmacists®, Bethesda, MD. 2006.
  6. DRUGDEX® System: Klasco RK (Ed):DRUGDEX® System. Online edition. Thomson Micromedex, Greenwood Village, CO.
  7. Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. 2006
  8. PDR® Electronic Library, Thomson Micromedex, Greenwood Village, Colorado (Edition expires 2006).
  9. Smith SC Jr, Feldman TE, Hirshfeld JW Jr, Jacobs AK, Kern MJ, King SB III, Morrison DA, O'Neill WW, Schaff HV, Whitlow PL, Williams DO. ACC/AHA/SCAI 2005 guideline update for percutaneous coronary intervention: a report of the American College of Cardiology/American Heart Assoc Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to update the 2001 guidelines for PCI). Bethesda (MD): American College of Cardiology Foundation (ACCF); 2005.
  10. American College of Cardiology Foundation, American Heart Association. ACC/AHA guidelines for the management of patients with unstable angina and non-ST-segment elevation myocardial infarction. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Bethesda (MD): American College of Cardiology Foundation (ACCF); 2002 Mar. 95
  11. Antman EM, Anbe DT, Armstrong PW, Bates ER, Green LA, Hand M, Hochman JS, Krumholz HM, Kushner FG, Lamas GA, Mullany CJ, Ornato JP, Pearle DL, Sloan MA, Smith SC Jr. ACC/AHA guidelines for the management of patients with ST-elevation myocardial infarction. A report of the Am Coll of Cardiol/Am Heart Assoc Task Force on Practice Guidelines (Committee to revise the 1999 guidelines). Bethesda (MD): American College of Cardiology, American Heart Association; 2004.
  12. Chan FK, Ching JY, Hung LC, et al.  Clopidogrel versus aspirin and esomeprazole to prevent recurrent ulcer bleeding.  N Engl J Med. 2005;352:238-44.
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  15. Coull BM, Williams LS, Goldstein LB, et al.  Anticoagulants and antiplatelet agents in acute ischemic stroke: Report of the JOint STroke Guideline Development Committee of the American Academy of Neurology and the American Stroke Association (A Division of the American Heart Association).  Neurology. 2002;59:13-22.
  16. American College of Cardiology Foundation, American Heart Association. ACC/AHA 2002 guideline update for the management of patients with chronic stable angina: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to update the 1999 guidelines). Bethesda MD: American College of Cardiology Foundation; 2002.
  17. Snow V, Barry P, Fihn SD, et al.  Primary care management of chronic stable angina and asymptomatic suspected or known coronary artery disease: A Clinical Practice Guideline from the American College of Physicians.  Ann Intern Med. 2004;141:562-7.
  18. American College of Cardiology Foundation, American Heart Association. ACC/AHA guidelines for the management of patients with unstable angina and non-ST-segment elevation myocardial infarction. A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Bethesda MD: American College of Cardiology Foundation (ACCF): March 2002.
  19. Institute for Clinical Systems Improvement (ICSI).  Diagnosis and treatment of chest pain and acute coronary syndrome (ACS).  Bloomington, MN: Institute for Clinical Systems Improvement (ICSI); 2004 Nov.  www.icsi.org.
  20. Antman EM, Anbe DT, Armstrong PW, et al. ACC/AHA guidelines for the management of patients with ST-elevation myocardial infarction. A report of the Am Coll of Cardiol/Am Heart Assoc Task Force on Practice Guidelines (Committee to revise the 1999 guidelines). Bethesda MD: American College of Cardiology, American Heart Association; 2004.
  21. Patrono C, et al. Platelet-active drugs: the relationships among dose, effectiveness, and side effects: The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy.  Chest. 2004;126(suppl):234S-264S.
  22. Weitz JI, Hirsh J, Samama MM. New anticoagulant drugs: The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy.  Chest. 2004;126(suppl):265S-286S.
  23. Monagle P, et al.  Antithrombotic therapy in children: The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy.  Chest. 2004;126(suppl):645S-687S.
  24. Clagett GP, Sobel M, Jackson MR, et al.  Antithrombotic therapy in peripheral arterial occlusive fisease, The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy.  Chest. 2004;126(suppl):609S-626S.
  25. Popma JJ, et al. Antithrombotic therapy in patients undergoing percutaneous coronary intervention, The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy.  Chest. 2004;126(suppl):576S-599S.
  26. Stein PD, et al. Antithrombotic therapy in patients with saphenous vein and internal mammary artery bypass grafts: The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy.  Chest. 2004;126(suppl):600S-608S.
  27. Harrington RA, Becker RC, Ezekowitz M, et al. Antithrombotic agents in coronary artery disease: The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy.  Chest. 2004;126(suppl):513S-548S.
  28. Menon V, Harrington RA, Hochman JS, et al.  Thrombolysis and adjunctive therapy in acute myocardial infarction: The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy.  Chest. 2004;126(suppl):549S-575S.
  29. Salem DN, et al. Antithrombotic therapy in valvular heart disease – native and prosthetic: The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy.  Chest. 2004;126(suppl):457S-482S
  30. Singer DE, Albers GW, Dalen JE, et al.  Antithrombotic therapy in atrial fibrillation: The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy.  Chest. 2004;126(suppl):429S-456S.
  31. Buller HR, Agnelli G, Hull RD, et al. Antithrombotic therapy for venous thromboembolic disease: The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy.  Chest. 2004;126(suppl):401S-428S.
  32. Geerts WH, et al. Prevention of venous thromboembolism: The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy.  Chest. 2004;126(suppl):338S-400S.
  33. Bates SM, Greer IA, Hirsh J, Ginsberg JS, et al.  Use of antithrombotic agents during pregnancy: The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy.  Chest. 2004;126(suppl):627S-644S.
  34. Levine MN, et al. Hemorrhagic complications of anticoagulant treatment: The Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy.  Chest. 2004;126(suppl):287S-310S.
  35. Urban P et al.  Randomized evaluation of anticoagulation versus antiplatelet therapy after coronary stent implantation in high-risk patients. The Multicenter Aspirin and Ticlopidine Trial after Intracoronary Stenting (MATTIS).  Circulation 1998; 98: 2126-2132.
  36. CAPRIE Steering Committee.  A randomized, blinded, trial of clopidogrel versus aspirin in patients at risk of ischemic events (CAPRIE).  Lancet 1996; 348; 1329-1339.
  37. Hirsh J, Bhatt DL. Comparative benefits of clopidogrel and aspirin in high-risk patient populations: lessons from the CAPRIE and CURE studies.  Arch Intern Med. 2004;164:2106-10. 
  38. Diener HC, Bogousslavsky J, Brass LM, et al.; MATCH investigators Aspirin and clopidogrel compared with clopidogrel alone after recent ischaemic stroke or transient ischaemic attack in high-risk patients (MATCH): randomised, double-blind, placebo-controlled trial.  Lancet. 2004;364(9431):331-7.
  39. Wodlinger AM, Pieper JA.  the role of clopidogrel in the management of acute coronary syndromes.  Clin Ther.  2003;25:2155-81.
  40. Peters RJG, Mehta SR, Fox KAA, et al.  Effects of aspirin dose when used alone or in combination with clopidogrel in patients with acute coronary syndromes.  Circulation.  2003;108:1682-87.
  41. Budaj A, Yusuf S, Mehta SR, et al.  Benefit of clopidogrel in patients with acute coronary syndromes without ST-segment elevation in various risk groups.  Circulation.  2002;106:1622-26.
  42. Mehta SR, Yusuf S.  Short-and long-term oral antiplatelet therapy in acute coronary syndromes and percutaneous coronary intervention.  J Am coll Cardiol.  2003;41:79S-88S.
  43. Gerschutz GP, Bhatt DL.  The clopidogrel in unstable angina to prevent recurrent events (CURE) study: to what extent should the results be generalizable?  Am Heart J. 2003;145:595-601.
  44. Yusuf S, Mehta SR, Zhao F, et al.  Early and late effects of clopidogrel inpatients with acute coronary syndromes.  Circulation.  2003;107:966-72.
  45. Steinhubl SR, Berger PB, Mann JT, III, et al.  Early and sustained dual oral antiplatelet therapy following percutaneous coronary intervention.  JAMA.  2002;288:2411-20.
  46. Sabatine MS, Cannon CP, Gibson CM, et al.; CLARITY-TIMI 28 Investigators.  Addition of clopidogrel to aspirin and fibrinolytic therapy for myocardial infarction with ST-segment elevation.  N Engl J Med.  2005;352:1179-89.
  47. Woodward N, Lower GD, Francis LM, Rumley A, Cobbe SM; CADET Study Investigators.  A randomized comparison of the effects of aspirin and clopidogrel on thrombotic risk factors and C-reactive protein following myocardial infarction: the CADET trial.  J Thromb Haemost. 2004;2:1934-40.
  48. Juergens CP, Wong AM, Leung DY,et al. A randomized comparison of clopidogrel and aspirin versus ticlopidine and aspirin after coronary stent implantation.  Am Heart J. 2004;147(4):E15.
  49. Serebruany VL, Malinin AI, Sane DC, et al.  Magnitude and time course of platelet inhibition with Aggrenox and Aspirin in patients after ischemic stroke: the AGgrenox versus Aspirin Therapy Evaluation (AGATE) trial.  Eur J Pharmacol. 2004;499:315-24.
  50. Bhatt DL, Fox KA, Hacke W, et al. CHARISMA Investigators. Clopidogrel and aspirin versus aspirin alone for the prevention of atherothrombotic events. N Engl J Med. 2006;354:1706-17.
  51. Smith SC Jr, Feldman TE, Hirshfeld JW, et al. ACC/AHA/SCAI 2005 guideline update for percutaneous coronary intervention: a report of the American College of Cardiology/American Heart Assoc Task Force on Practice Guidelines: American College of Cardiology Foundation; 2005.
  52. Goldstein LB, Adams R, Alberts MJ, et al. Primary Prevention if ischemic stroke. A guideline from the American Heart Association/American Stroke Association Stroke Council: Cosponsored by the Atherosclerotic Peripheral Vascular Disease Interdisciplinary Working Group; Cardiovascular Nursing Council; Clinical Cardiology Council; Nutrition, Physical Activity, and Metbolism Council; and the Quality of Care and Outcomes Research Interdisciplinary Working Group. Stroke published online May 4, 2006.
  53. Sacco RL, Adams R, Albers G, et al. Guidelines for prevention of stroke in patients with ischemic stroke or transient ischemic attack: A statement for healthcare professionals from the American Heart Association/American Stroke Association Council on Stroke: co-sponsored by the Council on Cardiovascular Radiology and Intervention: The American Academy of Neurology affirms the value of this guideline. Stroke 2006;37;577-617.

 

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.

January 16, 2007
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