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

Status Drug PR PR-QL PR-AL ST M EX‡
FE Ranexa®  (ranolazine)   X   X X


Policy:

  1. Precertification Criteria
  2. Under some plans, including plans that use an open or closed formulary, Ranexa is subject to precertification. If precertification requirements apply Aetna considers Ranexa to be medically necessary for those members who meet the following precertification criteria:

    According to the manufacturer, Ranexa can be dosed up to a maximum daily dose at the interval
    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
    Ranexa 2000 mg / twice daily 500 mg Up to 120 tablets in 30 days
    Ranexa 2000 mg / twice daily 1000 mg Up to 60 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 Ranexa will be considered medically necessary for those members who meet ANY of the following criteria:

    • Member's dose is being titrated by physician (3-month limit) OR
    • Member's physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for use of a higher dose.


  3. Step Therapy Criteria
  4. Under some plans, including plans that use an open or closed formulary, Ranexa is subject to step-therapy.  Aetna considers Ranexa to be medically necessary for those members who meet the following step-therapy criteria:

    Use of Norvasc or amlodipine, a beta-blocker (BUT NOT sotalol AF, sotalol, sorine, Betapace, or Betapace AF), AND a nitrate.

    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 III below.)

  5. Medical Exception Criteria
  6. Ranexa is currently listed on the Aetna Formulary Exclusions and Step Therapy List.* Therefore, it 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 Ranexa  to be medically necessary for those members who meet the criteria specified below

    A. A documented:

    • Contraindication to three preferred alternatives - Norvasc or amlodipine, a beta-blocker (BUT NOT sotalol AF, sotalol, sorine, Betapace, or Betapace AF), AND a nitrate -- indicated for the member's condition OR,
    • Intolerance to three preferred alternatives - Norvasc or amlodipine, a beta-blocker (BUT NOT sotalol AF, sotalol, sorine, Betapace, or Betapace AF), AND a nitrate -- indicated for the member's condition OR,
    • Allergy to three preferred alternatives -- Norvasc or amlodipine, a beta-blocker (BUT NOT sotalol AF, sotalol, sorine, Betapace, or Betapace AF), AND a nitrate -- indicated for the member's condition OR
    • Failure of an adequate trial of two-weeks each of the three preferred alternatives -- Norvasc or amlodipine, a beta-blocker (BUT NOT sotalol AF, sotalol, sorine, Betapace, or Betapace AF), AND a nitrate -- indicated for the member's condition.

    •      

    Beta-Blocker Examples

    acebutolol

    Inderal LA

    Propranolol

    atenolol

    Innopran XL

    Sectral

    betaxolol

    Kerlone

    Timolol maleate

    Bisoprolol

    Levatol

    Tenormin

    Blocadren

    Lopressor

    Toprol XL

    Corgard

    Metoprolol

    Zebeta

    Cartrol

    Nadolol

     

    Inderal

    Pindolol

     

    Nitrate Examples

    Dilatrate SR

    Monoket

    Nitrolingual

    Imdur

    Nitrek

    Nitroquick

    Ismo

    Nitrobid

    Nitrostat

    Isochron

    Nitro-dur

    Nitrotab

    Isordil

    Nitrogard

    Nitro-time

    Isosorbide dinitrate

    Nitroglycerin

    Nitro-transderm

    Isosorbide mononitrate

    Nitroglycerin SL

     

    minitran

    Nitroglycerin SR

     

     


Place of Service:

Outpatient

The above policy is based on the following references:
  1. USP DI® Drug Information For The Health Care Professional - 26th Ed. (online from www.statref.com) Thomson Micromedex, Greenwood Village, CO. 2006
  2. AHFS Drug Information® with AHFSfirstReleasesä. (online from www.statref.com), American Society Of Health-System Pharmacists, Bethesda, MD. 2005.
  3. DRUGDEX® System: Klasco RK (Ed):DRUGDEX® System. Online edition. Thomson Micromedex, Greenwood Village, CO.
  4. Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. 2006
  5. Ranexa Prescribing Information. CV Therapeutics, Palo Alto, CA. January 2006.
  6. Timmis AD, Chaitman Br, and Crager M. Effects of ranolazine on exercise tolerance and HBA1c in patients with chronic angina and diabetes. Eur Heart J. 2006;27(1):42-8.
  7. Rousseau MF, Pouleur H, Cocco G, and Wolff AA. Comparative efficacy of ranolazine versus atenolol for chronic angina pectoris. Am J Cardiol 2005;95:311-6.
  8. Pepine CJ and Wolff AA; ranolazine study group. A controlled trial with a novel anti-ischemic agent. Ranolazine, in chronic stable angina pectoris that is responsive to conventional antianginal agents. Am J Cardiol 1999;84:46-50.
  9. Chaitman Br, Pepine CJ, Parker JO, et al. Effects of ranolazine with atenolol, amlodipine, or diltiazem on exercise tolerance and angina frequency in patients with severe chronic angina. JAMA 2004;291:309-16.
  10. Chaitman BR, Parker JO, Meluzin J, et al; for the MARISA Investigators. Anti-ischemic effects and long-term survival during ranolazine monotherapy in patients with chronic severe angina. J Am Coll Cardiol 2004;43:1375-82.
  11. Heidenreich PA, McDonald KM, Hastie T, et al. Meta-analysis of trials comparing beta-blockers, calcium antagonists, and nitrates for stable angina. JAMA 1999;281:1927-36.
  12. Snow V, Barry P, Fihn SD, Gibbons RJ, Owens DK, Williams SV, Mottur-Pilson C, Weiss KB. 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(7):562-7.
  13. 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.
  14. Gaffney SM. Ranolazine, a novel agent for chronic stable angina. Pharmacotherapy 2006;26:135-42.

 

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.

November 12, 2007
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