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Pharmacy Clinical Policy Bulletins
Aetna Medicare Prescription Drug Plan
Subject: Beta Adrenergic Blocking Agents

Status Drug PR-B/D PR PR-QL PR-AL ST M EX‡ TOC§
C acebutolol              
C atenolol              
C betaxolol              
C carvedilol              
C bisoprolol              
C labetalol              
C metoprolol              
C metoprolol ER              
C nadolol              
C nadolol/ bendroflumethiazide              
C pindolol              
C propranolol, propranolol ER              
C Sorine™ (sotalol)              
C sotalol, sotalol AF              
C timolol              
C atenolol/chlorthalidone              
C bisoprolol/hydrochlorothiazide              
C propranolol/hydrochlorothiazide              
C Coreg®  (carvedilol)              
C Coreg CR®  (carvedilol SR)              
C Toprol XL®  (metoprolol ER)              
NC Betapace®  (sotalol)           X  
NC Betapace® AF  (sotalol)           X  
NC Blocadren®  (timolol)           X  
NC Cartrol®  (cartelol)           X  
NC Corgard®  (nadolol)           X  
NC Corzide®  (nadolol/bendroflumethiazide)           X  
NC Inderal®  (propranolol)           X  
NC Inderal LA®  (propranolol ER)           X  
NC Inderide®  (propranolol/ hydrochlorothiazide)           X  
NC Innopran XL®  (propranolol)           X  
NC Kerlone®  (betaxolol)           X  
NC Levatol®  (penbutolol)           X  
NC Lopressor®  (metoprolol)           X  
NC Lopressor HCT®  (metoprolol/hydrochlorothiazide)           X  
NC Normodyne®  (labetalol)           X  
NC Sectral®  (acebutolol)           X  
NC Tenoretic®  (atenolol/chlorthalidone)           X  
NC Tenormin®  (atenolol)           X  
NC Timolide®  (timolol/hydrochlorothiazide)           X  
NC Trandate®  (labetalol)           X  
NC Zebeta®  (bisoprolol)           X  
NC Ziac®  (bisoprolol/hydrochlorothiazide)           X  


Policy:

  1. Step Therapy Criteria


    2.  

  2. Medical Exception Criteria

    3. Betapace, Betapace AF, Blocadren, Cartrol, Corgard, Corzide, Inderal, Inderal LA, Inderide, Innopran XL, Kerlone, Levatol, Lopressor, Lopressor HCT, Normodyne, Sectral, Tenoretic, Tenormin, Timolide, Trandate, Zebeta and Ziac 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 Betapace, Betapace AF, Blocadren, Cartrol, Corgard, Corzide, Inderal, Inderal LA, Inderide, Innopran XL, Kerlone, Levatol, Lopressor, Lopressor HCT, Normodyne, Sectral, Tenoretic, Tenormin, Timolide, Trandate, Visken, Zebeta or Ziac to be medically necessary for those members who meet the criteria as specified below:

    For Corzide, Inderide, Lopressor HCT, Tenoretic, Timolide and Ziac:
    A.   A documented:

    • Contraindication to two covered alternatives, one of which was a beta blocker/diuretic combination, indicated for the member's condition OR
    • Intolerance to two covered alternatives, one of which was a beta blocker/diuretic combination, indicated for the member's condition OR
    • Allergy to two covered alternatives, one of which was a beta blocker/diuretic combination, indicated for the member's condition OR
    • Failure of an adequate trial of one month each of at least two covered alternatives, one of which was a beta blocker/diuretic combination, indicated for the member's condition.

    For Betapace, Betapace AF, Blocadren, Cartrol, Corgard, Inderal, Inderal LA, Innopran XL, Kerlone, Levatol, Lopressor, Normodyne, Sectral, Tenormin, Trandate and Zebeta:
    A.  A documented:

    • Intolerance to two covered alternatives indicated for the member's condition OR
    • Contraindication to two covered alternatives indicated for the member's condition OR
    • Allergy to two covered alternatives indicated for the member's condition OR
    • Failure of an adequate trial of one month each of two covered alternatives indicated for the member's condition.

    OR

    B.  Member is documented to be currently stabilized on respective drug, for Cartrol, Kerlone, Levatol, or Zebeta only.


Place of Service:

Outpatient

The above policy is based on the following references:
  1. Sallach JA, et al.  B-Blockers Experiences in Heart Failure Mortality Trials. Drug Benefit Trends. October 2002; 14(10):41-48.
  2. Wikstrand J, et al.  Dose of Metoprolol CR/XL and Clinical Outcomes in Patients with Heart Failure, Analysis of the Experience in Metoprolol CR/XL Randomized Intervention Trial in Chronic Heart Failure (MERIT-HR). Journal of the American College of Cardiology. August 7, 2002; 40(3):491-504.
  3. Foody JM., et al.  B-Blocker Therapy in Heart Failure, Scientific Review. JAMA. February 20, 2002; 287(7):883-889.
  4. Farrell MH, et al.  B-Blockers in Heart Failure, Clinical Applications. JAMA. February 20, 2002; 287(7):890-897.
  5. Schmidt M, et al.  Forecasting the Impact of a Clinical Practice Guideline for Perioperative B-Blockers to Reduce Cardiovascular Morbidity and Mortality. Arch Intern Med. January 14, 2002; 162:63-69.
  6. Leizorovicz A., et al.  Bisoprolol for the treatment of chronic heart failure: A meta-analysis on individual data of two placebo-controlled studies-CIBIS and CIBIS-II. Am Heart J. February 2002;143:301-7.
  7. Niskanen L., et al.  Reduced Cardiovascular Morbidity and Mortality in Hypertensive Diabetic Patients on First-Line Therapy with an ACE Inhibitor Compared with a Diuretic/B-Blocker-Based Treatment Regimen, A subanalyisis of the Captopril Prevention Project. Diabetes Care. December 2001; 24(12):2091-2096.
  8. Azevedo ER, et al. Nonselective Versus Selective B-Adrenergic Receptor Blockade in Congestive Heart Failure. Circulation. October 30, 2001; 104:2194-2199.
  9. Goldstein S. Benefits of B-Blocker Therapy for Heart Failure, Weighing the Evidence. Arch Intern Med. March 25, 2002; 162:641-648.
  10. McMurray J, Pfeffer MA. New Therapeutic Options in Congestive Heart Failure. Circulation. May 7, 2002; 105:2223-2228.
  11. Stevenson LW.  Beta-Blockers for Stable Heart Failure. N Engl J Med. May 2, 2002; 346(18):1346-1347.
  12. Packer M et al. Comparative effects of carvedilol and metoprolol on left ventricular ejection fraction in heart failure: Results of a meta-analysis. Am Heart J. June 2001; 141(6).
  13. Bonet S, et al.  B-Adrenergic Blocking Agents in Heart Failure, Benefits of Vasodilating and Nonvasodilating Agents According to Patients' Characteristics: A Meta-analysis of Clinical Trials. Arch Intern Med. March 13, 2000; 160(5):621-627.
  14. Goldstein S. The Effect of B-Blockers on Morbidity and Mortality Associated with Heart Failure. Am J Managed Care. April 2000; 6(6):S308-312.
  15. Abraham WT.  B-Blockers, The New Standard of Therapy for Mild Heart Failure. Arch Intern Med. May 8, 2000; 160:1237-1247.
  16. Dall L, et al. Beta-Blocker Use in Patients with Acute Myocardial Infarction Treated by Hospitals. Managed Care Interface. May 2000;61-63.
  17. Too many beta-blockers. Drug and Therapeutics Bulletin. 1996;34(7):49-52.
  18. Task Force of the Working Group on Heart Failure of the European Society of Cardiology. The treatment of heart failure. Eur Heart J. 1997;18:736-53.
  19. Heidenreich PA, Lee TT, Massie BM. Effect of beta-blockade on mortality in patients with heart failure: a meta-analysis of randomized clinical trials.  J Am Coll Cardiol. 1997;30:27-34.
  20. Dunn CJ, Lea AP, Wagstaff AJ. Carvedilol: a reappraisal of its pharmacological properties and therapeutic use in cardiovascular disorders. Drugs. 1997;54:161-85.
  21. Cohn JN. The management of chronic heart failure. N Engl J Med. 1996;335:490-8.
  22. Eichorn EF, Bristow MR. Practical guidelines for initiation of beta-adrenergic blockade in patients with chronic heart failure. Am J Cardiol. 1997;794-8.
  23. Bristow MR.   -adrenergic receptor blockade in chronic heart failure.  Circulation. 2000;101:558-69.
  24. CIBIS-II Investigators and committees.  The Cardiac Insufficiency Bisoprolol Study II (CIBIS-II): a randomized trial.  Lancet. 1999;353:9-13.
  25. MERIT-HF Study Group.  Effect of metoprolol CR/XL in chronic heart failure: Metoprolol CR/XL Randomized Intervention Trial in Congestive Heart Failure (MERIT-HF).  Lancet. 1999;353:2001-6.
  26. Hjalmarson A, Goldstein, Fagerberg, et al., for the MERIT-HF Study Group.  Effects of controlled-release metoprolol on total mortality, hospitalizations, and well-being in patients with heart failure: Metoprolol CR/XL Randomized Intervention Trial in Congestive Heart Failure (MERIT-HF).  JAMA 2000;283:1295-1302.
  27. Packer, M., Beta Blocker Reduces Hospitalization in Patients with the Most Advanced Chronic Heart Failure, presented at the American College of Cardiology 50th Annual Scientific Session in Orlando, Florida, March 20, 2001.
  28. Dargie H. for The CAPRICORN Investigator, Effect of Carvedilol on Outcome After Myocardial Infarction in Patients with Left-Ventricular Dysfunction: The CAPRICORN Randomised Trial. Lancet. May 5, 2001; 357:1385-90.
  29. Drugs for Hypertension. The Medical Letter on Drugs and Therapeutics. March 5, 2001; 43(1099):17-22.
  30. Gattis WA. Metoprolol CR/XR in the Treatment of Chronic Heart Failure. Pharmacotherapy 2001;21(5):604-613.
  31. Mailtand MG et al. Treatment of Congestive Heart Failure, Guidelines for the Primary Care Physician and the Heart Failure Specialist.  Arch Intern Med February 12, 2001;161:342-352.
  32. Padwal R, et al. Evidence Based Management of Hypertension, Cardiovascular Risk Factors and Their Effects on the Decision to Treat Hypertension: Evidence Based Review. BMJ. April 21, 2001;322:877-80.
  33. Groenning BA, et al. Antiremodeling Effects on the Left Ventricle During Beta-Blockade with Metoprolol in the Treatment of Chronic Heart Failure. J Am Coll Cardiol. December 2000;36(7)2072-80.
  34. Chavey WE. The Importance of Beta-Blockers in the Treatment of Heart Failure. Am Fam Physician 2000;62:2453-62.
  35. Howard PA, Ellerbeck EF. Optimizing Beta-Blocker Use After Myocardial Infarction. Am Fam Physician., October 15, 2000;62.
  36. Califf RM, O'Connor CM.  B-Blocker Therapy for Heart Failure, The Evidence Is In, Now the Work Begins. JAMA. March 8, 2000; 283(10).
  37. Metra M, et al.  Congestive Heart Failure, A rationale for the use of beta-blockers as standard treatment for heart failure. Am Heart Journal. March 2000; 139(3).
  38. Eichhorn EJ. New Insights into Dilated Cardiomyopathy, Medical Therapy of Chronic Heart Failure, Role, of ACE Inhibitor and beta-blockers, November 1998, 16(4).
  39. O'Connor CM, et al.  Managing the Patient with Advanced Heart Failure, Current and novel pharmacologic approaches in advanced heart failure. Am Heart J. June 1998; 135(6).
  40. Williams JF, et al. ACC/AHA Task Force Report, Guidelines for the Evaluation and Management of Heart Failure, Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee on Evaluation and Management of Heart Failure). J Am College Cardiology. November 1, 1995; 26(5):1376-98.
  41. Pfeffer MA. B-Adrenergic Blockers and Survival in Heart Failure. N Engl J Med. May 23, 1996;334(21):1396-7.
  42. Constant J. A Review of Why and How We May Use Beta-Blockers in Congestive Heart Failure. Chest. March 1998; 113(3).
  43. Lampert R, Ickovics J, Viscoli C, Horwitz R, Lee F. Effects of propranolol on recovery of heart rate variability following acute myocardial infarction and relation to outcome in the beta-blocker heart attack trial. Am J Cardiol   2003; 91: 137-142.
  44. The CAPRICORN Investigators. Effect of carvedilol on outcome after myocardial infarction in patients with left ventricular dysfunction: the CAPRICORN randomized trial. Lancet 2001; 357: 1385-1390.
  45. Gottlieb S, McCarter R. Comparative effects of three beta-blockers (atenolol, metoprolol, and propranolol) on survival after acute myocardial infarction. Am J Cardiol 2001; 87: 823-826.
  46. Gottlieb S, Fisher M, Kjekshus J, Deedwania P, Gullestad L, Vitovec J, Wikstrand J. on behalf of the MERIT-HF Investigators. Tolerability of B-Blocker initiation and titration in the metoprolol CR/XL randomized intervention trial  in congestive heart failure. Circulation 2002; 105: 1182-1188.
  47. Metra M, Giubbini R, Nodari S, et al. Differential effects of ß-blockers in patients with heart failure. A prospective, randomized, double-blind comparison of the long-term effects of metoprolol versus carvedilol. Circulation 2000; 102: 546-551.
  48. Packer M, Antonopoulos G, Berlin J, Chittams J, Konstam M, Udelson J. Comparative effects of carvedilol and metoprolol on left ventricular ejection fraction in heart failure: results of a meta-analysis. Am J Heart 2001; 141: 899-907.
  49. Krum H, Roecker E, Mohacsi P, et al. Effects of initiating carvedilol in patients with severe chronic heart failure. Results from the COPERNICUS study. JAMA 2003; 289: 712-718.
  50. Packer M, Coats A, Fowler M, et al. Effect of carvedilol on survival in severe chronic heart failure. N Engl J Med 2001; 344: 1651-1658.
  51. Gattis W, O'Conner C, Leimberger J, et al. Clinical outcomes in patients on beta-blocker therapy admitted with worsening chronic hear failure. Am J Cardiol 2003; 91: 169-174.
  52. USPDI Drug Information for the HealthCare Professional (online). Thomson MICROMEDEX, Greenwood Village, Colorado; 2004.
  53. McEvoy GK, editor. AHFS Drug Information (online). American Society of Health-Systems Pharmacists, Bethesda, Maryland; 2004.
  54. Olin BR, editor. Drugs Facts and Comparisons (electronic online version). St. Louis: J.B. Lippincott Company, 2004.
  55. Medical Economics, Inc., PDR Electronic Library. Thomson Medical Economics, Montvale, NJ; 2004.
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.

October 2, 2007
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