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Pharmacy Clinical Policy Bulletins
Aetna Medicare Prescription Drug Plan
Subject: Angiotensin II Receptor Antagonists (AIIRAs, ARBs)/Combinations

Status Drug PR-B/D PR PR-QL PR-AL ST M EX‡ TOC§
C Cozaar®  (losartan)     X        
C Diovan HCT®  (valsartan/hydrochlorothiazide)     X        
C Diovan®  (valsartan)     X        
C Exforge®  (amlodipine/valsartan)     X        
C Hyzaar®  (losartan/hydrochlorothiazide)     X        
NC Atacand HCT®  (candesartan/hydrochlorothiazide)     X   X X  
NC Atacand®  (candesartan)     X   X X  
NC Avalide®  (irbesartan/hydrochlorothiazide)     X   X X  
NC Avapro®  (irbesartan)     X   X X  
NC Azor®  (amlodipine-olmesartan)     X   X X  
NC Benicar HCT®  (olmesartan/hydrochlorothiazide)     X   X X  
NC Benicar®  (olmesartan)     X   X X  
NC Micardis HCT®  (telmisartan/hydrochlorothiazide)     X   X X  
NC Micardis®  (telmisartan)     X   X X  
NC Teveten HCT®  (eprosartan/hydrochlorothiazide)         X X  
NC Teveten®  (eprosartan)     X   X X  


Policy:

  1. Precertification Criteria

    2. Under some plans, including plans that use an open or closed formulary, Atacand, Atacand HCT, Avalide, Avapro, Azor, Benicar, Benicar HCT, Cozaar, Diovan, Diovan HCT, Exforge, Hyzaar, Micardis, Micardis HCT, and Teveten are subject to precertification.  If precertification requirements apply Aetna considers Atacand, Atacand HCT Avalide, Avapro, Azor, Benicar, Benicar HCT, Cozaar, Diovan, Diovan HCT, Exforge, Hyzaar, Micardis, Micardis HCT, and Teveten to be medically necessary for those members who meet the following precertification criteria:

    Quantity limits:  

    According to the manufacturer, the angiotensin II receptor antagonists and angiotensin II receptor antagonist combinations 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
    Atacand 32 mg/ Once daily 4, 8, 16 mg Up to 60 tablets in 30 days
    Atacand 32 mg/ Once daily 32 mg None
    Atacand HCT 32 mg/ Once daily 16/12.5 mg Up to 60 tablets in 30 days
    Atacand HCT 32 mg/ Once daily 32/12.5 mg None
    Avalide 300 mg/ Once daily 150/12.5 mg Up to 30 tablets in 30 days
    Avalide 300 mg/ Once daily 300/12.5 mg None
    Avapro 300 mg/ Once daily 75 mg, 150 mg Up to 30 tablets in 30 days
    Avapro 300 mg/ Once daily 300 mg None
    Azor 10/40/ Once daily 5/20 mg; 5/40 mg; 10/20 mg; 10/40 mg Up to 30 tablets in 30 days
    Benicar 40 mg/ Once daily 5 mg, 20 mg Up to 30 tablets in 30 days
    Benicar 40 mg/ Once daily 40 mg None
    Benicar HCT 40 mg/ Once daily 20/12.5 mg Up to 30 tablets in 30 days
    Benicar HCT 40 mg/ Once daily 40/12.5 mg, 40/25 mg None
    Cozaar 100 mg/ Once daily 25 mg, 50 mg Up to 60 tablets in 30 days
    Cozaar 100 mg/ Once daily 100 mg None
    Diovan 320 mg/ Once daily 40, 80, 160 mg Up to 60 tablets in 30 days
    Diovan 320 mg/ Once daily 320 mg None
    Diovan HCT 320 mg/ Once daily 80/12.5 mg Up to 30 tablets in 30 days
    Diovan HCT 320 mg/ Once daily 160/12.5mg, 160/25 mg Up to 30 tablets in 30 days
    Diovan HCT 320 mg/Once daily 320/12.5mg, 320/25 mg None
    Exforge 10 mg/320 mg/ Once daily 5/160 mg, 10/160 mg, 5/320 mg, 10/320 mg Up to 30 tablets in 30 days
    Hyzaar 100 mg/ Once daily 50/12.5 mg Up to 30 tablets in 30 days
    Hyzaar 100 mg/ Once daily 100/25 mg, 100/12.5 mg None
    Micardis 80 mg/ Once daily 20 mg, 40 mg Up to 30 tablets in 30 days
    Micardis 80 mg/ Once daily 80 mg None
    Micardis HCT 80 mg/ Once daily 40/12.5 mg Up to 30 tablets in 30 days
    Micardis HCT 80 mg/ Once daily 80/12.5 mg None
    Teveten 800 mg/ Once daily 400 mg Up to 60 tablets in 30 days
    Teveten 800 mg/ Once daily 600 mg None


    For coverage of additional quantities, a member's treating physician must request prior authorization through the Aetna Pharmacy Management Precertification Unit.  Additional quantities of these angiotensin II receptor antagonists 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 the maximum labeled dose AND has a therapeutic response to a higher dose OR
    • Member has a diagnosis of heart failure, NYHA class II-IV or left ventricular dysfunction, post-myocardial infarction (Diovan 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, Atacand, Atacand HCT, Avalide, Avapro, Azor, Benicar, Benicar HCT, Micardis, Micardis HCT, Teveten and Teveten HCT are subject to step-therapy.  Aetna considers Atacand, Atacand HCT, Avalide, Avapro, Azor, Benicar, Benicar HCT, Micardis, Micardis HCT, Teveten and Teveten HCT to be medically necessary for those members who meet the following step-therapy criterion:

    For Atacand, Atacand HCT, Avalide, Avapro, Benicar, Benicar HCT, Micardis, Micardis HCT, Teveten and Teveten HCT

    A documented trial of one month each of BOTH losartan (Cozaar/Hyzaar) AND valsartan (Diovan/ Diovan-HCT) - alternatives on the Aetna Medicare Preferred Drug List.

    For Azor

    A documented trial of one month of concurrent use of the covered alternatives amlodipine/benazepril or amlodipine AND losartan (Cozaar/Hyzaar) or valsartan (Diovan/ Diovan-HCT).

    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 III below.)


  3. Medical Exception Criteria

    4. Atacand, Atacand HCT, Avalide, Avapro, Azor, Benicar, Benicar HCT, Micardis, Micardis HCT, Teveten and Teveten HCT 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 Atacand, Atacand HCT, Avalide, Avapro, Azor, Benicar, Benicar HCT, Micardis, Micardis HCT, Teveten and Teveten HCT to be medically necessary for those members who meet ANY of the following criteria:

    For Atacand, Atacand HCT, Avalide, Avapro, Benicar, Benicar HCT, Micardis, Micardis HCT, Teveten and Teveten HCT

    A.  A documented:

    • Contraindication to both covered angiotensin II antagonists, losartan (Cozaar/Hyzaar) AND valsartan (Diovan/ Diovan-HCT) OR
    • Intolerance to both covered angiotensin II antagonists, losartan (Cozaar/Hyzaar) AND valsartan (Diovan/ Diovan-HCT) OR
    • Allergy to both covered angiotensin II antagonists, losartan (Cozaar/Hyzaar) AND valsartan (Diovan/ Diovan-HCT) OR
    • Failure of an adequate trial of one month each of both covered angiotensin II antagonists, losartan (Cozaar/Hyzaar) AND valsartan (Diovan/ Diovan-HCT)

    For Azor

    A documented:

    • Contraindication to amlodipine/benazepril or amlodipine AND losartan (Cozaar/Hyzaar) or valsartan (Diovan/ Diovan-HCT) OR
    • Intolerance to amlodipine/benazepril or amlodipine AND losartan (Cozaar/Hyzaar) or valsartan (Diovan/ Diovan-HCT) OR
    • Allergy to amlodipine/benazepril or amlodipine AND losartan (Cozaar/Hyzaar) or valsartan (Diovan/ Diovan-HCT) OR
    • Failure of an adequate trial of one month of concurrent use of amlodipine/benazepril or amlodipine AND losartan (Cozaar/Hyzaar) or valsartan (Diovan/ Diovan-HCT)

       


Place of Service:

Outpatient

The above policy is based on the following references:
  1. Cohn JN, et al. A Randomized Trial of the Angiotensin-Receptor Blocker Valsartan in Chronic Heart Failure. New Eng J Med. Dec 6, 2001; 345(23(:1667-75.
  2. Lewis ED, et al.  Renoprotective effect of the Angiotensin-Receptor Antagonist Irbesartan in Patients with Nephropathy Due to Type 2 Diabetes.  New Eng J Med. Sept. 20, 2001; 345(12):851-60.
  3. Viberti G, Wheeldon, NM for the MARVAL Investigators.  Microalbuminuria with valsartan in patients with type 2 diabetes mellitus.  A blood pressure independent effect.  Circulation. 2002;106:672-678.
  4. Kjeldsen SE, et al. for the LIFE Study Group.  Effects of Losartan on Cardiovascular Morbidity and Mortality in Patients with Isolated Systolic Hypertension and Left Ventricular Hypertrophy, A Losarten Intervention for Endpoint Reduction (LIFE) Substudy. JAMA. 2002;288:1491-1498.
  5. Dickstein K, Kjekshus J, and the OPTIMAAL Steering Committee, for the OPTIMAAL Study Group, Effects of losartan and captopril on mortality and morbidity in high-risk patients after acute myocardial infarction: the OPTIMAAL randomised trial. Lancet. 2002;360:752-60.
  6. Wong M, et al, for the Val-HeFT Heart Failure Trial Investigators. Valsartan Benefits Left Ventricular Structure and Function in Heart Failure: Val-HeFT Echocaardiographic Study.  J Amer Coll Cardiology. September 2002; 40(5):970-5.
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  17. Kalus JS, White CM.  Amlodipine vs Angiotensin-Receptor Blockers for Nonhypertension Indications. Ann Pharmacother. 2002 November; 2002; 36:1759-66.
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  19. Sever P, Holzgreve H.  Long-term efficacy and tolerability of candesartan cilexetil in patients with mild to moderate hypertension.  J Hum Hypertens. 1997; 11(Suppl 2): S69-S73.
  20. Packer M et al.  Consensus recommendations for the management of chronic heart failure.  Am J Cardiol. 1999; 83(2A): 1A-38A.
  21. Tenero D et al.  Pharmacokinetics of intravenously and orally administered eprosartan in healthy males: Absolute bioavailability and effect of food.  Biopharm Drug Dispos. 1998; 19(6): 351-356.
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  24. Mckelvie R et al.  Comparison of candesartan, enalapril, and their combination in congestive heart failure: Randomized Evaluation of Strategies for Left Ventricular Dysfunction (RESOLVD pilot study).  Eur Hear J 1998; 19 (Suppl): 133.
  25. Song J. Review of Therapeutics, Pharmacologic, Pharmacokinetic and Therapeutic Differences Among Angiotensin II Receptor Antagonists. Pharmacotherapy. 2000;20(2):130-139.
  26. McMahon E.  Recent Studies with Eplerone, a Novel selective aldosterone receptor antagonist. Current Opinion in Pharmacology. 2001;1:190-196.
  27. Kaplan N. Should New Drugs Be Used Without Outcome Data?  Implications of the ALLHAT and ELITE II. Arch Intern. Med. 2001;161:511-512.
  28. Cohn JN, et al.  A Randomized Trial of the Angiotensin-Receptor Blocker Valsartan in Chronic Heart Failure Trial (Val-HeFT).  New Eng J Med. December 6, 2001; 245:1667-75.
  29. Thurmann PA, et al. Influence of the Angiotensin II Antagonist Valsartan on Left Ventricular Hypertrophy in Patients with Essential Hypertension. Circulation. 1998:2037-2042.
  30. Plum J, et al.  Effects of the Angiotensin II Antagonist Valsartan on Blood Pressure, Proteinuria, and Renal Hemodynamics in Patients with Chronic Renal Failure and Hypertension. J Am Soc Nephrol. 1998,9:2223-2234.
  31. Hedner T.  A Comparison of the Angiotensin II Antagonists Valsartan and Losartan in the Treatment of Essential Hypertension. AJH. April 1999;12(4):414-417.
  32. Fogari R et al.  Comparative Efficacy of Losartan and Valsartan in Mild-to-Moderate Hypertension:  Results of 24-Hour Ambulatory Blood Pressure Monitoring. Current Therapeutic Research. April 1999;60(4):195-205.
  33. Baruch L, et al.  Augmented Short and Long Term Hemodynamic and Hormonal Effects of an Angiotensin Receptor Blocker Added to Angiotensin Converting Enzyme Inhibitor Therapy in Patients with Heart Failure. Circulation. May 1999;99(20):2658-2664.
  34. Mazayev VP, et al. Valsartan in Heart Failure Patients Previously Untreated with an ACE Inhibitor. International Journal of Cardiology. 1998;65:239-246.
  35. Burnier M, Brunner HR. Comparative Antihypertensive Effects of Angiotensin II Receptor Antagonists.  Journal of the Amer. Society of Nephrology. April 1999, 10(Suppl 12):S278-S282.
  36. Carson PE. Rationale for the Use of Combination Angiotensin-Converting Enzyme Inhibitor/Angiotensin II Receptor Blocker Therapy in Heart Failure. American Heart Journal. September 2000, 140(3).
  37. Martineua P, Goulet J.  New Competition in the Realm of Renin-Angiotensin Axis Inhibition; the Angiotensin II Receptor Antagonists in Congestive Heart Failure. Ann Pharmacother. 2001;35:71-84.
  38. Struckman DR, Rivey MP. Combined Therapy with an Antiotensin II Receptor Blocker and an Angiotensin-Converting Enzyme Inhibitor in Heart Failure. Ann Pharmacother.  2001;35:242-8.
  39. Gavras H.  Historical Evolution of Angiotensin II Receptor Blockers: Therapeutic Advantages. Journal of the American Society of Nephrology. April 1999;10(Suppl 12):S255-S257.
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  42. Barbe SJ.  Comparison Between Angiotensin Receptor Antagonism and Converting Enzyme Inhibition in Heart Failure.  Differential Acute Effects According to the Renin-Angiotensin System Activation. Basic Res Cardiol. April 1999;94(2):128-35.
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  45. Brenner BM, et al.  Effects of Losartan on Renal and Cardiovascular Outcomes in Patients with Type 2 Diabetes and Nephropathy. New Eng J Med. September 20, 2001;345:891-9.
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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 19, 2007
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