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Pharmacy Clinical Policy Bulletins
Aetna Medicare Prescription Drug Plan
Subject: Calcium Channel Blockers, Dihydropyridines

Status Drug PR-B/D PR PR-QL PR-AL ST M EX‡ TOC§
C felodipine     X        
C nicardipine              
C nifedical XL     X        
C nifedipine       X      
C nifedipine CR/ER     X        
C Nimotop®  (nimodipine)              
C Norvasc®  (amlodipine)     X        
NC Adalat CC®  (nifedipine er)     X   X X  
NC Cardene®  (nicardipine)         X X  
NC Cardene SR®  (nicardipine sr)           X  
NC Dynacirc CR®  (isradipine cr)           X X
NC Dynacirc®  (isradipine)           X X
NC Plendil®  (felodipine)     X   X X  
NC Procardia®  (nifedipine)       X X X  
NC Procardia XL®  (nifedipine er)     X   X X  
NC Sular®  (nisoldipine)     X     X X


Policy:

  1. Precertification Criteria
  2. Under some plans, including plans that use an open or closed formulary, Adalat CC, felodipine, nifedical XL, nifedipine, nifedipine CR/ER, Norvasc, Plendil, Procardia, Procardia XL and Sular are subject to precertification. If precertification requirements apply Aetna considers Adalat CC, felodipine, nifedical XL, nifedipine, nifedipine CR/ER, Norvasc, Plendil, Procardia, Procardia XL and Sular to be medically necessary for those members who meet any of the following precertification criteria ≥:

    For Adalat CC, felodipine, nifedical XL, nifedipine CR/ER, Norvasc, Plendil, Procardia XL, and Sular

    A.  Quantity limits: 

    According to the manufacturer, the calcium channel blockers (dihydropyridines) 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

    Adalat CC
    nifedical XL, nifedipine CR/ER, Procardia XL

    120 mg/ Once daily 30 mg Up to 30 tablets in 30 days

    Adalat CC,
    nifedical XL, nifedipine CR/ER, Procardia XL

    120 mg/ Once daily 60 mg Up to 60 tablets in 30 days

    Adalat CC,
    nifedical XL, nifedipine CR/ER, Procardia XL

    120 mg/ Once daily 90 mg No quantity limits

    Norvasc, Plendil, felodipine

    10 mg/ Once daily 2.5 mg, 5 mg Up to 30 tablets in 30 days

    Norvasc, Plendil, felodipine

    10 mg/ Once daily 10 mg No quantity limits

    Sular

    60 mg/ Once daily 10 mg, 20 mg Up to 30 tablets in 30 days

    Sular

    60 mg/ Once daily 30 mg Up to 60 tablets in 30 days

    Sular

    60 mg/ Once daily 40 mg No quantity limits


    For coverage of additional quantities, a member's treating physician must request prior authorization through the Aetna Pharmacy Management Precertification Unit.  Additional quantities of calcium channel blockers (dihydropyridines) will be considered medically necessary for those members who meet 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's physician provides documentation (controlled clinical trial) from the peer-reviewed medical literature for use of a higher dose.


    For nifedipine and Procardia

    A. Age Limits --  For members greater than or equal to 65 years of age.

    • Member has tried and failed alternative drugs that are appropriate in the elderly to the treat the condition OR
    • Member has been stabilized on the drug for an extended period and discontinuation or change in the drug might result in physical and/or mental impairment OR
    • Member is in a critical or terminal state and disruption of therapy at this point would be inappropriate AND
    • Member is being monitored  AND
    • Member has no known history of emergency department visits and/or hospital admissions from use of the drug in the member.


  3. Step Therapy Criteria
  4. Under some plans, including plans that use an open or closed formulary, Adalat CC, Cardene, Plendil, Procardia and Procardia XL are subject to step-therapy.  Aetna considers Adalat CC, Cardene, Plendil, Procardia, and Procardia XL to be medically necessary for those members who meet the following step-therapy criterion:

    A documented trial of one month of one of: felodipine, nifedipine cr/er or nicardipine - alternatives on the Aetna Medicare Preferred Drug List.

    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.)

  5. Medical Exception Criteria
  6. Adalat CC, Cardene, Plendil, Procardia and Procardia XL are currently listed on the Aetna Step-Therapy List.* If it is medically necessary for a member to be treated initially with one of these medications subject to step-therapy, Aetna considers these drugs to be medically necessary for those members who meet the criteria below. 

    Adalat CC, Cardene SR, Dynacirc, Dynacirc CR, Procardia, Procardia XL, and Sular 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 these drugs to be medically necessary for those members who meet the criteria below:

    A. Member has a documented:

    • Contraindication to one covered alternative dihydropyridine calcium channel blocker OR
    • Intolerance to one covered alternative dihydropyridine calcium channel blocker OR
    • Allergy to one covered alternative dihydropyridine calcium channel blocker OR
    • Failure of an adequate trial of one month of one covered alternative dihydropyridine calcium channel blocker

    OR

    For Sular, Dynacirc and Dynacirc CR only

    B. Transition of Coverage:

    • Member is within 90 days of his or her effective date of enrollment
    • Member is stable on Sular or Dynacirc or Dynacirc CR for 30 days or longer

    If applicable, quantity limits, age or gender edits will apply.  Approval is valid one year from the date of request.
    If the member has been a Medicare member for 91 days or longer and is not residing in a LTC facility then standard precertification, step-therapy, or medical exception criteria will apply.

* Coverage is provided through a Medicare Prescription Drug Plan Sponsor with a Medicare contract and benefits, limitations, service areas and premiums are subject to change on January 1 of each year.

Place of Service:

Outpatient

The above policy is based on the following references:
  1. Olin BR, editor. Drugs Facts and Comparisons (electronic online version). St. Louis: J.B. Lippincott Company, 2004.
  2. USPDI Drug Information for the HealthCare Professional (online through Stat!Ref). Thomson MICROMEDEX, Greenwood Village, Colorado; 2004.
  3. McEvoy GK, editor. AHFS Drug Information (online through Stat!Ref). American Society of Health-Systems Pharmacists, Bethesda, Maryland; 2004.
  4. The Sixth Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Bethesda, MD: National Heart, Lung and Blood Institute; November 1997. NIH Publication No. 98-4080.
  5. Gavras I et al. Drug therapy for hypertension. Am Fam Phys 1997; 55(5): 1823-1834.
  6. Neaton JD et al. Treatment of mild hypertension study: Final results. JAMA 1993; 270: 713-724.
  7. Freis ED & Papademetriou V. Current drug treatment and treatment patterns with antihypertensive drugs. Drugs 1996; 52(1): 1-16.
  8. Gifford RW. What's new in the treatment of hypertension. Cleveland Clin J Med 1997; 64(3): 143-150.
  9. Moser M. Angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonists and calcium channel blocking agents: A review of potential benefits and possible adverse reactions. J Am Coll Cardiol 1997; 29: 1414-1421.
  10. Conti CR. Re-examining the clinical safety and roles of calcium antagonists in cardiovascular medicine. Am J Cardiol. 1996;78(suppl A):13-18.
  11. Ferrari R. Prognosis of patients with unstable angina or acute myocardial infarction treated with calcium channel antagonists. Am J Cardiol 1996;77:22D-25D.
  12. Medical Economics, Inc., PDR Electronic Library. Thomson Medical Economics, Montvale, NJ; 2004.
  13. 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.
  14. Zahn C, Sangl J, Bierman AS, et al.  Potentially inappropriate medication use in the community-dwelling elderly.  JAMA.  2001;286:2823-29.
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.

July 24, 2006
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