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

Status Drug PR-B/D PR PR-QL PR-AL ST M EX‡ TOC§
C Cartia XT® (diltiazem sr)     X        
C Diltia XT® (diltiazem sr)     X        
C diltiazem              
C diltiazem CD/CR/ER/XT     X        
C diltiazem SR     X        
C diltiazem extended release beads SR     X        
C Taztia XT® (diltiazem er beads)     X        
C verapamil              
C verapamil CR/ER/SR     X        
C Cardizem LA®  (diltiazem sr)     X        
NC Calan®  (verapamil)         X X  
NC Calan SR®  (verapamil cr)     X   X X  
NC Cardizem®  (diltiazem)         X X  
NC Cardizem CD®  (diltiazem sr)     X   X X  
NC Covera HS®  (verapamil sr)     X   X X  
NC Dilacor XR®  (diltiazem sr)     X   X X  
NC Isoptin SR®  (verapamil cr)     X   X X  
NC Tiazac®  (diltiazem er beads)     X   X X  
NC Verelan®  (verapamil)     X   X X  
NC Verelan PM®  (verapamil sr)     X     X  


Policy:

  1. Precertification Criteria
  2. Under some plans, including plans that use an open or closed formulary, Calan SR, Cardizem CD, Cardizem LA, Cartia xt, Covera HS, Dilacor XR, Diltia xt, diltiazem CD/CR/ER/XT, diltiazem SR, diltiazem extended release beads SR, Isoptin SR, Taztia xt, Tiazac, verapamil CR/ER/SR, Verelan and Verelan PM are subject to precertification.   If precertification requirements apply Aetna considers these medications to be medically necessary for those members who meet any of the following precertification criteria:


    A.  Quantity limits: 

    According to the manufacturers, the calcium channel blockers (non-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
    Calan SR, Isoptin SR, Verelan, verapamil CR/ER/SR 480 mg/ Once per day 120 mg Up to 30 tablets/capsules in 30 days
    Calan SR, Covera HS, Isoptin SR, Verelan, verapamil CR/ER/SR 480 mg/ Once per day 180 mg Up to 60 tablets/capsules in 30 days
    Calan SR, Covera HS, Isoptin SR, Verelan, verapamil CR/ER/SR 480 mg/ Once per day 240 mg No quantity limits apply
    Verelan 480 mg/ Once per day 360 mg No quantity limits apply
    Verelan PM 480 mg/ Once per day 100 mg Up to 30 capsules in 30 days
    Verelan PM 480 mg/ Once per day 200 mg Up to 60 capsules in 30 days
    Verelan PM 480 mg/ Once per day 300 mg No quantity limits apply
    Cardizem CD, Cardizem LA, Dilacor XR, Cartia xt, Diltia xt, diltiazem CD/CR/ER/XT 540 mg/ Once per day 120 mg Up to 30 tablets/capsules in 30 days
    Cardizem CD, Cardizem LA, Dilacor XR, Cartia xt, Diltia xt, diltiazem CD/CR/ER/XT 540 mg/ Once per day 180 mg Up to 90 tablets/capsules in 30 days
    Cardizem CD, Cardizem LA, Dilacor XR, Cartia xt, Diltia xt, diltiazem CD/CR/ER/XT 540 mg/ Once per day 240 mg, 300 mg, 360 mg, 420 mg No quantity limits
    Tiazac, Taztia xt, diltiazem extended release beads 540 mg/ Once per day 120 mg Up to 30 E.R. bead capsules in 30 days
    Tiazac, Taztia xt, diltiazem extended release beads 540 mg/ Once per day 180 mg Up to 90 ER bead capsules in 30 days
    Tiazac, Taztia xt, diltiazem extended release beads 540 mg/ Once per day 240 mg, 300 mg, 360 mg No quantity limits
    Tiazac 540 mg/ Once per day 420 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 these calcium channel blockers (non-dihydropyridines) will be considered medically necessary for those members who meet the following criteria:

    • 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 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, Calan, Calan SR, Cardizem, Cardizem CD, Covera HS, Dilacor XR, Isoptin SR, Tiazac and Veralan are subject to step-therapy.  Aetna considers Calan, Calan SR, Cardizem, Cardizem CD, Covera HS, Dilacor XR, Isoptin, Isoptin SR, Tiazac and Veralan to be medically necessary for those members who meet the following step-therapy criterion:

    A. A documented trial of one month of one of the corresponding generic alternative agents on the Aetna Medicare Preferred Drug List:

    • Calan - verapamil  
    • Calan SR, Covera HS, Isoptin SR, Verelan - verapamil CR/ER/SR
    • Cardizem - diltiazem
    • Cardizem CD, Dilacor XR - Cartia xt, Diltia xt, diltiazem CD/CR/ER/XT
    • Tiazac - diltiazem extended release beads, Taztia xt

    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. Calan, Calan SR, Cardizem, Cardizem CD, Covera HS, Dilacor XR, Isoptin SR, Tiazac and Verelan are currently Not Covered Part D drugs under the Aetna Medicare Prescription Drug Plan* and are on the Aetna Step-Therapy List.  Therefore, they are 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 these drugs to be medically necessary for those members who meet the criteria below:  

    A.  A documented:

    • Contraindication to one covered alternative non-dihydropyridine indicated for the member's condition OR
    • Intolerance to one covered alternative non-dihydropyridine indicated for the member's condition OR
    • Allergy to one covered alternative non-dihydropyridine indicated for the member's condition OR
    • Failure of an adequate trial of one month of one covered alternative non-dihydropyridine indicated for the member's condition

    Verelan PM is currently a Not Covered Part D drug under the Aetna Medicare Prescription Drug Plan.*  Therefore, it is excluded from coverage for members enrolled in prescription drug benefit plans that use a closed formulary, unless a medical exception is granted.  Aetna considers this medication to be medically necessary for those members who meet the criteria below:

    A.  A documented:

    • Contraindication to the covered generic verapamil SR/ER/CR OR
    • Intolerance to the covered generic verapamil SR/ER/CR OR
    • Allergy to the covered generic verapamil SR/ER/CR OR
    • Failure of an adequate trial of one month of the covered generic verapamil SR/ER/CR
* 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: 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; 2003.
  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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