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

Status Drug PR PR-QL PR-AL ST M EX‡
P Cartia xt® (diltiazem sr)   X      
P Diltia xt® (diltiazem sr)   X      
P diltiazem          
P diltiazem CD/CR/ER/XT   X      
P diltiazem extended-release beads SR   X      
P Taztia xt® (diltiazem er beads)   X      
P verapamil          
P verapamil CR/ER/SR   X      
P Cardizem LA®  (diltiazem sr)   X      
NP Calan®  (verapamil)       X X
NP Calan SR®  (verapamil cr)   X   X X
NP Cardizem®  (diltiazem)       X X
NP Cardizem CD®  (diltiazem sr)   X   X X
NP Dilacor XR®  (diltiazem sr)   X   X X
NP Isoptin®  (verapamil)       X X
NP Isoptin SR®  (verapamil cr)   X   X X
NP Tiazac®  (diltiazem er beads)   X   X X
NP Verelan®  (verapamil)   X   X X
NP Verelan PM®  (verapamil sr)   X      
FE Covera HS®  (verapamil sr)   X   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 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:

    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 60 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 er 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 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, Isoptin SR, Tiazac, and Verelan 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 criteria:

    A documented trial of one month of one of the corresponding generic alternative agents:

    For Calan, Isoptin - verapamil
    For Calan SR, Covera HS, Isoptin SR, Verelan - verapamil CR/ER/SR
    For Cardizem -  diltiazem
    For Cardizem CD, Dilacor XR - Cartia xt, Diltia xt, diltiazem CD/CR/ER/XT.
    For 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, Dilacor XR, Isoptin, Isoptin SR, Tiazac, and Verelan 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:  

    A. A documented:

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

    Covera HS is currently listed on the Aetna Formulary Exclusions and Step-Therapy lists.* 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 this medication to be medically necessary for those members who meet the criteria below:

    A.  A documented:

    • Contraindication to the preferred generic verapamil SR/ER/CR OR
    • Intolerance to the preferred generic verapamil SR/ER/CR OR
    • Allergy to the preferred generic verapamil SR/ER/CR OR
    • Failure of an adequate trial of one month for hypertension or one week for angina or arrhythmia of the preferred generic verapamil SR/ER/CR.

    OR

    B.  Member is documented to be currently stabilized on Covera HS


Place of Service:

Outpatient

The above policy is based on the following references:
  1. Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. 2006.
  2. USP DI® Drug Information For The Health Care Professional - 26th Ed. (online from www.statref.com) Thomson Micromedex, Greenwood Village, CO. 2006 .
  3. AHFS Drug Information® with AHFSfirstReleases®. (online from www.statref.com), American Society Of Health-System Pharmacists®, Bethesda, MD. 2006.
  4. DRUGDEX® System: Klasco RK (Ed):DRUGDEX® System. Online edition. Thomson Micromedex, Greenwood Village, CO.
  5. PDR® Electronic Library, Thomson Micromedex, Greenwood Village, Colorado (Edition expires 2006).
  6. Gifford RW. What's new in the treatment of hypertension. Cleveland Clin J Med 1997; 64: 143-150.
  7. 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.
  8. Conti CR. Re-examining the clinical safety and roles of calcium antagonists in cardiovascular medicine. Am J Cardiol. 1996;78(suppl A):13-18.
  9. Ferrari R. Prognosis of patients with unstable angina or acute myocardial infarction treated with calcium channel antagonists. Am J Cardiol 1996;77:22D-25D.
  10. Chobanian AV, Bakris GL, Black HR, Cushman WC, Green LA, Izzo JL Jr, Jones DW, Materson BJ, Oparil S, Wright JT Jr, Roccella EJ. Seventh report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. Hypertension 2003 Dec;42(6):1206-52.
  11. Basile J. The role of existing and newer calcium channel blockers in the treatment of hypertension. J Clin Hypertens. 2004;6(11): 621-9.
  12. Israili ZH. The use of calcium antagonists in the therapy of hypertension in the elderly. Am J Ther. 2003;10(6):383-95.

 

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.

January 01, 2007
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