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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     X        
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     X        
C verapamil CR/ER/SR     X        
NC Calan®  (verapamil)     X   X X  
NC Calan SR®  (verapamil cr)     X   X X  
NC Cardizem®  (diltiazem)     X   X X  
NC Cardizem CD®  (diltiazem sr)     X   X X  
NC Cardizem LA®  (diltiazem sr)     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, Calan SR, Cardizem, Cardizem CD, Cardizem LA, cartia xt, Covera HS, Dilacor XR, diltia xt, diltiazem, diltiazem CD/CR/ER/XT, diltiazem SR, diltiazem extended release beads SR, Isoptin SR, taztia xt, Tiazac, verapamil, 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, verapamil 480 mg/ in divided doses daily 40 mg, 80 mg, 120 mg Up to 120 tablets in 30 days
    Calan SR, Covera HS, Isoptin SR, Verelan, verapamil CR/ER/SR 480 mg/ Once per day 120 mg Up to 30 tablets/capsules in 30 days
    Calan SR, 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, verapamil ER 480 mg/ Once per day 100 mg Up to 30 capsules in 30 days
    Verelan PM, verapamil ER 480 mg/ Once per day 200 mg Up to 60 capsules in 30 days
    Verelan PM, verapamil ER 480 mg/ Once per day 300 mg No quantity limits apply
    Cardizem, diltiazem 360mg/ in divided doses daily 30 mg, 60 mg, 90 mg Up to 120 tablets in 30 days
    Cardizem, diltiazem 360mg/ in divided doses daily 120 mg Up to 90 tablets in 30 days
    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
    Diltzac, Tiazac, Taztia xt, diltiazem extended release beads 540 mg/ Once per day 120 mg Up to 30 E.R. bead capsules in 30 days
    Diltzac, Tiazac, Taztia xt, diltiazem extended release beads 540 mg/ Once per day 180 mg Up to 90 ER bead capsules in 30 days
    Diltzac, 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 requires a dose including half tablets and cumulative daily dose falls within maximum daily dose limits OR
    • Member's dose is being titrated by physician and cumulative daily dose falls within maximum daily dose limits  (3-month limit) OR
    • Member has not tolerated the drug administered at the recommended dosing interval and requires more frequent dosing to achieve the same cumulative 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.


  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, 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, Cardizem LA, 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:  

    For Calan

    A.  A documented:

    • Contraindication to the preferred generic alternative verapamil OR
    • Intolerance to the preferred generic alternative verapamil OR
    • Allergy to the preferred generic alternative verapamil OR
    • Failure of an adequate trial of one month of the preferred generic alternative verapamil

    For Calan SR, Covera HS, Isoptin SR and Verelan

    A.  A documented:

    • Contraindication to the preferred generic alternative verapamil CR/ER/SR OR
    • Intolerance to the preferred generic alternative verapamil CR/ER/SR OR
    • Allergy to the preferred generic alternative verapamil CR/ER/SR OR
    • Failure of an adequate trial of one month of the preferred generic alternative verapamil CR/ER/SR

    For Cardizem

    A.  A documented:

    • Contraindication to the preferred generic alternative diltiazem OR
    • Intolerance to the preferred generic alternative diltiazem OR
    • Allergy to the preferred generic alternative diltiazem OR
    • Failure of an adequate trial of one month of the preferred generic alternative diltiazem

    For Cardizem CD and Dilacor XR

    A.  A documented:

    • Contraindication to one of the following preferred generic alternatives: cartia xt, diltia xt or diltiazem CD/CR/ER/XT OR
    • Intolerance to one of the following preferred generic alternatives: cartia xt, diltia xt or diltiazem CD/CR/ER/XT OR
    • Allergy to one of the following preferred generic alternatives: cartia xt, diltia xt or diltiazem CD/CR/ER/XT OR
    • Failure of an adequate trial of one month of one of the following preferred generic alternatives: cartia xt, diltia xt or diltiazem CD/CR/ER/XT

    For Tiazac

    A.  A documented:

    • Contraindication to one of the following preferred generic alternatives: diltiazem extended release beads or taztia xt OR
    • Intolerance to one of the following preferred generic alternatives: diltiazem extended release beads or taztia xt OR
    • Allergy to one of the following preferred generic alternatives: diltiazem extended release beads or taztia xt OR
    • Failure of an adequate trial of one month of one of the following preferred generic alternatives: diltiazem extended release beads or taztia xt

    Cardizem LA and Verelan PM 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 this medication to be medically necessary for those members who meet the criteria below:

    For Cardizem LA

    A.  A documented:

    • Contraindication to one of the following preferred generic alternatives: cartia xt, diltia xt or diltiazem CD/CR/ER/XT OR
    • Intolerance to one of the following preferred generic alternatives: cartia xt, diltia xt or diltiazem CD/CR/ER/XT OR
    • Allergy to one of the following preferred generic alternatives: cartia xt, diltia xt or diltiazem CD/CR/ER/XT OR
    • Failure of an adequate trial of one month of one of the following preferred generic alternatives: cartia xt, diltia xt or diltiazem CD/CR/ER/XT


    For Verelan PM

    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 of the preferred generic verapamil SR/ER/CR.

Place of Service:

Outpatient

The above policy is based on the following references:

1. DrugPoints® System ( www.statref.com) Thomson Micromedex, Greenwood Village, CO. Updated periodically.
2. AHFS Drug Information® with AHFSfirstReleases®. ( www.statref.com), American Society Of Health-System Pharmacists®, Bethesda, MD. Updated periodically.
3. DRUGDEX® System [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically.
4. Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. Updated periodically.
5. PDR® Electronic Library™ [Internet database]. Greenwood Village, Colo: Thomson Micromedex. Updated periodically.
6. Clinical Pharmacology [Internet database]. Gold Standard Inc. Tampa, FL. Updated periodically.
7. 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.
8. 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.

January 01, 2009
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