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Pharmacy Clinical Policy Bulletins

Subject: Calcium Channel Blockers, Non-Dihydropyridines

Class Edit Summary*
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

*P = Preferred; FE = Formulary Excluded; NP = Nonpreferred PR = Precertification; QL = Quantity Limits; AL = Age Limits; ST = Step-Therapy ‡M EX = Medical Exception - This means the physician or health care professional must obtain a medical exception from Aetna, in order for the medication to be eligible for coverage. Medical Exception criteria apply to Formulary Excluded drugs for members enrolled in or covered by closed benefits plans, and also apply to Step-Therapy drugs in cases where a member's physician believes it is medically necessary for the member to use a step-therapy drug in the first instance without a trial of the prerequisite alternative drug(s).

Important Note

This Pharmacy Clinical Policy Bulletin expresses Aetna's determination of whether certain services or supplies are medically necessary. Aetna has reached these conclusions based upon a review of currently available clinical information (including clinical outcome studies in the peer-reviewed published medical literature, regulatory status of the technology, evidence-based guidelines of public health and health research agencies, evidence-based guidelines and positions of leading national health professional organizations, views of physicians practicing in relevant clinical areas, and other relevant factors). Aetna expressly reserves the right to revise these conclusions as clinical information changes, and welcomes further relevant information. Each benefits plan defines which services are covered, which are excluded, and which are subject to dollar caps or other limits. Members and their health care providers will need to consult the member's benefits plan to determine if there are any exclusions or other benefit limitations applicable to this service or supply. The conclusion that a particular service or supply is medically necessary does not constitute a representation or warranty that this service or supply is covered (that is, will be paid for by Aetna) for a particular member. The member's benefits plan determines coverage. Some plans exclude coverage for services or supplies that Aetna considers medically necessary. If there is a discrepancy between this policy and a member's plan of benefits, the benefits plan will govern. In addition, coverage may be mandated by applicable legal requirements of a state, the federal government or CMS for Medicare and Medicaid members. CMS's Coverage Issues Manual can be found on the following website: http://cms.hhs.gov/manuals/pub06pdf/pub06pdf.asp.

Policy

  1. Precertification Criteria

    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:

    • 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 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.

  2. Step-Therapy Criteria

    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 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 criteria:

    A documented trial of one month of one of the corresponding generic alternative agents - alternatives on the Preferred Drug List.

      Calan, Isoptin - 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)

  3. Medical Exception Criteria

    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:

    1. 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:

    1. 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

    2. Member is documented to be currently stabilized on Covera HS
*Information regarding Aetna's Preferred Drug List, Formulary Exclusions list, Precertification and Step-Therapy lists is available on our website. In addition, members should refer to their plan documents and may call the toll-free telephone number on their ID card for information regarding their benefits. Health care professionals also may obtain information by calling the Pharmacy Management Precertification Unit at 1-800-414-2386, or they can register to use our password-protected provider website. Visit www.aetna.com, select "Doctors & Hospitals" and choose "Physician Self-Service." Once registration is completed, health care professionals may use our online Precertification/medical exception email request form.

The lists above are subject to change. Not all programs - for example step-therapy, precertification, and quantity limits - are available in all service areas (for example, step-therapy does not apply to fully insured New Jersey members).

Many medications on the Preferred Drug List are subject to manufacturer rebate arrangements between Aetna and the manufacturer of those medications. If the member's prescription benefits plan has a deductible or copay levels based on a percentage of Aetna's contracted rate with the participating pharmacy, the contracted rate does not include or reflect any manufacturer rebate arrangements between Aetna and the medication manufacturer. In prescription plans with a deductible or copayment or coinsurance tiers, use of drugs from the Preferred Drug List generally will result in lower costs to members. However, where the prescription plan utilizes a deductible or copayments or coinsurance calculated on a percentage basis, there could be some circumstances in which a preferred drug would cost the member more than a nonpreferred drug because (1) the negotiated pharmacy payment rate for the preferred drug may be more than the negotiated pharmacy payment rate for the nonpreferred drug, and (2) rebates received by Aetna from drug manufacturers are not reflected in the cost of a prescription drug obtained by a member. The Preferred Drug List is subject to change.

In evaluating clinically and therapeutically similar drugs for selection for the Preferred Drug List, Aetna reviews the costs of drugs and takes into account rebates negotiated between Aetna and drug manufacturers. Consequently, a drug may be included on the Preferred Drug list that is more expensive than a nonpreferred alternative before any rebates Aetna may receive from a drug manufacturer are taken into account. In addition, certain drugs may be chosen for "preferred" status because of their clinical or therapeutic advantages or level of acceptance among physicians even though they cost more than nonpreferred alternatives. The net cost to a self-funded plan sponsor for covered prescriptions will vary based on (1) the terms of Aetna's arrangements with participating pharmacies; (2) the amount of the member's copayment, coinsurance or deductible obligation under the terms of the plan; and (3) the percentage, if any, of rebates to which the plan sponsor is entitled under its agreement with Aetna. As a result, a self-funded plan sponsor's actual claim expense per prescription for a particular preferred drug may in some circumstances be higher than for a nonpreferred alternative.

For members in Texas, additions to the 2006 Preferred Drug List will be effective no later than January 1, 2006. In accordance with state law, fully insured members in Texas who are receiving coverage for medications that are removed from the Preferred Drug List during the plan year will continue to have those medications covered at the same benefit level until their plan's renewal date.

This definition of precertification is not the same as the definition used by Texas law. Our use of the term "precertification" relates to the prior authorization of your services by Aetna, based on our decision of whether the service is medically necessary. Precertification is not a guarantee of payment or "verification" as defined by Texas law.

California HMO members enrolled in a closed formulary benefits plan who are receiving coverage for medications that are moved to the Formulary Exclusions List, and California HMO members who are receiving coverage for medications added to the Precertification or Step-Therapy lists, will continue to have those medications covered, for as long as the treating physician continues prescribing them. This coverage, in accordance with state law, is only provided when the drug is appropriately prescribed and is considered safe and effective for treating the member's medical condition.

Nothing in this section shall preclude the prescribing health care professional from prescribing another drug covered by the plan that is medically appropriate for the enrollee, nor shall anything in this section be construed to prohibit generic drug substitutions.

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, 2005.
  2. USPDI Drug Information for the HealthCare Professional (online through Stat!Ref). Thomson MICROMEDEX, Greenwood Village, Colorado; 2005.
  3. McEvoy GK, editor. AHFS Drug Information (online through Stat!Ref). American Society of 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.
  4. Gavras I et al. Drug therapy for hypertension. Am Fam Phys 1997; 55(5): 1823-1834.
  5. Neaton JD et al. Treatment of mild hypertension study: Final results. JAMA 1993; 270: 713-724.
  6. Freis ED & Papademetriou V. Current drug treatment and treatment patterns with antihypertensive drugs. Drugs 1996; 52(1): 1-16.
  7. Gifford RW. What's new in the treatment of hypertension. Cleveland Clin J Med 1997; 64: 143-150.
  8. 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.
  9. Conti CR. Re-examining the clinical safety and roles of calcium antagonists in cardiovascular medicine. Am J Cardiol. 1996;78(suppl A):13-18.
  10. Ferrari R. Prognosis of patients with unstable angina or acute myocardial infarction treated with calcium channel antagonists. Am J Cardiol 1996;77:22D-25D.
  11. Medical Economics, Inc., PDR Electronic Library. Thomson Medical Economics, Montvale, NJ; 2003.

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 1, 2006