Under some plans, including plans that use an open or closed formulary, Adalat CC, amlodipine, Cardene, Cardene SR, Dynacirc, Dynacirc CR, felodipine, isradipine, nicardipine, nifedical XL, nifedipine, nifedipine CR/ER, nimodipine, Nimotop, Norvasc, Plendil, Procardia, Procardia XL and Sular are subject to precertification. If precertification requirements apply Aetna considers Adalat CC, amlodipine, Cardene, Cardene SR, Dynacirc, Dynacirc CR, felodipine, isradipine, nicardipine, nifedical XL, nifedipine, nifedipine CR/ER, nimodipine, Nimotop, Norvasc, Plendil, Procardia, Procardia XL and Sular to be medically necessary for those members who meet any of the following precertification criteria:
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
nicardipine,
Cardene
40 mg Three times daily
20 mg
Up to 180 capsules in 30 days
nicardipine,
Cardene
40 mg Three times daily
30 mg
Up to 120 capsules in 30 days
Cardene SR
60 mg Twice daily
30 mg, 45 mg
Up to 60 capsules in 30 days
Cardene SR
60 mg Twice daily
60 mg
No quantity limits
isradipine,
Dynacirc
20mg/ day
2.5 mg, 5 mg
Up to 120 capsules in 30 days
Dynacirc CR
20mg/ day
5 mg
Up to 30 tablets in 30 days
Dynacirc CR
20mg/ day
10 mg
No quantity limits
nifedipine,
Procardia
30 mg Four times daily
10 mg
Up to 360 capsules in 30 days
Adalat CC nifedical XL, nifedipine CR/ER, Procardia XL
60 mg (two 30 mg capsules) every 4 hours for 21 consecutive days
30 mg
Up to 252 capsules in 21 days
amlodipine, Norvasc, Plendil, felodipine
10 mg/ Once daily
2.5 mg, 5 mg
Up to 30 tablets in 30 days
amlodipine, 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.
Step Therapy Criteria
Under some plans, including plans that use an open or closed formulary, Adalat CC, Cardene, Procardia and Procardia XL are subject to step-therapy. Aetna considers Adalat CC, Cardene, 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 the following covered generic alternatives: amlodipine, felodipine, isradipine, nicardipine, nifedical XL or nifedipine cr/er.
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.)
Medical Exception Criteria
Adalat CC, Cardene, 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:
A. Member has a documented:
Contraindication to one of the following covered generic alternatives: amlodipine, felodipine, isradipine, nicardipine, nifedical XL or nifedipine cr/er OR,
Intolerance to one of the following covered generic alternatives: amlodipine, felodipine, isradipine, nicardipine, nifedical XL or nifedipine cr/er OR,
Allergy to one of the following covered generic alternatives: amlodipine, felodipine, isradipine, nicardipine, nifedical XL or nifedipine cr/er OR,
Failure of an adequate trial of one month of one of the following covered generic alternatives: amlodipine, felodipine, isradipine, nicardipine, nifedical XL or nifedipine cr/er
Cardene SR, Dynacirc, Dynacirc CR, Plendil 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.
Place of Service:
Outpatient
The above policy is based on the following references:
Olin BR, editor. Drugs Facts and Comparisons (electronic online version). St. Louis: J.B. Lippincott Company, 2004.
USPDI Drug Information for the HealthCare Professional (online through Stat!Ref). Thomson MICROMEDEX, Greenwood Village, Colorado; 2004.
McEvoy GK, editor. AHFS Drug Information (online through Stat!Ref). American Society of Health-Systems Pharmacists, Bethesda, Maryland; 2004.
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.
Gavras I et al. Drug therapy for hypertension. Am Fam Phys 1997; 55(5): 1823-1834.
Neaton JD et al. Treatment of mild hypertension study: Final results. JAMA 1993; 270: 713-724.
Freis ED & Papademetriou V. Current drug treatment and treatment patterns with antihypertensive drugs. Drugs 1996; 52(1): 1-16.
Gifford RW. What's new in the treatment of hypertension. Cleveland Clin J Med 1997; 64(3): 143-150.
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.
Conti CR. Re-examining the clinical safety and roles of calcium antagonists in cardiovascular medicine. Am J Cardiol. 1996;78(suppl A):13-18.
Ferrari R. Prognosis of patients with unstable angina or acute myocardial infarction treated with calcium channel antagonists. Am J Cardiol 1996;77:22D-25D.
Medical Economics, Inc., PDR Electronic Library. Thomson Medical Economics, Montvale, NJ; 2004.
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.
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.
*C = Covered, copay amount depends on benefits plan
NC = Not Covered Part D drug
PR-B/D = Precertification review criteria to determine coverage as Part B or Part D
PR = Precertification
QL = Quantity Limits
AL = Age Limits
ST = Step-Therapy
‡M EX = Medical Exception
§TOC = Transition of Coverage
*The lists above are subject to change. Not all programs - for example step-therapy, precertification, and quantity limits - are available in all service areas.