Cognex, Razadyne, Razadyne ER (was Reminyl) and Hydergine 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 benefit plans that use a closed formulary, unless a medical exception is granted. Aetna considers Cognex, Razadyne, Razadyne ER (was Reminyl) and Hydergine to be medically necessary for those members who meet ANY of the following criteria:
A. A documented:
Contraindication to two covered alternatives indicated for Alzheimer's Disease or dementia OR
Intolerance to two covered alternatives indicated for Alzheimer's Disease or dementia OR
Allergy to two covered alternatives indicated for Alzheimer's Disease or dementia OR
Failure of an adequate trial of three months each of two covered alternatives indicated for Alzheimer's Disease or dementia
OR
For Cognex, Razadyne and Razadyne ER (was Reminyl),
B. Transition of Coverage:
Member is within 90 days of his or her effective date of enrollment
Member is stable on Cognex or Razadyne, Razadyne ER for 30 days or longer
If applicable, quantity limits, age or gender edits will apply. Approval is valid one year from the date of request.
If the member has been a Medicare member for 91 days or longer and is not residing in a LTC facility then standard precertification, step-therapy, or medical exception criteria will apply.
* 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:
Small GW et al. Diagnosis and treatment of Alzheimer's disease and related disorders. Consensus statement of the American Association for Geriatric Psychiatry, the Alzheimer's Association, and the American Geriatrics Society. JAMA 1997; 278: 1363-1371.
Tariot PN et al. Treating Alzheimer's disease: Pharmacologic options now and in the near future. Postgrad Med 1997; 101: 73-90.
Farlow M et al. A controlled trial of tacrine in Alzheimer's disease. JAMA 1992; 268: 2523-2529.
Knapp MJ et al. A 30-week randomized controlled trial of high-dose tacrine in patients with Alzheimer's disease. JAMA 1994; 271: 985-991.
Crimson ML. Tacrine: First drug approved for Alzheimer's disease. Ann Pharmacother 1994; 28: 744-751.
Davis KL & Powchik P. Tacrine. Lancet 1995; 345: 625-630.
Farlow MR et al. Treatment outcome of tacrine therapy depends on apolipoprotein genotype and gender of the subjects with Alzheimer's disease. Neurology 1998; 50: 669-677.
Knopman D et al. Long-term tacrine (Cognex) treatment: Effects on nursing home placement and mortality. Neurology 1996; 47: 166-177.
Barner EL & Gray SL. Donepezil use in Alzheimer's disease. Ann Pharmacol 1998; 32(1): 70-77.
RogersSL et al. The efficacy and safety of donepezil in patients with Alzheimer's disease: results of aUSmulticenter, randomized, double-blind, placebo-controlled trial. Dementia 1996; 7: 293-303.
Rogers SL & Friedhoff LT. Long-term efficacy and safety of donepezil in the treatment of Alzheimer's disease: An interim analysis of the results of aUSmulticenter open label extension study. Eur Neuropsychopharmacol 1998; 8: 67-75.
Rogers SL et al. Donepezil improves cognition and global function in Alzheimer's disease. Arch Intern Med 1998; 158: 1021-1031.
Parys W. Development of Reminyl (galantamine), a novel acetylcholinesterase inhibitor, for the treatment of Alzheimer's disease. Alzheimer's Reports 1998; 1(Suppl 1):S19-S20.
Raskind M, Peskind ER, Wessel T, Yuan W, and the Galantamine USA-1 Study Group. Galantamine in AD. A 6-month randomized, placebo-conrolled trial with a 6-month extension. Neurology 2000;54:2261-8.
Tariot PN, Solomon, PR, Morris JC, et al. A 5-month, randomized, placebo-controlled trial of galantamine in AD. Neurology 2000;54:2269-2276.
Wilcock GK, Lilienfeld S, Gaens E. Efficacy and safety of galantamine in patients with mild to moderate Alzheimer’s disease: multicenter randomized controlled trial. BMJ. 2000;321:1-7.
Olin J, Schneider L. Galantamine for alzheimer’s disease. Cochrane Database Syst Rev. 2002;(3):CD001747.
Pearson VE. Galantamine: A new Alzheimer drug with a past life. Ann Pharmacother 2001;35:1406-13.
Jann MW, Shirley KL, Small GW. Clinical pharmacokinetics and pharmacodynamics of cholinesterase inhibitors. Clin Pharmacokinet. 2002;41(10):719-39.
Erkinjuntti T, Kurz A, Gauthier S, et al. Efficacy of galantamine in probable vascular dementia and Alzheimer’s disease combined with cerebrovascular disease: a randomized trial. Lancet 2002;359:1283-90;1265.
Cummings JL. Use of cholinesterase inhibitors in clinical practice: evidence-based recommendations. Am J Geriatr Psychiatry. 2003;11(2):131-45.
Scarpini E, Scheltens P, Feldman H. Treatment of Alzheimer’s disease: current status and new perspectives. Lancet Neurol. 2003;2(9):539-47.
Zarotsky V, Sramek JJ, Cutler NR. Galantamine hydrobromide: An agent for Alzheimer’s disease. Am J Health-Syst Pharm. 2003;60:446-52.
KawasCH.Early Alzheimer’s disease. N Engl J Med. 2003;349:1056-63.
Grossberg GT. Diagnosis and treatment of Alzheimer’s disease. J Clin Psychiatry. 2003;64[suppl 9]:3-6.
Doody RS. Current treatments for Alzheimer’s disease: Cholinesterase inhibitors. J Clin Psychiatry. 2003;64[suppl 9]:11-7.
McKeith I, Mintzer J, Aarsland D, et al. Dementia with Lewy bodies. Lancet Neurol. 2004;3(1):19-28.
Jones RW, Soininen H, Hager K, et al. A multinational, randomized, 12-week study comparing the effects of donepezil and galantamine in patients with mild to moderate Alzheimer’s disease. Int J Geriatr Psychiatry. 2004;19(1):58-67.
Birks JS, Harvey R. Donepezil for dementia due to Alzheimer’s disease (Cochrane Review). In: The Cochrane Library, Issue 1, 2004.Chichester,UK: John Wiley & Sons, Ltd.
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,BiermanAS, 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.
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