Under some plans, including plans that use an open or closed formulary, Amrix,carisoprodol, carisoprodol/aspirin, carisoprodol/aspirin/codeine, chlorzoxazone, cyclobenzaprine, Cyclobenzaprine Comfort Kit, Fexmid, Flexeril, methocarbamol, methocarbamol/aspirin, Norflex, orphenadrine, orphenadrine/aspirin/caffeine, Parafon Forte, Robaxin, Skelaxin, Soma, Soma Compound and Soma Compound/codeine are subject to precertification for members greater than or equal to 65 years of age. Aetna considers Amrix, carisoprodol, carisoprodol/aspirin, carisoprodol/aspirin/codeine, chlorzoxazone, cyclobenzaprine, Cyclobenzaprine Comfort Kit, Fexmid, Flexeril, methocarbamol, methocarbamol/aspirin, Norflex, orphenadrine, orphenadrine/aspirin/caffeine, Parafon Forte, Robaxin, Skelaxin, Soma, Soma Compound and Soma Compound/codeine to be medically necessary for those members who meet the following precertification criteria:
A. Age limit:
A. Member has tried and failed alternative drugs that are appropriate in the elderly to treat the condition. OR
B. 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
C. 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, Cyclobenzaprine Comfort Kit is subject to step-therapy. Aetna considers Cyclobenzaprine Comfort Kit to be medically necessary for those members who meet the following step-therapy criteria:
A documented trial of one month of the covered generic alternative cyclobenzaprine.
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
Amrix, Cyclobenzaprine Comfort Kit, Dantrium, Fexmid, Flexeril, Norflex, Parafon Forte, Robaxin, Skelaxin, Soma, Soma Compound, Soma Compound w/ codeine and Zanaflex 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 Amrix, Cyclobenzaprine Comfort Kit, Dantrium, Equagesic, Fexmid, Flexeril, Norflex, Parafon Forte, Robaxin, Skelaxin, Soma, Soma Compound, Soma Compound w/ codeine, and Zanaflex to be medically necessary for those members who meet the following criteria:
For Amrix, Dantrium, Fexmid, Flexeril, Norflex, Parafon Forte, Robaxin, Skelaxin, Soma, Soma Compound, Soma Compound w/ codeine and Zanaflex
A. A documented:
Contraindication to one covered alternative indicated for the member's condition OR
Intolerance to one covered alternative indicated for the member's condition OR
Allergy to one covered alternative indicated for the member's condition class OR
Failure of an adequate trial of one month each of one covered alternative indicated for the member's condition.
For Cyclobenzaprine Comfort Kit
A. A documented:
Contraindication to the covered generic alternative cyclobenzaprine OR
Intolerance to the covered generic alternative cyclobenzaprine OR
Allergy to the covered generic alternative cyclobenzaprine OR
Failure of an adequate trial of one month of the covered generic alternative cyclobenzaprine
Place of Service:
Outpatient
The above policy is based on the following references:
Ward A, Chaffman MO & Sorkin EM: Dantrolene: a review of its pharmacodynamic and pharmacokinetic properties and therapeutic use in malignant hyperthermia, the neuroleptic malignant syndrome and an update of its use in muscle spasticity. Drugs 1986; 32: 130-168.
Van Tulder MW, Touray T, et al: Muscle relaxants for non-specific low back pain. Cochrane Database Syst Rev.2003;(2): CD004252.
Borenstein DG,Korn S: Efficacy of a low-dose regimen of cyclobenzaprine hydrochloride in acute skeletal muscle spasm: results of two placebo-controlled trials. Clin Ther.2003 Apr;25(4):1056-73.
Turturro MA, Frater CR, D’Amico JF: Cyclobenzaprine with ibuprofen versus ibuprofen alone in acute myofacial strain: a randomized, double-blind clinical trial. Ann Emerg Med. 2003 Jun;41(6):818-26.
Hoogstraten MC, et al.Tizanidine versus baclofen in the treatment of spasticity in multiple sclerosis patients. Acta Neurol Scand 1998;77:224-30.
Meythaler JM, Guin-Renfroe S, Johnson A, Brunner RM: Propective assessment of tizanidine for spasticity due to acquired brain injury. Arch Phys Med Rehabil. 2001 Sep; 82(9):1155-63.
Tofferi JK, Jackson Jl, O’Malley PG: Treatment of fibromyalgia with cyclobenzaprine: A meta-analysis. Arthritis Rheum. 2004 Feb 15;51(1):9-13.
Zanaflex, Product Information. Elan Pharmaceuticals. 1996.
Baclofen, Product Information. Mylan Pharmaceuticals. May 1998.
Methocarbamol, Product Information. Geneva Pharmaceuticals. November 1999.
Carisoprodol, Product Information. Mutual Pharmaceutical. August 2000.
Cyclobenzaprine, Product Information. Danbury Pharmaceutical. February 2000.
Baclofen, Product Information. Zenith Pharmaceuticals. May 2000.
Orphenadrine, Aspirin, Caffeine, Product Information. Eon Labs. September 2001.
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.
Medical Economics, Inc., PDR Electronic Library. Thomson Medical Economics, Montvale, NJ; 2003.
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.
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