Amrix, Dantrium , Equagesic, Fexmid, Prazolamine Pak, Therabenzaprine Pak and Zanaflex are currently listed on the Aetna Formulary Exclusions List.* Therefore, Amrix, Dantrium, Equagesic, Fexmid, Prazolamine Pak, Therabenzaprine Pak and Zanaflex 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, Dantrium, Equagesic, Fexmid, Prazolamine Pak, Therabenzaprine Pak and Zanaflex to be medically necessary for those members who meet ANY of the following criteria:
For Dantrium, Equagesic and Zanaflex:
A. A documented:
Contraindication to two preferred alternatives indicated for the member's condition OR
Intolerance to two preferred alternatives indicated for the member's condition OR
Allergy to two preferred alternatives indicated for the member's condition class OR
Failure of an adequate trial of one month each of two preferred alternatives indicated for the member's condition
For Prazolamine Pak, Therabenzaprine Pak
A. A documented:
Contraindication to two preferred alternatives (one of which should be carisoprodol) indicated for the member's condition OR
Intolerance to two preferred alternatives (one of which should be carisoprodol) indicated for the member's condition OR
Allergy to two preferred alternatives (one of which should be carisoprodol) indicated for the member's condition class OR
Failure of an adequate trial of one month each of two preferred alternatives (one of which should be carisoprodol) indicated for the member's condition
For Amrix, Fexmid
A. A documented:
Contraindication to two preferred alternatives (one of which should be cyclobenzaprine) indicated for the member's condition OR
Intolerance to two preferred alternatives (one of which should be cyclobenzaprine) indicated for the member's condition OR
Allergy to two preferred alternatives (one of which should be cyclobenzaprine) indicated for the member's condition class OR
Failure of an adequate trial of one month each of two preferred alternatives (one of which should be cyclobenzaprine) indicated for the member's condition
Place of Service:
Outpatient
The above policy is based on the following references:
Drug Facts and Comparisons on-line. (www.drugfacts.com), Wolters Kluwer Health, St. Louis, MO. 2006.
USP DI® Drug Information For The Health Care Professional - 26th Ed. (online from www.statref.com) Thomson Micromedex, Greenwood Village, CO. 2006.
AHFS Drug Information® with AHFSfirstReleases®. (online from www.statref.com), American Society Of Health-System Pharmacists®, Bethesda, MD. 2006.
Taricco M, Adone R, Pagliacci C, Telaro E. Pharmacological interventions for spasticity following spinal cord injury. Cochrane Database Syst Rev. 2000;(2):CD001131.
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;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;41(6):818-26.
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; 82(9):1155-63.
Tofferi JK, Jackson Jl, O’Malley PG: Treatment of fibromyalgia with cyclobenzaprine: A meta-analysis. Arthritis Rheum. 2004;51(1):9-13.
Schnitzer TJ, Ferraro A, Hunsche E, Kong SX. A comprehensive review of clinical trials on the efficacy and safety of drugs for the treatment of low back pain. J Pain Symptom Manage. 2004;28(1):72-95.
Chou R, Peterson K, Helfand M. Comparative efficacy and safety of skeletal muscle relaxants for spasticity and musculoskeletal conditions: a systematic review. J Pain Symptom Manage. 2004;28(2):140-75.
Beebe FA, Barkin RL, Barkin S. A clinical and pharmacologic review of skeletal muscle relaxants for musculoskeletal conditions. Am J Ther. 2005;12(2):151-71.
Taricco M, Pagliacci MC, Telaro E, Adone R. Pharmacological interventions for spasticity following spinal cord injury: results of a Cochrane systematic review. Eura Medicophys. 2006;42(1):5-15.
Product Information Amrix® ECR Pharmaceuticals July 2006.
Copyright 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.
*P = Preferred
FE = Formulary Excluded
NP = Nonpreferred
PR = Precertification
QL = Quantity Limits
AL = Age Limits
ST = Step-Therapy
‡M EX = Medical Exception
*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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