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Pharmacy Clinical Policy Bulletins
Aetna Medicare Prescription Drug Plan
Subject: GI Antispasmotic Agents

Status Drug PR-B/D PR PR-QL PR-AL ST M EX‡ TOC§
C Atreza™ (atropine sulfate)       X      
C belladonna alkaloids and opium suppositories       X      
C dicyclomine              
C Dispas™ hyoscyamine sulfate       X      
C glycopyrrolate              
C hyoscyamine sulfate (immediate-release formulations ONLY)       X      
C methscopolamine              
C propantheline bromide       X      
C Symax SL® (hyoscyamine sulfate)       X      
NC Anaspaz®  (hyoscyamine sulfate)       X   X  
NC B&O supp supprett®  (belladonna alkaloids and opium suppositories)       X   X  
NC Bentyl®  (dicyclomine)           X  
NC Cantil®  (mepensolate)           X  
NC Colytrol®  (hyoscyamine sulfate)       X   X  
NC Levsin®, Levsin SL®  (hyoscyamine sulfate)       X   X  
NC Marspas®  (hyoscyamine sulfate)       X   X  
NC NuLev®  (hyoscyamine sulfate)       X   X  
NC Pamine®, Pamine Forte®  (methscopolamine)           X  
NC Quarzan®  (clidinium br)           X  
NC Robinul®, Robinul Forte®  (glycopyrrolate)           X  
NC Sal-Tropine®  (atropine sulfate)       X   X  


Policy:

  1. Precertification Criteria
  2. Under some plans, including plans that use an open or closed formulary, Anaspaz, Atreza, B&O,  belladonna alkaloids and opium suppositories, Colytrol, Dispas, hyoscyamine sulfate,  Levsin, Levsin SL, Marspas, NuLev, propantheline bromide, Sal-Tropine and Symax SL are subject to precertification for members greater than or equal to 65 years of age.  Aetna considers Anaspaz, Atreza, B&O, belladonna alkaloids and opium suppositories, Colytrol, Dispas, hyoscyamine sulfate, Levsin, Levsin SL, Marspas, NuLev, propantheline bromide, Sal-Tropine and Symax SL 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

  3. Medical Exception Criteria
  4. Anaspaz, B&O supprettes, Bentyl, Cantil, Colytrol, Levsin/Levsin SL, Marspas, NuLev, Pamine, Quarzan, Robinul/Robinul Forte and Sal-Tropine 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 benefits plans that use a closed formulary, unless a medical exception is granted.  Aetna considers Anaspaz, B&O supprettes, Bentyl, Cantil, Colytrol,  Levsin/Levsin SL, Marspas, NuLev, Pamine, Quarzan, Robinul/Robinul Forte and Sal-Tropine to be medically necessary for those members who meet any of the following criteria: 

    A.  A documented:

    • Contraindication to one preferred generic alternative agent indicated for the member's condition OR
    • Intolerance to one preferred generic alternative agent indicated for the member's condition OR
    • Allergy to one preferred generic alternative agent indicated for the member's condition OR
    • Failure of an adequate trial of one month of one preferred generic alternative agent indicated for the member's condition

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, 2004.
  2. USPDI Drug Information for the HealthCare Professional (online through Stat!Ref). Thomson MICROMEDEX, Greenwood Village, Colorado; 2004.
  3. McEvoy GK, editor. AHFS Drug Information (online through Stat!Ref). American Society of Health-Systems Pharmacists, Bethesda, Maryland; 2004.
  4. Medical Economics, Inc., PDR Electronic Library. Thomson Medical Economics, Montvale, NJ; 2003.
  5. 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.
  6. 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.

January 01, 2007
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